Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2026-01-03 @ 1:21 PM
Study NCT ID:
NCT03207867
Status:
TERMINATED
Last Update Posted:
2024-10-09
First Post:
2017-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D013132', 'term': 'Spinocerebellar Degenerations'}, {'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}, {'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D002526', 'term': 'Cerebellar Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000711728', 'term': 'spartalizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. Novartis does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'On-treatment and post-treatment safety follow-up: from first dose of study treatment to 150 days after last dose of NIR178+PDR001, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (Japan safety run-in; JSR). Deaths in survival period: from 151 days after last dose of NIR178+PDR001 until end of study, up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR).', 'description': 'Deaths in the survival period are not considered Adverse Events (AEs). No AEs were collected in the survival period.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1: RCC naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy. Safety data up to 150 days after last dose of NIR178+PDR001', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 10, 'seriousNumAtRisk': 11, 'deathsNumAffected': 4, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Part 1: RCC naïve + Pre 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC), naïve and pretreated with immuno-oncology therapy. Safety data up to 150 days after last dose of NIR178+PDR001', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 22, 'seriousNumAtRisk': 23, 'deathsNumAffected': 6, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Part 1: Pancreatic 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer. Safety data up to 150 days after last dose of NIR178+PDR001', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 14, 'seriousNumAtRisk': 14, 'deathsNumAffected': 10, 'seriousNumAffected': 9}, {'id': 'EG003', 'title': 'Part 1: Urothelial 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer. Safety data up to 150 days after last dose of NIR178+PDR001', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 14, 'seriousNumAtRisk': 14, 'deathsNumAffected': 6, 'seriousNumAffected': 7}, {'id': 'EG004', 'title': 'Part 1: H-N naïve + Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC), naïve and pretreated with immuno-oncology therapy. Safety data up to 150 days after last dose of NIR178+PDR001', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 25, 'seriousNumAtRisk': 26, 'deathsNumAffected': 8, 'seriousNumAffected': 16}, {'id': 'EG005', 'title': 'Part 1: H-N Pre 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy. Safety data up to 150 days after last dose of NIR178+PDR001', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 4, 'seriousNumAffected': 5}, {'id': 'EG006', 'title': 'Part 1: MSS CRC 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) and RAS wildtype, RAS mutant and RAS unknown status. Safety data up to 150 days after last dose of NIR178+PDR001', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 52, 'seriousNumAtRisk': 58, 'deathsNumAffected': 22, 'seriousNumAffected': 28}, {'id': 'EG007', 'title': 'Part 1: TNBC 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC). Safety data up to 150 days after last dose of NIR178+PDR001', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 29, 'seriousNumAtRisk': 30, 'deathsNumAffected': 9, 'seriousNumAffected': 14}, {'id': 'EG008', 'title': 'Part 1: Melanoma naïve + Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma, naïve and pretreated with immuno-oncology therapy. Safety data up to 150 days after last dose of NIR178+PDR001', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 14, 'seriousNumAtRisk': 16, 'deathsNumAffected': 7, 'seriousNumAffected': 4}, {'id': 'EG009', 'title': 'Part 1: DLBCL 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL). Safety data up to 150 days after last dose of NIR178+PDR001', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 13, 'seriousNumAtRisk': 13, 'deathsNumAffected': 9, 'seriousNumAffected': 7}, {'id': 'EG010', 'title': 'Part 1: DLBCL 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL). Safety data up to 150 days after last dose of NIR178+PDR001', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'Part 1: mCRPC 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC). Safety data up to 150 days after last dose of NIR178+PDR001', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 14, 'seriousNumAtRisk': 15, 'deathsNumAffected': 2, 'seriousNumAffected': 5}, {'id': 'EG012', 'title': 'Part 2: NSCLC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with non-small cell lung cancer (NSCLC). Safety data up to 150 days after last dose of NIR178+PDR001', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 22, 'seriousNumAtRisk': 22, 'deathsNumAffected': 6, 'seriousNumAffected': 11}, {'id': 'EG013', 'title': 'Part 2: NSCLC 160 mg 2wk-on/2wk-off', 'description': 'NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC). Safety data up to 150 days after last dose of NIR178+PDR001', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 16, 'seriousNumAtRisk': 20, 'deathsNumAffected': 4, 'seriousNumAffected': 9}, {'id': 'EG014', 'title': 'Part 2: NSCLC 160 mg 1wk-on/1wk-off', 'description': 'NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC). Safety data up to 150 days after last dose of NIR178+PDR001', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 17, 'seriousNumAtRisk': 20, 'deathsNumAffected': 6, 'seriousNumAffected': 7}, {'id': 'EG015', 'title': 'Part 3: TNBC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC). Safety data up to 150 days after last dose of NIR178+PDR001', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 4, 'seriousNumAffected': 3}, {'id': 'EG016', 'title': 'JSR: 80 mg Cont', 'description': 'NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in. Safety data up to 150 days after last dose of NIR178+PDR001', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG017', 'title': 'JSR: 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in. Safety data up to 150 days after last dose of NIR178+PDR001', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG018', 'title': 'JSR: 240 mg Cont', 'description': 'NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in. Safety data up to 150 days after last dose of NIR178+PDR001', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG019', 'title': 'Part 1: RCC naïve 160 mg_Survival Period', 'description': 'Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 3, 'seriousNumAffected': 0}, {'id': 'EG020', 'title': 'Part 1: RCC naïve + Pre 240 mg_Survival Period', 'description': 'Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 7, 'seriousNumAffected': 0}, {'id': 'EG021', 'title': 'Part 1: Pancreatic 160 mg_Survival Period', 'description': 'Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 3, 'seriousNumAffected': 0}, {'id': 'EG022', 'title': 'Part 1: Urothelial 160 mg_Survival Period', 'description': 'Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 4, 'seriousNumAffected': 0}, {'id': 'EG023', 'title': 'Part 1: H-N naïve + Pre 160 mg_Survival Period', 'description': 'Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 12, 'seriousNumAffected': 0}, {'id': 'EG024', 'title': 'Part 1: H-N Pre 240 mg_Survival Period', 'description': 'Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 4, 'seriousNumAffected': 0}, {'id': 'EG025', 'title': 'Part 1: MSS CRC 160 mg_Survival Period', 'description': 'Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 36, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 22, 'seriousNumAffected': 0}, {'id': 'EG026', 'title': 'Part 1: TNBC 160 mg_Survival Period', 'description': 'Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 12, 'seriousNumAffected': 0}, {'id': 'EG027', 'title': 'Part 1: Melanoma naïve + Pre 160 mg_Survival Period', 'description': 'Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 8, 'seriousNumAffected': 0}, {'id': 'EG028', 'title': 'Part 1: DLBCL 160 mg_Survival Period', 'description': 'Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG029', 'title': 'Part 1: DLBCL 240 mg_Survival Period', 'description': 'Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 3, 'seriousNumAffected': 0}, {'id': 'EG030', 'title': 'Part 1: mCRPC 240 mg_Survival Period', 'description': 'Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 7, 'seriousNumAffected': 0}, {'id': 'EG031', 'title': 'Part 2: NSCLC 160 mg cont_Survival Period', 'description': 'Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 8, 'seriousNumAffected': 0}, {'id': 'EG032', 'title': 'Part 2: NSCLC 160 mg 2wk-on/2wk-off_Survival Period', 'description': 'Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 9, 'seriousNumAffected': 0}, {'id': 'EG033', 'title': 'Part 2: NSCLC 160 mg 1wk-on/1wk-off_Survival Period', 'description': 'Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 7, 'seriousNumAffected': 0}, {'id': 'EG034', 'title': 'Part 3: TNBC 160 mg cont_Survival Period', 'description': 'Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG035', 'title': 'JSR: 80 mg cont_Survival Period', 'description': 'Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG036', 'title': 'JSR: 160 mg cont_Survival Period', 'description': 'Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG037', 'title': 'JSR: 240 mg cont_Survival Period', 'description': 'Deaths collected in the survival follow-up period (starting from Day 151 after last dose of NIR178+PDR001). No AEs were collected during this period.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 58, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 30, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG014', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG015', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 0}, {'groupId': 'EG020', 'numAtRisk': 0}, {'groupId': 'EG021', 'numAtRisk': 0}, {'groupId': 'EG022', 'numAtRisk': 0}, {'groupId': 'EG023', 'numAtRisk': 0}, {'groupId': 'EG024', 'numAtRisk': 0}, {'groupId': 'EG025', 'numAtRisk': 0}, {'groupId': 'EG026', 'numAtRisk': 0}, {'groupId': 'EG027', 'numAtRisk': 0}, {'groupId': 'EG028', 'numAtRisk': 0}, {'groupId': 'EG029', 'numAtRisk': 0}, {'groupId': 'EG030', 'numAtRisk': 0}, {'groupId': 'EG031', 'numAtRisk': 0}, {'groupId': 'EG032', 'numAtRisk': 0}, {'groupId': 'EG033', 'numAtRisk': 0}, {'groupId': 'EG034', 'numAtRisk': 0}, {'groupId': 'EG035', 'numAtRisk': 0}, {'groupId': 'EG036', 'numAtRisk': 0}, {'groupId': 'EG037', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 0}, {'groupId': 'EG020', 'numAtRisk': 0}, {'groupId': 'EG021', 'numAtRisk': 0}, {'groupId': 'EG022', 'numAtRisk': 0}, {'groupId': 'EG023', 'numAtRisk': 0}, {'groupId': 'EG024', 'numAtRisk': 0}, {'groupId': 'EG025', 'numAtRisk': 0}, {'groupId': 'EG026', 'numAtRisk': 0}, {'groupId': 'EG027', 'numAtRisk': 0}, {'groupId': 'EG028', 'numAtRisk': 0}, {'groupId': 'EG029', 'numAtRisk': 0}, {'groupId': 'EG030', 'numAtRisk': 0}, {'groupId': 'EG031', 'numAtRisk': 0}, {'groupId': 'EG032', 'numAtRisk': 0}, {'groupId': 'EG033', 'numAtRisk': 0}, {'groupId': 'EG034', 'numAtRisk': 0}, {'groupId': 'EG035', 'numAtRisk': 0}, {'groupId': 'EG036', 'numAtRisk': 0}, {'groupId': 'EG037', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 20, 'numAffected': 0}, 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'EG020', 'numAtRisk': 0}, {'groupId': 'EG021', 'numAtRisk': 0}, {'groupId': 'EG022', 'numAtRisk': 0}, {'groupId': 'EG023', 'numAtRisk': 0}, {'groupId': 'EG024', 'numAtRisk': 0}, {'groupId': 'EG025', 'numAtRisk': 0}, {'groupId': 'EG026', 'numAtRisk': 0}, {'groupId': 'EG027', 'numAtRisk': 0}, {'groupId': 'EG028', 'numAtRisk': 0}, {'groupId': 'EG029', 'numAtRisk': 0}, {'groupId': 'EG030', 'numAtRisk': 0}, {'groupId': 'EG031', 'numAtRisk': 0}, {'groupId': 'EG032', 'numAtRisk': 0}, {'groupId': 'EG033', 'numAtRisk': 0}, {'groupId': 'EG034', 'numAtRisk': 0}, {'groupId': 'EG035', 'numAtRisk': 0}, {'groupId': 'EG036', 'numAtRisk': 0}, {'groupId': 'EG037', 'numAtRisk': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part 1: Overall Response Rate (ORR) Per RECIST v1.1 for Solid Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '27', 'groupId': 'OG007'}, {'value': '29', 'groupId': 'OG008'}, {'value': '30', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}, {'value': '15', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: RCC naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG001', 'title': 'Part 1: RCC naïve 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG002', 'title': 'Part 1: RCC Pre 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'OG003', 'title': 'Part 1: Pancreatic 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer'}, {'id': 'OG004', 'title': 'Part 1: Urothelial 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer'}, {'id': 'OG005', 'title': 'Part 1: H-N naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG006', 'title': 'Part 1: H-N Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'OG007', 'title': 'Part 1: MSS CRC wt 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype'}, {'id': 'OG008', 'title': 'Part 1: MSS CRC mu 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant'}, {'id': 'OG009', 'title': 'Part 1: TNBC 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}, {'id': 'OG010', 'title': 'Part 1: Melanoma Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy'}, {'id': 'OG011', 'title': 'Part 1: mCRPC 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)'}], 'classes': [{'categories': [{'measurements': [{'value': '27.3', 'groupId': 'OG000', 'lowerLimit': '7.9', 'upperLimit': '56.4'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '7.2', 'upperLimit': '52.7'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '23.8'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '19.3'}, {'value': '7.1', 'groupId': 'OG004', 'lowerLimit': '0.4', 'upperLimit': '29.7'}, {'value': '13.3', 'groupId': 'OG005', 'lowerLimit': '2.4', 'upperLimit': '36.3'}, {'value': '0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '23.8'}, {'value': '0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '10.5'}, {'value': '3.4', 'groupId': 'OG008', 'lowerLimit': '0.2', 'upperLimit': '15.3'}, {'value': '10.0', 'groupId': 'OG009', 'lowerLimit': '2.8', 'upperLimit': '23.9'}, {'value': '0', 'groupId': 'OG010', 'lowerLimit': '0.0', 'upperLimit': '20.6'}, {'value': '0', 'groupId': 'OG011', 'lowerLimit': '0.0', 'upperLimit': '18.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3.9 years', 'description': 'ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR), based on local investigator assessment per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.\n\nFor RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 1 who received at least 1 full or partial dose of assigned combination of study drugs and were included in the selected advanced solid tumors groups defined in the study protocol for efficacy assessment: RCC naïve 160 mg, RCC naïve 240 mg, RCC pre 240 mg, pancreatic 160 mg, urothelial 160 mg, H-N naïve 160 mg, H-N pre 160 mg, MSS CRC wt 160 mg, MSS CRC mu 160 mg, TNBC 160 mg, melanoma pre 160 mg and mCRPC 240 mg'}, {'type': 'PRIMARY', 'title': 'Part 1: Overall Response Rate (ORR) Per Cheson 2014 for DLBCL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: DLBCL 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)'}], 'classes': [{'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '41.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2.5 years', 'description': 'ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR), based on local investigator assessment per Cheson 2014 criteria for diffuse large B-cell lymphoma (DLBCL).\n\nFor Cheson 2014 criteria, CR= Target nodes/nodal masses must regress to ≤1.5 cm in longest diameter (LDi), no extralymphatic sites of disease, absent non-measured lesions, organ enlargement regress to normal, no new lesions, and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative); PR= ≥50% decrease in the sum of the product of the perpendicular diameters (SPD) of up to 6 target measurable nodes, absent or regressed non-measured lesions, spleen must have regressed by \\>50% in length beyond normal, and no new lesions.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 1 who received at least 1 full or partial dose of assigned combination of study drugs and were included in the selected lymphoma group defined in the study protocol for efficacy assessment: DLBCL 160 mg'}, {'type': 'PRIMARY', 'title': 'Part 2: Overall Response Rate (ORR) Per RECIST v1.1 for Solid Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: NSCLC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG001', 'title': 'Part 2: NSCLC 160 mg 2wk-on/2wk-off', 'description': 'NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG002', 'title': 'Part 2: NSCLC 160 mg 1wk-on/1wk-off', 'description': 'NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}], 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '25.9'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '13.9'}, {'value': '10.0', 'groupId': 'OG002', 'lowerLimit': '1.8', 'upperLimit': '28.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4.7 years', 'description': 'ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR), based on local investigator assessment per RECIST v1.1.\n\nFor RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 2 who were randomized to the study treatment dosing schedule.'}, {'type': 'PRIMARY', 'title': 'Part 3: Overall Response Rate (ORR) Per RECIST v1.1 for Solid Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3: TNBC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '58.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 0.5 years', 'description': 'ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR), based on local investigator assessment per RECIST v1.1.\n\nFor RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 3 who received at least 1 full or partial dose of assigned combination of study drugs.'}, {'type': 'SECONDARY', 'title': 'Part 1: Overall Response Rate (ORR) Per iRECIST for Solid Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '27', 'groupId': 'OG007'}, {'value': '29', 'groupId': 'OG008'}, {'value': '30', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}, {'value': '15', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: RCC naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG001', 'title': 'Part 1: RCC naïve 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG002', 'title': 'Part 1: RCC Pre 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'OG003', 'title': 'Part 1: Pancreatic 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer'}, {'id': 'OG004', 'title': 'Part 1: Urothelial 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer'}, {'id': 'OG005', 'title': 'Part 1: H-N naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG006', 'title': 'Part 1: H-N Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'OG007', 'title': 'Part 1: MSS CRC wt 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype'}, {'id': 'OG008', 'title': 'Part 1: MSS CRC mu 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant'}, {'id': 'OG009', 'title': 'Part 1: TNBC 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}, {'id': 'OG010', 'title': 'Part 1: Melanoma Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy'}, {'id': 'OG011', 'title': 'Part 1: mCRPC 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)'}], 'classes': [{'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000', 'lowerLimit': '13.5', 'upperLimit': '65.0'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '7.2', 'upperLimit': '52.7'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '23.8'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '19.3'}, {'value': '7.1', 'groupId': 'OG004', 'lowerLimit': '0.4', 'upperLimit': '29.7'}, {'value': '13.3', 'groupId': 'OG005', 'lowerLimit': '2.4', 'upperLimit': '36.3'}, {'value': '0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '23.8'}, {'value': '0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '10.5'}, {'value': '3.4', 'groupId': 'OG008', 'lowerLimit': '0.2', 'upperLimit': '15.3'}, {'value': '10.0', 'groupId': 'OG009', 'lowerLimit': '2.8', 'upperLimit': '23.9'}, {'value': '0', 'groupId': 'OG010', 'lowerLimit': '0.0', 'upperLimit': '20.6'}, {'value': '0', 'groupId': 'OG011', 'lowerLimit': '0.0', 'upperLimit': '18.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3.9 years', 'description': 'ORR is the percentage of patients with a best overall response of complete response (iCR) or partial response (iPR), based on local investigator 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daily continuous in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG001', 'title': 'Part 2: NSCLC 160 mg 2wk-on/2wk-off', 'description': 'NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG002', 'title': 'Part 2: NSCLC 160 mg 1wk-on/1wk-off', 'description': 'NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}], 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '25.9'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '21.6'}, {'value': '15.0', 'groupId': 'OG002', 'lowerLimit': '4.2', 'upperLimit': '34.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4.7 years', 'description': 'ORR is the percentage of patients with a best overall response of complete response (iCR) or partial response (iPR), based on local investigator assessment per immune-related RECIST (iRECIST).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 2 who were randomized to the study treatment dosing schedule.'}, {'type': 'SECONDARY', 'title': 'Part 3: Overall Response Rate (ORR) Per iRECIST for Solid Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3: TNBC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '58.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 0.5 years', 'description': 'ORR is the percentage of patients with a best overall response of complete response (iCR) or partial response (iPR), based on local investigator assessment per immune-related RECIST (iRECIST).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 3 who received at least 1 full or partial dose of assigned combination of study drugs.'}, {'type': 'SECONDARY', 'title': 'Part 1: Mean Percentage Change in PSA From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: mCRPC 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)'}], 'classes': [{'categories': [{'measurements': [{'value': '214.46', 'spread': '329.459', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, up to 0.8 years', 'description': 'Prostate-specific antigen (PSA) levels were assessed in serum. Rising PSA is generally a manifestation of progression of prostate cancer.', 'unitOfMeasure': 'percentage change in PSA from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 1 who received at least 1 full or partial dose of assigned combination of study drugs and were included in the prostate cancer group defined in the study protocol for efficacy assessment: mCRPC 240 mg'}, {'type': 'SECONDARY', 'title': 'Part 1: Disease Control Rate (DCR) Per RECIST v1.1 for Solid Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '27', 'groupId': 'OG007'}, {'value': '29', 'groupId': 'OG008'}, {'value': '30', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}, {'value': '15', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: RCC naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG001', 'title': 'Part 1: RCC naïve 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG002', 'title': 'Part 1: RCC Pre 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'OG003', 'title': 'Part 1: Pancreatic 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer'}, {'id': 'OG004', 'title': 'Part 1: Urothelial 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer'}, {'id': 'OG005', 'title': 'Part 1: H-N naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG006', 'title': 'Part 1: H-N Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'OG007', 'title': 'Part 1: MSS CRC wt 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype'}, {'id': 'OG008', 'title': 'Part 1: MSS CRC mu 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant'}, {'id': 'OG009', 'title': 'Part 1: TNBC 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}, {'id': 'OG010', 'title': 'Part 1: Melanoma Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy'}, {'id': 'OG011', 'title': 'Part 1: mCRPC 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)'}], 'classes': [{'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000', 'lowerLimit': '27.1', 'upperLimit': '80.0'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '39.1', 'upperLimit': '87.7'}, {'value': '18.2', 'groupId': 'OG002', 'lowerLimit': '3.3', 'upperLimit': '47.0'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '19.3'}, {'value': '28.6', 'groupId': 'OG004', 'lowerLimit': '10.4', 'upperLimit': '54.0'}, {'value': '40.0', 'groupId': 'OG005', 'lowerLimit': '19.1', 'upperLimit': '64.0'}, {'value': '63.6', 'groupId': 'OG006', 'lowerLimit': '35.0', 'upperLimit': '86.5'}, {'value': '25.9', 'groupId': 'OG007', 'lowerLimit': '12.9', 'upperLimit': '43.2'}, {'value': '17.2', 'groupId': 'OG008', 'lowerLimit': '7.0', 'upperLimit': '32.9'}, {'value': '33.3', 'groupId': 'OG009', 'lowerLimit': '19.3', 'upperLimit': '49.9'}, {'value': '0', 'groupId': 'OG010', 'lowerLimit': '0.0', 'upperLimit': '20.6'}, {'value': '46.7', 'groupId': 'OG011', 'lowerLimit': '24.4', 'upperLimit': '70.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3.9 years', 'description': 'DCR is the percentage of patients with a best overall response of complete response (CR), partial response (PR), stable disease (SD) or Non-CR or Non-progressive disease (NCRNPD), based on local investigator assessment per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 1 who received at least 1 full or partial dose of assigned combination of study drugs and were included in the selected advanced solid tumors groups defined in the study protocol for efficacy assessment: RCC naïve 160 mg, RCC naïve 240 mg, RCC pre 240 mg, pancreatic 160 mg, urothelial 160 mg, H-N naïve 160 mg, H-N pre 160 mg, MSS CRC wt 160 mg, MSS CRC mu 160 mg, TNBC 160 mg, melanoma pre 160 mg and mCRPC 240 mg'}, {'type': 'SECONDARY', 'title': 'Part 1: Disease Control Rate (DCR) Per iRECIST for Solid Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '27', 'groupId': 'OG007'}, {'value': '29', 'groupId': 'OG008'}, {'value': '30', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}, {'value': '15', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: RCC naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG001', 'title': 'Part 1: RCC naïve 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG002', 'title': 'Part 1: RCC Pre 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'OG003', 'title': 'Part 1: Pancreatic 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer'}, {'id': 'OG004', 'title': 'Part 1: Urothelial 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer'}, {'id': 'OG005', 'title': 'Part 1: H-N naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG006', 'title': 'Part 1: H-N Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'OG007', 'title': 'Part 1: MSS CRC wt 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype'}, {'id': 'OG008', 'title': 'Part 1: MSS CRC mu 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant'}, {'id': 'OG009', 'title': 'Part 1: TNBC 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}, {'id': 'OG010', 'title': 'Part 1: Melanoma Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy'}, {'id': 'OG011', 'title': 'Part 1: mCRPC 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)'}], 'classes': [{'categories': [{'measurements': [{'value': '63.6', 'groupId': 'OG000', 'lowerLimit': '35.0', 'upperLimit': '86.5'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '39.1', 'upperLimit': '87.7'}, {'value': '18.2', 'groupId': 'OG002', 'lowerLimit': '3.3', 'upperLimit': '47.0'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '19.3'}, {'value': '35.7', 'groupId': 'OG004', 'lowerLimit': '15.3', 'upperLimit': '61.0'}, {'value': '40.0', 'groupId': 'OG005', 'lowerLimit': '19.1', 'upperLimit': '64.0'}, {'value': '54.5', 'groupId': 'OG006', 'lowerLimit': '27.1', 'upperLimit': '80.0'}, {'value': '25.9', 'groupId': 'OG007', 'lowerLimit': '12.9', 'upperLimit': '43.2'}, {'value': '13.8', 'groupId': 'OG008', 'lowerLimit': '4.9', 'upperLimit': '28.8'}, {'value': '36.7', 'groupId': 'OG009', 'lowerLimit': '22.1', 'upperLimit': '53.3'}, {'value': '0', 'groupId': 'OG010', 'lowerLimit': '0.0', 'upperLimit': '20.6'}, {'value': '46.7', 'groupId': 'OG011', 'lowerLimit': '24.4', 'upperLimit': '70.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3.9 years', 'description': 'DCR is the percentage of patients with a best overall response of complete response (iCR), partial response (iPR), stable disease (iSD) or Non-iCR or Non-unconfirmed progressive disease (NON-iCR or NON-iUPD), based on local investigator assessment per immune-related RECIST (iRECIST).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 1 who received at least 1 full or partial dose of assigned combination of study drugs and were included in the selected advanced solid tumors groups defined in the study protocol for efficacy assessment: RCC naïve 160 mg, RCC naïve 240 mg, RCC pre 240 mg, pancreatic 160 mg, urothelial 160 mg, H-N naïve 160 mg, H-N pre 160 mg, MSS CRC wt 160 mg, MSS CRC mu 160 mg, TNBC 160 mg, melanoma pre 160 mg and mCRPC 240 mg'}, {'type': 'SECONDARY', 'title': 'Part 1: Disease Control Rate (DCR) Per Cheson 2014 for DLBCL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: DLBCL 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)'}], 'classes': [{'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000', 'lowerLimit': '6.6', 'upperLimit': '49.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2.5 years', 'description': 'DCR is the percentage of patients with a best overall response of complete response (CR), partial response (PR) or stable disease (SD), based on local investigator assessment per Cheson 2014 criteria for diffuse large B-cell lymphoma (DLBCL).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 1 who received at least 1 full or partial dose of assigned combination of study drugs and were included in the selected lymphoma group defined in the study protocol for efficacy assessment: DLBCL 160 mg'}, {'type': 'SECONDARY', 'title': 'Part 2: Disease Control Rate (DCR) Per RECIST v1.1 for Solid Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: NSCLC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG001', 'title': 'Part 2: NSCLC 160 mg 2wk-on/2wk-off', 'description': 'NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG002', 'title': 'Part 2: NSCLC 160 mg 1wk-on/1wk-off', 'description': 'NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}], 'classes': [{'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000', 'lowerLimit': '19.6', 'upperLimit': '56.1'}, {'value': '40.0', 'groupId': 'OG001', 'lowerLimit': '21.7', 'upperLimit': '60.6'}, {'value': '35.0', 'groupId': 'OG002', 'lowerLimit': '17.7', 'upperLimit': '55.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4.7 years', 'description': 'DCR is the percentage of patients with a best overall response of complete response (CR), partial response (PR), stable disease (SD) or Non-CR or Non-progressive disease (NCRNPD), based on local investigator assessment per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 2 who were randomized to the study treatment dosing schedule.'}, {'type': 'SECONDARY', 'title': 'Part 2: Disease Control Rate (DCR) Per iRECIST for Solid Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: NSCLC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG001', 'title': 'Part 2: NSCLC 160 mg 2wk-on/2wk-off', 'description': 'NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG002', 'title': 'Part 2: NSCLC 160 mg 1wk-on/1wk-off', 'description': 'NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}], 'classes': [{'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000', 'lowerLimit': '19.6', 'upperLimit': '56.1'}, {'value': '45.0', 'groupId': 'OG001', 'lowerLimit': '25.9', 'upperLimit': '65.3'}, {'value': '45.0', 'groupId': 'OG002', 'lowerLimit': '25.9', 'upperLimit': '65.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4.7 years', 'description': 'DCR is the percentage of patients with a best overall response of complete response (iCR), partial response (iPR), stable disease (iSD) or Non-iCR or Non-unconfirmed progressive disease (NON-iCR or NON-iUPD), based on local investigator assessment per immune-related RECIST (iRECIST).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 2 who were randomized to the study treatment dosing schedule.'}, {'type': 'SECONDARY', 'title': 'Part 3: Disease Control Rate (DCR) Per RECIST v1.1 for Solid Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3: TNBC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '58.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 0.5 years', 'description': 'DCR is the percentage of patients with a best overall response of complete response (CR), partial response (PR), stable disease (SD) or Non-CR or Non-progressive disease (NCRNPD), based on local investigator assessment per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 3 who received at least 1 full or partial dose of assigned combination of study drugs.'}, {'type': 'SECONDARY', 'title': 'Part 3: Disease Control Rate (DCR) Per iRECIST for Solid Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3: TNBC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '58.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 0.5 years', 'description': 'DCR is the percentage of patients with a best overall response of complete response (iCR), partial response (iPR), stable disease (iSD) or Non-iCR or Non-unconfirmed progressive disease (NON-iCR or NON-iUPD), based on local investigator assessment per immune-related RECIST (iRECIST).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 3 who received at least 1 full or partial dose of assigned combination of study drugs.'}, {'type': 'SECONDARY', 'title': 'Part 1: Duration Of Response (DOR) Per RECIST v1.1 for Solid Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: RCC naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG001', 'title': 'Part 1: RCC naïve 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG002', 'title': 'Part 1: RCC Pre 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'OG003', 'title': 'Part 1: Pancreatic 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer'}, {'id': 'OG004', 'title': 'Part 1: Urothelial 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer'}, {'id': 'OG005', 'title': 'Part 1: H-N naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG006', 'title': 'Part 1: H-N Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'OG007', 'title': 'Part 1: MSS CRC wt 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype'}, {'id': 'OG008', 'title': 'Part 1: MSS CRC mu 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant'}, {'id': 'OG009', 'title': 'Part 1: TNBC 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}, {'id': 'OG010', 'title': 'Part 1: Melanoma Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy'}, {'id': 'OG011', 'title': 'Part 1: mCRPC 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to insufficient number of participants with events', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to insufficient number of participants with events', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to insufficient number of participants with events', 'groupId': 'OG008', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to insufficient number of participants with events', 'groupId': 'OG009', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 3.9 years', 'description': 'DOR only applies to patients for whom best overall response is complete response (CR) or partial response (PR) based on local investigator assessment per RECIST v1.1. DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, DOR was censored at the date of last adequate tumor assessment.\n\nDOR was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 1 for whom best overall response was CR or PR and were included in the selected advanced solid tumors groups defined in the study protocol for efficacy assessment: RCC naïve 160 mg, RCC naïve 240 mg, RCC pre 240 mg, pancreatic 160 mg, urothelial 160 mg, H-N naïve 160 mg, H-N pre 160 mg, MSS CRC wt 160 mg, MSS CRC mu 160 mg, TNBC 160 mg, melanoma pre 160 mg and mCRPC 240 mg'}, {'type': 'SECONDARY', 'title': 'Part 1: Duration Of Response (DOR) Per iRECIST for Solid Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: RCC naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG001', 'title': 'Part 1: RCC naïve 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG002', 'title': 'Part 1: RCC Pre 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'OG003', 'title': 'Part 1: Pancreatic 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer'}, {'id': 'OG004', 'title': 'Part 1: Urothelial 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer'}, {'id': 'OG005', 'title': 'Part 1: H-N naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG006', 'title': 'Part 1: H-N Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'OG007', 'title': 'Part 1: MSS CRC wt 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype'}, {'id': 'OG008', 'title': 'Part 1: MSS CRC mu 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant'}, {'id': 'OG009', 'title': 'Part 1: TNBC 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}, {'id': 'OG010', 'title': 'Part 1: Melanoma Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy'}, {'id': 'OG011', 'title': 'Part 1: mCRPC 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to insufficient number of participants with events', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to insufficient number of participants with events', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to insufficient number of participants with events', 'groupId': 'OG008', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to insufficient number of participants with events', 'groupId': 'OG009', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 3.9 years', 'description': 'DOR only applies to patients for whom best overall response is complete response (iCR) or partial response (iPR) based on local investigator assessment per iRECIST. DOR is defined as the time from the date of first documented response (iCR or iPR) to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, DOR was censored at the date of last adequate tumor assessment.\n\nDOR was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 1 for whom best overall response was iCR or iPR and were included in the selected advanced solid tumors groups defined in the study protocol for efficacy assessment: RCC naïve 160 mg, RCC naïve 240 mg, RCC pre 240 mg, pancreatic 160 mg, urothelial 160 mg, H-N naïve 160 mg, H-N pre 160 mg, MSS CRC wt 160 mg, MSS CRC mu 160 mg, TNBC 160 mg, melanoma pre 160 mg and mCRPC 240 mg'}, {'type': 'SECONDARY', 'title': 'Part 1: Duration Of Response (DOR) Per Cheson 2014 for DLBCL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: DLBCL 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 2.5 years', 'description': 'DOR only applies to patients for whom best overall response is complete response (CR) or partial response (PR) based on local investigator assessment per Cheson 2014 criteria for DLBCL. DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, DOR was censored at the date of last adequate tumor assessment. DOR was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 1 for whom best overall response was CR or PR and were included in the selected lymphoma group defined in the study protocol for efficacy assessment: DLBCL 160 mg'}, {'type': 'SECONDARY', 'title': 'Part 2: Duration Of Response (DOR) Per RECIST v1.1 for Solid Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: NSCLC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG001', 'title': 'Part 2: NSCLC 160 mg 2wk-on/2wk-off', 'description': 'NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG002', 'title': 'Part 2: NSCLC 160 mg 1wk-on/1wk-off', 'description': 'NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to insufficient number of participants with events', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 4.7 years', 'description': 'DOR only applies to patients for whom best overall response is complete response (CR) or partial response (PR) based on local investigator assessment per RECIST v1.1. DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, DOR was censored at the date of last adequate tumor assessment.\n\nDOR was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 2 for whom best overall response was CR or PR'}, {'type': 'SECONDARY', 'title': 'Part 2: Duration Of Response (DOR) Per iRECIST for Solid Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: NSCLC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG001', 'title': 'Part 2: NSCLC 160 mg 2wk-on/2wk-off', 'description': 'NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG002', 'title': 'Part 2: NSCLC 160 mg 1wk-on/1wk-off', 'description': 'NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to insufficient number of participants with events', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 4.7 years', 'description': 'DOR only applies to patients for whom best overall response is complete response (iCR) or partial response (iPR) based on local investigator assessment per iRECIST. DOR is defined as the time from the date of first documented response (iCR or iPR) to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, DOR was censored at the date of last adequate tumor assessment.\n\nDOR was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 2 for whom best overall response was iCR or iPR'}, {'type': 'SECONDARY', 'title': 'Part 3: Duration Of Response (DOR) Per RECIST v1.1 for Solid Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3: TNBC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 0.5 years', 'description': 'DOR only applies to patients for whom best overall response is complete response (CR) or partial response (PR) based on local investigator assessment per RECIST v1.1. DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, DOR was censored at the date of last adequate tumor assessment.\n\nDOR was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 3 for whom best overall response was CR or PR'}, {'type': 'SECONDARY', 'title': 'Part 3: Duration Of Response (DOR) Per iRECIST for Solid Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3: TNBC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 0.5 years', 'description': 'DOR only applies to patients for whom best overall response is complete response (iCR) or partial response (iPR) based on local investigator assessment per iRECIST. DOR is defined as the time from the date of first documented response (iCR or iPR) to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, DOR was censored at the date of last adequate tumor assessment.\n\nDOR was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 3 for whom best overall response was iCR or iPR'}, {'type': 'SECONDARY', 'title': 'Part 1: Progression-Free Survival (PFS) Per RECIST v1.1 for Solid Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '27', 'groupId': 'OG007'}, {'value': '29', 'groupId': 'OG008'}, {'value': '30', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}, {'value': '15', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: RCC naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG001', 'title': 'Part 1: RCC naïve 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG002', 'title': 'Part 1: RCC Pre 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'OG003', 'title': 'Part 1: Pancreatic 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer'}, {'id': 'OG004', 'title': 'Part 1: Urothelial 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer'}, {'id': 'OG005', 'title': 'Part 1: H-N naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG006', 'title': 'Part 1: H-N Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'OG007', 'title': 'Part 1: MSS CRC wt 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype'}, {'id': 'OG008', 'title': 'Part 1: MSS CRC mu 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant'}, {'id': 'OG009', 'title': 'Part 1: TNBC 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}, {'id': 'OG010', 'title': 'Part 1: Melanoma Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy'}, {'id': 'OG011', 'title': 'Part 1: mCRPC 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '15.4'}, {'value': '7.2', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '8.6'}, {'value': '1.9', 'groupId': 'OG002', 'lowerLimit': '1.7', 'upperLimit': '2.0'}, {'value': '1.7', 'groupId': 'OG003', 'lowerLimit': '1.6', 'upperLimit': '1.7'}, {'value': '1.9', 'groupId': 'OG004', 'lowerLimit': '1.7', 'upperLimit': '3.5'}, {'value': '2.0', 'groupId': 'OG005', 'lowerLimit': '1.6', 'upperLimit': '3.7'}, {'value': '3.5', 'groupId': 'OG006', 'lowerLimit': '1.7', 'upperLimit': '3.7'}, {'value': '1.7', 'groupId': 'OG007', 'lowerLimit': '1.6', 'upperLimit': '1.9'}, {'value': '1.9', 'groupId': 'OG008', 'lowerLimit': '1.7', 'upperLimit': '2.0'}, {'value': '1.7', 'groupId': 'OG009', 'lowerLimit': '1.6', 'upperLimit': '1.9'}, {'value': '1.8', 'groupId': 'OG010', 'lowerLimit': '1.6', 'upperLimit': '1.9'}, {'value': '3.7', 'groupId': 'OG011', 'lowerLimit': '1.7', 'upperLimit': '5.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 3.9 years', 'description': 'PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause, whichever happened first. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per RECIST v1.1.\n\nPFS was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 1 who received at least 1 full or partial dose of assigned combination of study drugs and were included in the selected advanced solid tumors groups defined in the study protocol for efficacy assessment: RCC naïve 160 mg, RCC naïve 240 mg, RCC pre 240 mg, pancreatic 160 mg, urothelial 160 mg, H-N naïve 160 mg, H-N pre 160 mg, MSS CRC wt 160 mg, MSS CRC mu 160 mg, TNBC 160 mg, melanoma pre 160 mg and mCRPC 240 mg'}, {'type': 'SECONDARY', 'title': 'Part 1: Progression-Free Survival (PFS) Per iRECIST for Solid Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '27', 'groupId': 'OG007'}, {'value': '29', 'groupId': 'OG008'}, {'value': '30', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}, {'value': '15', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: RCC naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG001', 'title': 'Part 1: RCC naïve 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG002', 'title': 'Part 1: RCC Pre 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'OG003', 'title': 'Part 1: Pancreatic 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer'}, {'id': 'OG004', 'title': 'Part 1: Urothelial 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer'}, {'id': 'OG005', 'title': 'Part 1: H-N naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG006', 'title': 'Part 1: H-N Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'OG007', 'title': 'Part 1: MSS CRC wt 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype'}, {'id': 'OG008', 'title': 'Part 1: MSS CRC mu 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant'}, {'id': 'OG009', 'title': 'Part 1: TNBC 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}, {'id': 'OG010', 'title': 'Part 1: Melanoma Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy'}, {'id': 'OG011', 'title': 'Part 1: mCRPC 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)'}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'comment': 'Not estimable due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': 'NA'}, {'value': '7.2', 'comment': 'Not estimable due to insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': 'NA'}, {'value': '1.9', 'groupId': 'OG002', 'lowerLimit': '1.7', 'upperLimit': '2.0'}, {'value': '1.7', 'groupId': 'OG003', 'lowerLimit': '1.1', 'upperLimit': '1.7'}, {'value': '2.1', 'groupId': 'OG004', 'lowerLimit': '1.7', 'upperLimit': '3.5'}, {'value': '2.0', 'groupId': 'OG005', 'lowerLimit': '1.6', 'upperLimit': '3.7'}, {'value': '3.5', 'groupId': 'OG006', 'lowerLimit': '1.7', 'upperLimit': '3.7'}, {'value': '1.8', 'groupId': 'OG007', 'lowerLimit': '1.6', 'upperLimit': '2.0'}, {'value': '1.9', 'groupId': 'OG008', 'lowerLimit': '1.7', 'upperLimit': '2.0'}, {'value': '1.8', 'groupId': 'OG009', 'lowerLimit': '1.6', 'upperLimit': '3.5'}, {'value': '1.8', 'groupId': 'OG010', 'lowerLimit': '1.6', 'upperLimit': '1.9'}, {'value': '3.7', 'groupId': 'OG011', 'lowerLimit': '1.7', 'upperLimit': '5.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 3.9 years', 'description': 'PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause, whichever happened first. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per iRECIST.\n\nPFS was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 1 who received at least 1 full or partial dose of assigned combination of study drugs and were included in the selected advanced solid tumors groups defined in the study protocol for efficacy assessment: RCC naïve 160 mg, RCC naïve 240 mg, RCC pre 240 mg, pancreatic 160 mg, urothelial 160 mg, H-N naïve 160 mg, H-N pre 160 mg, MSS CRC wt 160 mg, MSS CRC mu 160 mg, TNBC 160 mg, melanoma pre 160 mg and mCRPC 240 mg'}, {'type': 'SECONDARY', 'title': 'Part 1: Progression-Free Survival (PFS) Per Cheson 2014 for DLBCL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: DLBCL 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '2.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 2.5 years', 'description': 'PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause, whichever happened first. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per Cheson 2014 for DLBCL.\n\nPFS was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 1 who received at least 1 full or partial dose of assigned combination of study drugs and were included in the selected lymphoma group defined in the study protocol for efficacy assessment: DLBCL 160 mg'}, {'type': 'SECONDARY', 'title': 'Part 2: Progression-Free Survival (PFS) Per RECIST v1.1 for Solid Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: NSCLC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG001', 'title': 'Part 2: NSCLC 160 mg 2wk-on/2wk-off', 'description': 'NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG002', 'title': 'Part 2: NSCLC 160 mg 1wk-on/1wk-off', 'description': 'NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '3.8'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '3.7'}, {'value': '1.9', 'groupId': 'OG002', 'lowerLimit': '1.7', 'upperLimit': '3.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 4.7 years', 'description': 'PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause, whichever happened first. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per RECIST v1.1.\n\nPFS was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 2 who were randomized to the study treatment dosing schedule.'}, {'type': 'SECONDARY', 'title': 'Part 2: Progression-Free Survival (PFS) Per iRECIST for Solid Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: NSCLC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG001', 'title': 'Part 2: NSCLC 160 mg 2wk-on/2wk-off', 'description': 'NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG002', 'title': 'Part 2: NSCLC 160 mg 1wk-on/1wk-off', 'description': 'NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '3.8'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '3.7'}, {'value': '2.8', 'groupId': 'OG002', 'lowerLimit': '1.7', 'upperLimit': '9.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 4.7 years', 'description': 'PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause, whichever happened first. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per iRECIST.\n\nPFS was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 2 who were randomized to the study treatment dosing schedule.'}, {'type': 'SECONDARY', 'title': 'Part 3: Progression-Free Survival (PFS) Per RECIST v1.1 for Solid Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3: TNBC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '1.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 0.5 years', 'description': 'PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause, whichever happened first. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per RECIST v1.1.\n\nPFS was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 3 who received at least 1 full or partial dose of assigned combination of study drugs.'}, {'type': 'SECONDARY', 'title': 'Part 3: Progression-Free Survival (PFS) Per iRECIST for Solid Tumors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3: TNBC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '1.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 0.5 years', 'description': 'PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause, whichever happened first. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per iRECIST.\n\nPFS was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 3 who received at least 1 full or partial dose of assigned combination of study drugs.'}, {'type': 'SECONDARY', 'title': 'Part 1: 2-year Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '27', 'groupId': 'OG007'}, {'value': '29', 'groupId': 'OG008'}, {'value': '30', 'groupId': 'OG009'}, {'value': '13', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '15', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: RCC naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG001', 'title': 'Part 1: RCC naïve 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG002', 'title': 'Part 1: RCC Pre 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'OG003', 'title': 'Part 1: Pancreatic 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer'}, {'id': 'OG004', 'title': 'Part 1: Urothelial 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer'}, {'id': 'OG005', 'title': 'Part 1: H-N naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG006', 'title': 'Part 1: H-N Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'OG007', 'title': 'Part 1: MSS CRC wt 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype'}, {'id': 'OG008', 'title': 'Part 1: MSS CRC mu 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant'}, {'id': 'OG009', 'title': 'Part 1: TNBC 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}, {'id': 'OG010', 'title': 'Part 1: Melanoma Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy'}, {'id': 'OG011', 'title': 'Part 1: DLBCL 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)'}, {'id': 'OG012', 'title': 'Part 1: mCRPC 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)'}], 'classes': [{'categories': [{'measurements': [{'value': '63.6', 'groupId': 'OG000', 'lowerLimit': '35.5', 'upperLimit': '82.1'}, {'value': '42.1', 'groupId': 'OG001', 'lowerLimit': '14.6', 'upperLimit': '67.8'}, {'value': '27.3', 'groupId': 'OG002', 'lowerLimit': '8.9', 'upperLimit': '49.8'}, {'value': 'NA', 'comment': 'Not estimable due to insufficient number of participants with events', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '36.1', 'groupId': 'OG004', 'lowerLimit': '15.0', 'upperLimit': '57.9'}, {'value': '33.3', 'groupId': 'OG005', 'lowerLimit': '15.0', 'upperLimit': '52.9'}, {'value': '15.3', 'groupId': 'OG006', 'lowerLimit': '1.9', 'upperLimit': '41.2'}, {'value': '22.1', 'groupId': 'OG007', 'lowerLimit': '9.4', 'upperLimit': '38.2'}, {'value': '14.3', 'groupId': 'OG008', 'lowerLimit': '4.3', 'upperLimit': '29.9'}, {'value': '30.8', 'groupId': 'OG009', 'lowerLimit': '16.0', 'upperLimit': '46.9'}, {'value': 'NA', 'comment': 'Not estimable due to insufficient number of participants with events', 'groupId': 'OG010', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '23.1', 'groupId': 'OG011', 'lowerLimit': '7.5', 'upperLimit': '43.6'}, {'value': '31.4', 'groupId': 'OG012', 'lowerLimit': '10.8', 'upperLimit': '54.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'OS represents the percentage of participants who are alive after the start of study treatment. OS at 2 years was estimated using the Kaplan-Meier method as defined in the statistical analysis plan (SAP).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 1 who received at least 1 full or partial dose of assigned combination of study drugs and were included in the selected cancer groups defined in the protocol for efficacy assessment: RCC naïve 160 mg, RCC naïve 240 mg, RCC pre 240 mg, pancreatic 160 mg, urothelial 160 mg, H-N naïve 160 mg, H-N pre 160 mg, MSS CRC wt 160 mg, MSS CRC mu 160 mg, TNBC 160 mg, melanoma pre 160 mg, DLBCL 160 mg and mCRPC 240 mg'}, {'type': 'SECONDARY', 'title': 'Part 2: 2-year Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: NSCLC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG001', 'title': 'Part 2: NSCLC 160 mg 2wk-on/2wk-off', 'description': 'NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG002', 'title': 'Part 2: NSCLC 160 mg 1wk-on/1wk-off', 'description': 'NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}], 'classes': [{'categories': [{'measurements': [{'value': '33.6', 'groupId': 'OG000', 'lowerLimit': '15.5', 'upperLimit': '52.9'}, {'value': '22.7', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '42.7'}, {'value': '39.7', 'groupId': 'OG002', 'lowerLimit': '20.3', 'upperLimit': '58.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'OS represents the percentage of participants who are alive after the start of study treatment. OS at 2 years was estimated using the Kaplan-Meier method as defined in the statistical analysis plan.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 2 who were randomized to the study treatment dosing schedule.'}, {'type': 'SECONDARY', 'title': 'Part 3: 2-year Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3: TNBC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'OS represents the percentage of participants who are alive after the start of study treatment. OS at 2 years was estimated using the Kaplan-Meier method as defined in the statistical analysis plan.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 3 who received at least 1 full or partial dose of assigned combination of study drugs.'}, {'type': 'SECONDARY', 'title': 'Part 1: Change From Baseline in CD8 Percent Marker Area in Tumor Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '10', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '4', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: RCC naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG001', 'title': 'Part 1: RCC naïve 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG002', 'title': 'Part 1: RCC Pre 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'OG003', 'title': 'Part 1: Pancreatic 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer'}, {'id': 'OG004', 'title': 'Part 1: Urothelial 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer'}, {'id': 'OG005', 'title': 'Part 1: H-N naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG006', 'title': 'Part 1: H-N Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'OG007', 'title': 'Part 1: MSS CRC wt 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype'}, {'id': 'OG008', 'title': 'Part 1: MSS CRC mu 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant'}, {'id': 'OG009', 'title': 'Part 1: TNBC 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}, {'id': 'OG010', 'title': 'Part 1: Melanoma Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy'}, {'id': 'OG011', 'title': 'Part 1: DLBCL 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)'}, {'id': 'OG012', 'title': 'Part 1: mCRPC 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)'}], 'classes': [{'categories': [{'measurements': [{'value': '10.93', 'spread': '14.227', 'groupId': 'OG000'}, {'value': '10.53', 'spread': '12.456', 'groupId': 'OG001'}, {'value': '0.70', 'spread': '2.645', 'groupId': 'OG002'}, {'value': '-0.81', 'spread': '0.537', 'groupId': 'OG003'}, {'value': '0.96', 'spread': '1.345', 'groupId': 'OG004'}, {'value': '1.63', 'spread': '2.372', 'groupId': 'OG005'}, {'value': '-0.42', 'spread': '1.477', 'groupId': 'OG006'}, {'value': '0.70', 'spread': '1.141', 'groupId': 'OG007'}, {'value': '-0.01', 'spread': '1.164', 'groupId': 'OG008'}, {'value': '4.86', 'spread': '3.751', 'groupId': 'OG009'}, {'value': '0.16', 'spread': '0.540', 'groupId': 'OG010'}, {'value': '7.84', 'groupId': 'OG011'}, {'value': '2.67', 'spread': '4.156', 'groupId': 'OG012'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening and on-treatment (Cycle 2 Day 1 or Day 15). The duration of one cycle was 28 days.', 'description': 'The tumor expression of CD8 was measured by immunohistochemical (IHC) methods. Newly obtained pre- and on-treatment paired tumor samples were required and collected at screening and after approximately two cycles of therapy.', 'unitOfMeasure': 'CD8 percent marker area', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 1 who received any study drug, had paired tumor samples, had a valid assessment for the outcome measure and were included in the selected cancer groups defined in the protocol for efficacy assessment: RCC naïve 160 mg, RCC naïve 240 mg, RCC pre 240 mg, pancreatic 160 mg, urothelial 160 mg, H-N naïve 160 mg, H-N pre 160 mg, MSS CRC wt 160 mg, MSS CRC mu 160 mg, TNBC 160 mg, melanoma pre 160 mg, DLBCL 160 mg and mCRPC 240 mg'}, {'type': 'SECONDARY', 'title': 'Part 2: Change From Baseline in CD8 Percent Marker Area in Tumor Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: NSCLC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG001', 'title': 'Part 2: NSCLC 160 mg 2wk-on/2wk-off', 'description': 'NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG002', 'title': 'Part 2: NSCLC 160 mg 1wk-on/1wk-off', 'description': 'NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.81', 'spread': '4.551', 'groupId': 'OG000'}, {'value': '-2.35', 'spread': '5.586', 'groupId': 'OG001'}, {'value': '1.23', 'spread': '2.955', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening and on-treatment (Cycle 2 Day 1 or Day 15). The duration of one cycle was 28 days.', 'description': 'The tumor expression of CD8 was measured by immunohistochemical (IHC) methods. Newly obtained pre- and on-treatment paired tumor samples were required and collected at screening and after approximately two cycles of therapy.', 'unitOfMeasure': 'CD8 percent marker area', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 2 who received any study drug, had paired tumor samples and had a valid assessment for the outcome measure'}, {'type': 'SECONDARY', 'title': 'Part 3: Change From Baseline in CD8 Percent Marker Area in Tumor Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3: TNBC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.26', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening and on-treatment (Cycle 2 Day 1 or Day 15). The duration of one cycle was 28 days.', 'description': 'The tumor expression of CD8 was measured by immunohistochemical (IHC) methods. Newly obtained pre- and on-treatment paired tumor samples were required and collected at screening and after approximately two cycles of therapy.', 'unitOfMeasure': 'CD8 percent marker area', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 3 who received any study drug, had paired tumor samples and had a valid assessment for the outcome measure'}, {'type': 'SECONDARY', 'title': 'Part 1, 2 and 3: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '58', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '15', 'groupId': 'OG011'}, {'value': '22', 'groupId': 'OG012'}, {'value': '20', 'groupId': 'OG013'}, {'value': '20', 'groupId': 'OG014'}, {'value': '6', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: RCC naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG001', 'title': 'Part 1: RCC naïve + Pre 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC), naïve and pretreated with immuno-oncology therapy'}, {'id': 'OG002', 'title': 'Part 1: Pancreatic 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer'}, {'id': 'OG003', 'title': 'Part 1: Urothelial 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer'}, {'id': 'OG004', 'title': 'Part 1: H-N naïve + Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC), naïve and pretreated with immuno-oncology therapy'}, {'id': 'OG005', 'title': 'Part 1: H-N Pre 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'OG006', 'title': 'Part 1: MSS CRC 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) and RAS wildtype, RAS mutant and RAS unknown status'}, {'id': 'OG007', 'title': 'Part 1: TNBC 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}, {'id': 'OG008', 'title': 'Part 1: Melanoma naïve + Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma, naïve and pretreated with immuno-oncology therapy'}, {'id': 'OG009', 'title': 'Part 1: DLBCL 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)'}, {'id': 'OG010', 'title': 'Part 1: DLBCL 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)'}, {'id': 'OG011', 'title': 'Part 1: mCRPC 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)'}, {'id': 'OG012', 'title': 'Part 2: NSCLC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG013', 'title': 'Part 2: NSCLC 160 mg 2wk-on/2wk-off', 'description': 'NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG014', 'title': 'Part 2: NSCLC 160 mg 1wk-on/1wk-off', 'description': 'NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG015', 'title': 'Part 3: TNBC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '57', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}, {'value': '14', 'groupId': 'OG011'}, {'value': '22', 'groupId': 'OG012'}, {'value': '18', 'groupId': 'OG013'}, {'value': '18', 'groupId': 'OG014'}, {'value': '6', 'groupId': 'OG015'}]}]}, {'title': 'Treatment-related AEs', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '34', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '12', 'groupId': 'OG011'}, {'value': '15', 'groupId': 'OG012'}, {'value': '14', 'groupId': 'OG013'}, {'value': '9', 'groupId': 'OG014'}, {'value': '4', 'groupId': 'OG015'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '28', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '11', 'groupId': 'OG012'}, {'value': '7', 'groupId': 'OG013'}, {'value': '7', 'groupId': 'OG014'}, {'value': '3', 'groupId': 'OG015'}]}]}, {'title': 'Treatment-related SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'Fatal SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'Treatment-related fatal SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 4 years (Part 1), 4.8 years (Part 2) and 0.6 years (Part 3)', 'description': 'Number of participants with AEs (any AE regardless of seriousness) and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs.\n\nThe on-treatment period is defined from the day of first administration of study treatment up to 30 days after the date of its last administration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 1, 2 and 3 who received at least 1 dose of NIR178 or PDR001. For the safety endpoints, patients at each study part with the same type of cancer who are treated at the same dose level and dosing schedule are pooled together, independently of the immune-oncology (IO) pretreatment status and RAS mutation status.'}, {'type': 'SECONDARY', 'title': 'Part 1, 2 and 3: Number of Participants With Dose Reductions and Dose Interruptions of NIR178', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '58', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '15', 'groupId': 'OG011'}, {'value': '22', 'groupId': 'OG012'}, {'value': '20', 'groupId': 'OG013'}, {'value': '20', 'groupId': 'OG014'}, {'value': '6', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: RCC naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG001', 'title': 'Part 1: RCC naïve + Pre 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC), naïve and pretreated with immuno-oncology therapy'}, {'id': 'OG002', 'title': 'Part 1: Pancreatic 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer'}, {'id': 'OG003', 'title': 'Part 1: Urothelial 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer'}, {'id': 'OG004', 'title': 'Part 1: H-N naïve + Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC), naïve and pretreated with immuno-oncology therapy'}, {'id': 'OG005', 'title': 'Part 1: H-N Pre 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'OG006', 'title': 'Part 1: MSS CRC 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) and RAS wildtype, RAS mutant and RAS unknown status'}, {'id': 'OG007', 'title': 'Part 1: TNBC 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}, {'id': 'OG008', 'title': 'Part 1: Melanoma naïve + Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma, naïve and pretreated with immuno-oncology therapy'}, {'id': 'OG009', 'title': 'Part 1: DLBCL 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)'}, {'id': 'OG010', 'title': 'Part 1: DLBCL 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)'}, {'id': 'OG011', 'title': 'Part 1: mCRPC 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)'}, {'id': 'OG012', 'title': 'Part 2: NSCLC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG013', 'title': 'Part 2: NSCLC 160 mg 2wk-on/2wk-off', 'description': 'NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG014', 'title': 'Part 2: NSCLC 160 mg 1wk-on/1wk-off', 'description': 'NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG015', 'title': 'Part 3: TNBC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}], 'classes': [{'title': 'At least one dose reduction', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'At least one dose interruption', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '8', 'groupId': 'OG012'}, {'value': '5', 'groupId': 'OG013'}, {'value': '4', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 3.9 years (Part 1), 4.7 years (Part 2) and 0.5 years (Part 3)', 'description': 'Number of participants with at least one dose reduction of NIR178 and number of participants with at least one dose interruption of NIR178. Dose or schedule adjustments were permitted for patients who did not tolerate the protocol-specified dosing schedule.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 1, 2 and 3 who received at least 1 dose of NIR178 or PDR001. For the safety endpoints, patients at each study part with the same type of cancer who are treated at the same dose level and dosing schedule are pooled together, independently of the immune-oncology (IO) pretreatment status and RAS mutation status.'}, {'type': 'SECONDARY', 'title': 'Part 1, 2 and 3: Number of Participants With Dose Reductions and Dose Interruptions of PDR001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '58', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '15', 'groupId': 'OG011'}, {'value': '22', 'groupId': 'OG012'}, {'value': '20', 'groupId': 'OG013'}, {'value': '20', 'groupId': 'OG014'}, {'value': '6', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: RCC naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG001', 'title': 'Part 1: RCC naïve + Pre 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC), naïve and pretreated with immuno-oncology therapy'}, {'id': 'OG002', 'title': 'Part 1: Pancreatic 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer'}, {'id': 'OG003', 'title': 'Part 1: Urothelial 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer'}, {'id': 'OG004', 'title': 'Part 1: H-N naïve + Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 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and pretreated with immuno-oncology therapy'}, {'id': 'OG009', 'title': 'Part 1: DLBCL 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)'}, {'id': 'OG010', 'title': 'Part 1: DLBCL 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)'}, {'id': 'OG011', 'title': 'Part 1: mCRPC 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)'}, {'id': 'OG012', 'title': 'Part 2: NSCLC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG013', 'title': 'Part 2: NSCLC 160 mg 2wk-on/2wk-off', 'description': 'NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG014', 'title': 'Part 2: NSCLC 160 mg 1wk-on/1wk-off', 'description': 'NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG015', 'title': 'Part 3: TNBC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}], 'classes': [{'title': 'At least one dose reduction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 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Dose or schedule adjustments were permitted for patients who did not tolerate the protocol-specified dosing schedule. Dose reductions were not permitted for PDR001.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 1, 2 and 3 who received at least 1 dose of NIR178 or PDR001. For the safety endpoints, patients at each study part with the same type of cancer who are treated at the same dose level and dosing schedule are pooled together, independently of the immune-oncology (IO) pretreatment status and RAS mutation status.'}, {'type': 'SECONDARY', 'title': 'Part 1, 2 and 3: Dose Intensity of NIR178', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '58', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '15', 'groupId': 'OG011'}, {'value': '22', 'groupId': 'OG012'}, {'value': '20', 'groupId': 'OG013'}, {'value': '20', 'groupId': 'OG014'}, {'value': '6', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 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and neck (HNSCC), naïve and pretreated with immuno-oncology therapy'}, {'id': 'OG005', 'title': 'Part 1: H-N Pre 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'OG006', 'title': 'Part 1: MSS CRC 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) and RAS wildtype, RAS mutant and RAS unknown status'}, {'id': 'OG007', 'title': 'Part 1: TNBC 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}, {'id': 'OG008', 'title': 'Part 1: Melanoma naïve + Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma, naïve and pretreated with immuno-oncology therapy'}, {'id': 'OG009', 'title': 'Part 1: DLBCL 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)'}, {'id': 'OG010', 'title': 'Part 1: DLBCL 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)'}, {'id': 'OG011', 'title': 'Part 1: mCRPC 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)'}, {'id': 'OG012', 'title': 'Part 2: NSCLC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG013', 'title': 'Part 2: NSCLC 160 mg 2wk-on/2wk-off', 'description': 'NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG014', 'title': 'Part 2: NSCLC 160 mg 1wk-on/1wk-off', 'description': 'NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG015', 'title': 'Part 3: TNBC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}], 'classes': [{'categories': [{'measurements': [{'value': '316.7', 'groupId': 'OG000', 'lowerLimit': '187', 'upperLimit': '320'}, {'value': '477.3', 'groupId': 'OG001', 'lowerLimit': '321', 'upperLimit': '480'}, {'value': '320.0', 'groupId': 'OG002', 'lowerLimit': '241', 'upperLimit': '320'}, {'value': '295.7', 'groupId': 'OG003', 'lowerLimit': '140', 'upperLimit': '320'}, {'value': '309.8', 'groupId': 'OG004', 'lowerLimit': '141', 'upperLimit': '320'}, {'value': '480.0', 'groupId': 'OG005', 'lowerLimit': '272', 'upperLimit': '480'}, {'value': '320.0', 'groupId': 'OG006', 'lowerLimit': '134', 'upperLimit': 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'unitOfMeasure': 'mg/day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 1, 2 and 3 who received at least 1 dose of NIR178 or PDR001. For the safety endpoints, patients at each study part with the same type of cancer who are treated at the same dose level and dosing schedule are pooled together, independently of the immune-oncology (IO) pretreatment status and RAS mutation status.'}, {'type': 'SECONDARY', 'title': 'Part 1, 2 and 3: Dose Intensity of PDR001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '58', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '15', 'groupId': 'OG011'}, {'value': '22', 'groupId': 'OG012'}, {'value': '20', 'groupId': 'OG013'}, {'value': '20', 'groupId': 'OG014'}, {'value': '6', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 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and neck (HNSCC), naïve and pretreated with immuno-oncology therapy'}, {'id': 'OG005', 'title': 'Part 1: H-N Pre 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'OG006', 'title': 'Part 1: MSS CRC 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) and RAS wildtype, RAS mutant and RAS unknown status'}, {'id': 'OG007', 'title': 'Part 1: TNBC 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}, {'id': 'OG008', 'title': 'Part 1: Melanoma naïve + Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma, naïve and pretreated with immuno-oncology therapy'}, {'id': 'OG009', 'title': 'Part 1: DLBCL 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)'}, {'id': 'OG010', 'title': 'Part 1: DLBCL 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)'}, {'id': 'OG011', 'title': 'Part 1: mCRPC 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)'}, {'id': 'OG012', 'title': 'Part 2: NSCLC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG013', 'title': 'Part 2: NSCLC 160 mg 2wk-on/2wk-off', 'description': 'NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG014', 'title': 'Part 2: NSCLC 160 mg 1wk-on/1wk-off', 'description': 'NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG015', 'title': 'Part 3: TNBC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}], 'classes': [{'categories': [{'measurements': [{'value': '394.2', 'groupId': 'OG000', 'lowerLimit': '300', 'upperLimit': '400'}, {'value': '396.2', 'groupId': 'OG001', 'lowerLimit': '267', 'upperLimit': '431'}, {'value': '400.0', 'groupId': 'OG002', 'lowerLimit': '395', 'upperLimit': '400'}, {'value': '393.1', 'groupId': 'OG003', 'lowerLimit': '350', 'upperLimit': '400'}, {'value': '398.2', 'groupId': 'OG004', 'lowerLimit': '319', 'upperLimit': '402'}, {'value': '400.0', 'groupId': 'OG005', 'lowerLimit': '365', 'upperLimit': '407'}, {'value': '400.0', 'groupId': 'OG006', 'lowerLimit': '236', 'upperLimit': '405'}, {'value': '400.0', 'groupId': 'OG007', 'lowerLimit': '305', 'upperLimit': '404'}, {'value': '400.0', 'groupId': 'OG008', 'lowerLimit': '389', 'upperLimit': '406'}, {'value': '400.0', 'groupId': 'OG009', 'lowerLimit': '386', 'upperLimit': '400'}, {'value': '400.0', 'groupId': 'OG010', 'lowerLimit': '400', 'upperLimit': '400'}, {'value': '400.0', 'groupId': 'OG011', 'lowerLimit': '378', 'upperLimit': '404'}, {'value': '400.0', 'groupId': 'OG012', 'lowerLimit': '224', 'upperLimit': '406'}, {'value': '400.0', 'groupId': 'OG013', 'lowerLimit': '300', 'upperLimit': '401'}, {'value': '400.0', 'groupId': 'OG014', 'lowerLimit': '387', 'upperLimit': '410'}, {'value': '400.0', 'groupId': 'OG015', 'lowerLimit': '400', 'upperLimit': '400'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 3.9 years (Part 1), 4.7 years (Part 2) and 0.5 years (Part 3)', 'description': 'Dose intensity of PDR001 was calculated as cumulative actual dose in milligrams divided by duration of exposure in days and then multiplied by 28 days.', 'unitOfMeasure': 'mg/28 days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 1, 2 and 3 who received at least 1 dose of NIR178 or PDR001. For the safety endpoints, patients at each study part with the same type of cancer who are treated at the same dose level and dosing schedule are pooled together, independently of the immune-oncology (IO) pretreatment status and RAS mutation status.'}, {'type': 'SECONDARY', 'title': 'Part 1, 2 and 3: Number of Participants With Anti-PDR001 Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '52', 'groupId': 'OG006'}, {'value': '27', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}, {'value': '10', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '21', 'groupId': 'OG012'}, {'value': '19', 'groupId': 'OG013'}, {'value': '17', 'groupId': 'OG014'}, {'value': '6', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: RCC naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG001', 'title': 'Part 1: RCC naïve + Pre 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC), naïve and pretreated with immuno-oncology therapy'}, {'id': 'OG002', 'title': 'Part 1: Pancreatic 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer'}, {'id': 'OG003', 'title': 'Part 1: Urothelial 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer'}, {'id': 'OG004', 'title': 'Part 1: H-N naïve + Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC), naïve and pretreated with immuno-oncology therapy'}, {'id': 'OG005', 'title': 'Part 1: H-N Pre 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'OG006', 'title': 'Part 1: MSS CRC 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) and RAS wildtype, RAS mutant and RAS unknown status'}, {'id': 'OG007', 'title': 'Part 1: TNBC 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}, {'id': 'OG008', 'title': 'Part 1: Melanoma naïve + Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma, naïve and pretreated with immuno-oncology therapy'}, {'id': 'OG009', 'title': 'Part 1: DLBCL 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)'}, {'id': 'OG010', 'title': 'Part 1: DLBCL 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)'}, {'id': 'OG011', 'title': 'Part 1: mCRPC 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)'}, {'id': 'OG012', 'title': 'Part 2: NSCLC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG013', 'title': 'Part 2: NSCLC 160 mg 2wk-on/2wk-off', 'description': 'NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG014', 'title': 'Part 2: NSCLC 160 mg 1wk-on/1wk-off', 'description': 'NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG015', 'title': 'Part 3: TNBC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}], 'classes': [{'title': 'ADA-negative at baseline', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '49', 'groupId': 'OG006'}, {'value': '27', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}, {'value': '10', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '21', 'groupId': 'OG012'}, {'value': '19', 'groupId': 'OG013'}, {'value': '17', 'groupId': 'OG014'}, {'value': '6', 'groupId': 'OG015'}]}]}, {'title': 'ADA-positive at baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'ADA-negative post-baseline', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '48', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}, {'value': '13', 'groupId': 'OG008'}, {'value': '10', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '11', 'groupId': 'OG011'}, {'value': '21', 'groupId': 'OG012'}, {'value': '14', 'groupId': 'OG013'}, {'value': '14', 'groupId': 'OG014'}, {'value': '5', 'groupId': 'OG015'}]}]}, {'title': 'Treatment-reduced ADA-positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'Treatment-induced ADA-positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '5', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}]}]}, {'title': 'Treatment-boosted ADA-positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'ADA-inconclusive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 5 years', 'description': 'PDR001 immunogenicity was evaluated in serum samples. Patient anti-drug antibodies (ADA) status was defined as follows:\n\n* ADA-negative at baseline: ADA-negative sample at baseline\n* ADA-positive at baseline: ADA-positive sample at baseline\n* ADA-negative post-baseline: ADA-negative sample at baseline and at least 1 post-baseline sample, all of which are ADA-negative samples\n* Treatment-reduced ADA-positive: ADA-positive sample at baseline and at least 1 post-baseline sample, all of which are ADA-negative samples\n* Treatment-induced ADA-positive: ADA-negative sample at baseline and at least 1 treatment-induced ADA-positive sample\n* Treatment-boosted ADA-positive: ADA-positive sample at baseline and at least 1 treatment-boosted ADA-positive sample\n* ADA-inconclusive: patient who does not qualify for any of the above definitions or a patient for which the baseline sample is missing', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from Part 1, 2 and 3 who received at least 1 dose of NIR178 or PDR001 and had a determinant baseline immunogenicity (IG) sample and at least 1 determinant post-baseline IG sample for assessing anti-PDR001 antibodies. For the safety endpoints, patients at each study part with the same type of cancer who are treated at the same dose level and dosing schedule are pooled together, independently of the immune-oncology (IO) pretreatment status and RAS mutation status.'}, {'type': 'SECONDARY', 'title': 'Japan Safety Run-in: Number of Participants With Dose-Limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'JSR: 80 mg Cont', 'description': 'NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in'}, {'id': 'OG001', 'title': 'JSR: 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in'}, {'id': 'OG002', 'title': 'JSR: 240 mg Cont', 'description': 'NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications, which occurs within the first 28 days of treatment with NIR178 as single agent or in combination with PDR001 during the Japan safety run-in part of the study. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients in the Japan safety run-in who either met the minimum exposure criterion defined in the protocol and had sufficient safety evaluations, or had experienced a DLT during Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Japan Safety Run-in: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'JSR: 80 mg Cont', 'description': 'NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in'}, {'id': 'OG001', 'title': 'JSR: 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in'}, {'id': 'OG002', 'title': 'JSR: 240 mg Cont', 'description': 'NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Treatment-related AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Treatment-related SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Fatal SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Treatment-related fatal SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 0.7 years', 'description': 'Number of participants with AEs (any AE regardless of seriousness) and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs.\n\nThe on-treatment period is defined from the day of first administration of study treatment up to 30 days after the date of its last administration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients from the Japan safety run-in who received at least 1 dose of NIR178 or PDR001.'}, {'type': 'SECONDARY', 'title': 'All Study Parts: Maximum Observed Plasma Concentration (Cmax) of NIR178', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'NIR178 160 mg Capsule in Non-Japanese (Part 1 and 2)', 'description': 'Patients in Part 1 and 2 who received NIR178 160 mg as a capsule in combination with PDR001 400 mg every 4 weeks'}, {'id': 'OG001', 'title': 'NIR178 240 mg Capsule in Non-Japanese (Part 1)', 'description': 'Patients in Part 1 who received NIR178 240 mg as a capsule in combination with PDR001 400 mg every 4 weeks'}, {'id': 'OG002', 'title': 'NIR178 160 mg Tablet in Non-Japanese (Part 3)', 'description': 'Patients in Part 3 who received NIR178 160 mg as a film-coated tablet in combination with PDR001 400 mg every 4 weeks'}, {'id': 'OG003', 'title': 'JSR: 80 mg Cont', 'description': 'NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in'}, {'id': 'OG004', 'title': 'JSR: 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in'}, {'id': 'OG005', 'title': 'JSR: 240 mg Cont', 'description': 'NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in'}], 'classes': [{'title': 'Cycle 1 Day 1 (all regimens)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '129', 'spread': '335.0', 'groupId': 'OG000'}, {'value': '160', 'spread': '247.8', 'groupId': 'OG001'}, {'value': '75.1', 'spread': '382.3', 'groupId': 'OG002'}, {'value': '81.8', 'spread': '99.9', 'groupId': 'OG003'}, {'value': '30.1', 'spread': '32.9', 'groupId': 'OG004'}, {'value': '234', 'spread': '70.9', 'groupId': 'OG005'}]}]}, {'title': 'Cycle 1 Day 7 (1 wk-on/1 wk-off)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '576', 'spread': '83.1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 14 (2 wk-on/2 wk-off)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '392', 'spread': '212.7', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 28 (continuous)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '297', 'spread': '291.4', 'groupId': 'OG000'}, {'value': '622', 'spread': '154.3', 'groupId': 'OG001'}, {'value': '723', 'spread': '295.5', 'groupId': 'OG002'}, {'value': '311', 'spread': '91.5', 'groupId': 'OG003'}, {'value': '167', 'spread': '40.9', 'groupId': 'OG004'}, {'value': '3760', 'spread': '39.6', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 (all), Cycle 1 Day 7 (1wk-on/1wk-off), Cycle 1 Day 14 (2wk-on/2wk-off) and Cycle 1 Day 28 (continuous dosing): pre-dose, 15 and 30 minutes, 1, 1.5, 2, 3, 4 and 8 hours after morning dose and 12 hours after evening dose. 1 cycle=28 days', 'description': 'Pharmacokinetic (PK) parameters were calculated based on NIR178 plasma concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed plasma concentration following a dose.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the pharmacokinetic analysis set (PAS) who received NIR178 and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one PK parameter and did not vomit within 4 hours after dosing with NIR178. Patients from the same ethnicity (Non-Japanese, Japanese) treated with the same formulation (capsule, tablet) at the same NIR178 dose level are pooled together.'}, {'type': 'SECONDARY', 'title': 'All Study Parts: Time to Reach Maximum Plasma Concentration (Tmax) of NIR178', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'NIR178 160 mg Capsule in Non-Japanese (Part 1 and 2)', 'description': 'Patients in Part 1 and 2 who received NIR178 160 mg as a capsule in combination with PDR001 400 mg every 4 weeks'}, {'id': 'OG001', 'title': 'NIR178 240 mg Capsule in Non-Japanese (Part 1)', 'description': 'Patients in Part 1 who received NIR178 240 mg as a capsule in combination with PDR001 400 mg every 4 weeks'}, {'id': 'OG002', 'title': 'NIR178 160 mg Tablet in Non-Japanese (Part 3)', 'description': 'Patients in Part 3 who received NIR178 160 mg as a film-coated tablet in combination with PDR001 400 mg every 4 weeks'}, {'id': 'OG003', 'title': 'JSR: 80 mg Cont', 'description': 'NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in'}, {'id': 'OG004', 'title': 'JSR: 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in'}, {'id': 'OG005', 'title': 'JSR: 240 mg Cont', 'description': 'NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in'}], 'classes': [{'title': 'Cycle 1 Day 1 (all regimens)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '0.250', 'upperLimit': '8.00'}, {'value': '2.13', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '8.00'}, {'value': '1.50', 'groupId': 'OG002', 'lowerLimit': '0.450', 'upperLimit': '4.05'}, {'value': '1.50', 'groupId': 'OG003', 'lowerLimit': '1.47', 'upperLimit': '1.50'}, {'value': '1.50', 'groupId': 'OG004', 'lowerLimit': '0.583', 'upperLimit': '3.95'}, {'value': '3.00', 'groupId': 'OG005', 'lowerLimit': '2.03', 'upperLimit': '3.03'}]}]}, {'title': 'Cycle 1 Day 7 (1 wk-on/1 wk-off)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.45', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '4.00'}]}]}, {'title': 'Cycle 1 Day 14 (2 wk-on/2 wk-off)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.97', 'groupId': 'OG000', 'lowerLimit': '0.550', 'upperLimit': '7.67'}]}]}, {'title': 'Cycle 1 Day 28 (continuous)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '0.267', 'upperLimit': '8.00'}, {'value': '2.02', 'groupId': 'OG001', 'lowerLimit': '0.250', 'upperLimit': '7.60'}, {'value': '1.52', 'groupId': 'OG002', 'lowerLimit': '0.50', 'upperLimit': '3.00'}, {'value': '1.43', 'groupId': 'OG003', 'lowerLimit': '0.50', 'upperLimit': '1.48'}, {'value': '1.45', 'groupId': 'OG004', 'lowerLimit': '0.50', 'upperLimit': '1.50'}, {'value': '2.87', 'groupId': 'OG005', 'lowerLimit': '1.92', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 1 (all), Cycle 1 Day 7 (1wk-on/1wk-off), Cycle 1 Day 14 (2wk-on/2wk-off) and Cycle 1 Day 28 (continuous dosing): pre-dose, 15 and 30 minutes, 1, 1.5, 2, 3, 4 and 8 hours after morning dose and 12 hours after evening dose. 1 cycle=28 days', 'description': 'Pharmacokinetic (PK) parameters were calculated based on NIR178 plasma concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) plasma concentration following a dose. Actual recorded sampling times were considered for the calculations.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the pharmacokinetic analysis set (PAS) who received NIR178 and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one PK parameter and did not vomit within 4 hours after dosing with NIR178. Patients from the same ethnicity (Non-Japanese, Japanese) treated with the same formulation (capsule, tablet) at the same NIR178 dose level are pooled together.'}, {'type': 'SECONDARY', 'title': 'All Study Parts: Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC0-12hr) of NIR178', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'NIR178 160 mg Capsule in Non-Japanese (Part 1 and 2)', 'description': 'Patients in Part 1 and 2 who received NIR178 160 mg as a capsule in combination with PDR001 400 mg every 4 weeks'}, {'id': 'OG001', 'title': 'NIR178 240 mg Capsule in Non-Japanese (Part 1)', 'description': 'Patients in Part 1 who received NIR178 240 mg as a capsule in combination with PDR001 400 mg every 4 weeks'}, {'id': 'OG002', 'title': 'NIR178 160 mg Tablet in Non-Japanese (Part 3)', 'description': 'Patients in Part 3 who received NIR178 160 mg as a film-coated tablet in combination with PDR001 400 mg every 4 weeks'}, {'id': 'OG003', 'title': 'JSR: 80 mg Cont', 'description': 'NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in'}, {'id': 'OG004', 'title': 'JSR: 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in'}, {'id': 'OG005', 'title': 'JSR: 240 mg Cont', 'description': 'NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in'}], 'classes': [{'title': 'Cycle 1 Day 1 (all regimens)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '295', 'spread': '198.3', 'groupId': 'OG000'}, {'value': '487', 'spread': '126.3', 'groupId': 'OG001'}, {'value': '232', 'spread': '437.4', 'groupId': 'OG002'}, {'value': '170', 'spread': '124.9', 'groupId': 'OG003'}, {'value': '63.3', 'spread': '88.0', 'groupId': 'OG004'}, {'value': '550', 'groupId': 'OG005'}]}]}, {'title': 'Cycle 1 Day 7 (1 wk-on/1 wk-off)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1260', 'spread': '63.2', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 14 (2 wk-on/2 wk-off)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1680', 'spread': '94.4', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 28 (continuous)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '918', 'spread': '187.5', 'groupId': 'OG000'}, {'value': '1620', 'spread': '147.9', 'groupId': 'OG001'}, {'value': '938', 'spread': '412.2', 'groupId': 'OG002'}, {'value': '697', 'spread': '131.8', 'groupId': 'OG003'}, {'value': '242', 'spread': '13.5', 'groupId': 'OG004'}, {'value': '12800', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 (all), Cycle 1 Day 7 (1wk-on/1wk-off), Cycle 1 Day 14 (2wk-on/2wk-off) and Cycle 1 Day 28 (continuous dosing): pre-dose, 15 and 30 minutes, 1, 1.5, 2, 3, 4 and 8 hours after morning dose and 12 hours after evening dose. 1 cycle=28 days', 'description': 'PK parameters were calculated based on NIR178 plasma concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC0-12hr calculation.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the pharmacokinetic analysis set (PAS) who received NIR178 and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one PK parameter and did not vomit within 4 hours after dosing with NIR178. Patients from the same ethnicity (Non-Japanese, Japanese) treated with the same formulation (capsule, tablet) at the same NIR178 dose level are pooled together.'}, {'type': 'SECONDARY', 'title': 'All Study Parts: Maximum Observed Plasma Concentration (Cmax) of NJI765 (NIR178 Metabolite)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'NIR178 160 mg Capsule in Non-Japanese (Part 1 and 2)', 'description': 'Patients in Part 1 and 2 who received NIR178 160 mg as a capsule in combination with PDR001 400 mg every 4 weeks'}, {'id': 'OG001', 'title': 'NIR178 240 mg Capsule in Non-Japanese (Part 1)', 'description': 'Patients in Part 1 who received NIR178 240 mg as a capsule in combination with PDR001 400 mg every 4 weeks'}, {'id': 'OG002', 'title': 'NIR178 160 mg Tablet in Non-Japanese (Part 3)', 'description': 'Patients in Part 3 who received NIR178 160 mg as a film-coated tablet in combination with PDR001 400 mg every 4 weeks'}, {'id': 'OG003', 'title': 'JSR: 80 mg Cont', 'description': 'NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in'}, {'id': 'OG004', 'title': 'JSR: 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in'}, {'id': 'OG005', 'title': 'JSR: 240 mg Cont', 'description': 'NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in'}], 'classes': [{'title': 'Cycle 1 Day 1 (all regimens)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '25.5', 'spread': '85.2', 'groupId': 'OG000'}, {'value': '33.7', 'spread': '64.2', 'groupId': 'OG001'}, {'value': '20.1', 'spread': '99.2', 'groupId': 'OG002'}, {'value': '25.9', 'spread': '77.0', 'groupId': 'OG004'}, {'value': '28.5', 'spread': '99.9', 'groupId': 'OG005'}]}]}, {'title': 'Cycle 1 Day 7 (1 wk-on/1 wk-off)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '62.9', 'spread': '39.4', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 14 (2 wk-on/2 wk-off)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '71.3', 'spread': '43.3', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 28 (continuous)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '42.6', 'spread': '82.2', 'groupId': 'OG000'}, {'value': '77.3', 'spread': '49.9', 'groupId': 'OG001'}, {'value': '54.1', 'spread': '102.4', 'groupId': 'OG002'}, {'value': '45.6', 'spread': '74.0', 'groupId': 'OG003'}, {'value': '53.9', 'spread': '64.2', 'groupId': 'OG004'}, {'value': '111', 'spread': '36.6', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 (all), Cycle 1 Day 7 (1wk-on/1wk-off), Cycle 1 Day 14 (2wk-on/2wk-off) and Cycle 1 Day 28 (continuous dosing): pre-dose, 15 and 30 minutes, 1, 1.5, 2, 3, 4 and 8 hours after morning dose and 12 hours after evening dose. 1 cycle=28 days', 'description': 'NJI765 is a NIR178 metabolite. PK parameters were calculated based on NJI765 plasma concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed plasma concentration following a dose.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the pharmacokinetic analysis set (PAS) who received NIR178 and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one PK parameter and did not vomit within 4 hours after dosing with NIR178. Patients from the same ethnicity (Non-Japanese, Japanese) treated with the same formulation (capsule, tablet) at the same NIR178 dose level are pooled together.'}, {'type': 'SECONDARY', 'title': 'All Study Parts: Time to Reach Maximum Plasma Concentration (Tmax) of NJI765 (NIR178 Metabolite)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'NIR178 160 mg Capsule in Non-Japanese (Part 1 and 2)', 'description': 'Patients in Part 1 and 2 who received NIR178 160 mg as a capsule in combination with PDR001 400 mg every 4 weeks'}, {'id': 'OG001', 'title': 'NIR178 240 mg Capsule in Non-Japanese (Part 1)', 'description': 'Patients in Part 1 who received NIR178 240 mg as a capsule in combination with PDR001 400 mg every 4 weeks'}, {'id': 'OG002', 'title': 'NIR178 160 mg Tablet in Non-Japanese (Part 3)', 'description': 'Patients in Part 3 who received NIR178 160 mg as a film-coated tablet in combination with PDR001 400 mg every 4 weeks'}, {'id': 'OG003', 'title': 'JSR: 80 mg Cont', 'description': 'NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in'}, {'id': 'OG004', 'title': 'JSR: 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in'}, {'id': 'OG005', 'title': 'JSR: 240 mg Cont', 'description': 'NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in'}], 'classes': [{'title': 'Cycle 1 Day 1 (all regimens)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '0.250', 'upperLimit': '8.05'}, {'value': '2.08', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '8.00'}, {'value': '2.10', 'groupId': 'OG002', 'lowerLimit': '0.450', 'upperLimit': '4.05'}, {'value': '1.95', 'groupId': 'OG004', 'lowerLimit': '0.583', 'upperLimit': '2.00'}, {'value': '3.00', 'groupId': 'OG005', 'lowerLimit': '2.03', 'upperLimit': '3.03'}]}]}, {'title': 'Cycle 1 Day 7 (1 wk-on/1 wk-off)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.50', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '4.00'}]}]}, {'title': 'Cycle 1 Day 14 (2 wk-on/2 wk-off)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.98', 'groupId': 'OG000', 'lowerLimit': '0.550', 'upperLimit': '3.00'}]}]}, {'title': 'Cycle 1 Day 28 (continuous)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '0.483', 'upperLimit': '8.03'}, {'value': '2.10', 'groupId': 'OG001', 'lowerLimit': '0.250', 'upperLimit': '7.88'}, {'value': '0.750', 'groupId': 'OG002', 'lowerLimit': '0.50', 'upperLimit': '2.03'}, {'value': '2.23', 'groupId': 'OG003', 'lowerLimit': '1.43', 'upperLimit': '3.02'}, {'value': '1.45', 'groupId': 'OG004', 'lowerLimit': '0.50', 'upperLimit': '1.50'}, {'value': '2.87', 'groupId': 'OG005', 'lowerLimit': '1.92', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 1 (all), Cycle 1 Day 7 (1wk-on/1wk-off), Cycle 1 Day 14 (2wk-on/2wk-off) and Cycle 1 Day 28 (continuous dosing): pre-dose, 15 and 30 minutes, 1, 1.5, 2, 3, 4 and 8 hours after morning dose and 12 hours after evening dose. 1 cycle=28 days', 'description': 'NJI765 is a NIR178 metabolite. Pharmacokinetic (PK) parameters were calculated based on NJI765 plasma concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) plasma concentration following a dose. Actual recorded sampling times were considered for the calculations.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the pharmacokinetic analysis set (PAS) who received NIR178 and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one PK parameter and did not vomit within 4 hours after dosing with NIR178. Patients from the same ethnicity (Non-Japanese, Japanese) treated with the same formulation (capsule, tablet) at the same NIR178 dose level are pooled together.'}, {'type': 'SECONDARY', 'title': 'All Study Parts: Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC0-12hr) of NJI765 (NIR178 Metabolite)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'NIR178 160 mg Capsule in Non-Japanese (Part 1 and 2)', 'description': 'Patients in Part 1 and 2 who received NIR178 160 mg as a capsule in combination with PDR001 400 mg every 4 weeks'}, {'id': 'OG001', 'title': 'NIR178 240 mg Capsule in Non-Japanese (Part 1)', 'description': 'Patients in Part 1 who received NIR178 240 mg as a capsule in combination with PDR001 400 mg every 4 weeks'}, {'id': 'OG002', 'title': 'NIR178 160 mg Tablet in Non-Japanese (Part 3)', 'description': 'Patients in Part 3 who received NIR178 160 mg as a film-coated tablet in combination with PDR001 400 mg every 4 weeks'}, {'id': 'OG003', 'title': 'JSR: 80 mg Cont', 'description': 'NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in'}, {'id': 'OG004', 'title': 'JSR: 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in'}, {'id': 'OG005', 'title': 'JSR: 240 mg Cont', 'description': 'NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in'}], 'classes': [{'title': 'Cycle 1 Day 1 (all regimens)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '98.2', 'spread': '87.1', 'groupId': 'OG000'}, {'value': '122', 'spread': '75.6', 'groupId': 'OG001'}, {'value': '77.1', 'spread': '35.9', 'groupId': 'OG002'}, {'value': '117', 'spread': '68.2', 'groupId': 'OG004'}, {'value': '119', 'groupId': 'OG005'}]}]}, {'title': 'Cycle 1 Day 7 (1 wk-on/1 wk-off)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '243', 'spread': '57.5', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 14 (2 wk-on/2 wk-off)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '288', 'spread': '23.7', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 28 (continuous)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '214', 'spread': '76.6', 'groupId': 'OG000'}, {'value': '382', 'spread': '43.7', 'groupId': 'OG001'}, {'value': '226', 'spread': '147.0', 'groupId': 'OG002'}, {'value': '277', 'spread': '69.0', 'groupId': 'OG004'}, {'value': '362', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 (all), Cycle 1 Day 7 (1wk-on/1wk-off), Cycle 1 Day 14 (2wk-on/2wk-off) and Cycle 1 Day 28 (continuous dosing): pre-dose, 15 and 30 minutes, 1, 1.5, 2, 3, 4 and 8 hours after morning dose and 12 hours after evening dose. 1 cycle=28 days', 'description': 'NJI765 is a NIR178 metabolite. PK parameters were calculated based on NJI765 plasma concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC0-12hr calculation.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the pharmacokinetic analysis set (PAS) who received NIR178 and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one PK parameter and did not vomit within 4 hours after dosing with NIR178. Patients from the same ethnicity (Non-Japanese, Japanese) treated with the same formulation (capsule, tablet) at the same NIR178 dose level are pooled together.'}, {'type': 'SECONDARY', 'title': 'All Study Parts: Maximum Observed Serum Concentration (Cmax) of PDR001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Japanese Patients', 'description': 'Patients in Parts 1, 2 and 3 who received NIR178 (any dose level) in combination with PDR001 400 mg every 4 weeks'}, {'id': 'OG001', 'title': 'Japanese Patients', 'description': 'Patients in the Japanese safety run-in part who received NIR178 (any dose level) in combination with PDR001 400 mg every 4 weeks'}], 'classes': [{'title': 'First dose (Cycle 1 Day 1 or Cycle 2 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93.2', 'spread': '30.8', 'groupId': 'OG000'}, {'value': '85.0', 'spread': '12.8', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '126', 'spread': '37.4', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'First dose (Cycle 1 Day 1 or Cycle 2 Day 1 for Japanese patients treated with NIR178 80 or 160 mg) and Cycle 3 Day 1: pre-infusion, 1, 168, 336, 504 and 672 hours after end of infusion. Average duration of infusion=30 minutes. 1 cycle=28 days', 'description': 'PK parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the pharmacokinetic analysis set (PAS) who received PDR001 and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one PK parameter and did not vomit within 4 hours after dosing with NIR178. Patients from the same ethnicity (Non-Japanese, Japanese) treated at the same PDR001 dose level are pooled together.'}, {'type': 'SECONDARY', 'title': 'All Study Parts: Time to Reach Maximum Serum Concentration (Tmax) of PDR001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Japanese Patients', 'description': 'Patients in Parts 1, 2 and 3 who received NIR178 (any dose level) in combination with PDR001 400 mg every 4 weeks'}, {'id': 'OG001', 'title': 'Japanese Patients', 'description': 'Patients in the Japanese safety run-in part who received NIR178 (any dose level) in combination with PDR001 400 mg every 4 weeks'}], 'classes': [{'title': 'First dose (Cycle 1 Day 1 or Cycle 2 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.50', 'groupId': 'OG000', 'lowerLimit': '0.333', 'upperLimit': '718'}, {'value': '1.50', 'groupId': 'OG001', 'lowerLimit': '1.48', 'upperLimit': '1.52'}]}]}, {'title': 'Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.50', 'groupId': 'OG000', 'lowerLimit': '0.550', 'upperLimit': '358'}, {'value': '1.65', 'groupId': 'OG001', 'lowerLimit': '1.65', 'upperLimit': '1.65'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'First dose (Cycle 1 Day 1 or Cycle 2 Day 1 for Japanese patients treated with NIR178 80 or 160 mg) and Cycle 3 Day 1: pre-infusion, 1, 168, 336, 504 and 672 hours after end of infusion. Average duration of infusion=30 minutes. 1 cycle=28 days', 'description': 'PK parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the pharmacokinetic analysis set (PAS) who received PDR001 and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one PK parameter and did not vomit within 4 hours after dosing with NIR178. Patients from the same ethnicity (Non-Japanese, Japanese) treated at the same PDR001 dose level are pooled together.'}, {'type': 'SECONDARY', 'title': 'All Study Parts: Area Under the Serum Concentration-time Curve From Time Zero to 28 Days Post Dose (AUC0-28day) of PDR001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Japanese Patients', 'description': 'Patients in Parts 1, 2 and 3 who received NIR178 (any dose level) in combination with PDR001 400 mg every 4 weeks'}, {'id': 'OG001', 'title': 'Japanese Patients', 'description': 'Patients in the Japanese safety run-in part who received NIR178 (any dose level) in combination with PDR001 400 mg every 4 weeks'}], 'classes': [{'title': 'First dose (Cycle 1 Day 1 or Cycle 2 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1140', 'spread': '31.2', 'groupId': 'OG000'}, {'value': '1110', 'spread': '13.9', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2030', 'spread': '41.3', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'First dose (Cycle 1 Day 1 or Cycle 2 Day 1 for Japanese patients treated with NIR178 80 or 160 mg) and Cycle 3 Day 1: pre-infusion, 1, 168, 336, 504 and 672 hours after end of infusion. Average duration of infusion=30 minutes. 1 cycle=28 days', 'description': 'PK parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC0-28day calculation.', 'unitOfMeasure': 'day*µg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the pharmacokinetic analysis set (PAS) who received PDR001 and had an available value for the outcome measure at each timepoint. PAS consists of all patients who received one of the planned treatments, provided at least one PK parameter and did not vomit within 4 hours after dosing with NIR178. Patients from the same ethnicity (Non-Japanese, Japanese) treated at the same PDR001 dose level are pooled together.'}, {'type': 'POST_HOC', 'title': 'All-Collected Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '58', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '15', 'groupId': 'OG011'}, {'value': '22', 'groupId': 'OG012'}, {'value': '20', 'groupId': 'OG013'}, {'value': '20', 'groupId': 'OG014'}, {'value': '6', 'groupId': 'OG015'}, {'value': '3', 'groupId': 'OG016'}, {'value': '3', 'groupId': 'OG017'}, {'value': '3', 'groupId': 'OG018'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: RCC naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'OG001', 'title': 'Part 1: RCC naïve + Pre 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC), naïve and pretreated with immuno-oncology therapy'}, {'id': 'OG002', 'title': 'Part 1: Pancreatic 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer'}, {'id': 'OG003', 'title': 'Part 1: Urothelial 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer'}, {'id': 'OG004', 'title': 'Part 1: H-N naïve + Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC), naïve and pretreated with immuno-oncology therapy'}, {'id': 'OG005', 'title': 'Part 1: H-N Pre 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'OG006', 'title': 'Part 1: MSS CRC 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) and RAS wildtype, RAS mutant and RAS unknown status'}, {'id': 'OG007', 'title': 'Part 1: TNBC 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}, {'id': 'OG008', 'title': 'Part 1: Melanoma naïve + Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma, naïve and pretreated with immuno-oncology therapy'}, {'id': 'OG009', 'title': 'Part 1: DLBCL 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)'}, {'id': 'OG010', 'title': 'Part 1: DLBCL 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)'}, {'id': 'OG011', 'title': 'Part 1: mCRPC 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)'}, {'id': 'OG012', 'title': 'Part 2: NSCLC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG013', 'title': 'Part 2: NSCLC 160 mg 2wk-on/2wk-off', 'description': 'NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG014', 'title': 'Part 2: NSCLC 160 mg 1wk-on/1wk-off', 'description': 'NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'OG015', 'title': 'Part 3: TNBC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}, {'id': 'OG016', 'title': 'JSR: 80 mg Cont', 'description': 'NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in'}, {'id': 'OG017', 'title': 'JSR: 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in'}, {'id': 'OG018', 'title': 'JSR: 240 mg Cont', 'description': 'NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in'}], 'classes': [{'title': 'On-treatment and post-treatment safety follow-up deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '58', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '15', 'groupId': 'OG011'}, {'value': '22', 'groupId': 'OG012'}, {'value': '20', 'groupId': 'OG013'}, {'value': '20', 'groupId': 'OG014'}, {'value': '6', 'groupId': 'OG015'}, {'value': '3', 'groupId': 'OG016'}, {'value': '3', 'groupId': 'OG017'}, {'value': '3', 'groupId': 'OG018'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '22', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '4', 'groupId': 'OG013'}, {'value': '6', 'groupId': 'OG014'}, {'value': '4', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '1', 'groupId': 'OG018'}]}]}, {'title': 'Survival follow-up deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '36', 'groupId': 'OG006'}, {'value': '21', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '13', 'groupId': 'OG011'}, {'value': '16', 'groupId': 'OG012'}, {'value': '16', 'groupId': 'OG013'}, {'value': '14', 'groupId': 'OG014'}, {'value': '2', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '1', 'groupId': 'OG018'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '22', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}, {'value': '8', 'groupId': 'OG012'}, {'value': '9', 'groupId': 'OG013'}, {'value': '7', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG018'}]}]}, {'title': 'All deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '58', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '15', 'groupId': 'OG011'}, {'value': '22', 'groupId': 'OG012'}, {'value': '20', 'groupId': 'OG013'}, {'value': '20', 'groupId': 'OG014'}, {'value': '6', 'groupId': 'OG015'}, {'value': '3', 'groupId': 'OG016'}, {'value': '3', 'groupId': 'OG017'}, {'value': '3', 'groupId': 'OG018'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '44', 'groupId': 'OG006'}, {'value': '21', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}, {'value': '9', 'groupId': 'OG011'}, {'value': '14', 'groupId': 'OG012'}, {'value': '13', 'groupId': 'OG013'}, {'value': '13', 'groupId': 'OG014'}, {'value': '5', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '2', 'groupId': 'OG018'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'On-treatment and safety follow-up (FU) deaths: up to 4.3 years (Part 1), 5.1 years (Part 2), 0.9 years (Part 3) and 0.9 years (JSR). Survival FU deaths: up to 4.3 years (Part 1), 5.1 years (Part 2) and 0.9 years (Part 3) and 0.9 years (JSR)', 'description': 'On-treatment and post-treatment safety follow-up deaths were collected from first dose of study medication to 150 days after last dose of NIR178+PDR001. Survival follow-up deaths were collected from 151 days after last dose of NIR178+PDR001 until end of study. All deaths refer to the sum of on-treatment and post-treatment safety follow-up deaths plus survival follow-up deaths.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received at least one dose of study treatment. Patients at each study part with the same type of cancer who are treated at the same dose level and dosing schedule are pooled together, independently of the immune-oncology (IO) pretreatment status and RAS mutation status.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1: RCC naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'FG001', 'title': 'Part 1: RCC naïve 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'FG002', 'title': 'Part 1: RCC Pre 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'FG003', 'title': 'Part 1: Pancreatic 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer'}, {'id': 'FG004', 'title': 'Part 1: Urothelial 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer'}, {'id': 'FG005', 'title': 'Part 1: H-N naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'FG006', 'title': 'Part 1: H-N Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'FG007', 'title': 'Part 1: H-N Pre 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'FG008', 'title': 'Part 1: MSS CRC wt 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype'}, {'id': 'FG009', 'title': 'Part 1: MSS CRC mu 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant'}, {'id': 'FG010', 'title': 'Part 1: MSS CRC Unk 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with unknown RAS status'}, {'id': 'FG011', 'title': 'Part 1: TNBC 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}, {'id': 'FG012', 'title': 'Part 1: Melanoma naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had not been previously treated with immuno-oncology therapy'}, {'id': 'FG013', 'title': 'Part 1: Melanoma Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy'}, {'id': 'FG014', 'title': 'Part 1: DLBCL 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)'}, {'id': 'FG015', 'title': 'Part 1: DLBCL 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)'}, {'id': 'FG016', 'title': 'Part 1: mCRPC 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)'}, {'id': 'FG017', 'title': 'Part 2: NSCLC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'FG018', 'title': 'Part 2: NSCLC 160 mg 2wk-on/2wk-off', 'description': 'NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'FG019', 'title': 'Part 2: NSCLC 160 mg 1wk-on/1wk-off', 'description': 'NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'FG020', 'title': 'Part 3: TNBC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}, {'id': 'FG021', 'title': 'JSR: 80 mg Cont', 'description': 'NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in'}, {'id': 'FG022', 'title': 'JSR: 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in'}, {'id': 'FG023', 'title': 'JSR: 240 mg Cont', 'description': 'NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '14'}, {'groupId': 'FG005', 'numSubjects': '15'}, {'groupId': 'FG006', 'numSubjects': '11'}, {'groupId': 'FG007', 'numSubjects': '12'}, {'groupId': 'FG008', 'numSubjects': '27'}, {'groupId': 'FG009', 'numSubjects': '29'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '30'}, {'groupId': 'FG012', 'numSubjects': '3'}, {'groupId': 'FG013', 'numSubjects': '13'}, {'groupId': 'FG014', 'numSubjects': '13'}, {'groupId': 'FG015', 'numSubjects': '6'}, {'groupId': 'FG016', 'numSubjects': '15'}, {'groupId': 'FG017', 'numSubjects': '22'}, {'groupId': 'FG018', 'numSubjects': '20'}, {'groupId': 'FG019', 'numSubjects': '20'}, {'groupId': 'FG020', 'numSubjects': '6'}, {'groupId': 'FG021', 'numSubjects': '3'}, {'groupId': 'FG022', 'numSubjects': '3'}, {'groupId': 'FG023', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '0'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '0'}, {'groupId': 'FG023', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '14'}, {'groupId': 'FG005', 'numSubjects': '15'}, {'groupId': 'FG006', 'numSubjects': '11'}, {'groupId': 'FG007', 'numSubjects': '12'}, {'groupId': 'FG008', 'numSubjects': '27'}, {'groupId': 'FG009', 'numSubjects': '29'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '30'}, {'groupId': 'FG012', 'numSubjects': '3'}, {'groupId': 'FG013', 'numSubjects': '13'}, {'groupId': 'FG014', 'numSubjects': '13'}, {'groupId': 'FG015', 'numSubjects': '6'}, {'groupId': 'FG016', 'numSubjects': '15'}, {'groupId': 'FG017', 'numSubjects': '22'}, {'groupId': 'FG018', 'numSubjects': '20'}, {'groupId': 'FG019', 'numSubjects': '20'}, {'groupId': 'FG020', 'numSubjects': '6'}, {'groupId': 'FG021', 'numSubjects': '3'}, {'groupId': 'FG022', 'numSubjects': '3'}, {'groupId': 'FG023', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '3'}, {'groupId': 'FG017', 'numSubjects': '1'}, {'groupId': 'FG018', 'numSubjects': '2'}, {'groupId': 'FG019', 'numSubjects': '1'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '0'}, {'groupId': 'FG023', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '2'}, {'groupId': 'FG018', 'numSubjects': '0'}, {'groupId': 'FG019', 'numSubjects': '1'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '0'}, {'groupId': 'FG023', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '4'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '4'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '2'}, {'groupId': 'FG015', 'numSubjects': '1'}, {'groupId': 'FG016', 'numSubjects': '1'}, {'groupId': 'FG017', 'numSubjects': '2'}, {'groupId': 'FG018', 'numSubjects': '1'}, {'groupId': 'FG019', 'numSubjects': '3'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '0'}, {'groupId': 'FG023', 'numSubjects': '0'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '9'}, {'groupId': 'FG007', 'numSubjects': '8'}, {'groupId': 'FG008', 'numSubjects': '19'}, {'groupId': 'FG009', 'numSubjects': '23'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '24'}, {'groupId': 'FG012', 'numSubjects': '3'}, {'groupId': 'FG013', 'numSubjects': '11'}, {'groupId': 'FG014', 'numSubjects': '9'}, {'groupId': 'FG015', 'numSubjects': '5'}, {'groupId': 'FG016', 'numSubjects': '10'}, {'groupId': 'FG017', 'numSubjects': '14'}, {'groupId': 'FG018', 'numSubjects': '13'}, {'groupId': 'FG019', 'numSubjects': '14'}, {'groupId': 'FG020', 'numSubjects': '6'}, {'groupId': 'FG021', 'numSubjects': '3'}, {'groupId': 'FG022', 'numSubjects': '3'}, {'groupId': 'FG023', 'numSubjects': '3'}]}, {'type': 'Patient/guardian Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '2'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '1'}, {'groupId': 'FG017', 'numSubjects': '3'}, {'groupId': 'FG018', 'numSubjects': '4'}, {'groupId': 'FG019', 'numSubjects': '1'}, {'groupId': 'FG020', 'numSubjects': '0'}, {'groupId': 'FG021', 'numSubjects': '0'}, {'groupId': 'FG022', 'numSubjects': '0'}, {'groupId': 'FG023', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in 21 investigative sites in 15 countries.', 'preAssignmentDetails': 'The screening period began once patients had signed the study informed consent. Screening evaluations had to be completed within 21 days prior to the first dose of treatment except for the radiological tumor assessment which had to be performed within 28 days prior to the first dose. After screening, the treatment period started on Cycle 1 Day 1.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '27', 'groupId': 'BG008'}, {'value': '29', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '30', 'groupId': 'BG011'}, {'value': '3', 'groupId': 'BG012'}, {'value': '13', 'groupId': 'BG013'}, {'value': '13', 'groupId': 'BG014'}, {'value': '6', 'groupId': 'BG015'}, {'value': '15', 'groupId': 'BG016'}, {'value': '22', 'groupId': 'BG017'}, {'value': '20', 'groupId': 'BG018'}, {'value': '20', 'groupId': 'BG019'}, {'value': '6', 'groupId': 'BG020'}, {'value': '3', 'groupId': 'BG021'}, {'value': '3', 'groupId': 'BG022'}, {'value': '3', 'groupId': 'BG023'}, {'value': '315', 'groupId': 'BG024'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1: RCC naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'BG001', 'title': 'Part 1: RCC naïve 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'BG002', 'title': 'Part 1: RCC Pre 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with renal cell carcinoma (RCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'BG003', 'title': 'Part 1: Pancreatic 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with pancreatic cancer'}, {'id': 'BG004', 'title': 'Part 1: Urothelial 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with urothelial cancer'}, {'id': 'BG005', 'title': 'Part 1: H-N naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had not been previously treated with immuno-oncology therapy'}, {'id': 'BG006', 'title': 'Part 1: H-N Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'BG007', 'title': 'Part 1: H-N Pre 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with squamous cell carcinoma of head and neck (HNSCC) who had been pretreated with immuno-oncology therapy'}, {'id': 'BG008', 'title': 'Part 1: MSS CRC wt 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS wildtype'}, {'id': 'BG009', 'title': 'Part 1: MSS CRC mu 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with RAS mutant'}, {'id': 'BG010', 'title': 'Part 1: MSS CRC Unk 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with microsatellite stable colorectal cancer (MSS CRC) with unknown RAS status'}, {'id': 'BG011', 'title': 'Part 1: TNBC 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}, {'id': 'BG012', 'title': 'Part 1: Melanoma naïve 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had not been previously treated with immuno-oncology therapy'}, {'id': 'BG013', 'title': 'Part 1: Melanoma Pre 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with cutaneous melanoma who had been pretreated with immuno-oncology therapy'}, {'id': 'BG014', 'title': 'Part 1: DLBCL 160 mg', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)'}, {'id': 'BG015', 'title': 'Part 1: DLBCL 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with diffuse large B-cell lymphoma (DLBCL)'}, {'id': 'BG016', 'title': 'Part 1: mCRPC 240 mg', 'description': 'NIR178 240 mg twice daily continuous in combination with PDR001 in patients with metastatic castration resistant prostate cancer (mCRPC)'}, {'id': 'BG017', 'title': 'Part 2: NSCLC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'BG018', 'title': 'Part 2: NSCLC 160 mg 2wk-on/2wk-off', 'description': 'NIR178 160 mg twice daily 2 weeks on/2 weeks off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'BG019', 'title': 'Part 2: NSCLC 160 mg 1wk-on/1wk-off', 'description': 'NIR178 160 mg twice daily 1 week on/1 week off in combination with PDR001 in patients with non-small cell lung cancer (NSCLC)'}, {'id': 'BG020', 'title': 'Part 3: TNBC 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 in patients with triple negative breast cancer (TNBC)'}, {'id': 'BG021', 'title': 'JSR: 80 mg Cont', 'description': 'NIR178 80 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in'}, {'id': 'BG022', 'title': 'JSR: 160 mg Cont', 'description': 'NIR178 160 mg twice daily continuous in combination with PDR001 (starting Cycle 2 Day 1) in the Japan safety run-in'}, {'id': 'BG023', 'title': 'JSR: 240 mg Cont', 'description': 'NIR178 140 mg twice daily continuous in combination with PDR001 (starting Cycle 1 Day 1) in the Japan safety run-in'}, {'id': 'BG024', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.5', 'spread': '10.86', 'groupId': 'BG000'}, {'value': '60.0', 'spread': '11.96', 'groupId': 'BG001'}, {'value': '60.6', 'spread': '8.54', 'groupId': 'BG002'}, {'value': '60.4', 'spread': '8.98', 'groupId': 'BG003'}, {'value': '66.9', 'spread': '9.63', 'groupId': 'BG004'}, {'value': '61.6', 'spread': '7.13', 'groupId': 'BG005'}, {'value': '59.4', 'spread': '9.05', 'groupId': 'BG006'}, {'value': '60.2', 'spread': '7.07', 'groupId': 'BG007'}, {'value': '56.5', 'spread': '9.04', 'groupId': 'BG008'}, {'value': '58.1', 'spread': '11.21', 'groupId': 'BG009'}, {'value': '46.0', 'spread': '15.56', 'groupId': 'BG010'}, {'value': '49.8', 'spread': '10.81', 'groupId': 'BG011'}, {'value': '50.3', 'spread': '20.65', 'groupId': 'BG012'}, {'value': '54.2', 'spread': '14.87', 'groupId': 'BG013'}, {'value': '55.0', 'spread': '18.65', 'groupId': 'BG014'}, {'value': '61.5', 'spread': '13.10', 'groupId': 'BG015'}, {'value': '68.3', 'spread': '8.14', 'groupId': 'BG016'}, {'value': '65.0', 'spread': '9.02', 'groupId': 'BG017'}, {'value': '61.8', 'spread': '9.51', 'groupId': 'BG018'}, {'value': '64.2', 'spread': '8.94', 'groupId': 'BG019'}, {'value': '58.5', 'spread': '16.16', 'groupId': 'BG020'}, {'value': '61.3', 'spread': '10.69', 'groupId': 'BG021'}, {'value': '57.0', 'spread': '9.54', 'groupId': 'BG022'}, {'value': '44.3', 'spread': '8.33', 'groupId': 'BG023'}, {'value': '59.5', 'spread': '11.59', 'groupId': 'BG024'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '30', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '3', 'groupId': 'BG013'}, {'value': '7', 'groupId': 'BG014'}, {'value': '3', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '7', 'groupId': 'BG017'}, {'value': '7', 'groupId': 'BG018'}, {'value': '8', 'groupId': 'BG019'}, {'value': '6', 'groupId': 'BG020'}, {'value': '3', 'groupId': 'BG021'}, {'value': '1', 'groupId': 'BG022'}, {'value': '1', 'groupId': 'BG023'}, {'value': '119', 'groupId': 'BG024'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '18', 'groupId': 'BG008'}, {'value': '21', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}, {'value': '10', 'groupId': 'BG013'}, {'value': '6', 'groupId': 'BG014'}, {'value': '3', 'groupId': 'BG015'}, {'value': '15', 'groupId': 'BG016'}, {'value': '15', 'groupId': 'BG017'}, {'value': '13', 'groupId': 'BG018'}, {'value': '12', 'groupId': 'BG019'}, {'value': '0', 'groupId': 'BG020'}, {'value': '0', 'groupId': 'BG021'}, {'value': '2', 'groupId': 'BG022'}, {'value': '2', 'groupId': 'BG023'}, {'value': '196', 'groupId': 'BG024'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '20', 'groupId': 'BG008'}, {'value': '23', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '21', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '13', 'groupId': 'BG013'}, {'value': '7', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '13', 'groupId': 'BG016'}, {'value': '10', 'groupId': 'BG017'}, {'value': '7', 'groupId': 'BG018'}, {'value': '7', 'groupId': 'BG019'}, {'value': '1', 'groupId': 'BG020'}, {'value': '0', 'groupId': 'BG021'}, {'value': '0', 'groupId': 'BG022'}, {'value': '0', 'groupId': 'BG023'}, {'value': '200', 'groupId': 'BG024'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}, {'value': '0', 'groupId': 'BG019'}, {'value': '0', 'groupId': 'BG020'}, {'value': '3', 'groupId': 'BG021'}, {'value': '3', 'groupId': 'BG022'}, {'value': '3', 'groupId': 'BG023'}, {'value': '10', 'groupId': 'BG024'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '4', 'groupId': 'BG014'}, {'value': '6', 'groupId': 'BG015'}, {'value': '2', 'groupId': 'BG016'}, {'value': '11', 'groupId': 'BG017'}, {'value': '13', 'groupId': 'BG018'}, {'value': '12', 'groupId': 'BG019'}, {'value': '0', 'groupId': 'BG020'}, {'value': '0', 'groupId': 'BG021'}, {'value': '0', 'groupId': 'BG022'}, {'value': '0', 'groupId': 'BG023'}, {'value': '78', 'groupId': 'BG024'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}, {'value': '0', 'groupId': 'BG019'}, {'value': '0', 'groupId': 'BG020'}, {'value': '0', 'groupId': 'BG021'}, {'value': '0', 'groupId': 'BG022'}, {'value': '0', 'groupId': 'BG023'}, {'value': '1', 'groupId': 'BG024'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '1', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}, {'value': '0', 'groupId': 'BG019'}, {'value': '3', 'groupId': 'BG020'}, {'value': '0', 'groupId': 'BG021'}, {'value': '0', 'groupId': 'BG022'}, {'value': '0', 'groupId': 'BG023'}, {'value': '5', 'groupId': 'BG024'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '7', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '2', 'groupId': 'BG014'}, {'value': '0', 'groupId': 'BG015'}, {'value': '0', 'groupId': 'BG016'}, {'value': '0', 'groupId': 'BG017'}, {'value': '0', 'groupId': 'BG018'}, {'value': '1', 'groupId': 'BG019'}, {'value': '2', 'groupId': 'BG020'}, {'value': '0', 'groupId': 'BG021'}, {'value': '0', 'groupId': 'BG022'}, {'value': '0', 'groupId': 'BG023'}, {'value': '21', 'groupId': 'BG024'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-22', 'size': 1899298, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-02-05T10:48', 'hasProtocol': True}, {'date': '2023-04-12', 'size': 977327, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-02-05T10:48', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Part 1, Part 3 and the Japanese safety run-in part were not randomized. In Part 2, patients were randomized to one of the 3 treatment arms in a ratio of 1:1:1.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 315}}, 'statusModule': {'whyStopped': 'Sponsor decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-07', 'studyFirstSubmitDate': '2017-06-19', 'resultsFirstSubmitDate': '2024-02-05', 'studyFirstSubmitQcDate': '2017-06-30', 'lastUpdatePostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-05', 'studyFirstPostDateStruct': {'date': '2017-07-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Overall Response Rate (ORR) Per RECIST v1.1 for Solid Tumors', 'timeFrame': 'Up to 3.9 years', 'description': 'ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR), based on local investigator assessment per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.\n\nFor RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.'}, {'measure': 'Part 1: Overall Response Rate (ORR) Per Cheson 2014 for DLBCL', 'timeFrame': 'Up to 2.5 years', 'description': 'ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR), based on local investigator assessment per Cheson 2014 criteria for diffuse large B-cell lymphoma (DLBCL).\n\nFor Cheson 2014 criteria, CR= Target nodes/nodal masses must regress to ≤1.5 cm in longest diameter (LDi), no extralymphatic sites of disease, absent non-measured lesions, organ enlargement regress to normal, no new lesions, and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative); PR= ≥50% decrease in the sum of the product of the perpendicular diameters (SPD) of up to 6 target measurable nodes, absent or regressed non-measured lesions, spleen must have regressed by \\>50% in length beyond normal, and no new lesions.'}, {'measure': 'Part 2: Overall Response Rate (ORR) Per RECIST v1.1 for Solid Tumors', 'timeFrame': 'Up to 4.7 years', 'description': 'ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR), based on local investigator assessment per RECIST v1.1.\n\nFor RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.'}, {'measure': 'Part 3: Overall Response Rate (ORR) Per RECIST v1.1 for Solid Tumors', 'timeFrame': 'Up to 0.5 years', 'description': 'ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR), based on local investigator assessment per RECIST v1.1.\n\nFor RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.'}], 'secondaryOutcomes': [{'measure': 'Part 1: Overall Response Rate (ORR) Per iRECIST for Solid Tumors', 'timeFrame': 'Up to 3.9 years', 'description': 'ORR is the percentage of patients with a best overall response of complete response (iCR) or partial response (iPR), based on local investigator assessment per immune-related RECIST (iRECIST).'}, {'measure': 'Part 2: Overall Response Rate (ORR) Per iRECIST for Solid Tumors', 'timeFrame': 'Up to 4.7 years', 'description': 'ORR is the percentage of patients with a best overall response of complete response (iCR) or partial response (iPR), based on local investigator assessment per immune-related RECIST (iRECIST).'}, {'measure': 'Part 3: Overall Response Rate (ORR) Per iRECIST for Solid Tumors', 'timeFrame': 'Up to 0.5 years', 'description': 'ORR is the percentage of patients with a best overall response of complete response (iCR) or partial response (iPR), based on local investigator assessment per immune-related RECIST (iRECIST).'}, {'measure': 'Part 1: Mean Percentage Change in PSA From Baseline', 'timeFrame': 'Baseline, up to 0.8 years', 'description': 'Prostate-specific antigen (PSA) levels were assessed in serum. Rising PSA is generally a manifestation of progression of prostate cancer.'}, {'measure': 'Part 1: Disease Control Rate (DCR) Per RECIST v1.1 for Solid Tumors', 'timeFrame': 'Up to 3.9 years', 'description': 'DCR is the percentage of patients with a best overall response of complete response (CR), partial response (PR), stable disease (SD) or Non-CR or Non-progressive disease (NCRNPD), based on local investigator assessment per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.'}, {'measure': 'Part 1: Disease Control Rate (DCR) Per iRECIST for Solid Tumors', 'timeFrame': 'Up to 3.9 years', 'description': 'DCR is the percentage of patients with a best overall response of complete response (iCR), partial response (iPR), stable disease (iSD) or Non-iCR or Non-unconfirmed progressive disease (NON-iCR or NON-iUPD), based on local investigator assessment per immune-related RECIST (iRECIST).'}, {'measure': 'Part 1: Disease Control Rate (DCR) Per Cheson 2014 for DLBCL', 'timeFrame': 'Up to 2.5 years', 'description': 'DCR is the percentage of patients with a best overall response of complete response (CR), partial response (PR) or stable disease (SD), based on local investigator assessment per Cheson 2014 criteria for diffuse large B-cell lymphoma (DLBCL).'}, {'measure': 'Part 2: Disease Control Rate (DCR) Per RECIST v1.1 for Solid Tumors', 'timeFrame': 'Up to 4.7 years', 'description': 'DCR is the percentage of patients with a best overall response of complete response (CR), partial response (PR), stable disease (SD) or Non-CR or Non-progressive disease (NCRNPD), based on local investigator assessment per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.'}, {'measure': 'Part 2: Disease Control Rate (DCR) Per iRECIST for Solid Tumors', 'timeFrame': 'Up to 4.7 years', 'description': 'DCR is the percentage of patients with a best overall response of complete response (iCR), partial response (iPR), stable disease (iSD) or Non-iCR or Non-unconfirmed progressive disease (NON-iCR or NON-iUPD), based on local investigator assessment per immune-related RECIST (iRECIST).'}, {'measure': 'Part 3: Disease Control Rate (DCR) Per RECIST v1.1 for Solid Tumors', 'timeFrame': 'Up to 0.5 years', 'description': 'DCR is the percentage of patients with a best overall response of complete response (CR), partial response (PR), stable disease (SD) or Non-CR or Non-progressive disease (NCRNPD), based on local investigator assessment per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.'}, {'measure': 'Part 3: Disease Control Rate (DCR) Per iRECIST for Solid Tumors', 'timeFrame': 'Up to 0.5 years', 'description': 'DCR is the percentage of patients with a best overall response of complete response (iCR), partial response (iPR), stable disease (iSD) or Non-iCR or Non-unconfirmed progressive disease (NON-iCR or NON-iUPD), based on local investigator assessment per immune-related RECIST (iRECIST).'}, {'measure': 'Part 1: Duration Of Response (DOR) Per RECIST v1.1 for Solid Tumors', 'timeFrame': 'Up to 3.9 years', 'description': 'DOR only applies to patients for whom best overall response is complete response (CR) or partial response (PR) based on local investigator assessment per RECIST v1.1. DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, DOR was censored at the date of last adequate tumor assessment.\n\nDOR was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.'}, {'measure': 'Part 1: Duration Of Response (DOR) Per iRECIST for Solid Tumors', 'timeFrame': 'Up to 3.9 years', 'description': 'DOR only applies to patients for whom best overall response is complete response (iCR) or partial response (iPR) based on local investigator assessment per iRECIST. DOR is defined as the time from the date of first documented response (iCR or iPR) to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, DOR was censored at the date of last adequate tumor assessment.\n\nDOR was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.'}, {'measure': 'Part 1: Duration Of Response (DOR) Per Cheson 2014 for DLBCL', 'timeFrame': 'Up to 2.5 years', 'description': 'DOR only applies to patients for whom best overall response is complete response (CR) or partial response (PR) based on local investigator assessment per Cheson 2014 criteria for DLBCL. DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, DOR was censored at the date of last adequate tumor assessment. DOR was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.'}, {'measure': 'Part 2: Duration Of Response (DOR) Per RECIST v1.1 for Solid Tumors', 'timeFrame': 'Up to 4.7 years', 'description': 'DOR only applies to patients for whom best overall response is complete response (CR) or partial response (PR) based on local investigator assessment per RECIST v1.1. DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, DOR was censored at the date of last adequate tumor assessment.\n\nDOR was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.'}, {'measure': 'Part 2: Duration Of Response (DOR) Per iRECIST for Solid Tumors', 'timeFrame': 'Up to 4.7 years', 'description': 'DOR only applies to patients for whom best overall response is complete response (iCR) or partial response (iPR) based on local investigator assessment per iRECIST. DOR is defined as the time from the date of first documented response (iCR or iPR) to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, DOR was censored at the date of last adequate tumor assessment.\n\nDOR was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.'}, {'measure': 'Part 3: Duration Of Response (DOR) Per RECIST v1.1 for Solid Tumors', 'timeFrame': 'Up to 0.5 years', 'description': 'DOR only applies to patients for whom best overall response is complete response (CR) or partial response (PR) based on local investigator assessment per RECIST v1.1. DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, DOR was censored at the date of last adequate tumor assessment.\n\nDOR was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.'}, {'measure': 'Part 3: Duration Of Response (DOR) Per iRECIST for Solid Tumors', 'timeFrame': 'Up to 0.5 years', 'description': 'DOR only applies to patients for whom best overall response is complete response (iCR) or partial response (iPR) based on local investigator assessment per iRECIST. DOR is defined as the time from the date of first documented response (iCR or iPR) to the date of first documented progression or death due to underlying cancer. If a patient did not have an event, DOR was censored at the date of last adequate tumor assessment.\n\nDOR was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.'}, {'measure': 'Part 1: Progression-Free Survival (PFS) Per RECIST v1.1 for Solid Tumors', 'timeFrame': 'Up to 3.9 years', 'description': 'PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause, whichever happened first. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per RECIST v1.1.\n\nPFS was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.'}, {'measure': 'Part 1: Progression-Free Survival (PFS) Per iRECIST for Solid Tumors', 'timeFrame': 'Up to 3.9 years', 'description': 'PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause, whichever happened first. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per iRECIST.\n\nPFS was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.'}, {'measure': 'Part 1: Progression-Free Survival (PFS) Per Cheson 2014 for DLBCL', 'timeFrame': 'Up to 2.5 years', 'description': 'PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause, whichever happened first. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per Cheson 2014 for DLBCL.\n\nPFS was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.'}, {'measure': 'Part 2: Progression-Free Survival (PFS) Per RECIST v1.1 for Solid Tumors', 'timeFrame': 'Up to 4.7 years', 'description': 'PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause, whichever happened first. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per RECIST v1.1.\n\nPFS was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.'}, {'measure': 'Part 2: Progression-Free Survival (PFS) Per iRECIST for Solid Tumors', 'timeFrame': 'Up to 4.7 years', 'description': 'PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause, whichever happened first. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per iRECIST.\n\nPFS was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.'}, {'measure': 'Part 3: Progression-Free Survival (PFS) Per RECIST v1.1 for Solid Tumors', 'timeFrame': 'Up to 0.5 years', 'description': 'PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause, whichever happened first. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per RECIST v1.1.\n\nPFS was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.'}, {'measure': 'Part 3: Progression-Free Survival (PFS) Per iRECIST for Solid Tumors', 'timeFrame': 'Up to 0.5 years', 'description': 'PFS is defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause, whichever happened first. If a patient did not have an event, PFS was censored at the date of the last adequate tumor assessment. Tumor response was based on local investigator assessment per iRECIST.\n\nPFS was analyzed using Kaplan-Meier estimates as defined in the statistical analysis plan.'}, {'measure': 'Part 1: 2-year Overall Survival (OS)', 'timeFrame': '2 years', 'description': 'OS represents the percentage of participants who are alive after the start of study treatment. OS at 2 years was estimated using the Kaplan-Meier method as defined in the statistical analysis plan (SAP).'}, {'measure': 'Part 2: 2-year Overall Survival (OS)', 'timeFrame': '2 years', 'description': 'OS represents the percentage of participants who are alive after the start of study treatment. OS at 2 years was estimated using the Kaplan-Meier method as defined in the statistical analysis plan.'}, {'measure': 'Part 3: 2-year Overall Survival (OS)', 'timeFrame': '2 years', 'description': 'OS represents the percentage of participants who are alive after the start of study treatment. OS at 2 years was estimated using the Kaplan-Meier method as defined in the statistical analysis plan.'}, {'measure': 'Part 1: Change From Baseline in CD8 Percent Marker Area in Tumor Tissue', 'timeFrame': 'Screening and on-treatment (Cycle 2 Day 1 or Day 15). The duration of one cycle was 28 days.', 'description': 'The tumor expression of CD8 was measured by immunohistochemical (IHC) methods. Newly obtained pre- and on-treatment paired tumor samples were required and collected at screening and after approximately two cycles of therapy.'}, {'measure': 'Part 2: Change From Baseline in CD8 Percent Marker Area in Tumor Tissue', 'timeFrame': 'Screening and on-treatment (Cycle 2 Day 1 or Day 15). The duration of one cycle was 28 days.', 'description': 'The tumor expression of CD8 was measured by immunohistochemical (IHC) methods. Newly obtained pre- and on-treatment paired tumor samples were required and collected at screening and after approximately two cycles of therapy.'}, {'measure': 'Part 3: Change From Baseline in CD8 Percent Marker Area in Tumor Tissue', 'timeFrame': 'Screening and on-treatment (Cycle 2 Day 1 or Day 15). The duration of one cycle was 28 days.', 'description': 'The tumor expression of CD8 was measured by immunohistochemical (IHC) methods. Newly obtained pre- and on-treatment paired tumor samples were required and collected at screening and after approximately two cycles of therapy.'}, {'measure': 'Part 1, 2 and 3: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period', 'timeFrame': 'Up to 4 years (Part 1), 4.8 years (Part 2) and 0.6 years (Part 3)', 'description': 'Number of participants with AEs (any AE regardless of seriousness) and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs.\n\nThe on-treatment period is defined from the day of first administration of study treatment up to 30 days after the date of its last administration.'}, {'measure': 'Part 1, 2 and 3: Number of Participants With Dose Reductions and Dose Interruptions of NIR178', 'timeFrame': 'Up to 3.9 years (Part 1), 4.7 years (Part 2) and 0.5 years (Part 3)', 'description': 'Number of participants with at least one dose reduction of NIR178 and number of participants with at least one dose interruption of NIR178. Dose or schedule adjustments were permitted for patients who did not tolerate the protocol-specified dosing schedule.'}, {'measure': 'Part 1, 2 and 3: Number of Participants With Dose Reductions and Dose Interruptions of PDR001', 'timeFrame': 'Up to 3.9 years (Part 1), 4.7 years (Part 2) and 0.5 years (Part 3)', 'description': 'Number of participants with at least one dose reduction of PDR001 and number of participants with at least one dose interruption of PDR001. Dose or schedule adjustments were permitted for patients who did not tolerate the protocol-specified dosing schedule. Dose reductions were not permitted for PDR001.'}, {'measure': 'Part 1, 2 and 3: Dose Intensity of NIR178', 'timeFrame': 'Up to 3.9 years (Part 1), 4.7 years (Part 2) and 0.5 years (Part 3)', 'description': 'Dose intensity of NIR178 was calculated as cumulative actual dose in milligrams divided by duration of exposure in days.'}, {'measure': 'Part 1, 2 and 3: Dose Intensity of PDR001', 'timeFrame': 'Up to 3.9 years (Part 1), 4.7 years (Part 2) and 0.5 years (Part 3)', 'description': 'Dose intensity of PDR001 was calculated as cumulative actual dose in milligrams divided by duration of exposure in days and then multiplied by 28 days.'}, {'measure': 'Part 1, 2 and 3: Number of Participants With Anti-PDR001 Antibodies', 'timeFrame': 'Up to approximately 5 years', 'description': 'PDR001 immunogenicity was evaluated in serum samples. Patient anti-drug antibodies (ADA) status was defined as follows:\n\n* ADA-negative at baseline: ADA-negative sample at baseline\n* ADA-positive at baseline: ADA-positive sample at baseline\n* ADA-negative post-baseline: ADA-negative sample at baseline and at least 1 post-baseline sample, all of which are ADA-negative samples\n* Treatment-reduced ADA-positive: ADA-positive sample at baseline and at least 1 post-baseline sample, all of which are ADA-negative samples\n* Treatment-induced ADA-positive: ADA-negative sample at baseline and at least 1 treatment-induced ADA-positive sample\n* Treatment-boosted ADA-positive: ADA-positive sample at baseline and at least 1 treatment-boosted ADA-positive sample\n* ADA-inconclusive: patient who does not qualify for any of the above definitions or a patient for which the baseline sample is missing'}, {'measure': 'Japan Safety Run-in: Number of Participants With Dose-Limiting Toxicities (DLTs)', 'timeFrame': '28 days', 'description': 'A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications, which occurs within the first 28 days of treatment with NIR178 as single agent or in combination with PDR001 during the Japan safety run-in part of the study. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.'}, {'measure': 'Japan Safety Run-in: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period', 'timeFrame': 'Up to 0.7 years', 'description': 'Number of participants with AEs (any AE regardless of seriousness) and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs.\n\nThe on-treatment period is defined from the day of first administration of study treatment up to 30 days after the date of its last administration.'}, {'measure': 'All Study Parts: Maximum Observed Plasma Concentration (Cmax) of NIR178', 'timeFrame': 'Cycle 1 Day 1 (all), Cycle 1 Day 7 (1wk-on/1wk-off), Cycle 1 Day 14 (2wk-on/2wk-off) and Cycle 1 Day 28 (continuous dosing): pre-dose, 15 and 30 minutes, 1, 1.5, 2, 3, 4 and 8 hours after morning dose and 12 hours after evening dose. 1 cycle=28 days', 'description': 'Pharmacokinetic (PK) parameters were calculated based on NIR178 plasma concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed plasma concentration following a dose.'}, {'measure': 'All Study Parts: Time to Reach Maximum Plasma Concentration (Tmax) of NIR178', 'timeFrame': 'Cycle 1 Day 1 (all), Cycle 1 Day 7 (1wk-on/1wk-off), Cycle 1 Day 14 (2wk-on/2wk-off) and Cycle 1 Day 28 (continuous dosing): pre-dose, 15 and 30 minutes, 1, 1.5, 2, 3, 4 and 8 hours after morning dose and 12 hours after evening dose. 1 cycle=28 days', 'description': 'Pharmacokinetic (PK) parameters were calculated based on NIR178 plasma concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) plasma concentration following a dose. Actual recorded sampling times were considered for the calculations.'}, {'measure': 'All Study Parts: Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC0-12hr) of NIR178', 'timeFrame': 'Cycle 1 Day 1 (all), Cycle 1 Day 7 (1wk-on/1wk-off), Cycle 1 Day 14 (2wk-on/2wk-off) and Cycle 1 Day 28 (continuous dosing): pre-dose, 15 and 30 minutes, 1, 1.5, 2, 3, 4 and 8 hours after morning dose and 12 hours after evening dose. 1 cycle=28 days', 'description': 'PK parameters were calculated based on NIR178 plasma concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC0-12hr calculation.'}, {'measure': 'All Study Parts: Maximum Observed Plasma Concentration (Cmax) of NJI765 (NIR178 Metabolite)', 'timeFrame': 'Cycle 1 Day 1 (all), Cycle 1 Day 7 (1wk-on/1wk-off), Cycle 1 Day 14 (2wk-on/2wk-off) and Cycle 1 Day 28 (continuous dosing): pre-dose, 15 and 30 minutes, 1, 1.5, 2, 3, 4 and 8 hours after morning dose and 12 hours after evening dose. 1 cycle=28 days', 'description': 'NJI765 is a NIR178 metabolite. PK parameters were calculated based on NJI765 plasma concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed plasma concentration following a dose.'}, {'measure': 'All Study Parts: Time to Reach Maximum Plasma Concentration (Tmax) of NJI765 (NIR178 Metabolite)', 'timeFrame': 'Cycle 1 Day 1 (all), Cycle 1 Day 7 (1wk-on/1wk-off), Cycle 1 Day 14 (2wk-on/2wk-off) and Cycle 1 Day 28 (continuous dosing): pre-dose, 15 and 30 minutes, 1, 1.5, 2, 3, 4 and 8 hours after morning dose and 12 hours after evening dose. 1 cycle=28 days', 'description': 'NJI765 is a NIR178 metabolite. Pharmacokinetic (PK) parameters were calculated based on NJI765 plasma concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) plasma concentration following a dose. Actual recorded sampling times were considered for the calculations.'}, {'measure': 'All Study Parts: Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post Dose (AUC0-12hr) of NJI765 (NIR178 Metabolite)', 'timeFrame': 'Cycle 1 Day 1 (all), Cycle 1 Day 7 (1wk-on/1wk-off), Cycle 1 Day 14 (2wk-on/2wk-off) and Cycle 1 Day 28 (continuous dosing): pre-dose, 15 and 30 minutes, 1, 1.5, 2, 3, 4 and 8 hours after morning dose and 12 hours after evening dose. 1 cycle=28 days', 'description': 'NJI765 is a NIR178 metabolite. PK parameters were calculated based on NJI765 plasma concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC0-12hr calculation.'}, {'measure': 'All Study Parts: Maximum Observed Serum Concentration (Cmax) of PDR001', 'timeFrame': 'First dose (Cycle 1 Day 1 or Cycle 2 Day 1 for Japanese patients treated with NIR178 80 or 160 mg) and Cycle 3 Day 1: pre-infusion, 1, 168, 336, 504 and 672 hours after end of infusion. Average duration of infusion=30 minutes. 1 cycle=28 days', 'description': 'PK parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Cmax is defined as the maximum (peak) observed serum concentration following a dose.'}, {'measure': 'All Study Parts: Time to Reach Maximum Serum Concentration (Tmax) of PDR001', 'timeFrame': 'First dose (Cycle 1 Day 1 or Cycle 2 Day 1 for Japanese patients treated with NIR178 80 or 160 mg) and Cycle 3 Day 1: pre-infusion, 1, 168, 336, 504 and 672 hours after end of infusion. Average duration of infusion=30 minutes. 1 cycle=28 days', 'description': 'PK parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.'}, {'measure': 'All Study Parts: Area Under the Serum Concentration-time Curve From Time Zero to 28 Days Post Dose (AUC0-28day) of PDR001', 'timeFrame': 'First dose (Cycle 1 Day 1 or Cycle 2 Day 1 for Japanese patients treated with NIR178 80 or 160 mg) and Cycle 3 Day 1: pre-infusion, 1, 168, 336, 504 and 672 hours after end of infusion. Average duration of infusion=30 minutes. 1 cycle=28 days', 'description': 'PK parameters were calculated based on PDR001 serum concentrations by using non-compartmental methods. The linear trapezoidal method was used for AUC0-28day calculation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunotherapy', 'A2aR', 'PDR001', 'NIR178', 'NSCLC', 'solid tumors'], 'conditions': ['NSCLC, Non Small Cell Lung Cancer', 'RCC, Renal Cell Cancer', 'Pancreatic Cancer', 'Urothelial Cancer', 'Head and Neck Cancer', 'DLBCL, Diffused Large B Cell Lymphoma', 'MSS, Microsatellite Stable Colon Cancer', 'TNBC, Triple Negative Breast Cancer', 'Melanoma', 'mCRPC, Metastatic Castration Resistant Prostate Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=2024', 'label': 'A Plain Language Trial Summary is available on www.novctrd.com'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this phase 2 study is to evaluate the efficacy and safety of NIR178 in combination with PDR001 in multiple solid tumors and diffuse large B-cell lymphoma (DLBCL) and further explore schedule variations of NIR178 to optimize immune activation through inhibition of A2aR.', 'detailedDescription': 'This is an open-label multi-part, phase II study evaluating the combination of NIR178 and PDR001 in patients with advanced solid tumors and diffuse large B cell lymphoma (DLBCL).\n\nThe study has three parts:\n\n* Part 1: Multi-arm Bayesian adaptive signal finding design in solid tumors and diffuse large B cell lymphoma (DLBCL) with continuous dosing of NIR178 in combination with PDR001.\n* Part 2: Exploration of continuous and intermittent NIR178 schedules in combination with PDR001 in patients with advanced non-small cell lung cancer (NSCLC).\n* Part 3: Further evaluation of optimal intermittent or continuous schedule of NIR178 in combination with PDR001 (if selected based on results of Part 2). As of protocol amendment 6, Part 3 explored the safety and pharmacokinetics of the film-coated tablet (FCT) formulation of NIR178 continuous dosing in combination with PDR001 in tiple negative breast cancer (TNBC) patients.\n\nIn addition, a separate safety run-in part was conducted in Japan in order to adequately characterize the safety and pharmacokinetic profiles of NIR178 as a single-agent and in combination with PDR001.\n\nPatients enrolled in this study received NIR178 either twice daily (BID) continuously or based on the assigned intermittent schedule within 60 minutes prior to PDR001 infusion. PDR001 400 mg was administered via IV infusion over 30 minutes once every 4 weeks. Each treatment cycle was 28 days. Patients enrolled in the Japanese safety run-in part received NIR178 as single agent for the first cycle (28 days). If the patients completed Cycle 1 without experiencing dose limiting toxicities (DLTs), they initiated combination therapy with PDR001 starting Cycle 2 onwards, and continued at the same dose of NIR178. An additional cohort in the Japanese safety run-in part of the study received NIR178 in combination with PDR001 starting with Cycle 1. If the patients complete Cycle 1 without experiencing DLTs, they continued to receive combination treatment.\n\nPatients received treatment with the combination until disease progression (assessed by investigator per immune-related response criteria (iRECIST) or Cheson 2014), unacceptable toxicity, death or discontinuation from study treatment for any other reason (e.g., withdrawal of consent, start of a new anti-neoplastic therapy or at the discretion of the investigator), otherwise known as End of Treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female patients ≥18 years of age. For Japan only: written consent is necessary both from the patient and his/her legal representative if he/she is under the age of 20 years.\n* Histologically documented advanced or metastatic solid tumors or lymphomas Part 1: histologically confirmed renal cell carcinoma (RCC), pancreatic cancer, urothelial cancer, head and neck cancer, diffuse large B-cell lymphoma (DLBCL), microsatellite stable (MSS) colon cancer, triple negative breast cancer (TNBC), melanoma, metastatic castration resistant prostate cancer (mCRPC) Part 2: histologically confirmed diagnosis of advanced/metastatic NSCLC. For those with mixed histology, there must be a predominant histology Part 3: histologically confirmed diagnosis of selected advanced/metastatic malignancies. Part 3 will be opened to further assess TNBC patients with a PD-L1 SP-142 IC score of 0 (\\<1%). A second tumor group will be considered for Part 3 after completion of Part 1.\n* Patient (except for those participating in Japanese safety run-in) must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patient must be willing to undergo a new tumor biopsy at screening, and again during therapy on this study.\n* Safety run-in part in Japanese patients can enroll any tumor type included in part 1, 2 and 3.\n\nThe collection of recent sample is permitted under the following conditions (both must be met):\n\nBiopsy was collected ≤ 6 months before 1st dose of study treatment and available at the site.\n\nNo immunotherapy was given to the patient since collection of biopsy.\n\n\\- Part 1 - 3 only: Patients (other than those with DLBCL) must previously have received at least 1 and no more than 3 prior lines of therapy for their disease (with the exception of IO-pretreated cutaneous melanoma, HNSCC and RCC), unless considered inappropriate for the patient (e.g. safety concern, label contraindication): Patients with NSCLC must have received a prior platinum-based combination. Patients with EGFR positive NSCLC with a T790M mutation must have progressed on osimertinib or discontinued due to toxicity.\n\nPatients with head and neck cancer must have received a prior platinum-containing regimen.\n\nPatients with bladder cancer must have received a prior platinum-containing regimen or be ineligible for cisplatin.\n\nPatients with renal cell carcinoma must have received a prior VEGF tyrosine kinase inhibitor (TKI).\n\nPatients with MSS colorectal cancer must have received (or be intolerant to) prior therapy with fluoropyrimidine-oxaliplatin- and irinotecan- based regimens.\n\nPatients with triple negative breast cancer:. Part 1: must have received a prior taxane-containing regimen Part 3: should have received no more than 2 prior lines of therapy including taxane-based chemotherapy and should have a known PD-L1 status as per local available testing as determined by VENTANA PD-L1 SP142 Assay with IC score of 0 (\\<1%) Patients with DLBCL should be limited to those with no available therapies of proven clinical benefit Patients should have had prior autologous hematopoietic stem cell transplantation (auto-HSCT) or determined to be ineligible for auto-HSCT.\n\nPatients with melanoma:\n\nBRAF V600E wild type patients: must have received anti-PD-1/PD-L1 single agent, or in combination with anti-CTLA-4 therapy BRAF V600E mutant patients: must have received prior anti-PD-1/PD-L1 single-agent, or in combination with anti-CTLA-4 therapy. In addition, subjects must have received prior BRAF V600E inhibitor therapy, either single-agent or in combination with a MEK inhibitor\n\nPatients with Metastatic Castration Resistant Prostate Cancer (mCRPC):\n\n* Of the 1-3 prior lines of therapy, patients must have received and failed at least one line of treatment after emergence of castration resistant disease\n* Patients must not have received prior immunotherapy (previous immune checkpoint inhibitors; single agent and/or combination therapy with anti-CTLA-4, anti-PD-1, anti-PD-L1), except for NSCLC patients enrolled in part 3 and Japanese safety run-in part.\n* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \\>20 mm with conventional techniques or as \\>10 mm with spiral computer tomography (CT) scan, Magnetic Resonance Imaging (MRI), or calipers by clinical exam.\n\nExclusion Criteria:\n\n* Ongoing or prior treatment with A2aR inhibitors. Patients previously treated with A2aR inhibitors for non-oncologic indications (e.g. Parkinson's disease) may be considered for enrollment on a case by case basis.\n* Current or prior use of immunosuppressive medication within 28 days before the first dose of PDR001, with the exception of intranasal/inhaled corticosteroids or systemic corticosteroids at physiological doses (not exceeding equivalent of 10 mg/day of prednisone)\n* History of another primary malignancy except for:\n\nMalignancy treated with curative intent and with no known active disease ≥2 years before the first dose of study drug and of low potential risk for recurrence Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease Adequately treated carcinoma in situ without evidence of disease\n\n* Active or prior documented autoimmune disease within the past 2 years. Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.\n* More than 3 prior lines of therapy except for Japanese safety run-in part.\n* History of interstitial lung disease or non-infectious pneumonitis\n* Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity, e.g. mitomycin C and nitrosoureas, 6 weeks is indicated as washout period. For patients receiving anticancer immunotherapies, 4 weeks is indicated as the washout period. GnRH therapy to maintain effective testosterone suppression levels is allowed for mCRPC patients."}, 'identificationModule': {'nctId': 'NCT03207867', 'briefTitle': 'A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase 2, Multi-center, Open Label Study of NIR178 in Combination With PDR001 in Patients With Selected Advanced Solid Tumors and Non-Hodgkin Lymphoma', 'orgStudyIdInfo': {'id': 'CNIR178X2201'}, 'secondaryIdInfos': [{'id': '2017-000241-49', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NIR178 + PDR001', 'description': 'Part 1: NIR178 continuously in combination with PDR001 400mg every 4 weeks. The part 1 enrolled 9 different tumor types.', 'interventionNames': ['Drug: NIR178', 'Drug: PDR001']}, {'type': 'EXPERIMENTAL', 'label': 'NIR178 BID Intermittent + PDR001', 'description': 'Part 2: Three different dosing schedules of NIR178 twice daily (BID) including continuous and two intermittent in combination with PDR001', 'interventionNames': ['Drug: NIR178', 'Drug: PDR001']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3', 'description': 'Further evaluation of optimal intermittent or continuous schedule of NIR178 in combination with PDR001 (if selected based on results of Part 2). A film-coated tablet of NIR178 was assessed.', 'interventionNames': ['Drug: NIR178', 'Drug: PDR001']}, {'type': 'EXPERIMENTAL', 'label': 'Japanese safety run-in part', 'description': 'Different dosing schedules of NIR178 were explored.', 'interventionNames': ['Drug: NIR178', 'Drug: PDR001']}], 'interventions': [{'name': 'NIR178', 'type': 'DRUG', 'otherNames': ['taminadenant'], 'description': 'NIR178, a new, non-xanthine based compound, is a potent oral adenosine A2a receptor against antagonist being developed by Novartis.\n\nNIR178 was administered orally twice daily (BID) as a capsule (Part 1, Part 2 and Japanese safety run-in) and as a film-coated table (Part 3). There were up to 3 dose levels assessed: 80, 160 and 240 mg. Three alternative dosing schedules were evaluated: continuous (Part 1, Part 2, Part 3, Japanese safety run-in), 2 weeks on/2 weeks off (Part 2) and 1 week on/1 week off (Part 2).\n\nEach cycle consisted of 28 days.', 'armGroupLabels': ['Japanese safety run-in part', 'NIR178 + PDR001', 'NIR178 BID Intermittent + PDR001', 'Part 3']}, {'name': 'PDR001', 'type': 'DRUG', 'otherNames': ['spartalizumab'], 'description': 'PDR001 is a human monoclonal antibody (MAb) administered on Day 1 of each cycle. PDR001 400 mg was administered via intravenous (i.v.) infusion over 30 minutes every 4 weeks (Q4W).', 'armGroupLabels': ['Japanese safety run-in part', 'NIR178 + PDR001', 'NIR178 BID Intermittent + PDR001', 'Part 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90904', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H Lee Moffitt Cancer Center and Research Institute .', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center/University of Texas', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'The University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': 'C1426ANZ', 'city': 'CABA', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Novartis Investigative Site'}, {'zip': '2148', 'city': 'Blacktown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -33.76667, 'lon': 150.91667}}, {'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '656 53', 'city': 'Brno', 'state': 'Czech Republic', 'country': 'Czechia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '13273', 'city': 'Marseille', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '20133', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '135 8550', 'city': 'Koto Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '3075 EA', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '168583', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '9007', 'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'zip': '10002', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}