Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-31 @ 10:36 PM
Study NCT ID:
NCT02054806
Status:
COMPLETED
Last Update Posted:
2023-10-30
First Post:
2014-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-028/KEYNOTE-28)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'France', 'Italy', 'Japan', 'Netherlands', 'South Korea', 'Spain', 'Taiwan', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'C565324', 'term': 'Parkinson Disease 4, Autosomal Dominant Lewy Body'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme LLC'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.\n\nAny information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to ~28 months for first course and up to ~49 months for second course. All-cause mortality (ACM): Up to ~86 months for first and second course.', 'description': 'ACM includes all randomized participants. Safety includes all participants receiving ≥1 dose of study treatment. Per protocol, AEs were collected and reported by treatment intervention irrespective of indication. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment were excluded as AEs. Participants receiving a second course of pembrolizumab per protocol were monitored for ACM and safety separately.', 'eventGroups': [{'id': 'EG000', 'title': 'First Course Pembrolizumab 10 mg/kg', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years.', 'otherNumAtRisk': 475, 'deathsNumAtRisk': 477, 'otherNumAffected': 429, 'seriousNumAtRisk': 475, 'deathsNumAffected': 426, 'seriousNumAffected': 160}, {'id': 'EG001', 'title': 'Second Course Pembrolizumab 10 mg/kg', 'description': "Qualified participants who completed the first course of pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 10 mg/kg IV Q2W for up to \\~1 year.", 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 10, 'seriousNumAtRisk': 11, 'deathsNumAffected': 6, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 101, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 39, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 59, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 31, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 105, 'numAffected': 93}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 177, 'numAffected': 102}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 30, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 149, 'numAffected': 124}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 99, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 68, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 176, 'numAffected': 165}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 47, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 97, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 39, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 45, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 41, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 36, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 106, 'numAffected': 102}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 37, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 33, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 46, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 36, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 101, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 64, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 49, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 34, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 54, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 73, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 26, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 45, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 89, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 67, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 25, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 88, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 71, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 28, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 19, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vulvovaginal dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 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'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Myelitis transverse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous 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'MedDRA 24.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Device occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ureteric dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Intermenstrual bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vulvovaginal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Noninfective bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tracheal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acute febrile neutrophilic dermatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pemphigoid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lymphorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 475, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}, {'value': '26', 'groupId': 'OG008'}, {'value': '23', 'groupId': 'OG009'}, {'value': '24', 'groupId': 'OG010'}, {'value': '18', 'groupId': 'OG011'}, {'value': '23', 'groupId': 'OG012'}, {'value': '25', 'groupId': 'OG013'}, {'value': '22', 'groupId': 'OG014'}, {'value': '26', 'groupId': 'OG015'}, {'value': '27', 'groupId': 'OG016'}, {'value': '25', 'groupId': 'OG017'}, {'value': '24', 'groupId': 'OG018'}, {'value': '23', 'groupId': 'OG019'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1: Colon or Rectal Adenocarcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with colon or rectal adenocarcinoma.'}, {'id': 'OG001', 'title': 'Cohort A2: Anal Canal Squamous Cell Carcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with anal canal squamous cell carcinoma.'}, {'id': 'OG002', 'title': 'Cohort A3: Pancreas Adenocarcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with pancreas adenocarcinoma.'}, {'id': 'OG003', 'title': 'Cohort A4: Esophageal Squamous Cell Carcinoma or Adenocarcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with esophageal squamous cell carcinoma or adenocarcinoma (including gastroesophageal (GE) junction).'}, {'id': 'OG004', 'title': 'Cohort A5: Biliary Tract Adenocarcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with biliary tract adenocarcinoma (gallbladder and biliary tree, but excluding ampulla of vater cancers).'}, {'id': 'OG005', 'title': 'Cohort A6: Carcinoid Tumors', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with carcinoid tumors.'}, {'id': 'OG006', 'title': 'Cohort A7: Neuroendocrine Carcinomas', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with neuroendocrine carcinomas (well or moderately differentiated pancreatic neuroendocrine tumor).'}, {'id': 'OG007', 'title': 'Cohort B1: ER Positive HER2 Negative Breast Cancer', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with estrogen receptor (ER) positive human epidermal growth factor receptor (HER2) negative breast cancer.'}, {'id': 'OG008', 'title': 'Cohort B2: Ovarian Epithelial, Fallopian Tube or Primary Peritoneal Carcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with ovarian epithelial, fallopian tube or primary peritoneal carcinoma.'}, {'id': 'OG009', 'title': 'Cohort B3: Endometrial Carcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with endometrial carcinoma.'}, {'id': 'OG010', 'title': 'Cohort B4: Cervical Squamous Cell Cancer', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with cervical squamous cell cancer.'}, {'id': 'OG011', 'title': 'Cohort B5: Vulvar Squamous Cell Carcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with vulvar squamous cell carcinoma.'}, {'id': 'OG012', 'title': 'Cohort C1: Small Cell Lung Cancer', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with small cell lung cancer.'}, {'id': 'OG013', 'title': 'Cohort C2: Mesothelioma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with mesothelioma (malignant pleural mesothelioma).'}, {'id': 'OG014', 'title': 'Cohort D1: Thyroid Cancer', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with thyroid cancer (papillary or follicular subtype).'}, {'id': 'OG015', 'title': 'Cohort D2: Salivary Gland Carcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with salivary gland carcinoma.'}, {'id': 'OG016', 'title': 'Cohort D3: Nasopharyngeal Carcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with nasopharyngeal carcinoma.'}, {'id': 'OG017', 'title': 'Cohort E1: Glioblastoma Multiforme', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with glioblastoma multiforme.'}, {'id': 'OG018', 'title': 'Cohort E2: Leiomyosarcoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with leiomyosarcoma.'}, {'id': 'OG019', 'title': 'Cohort E3: Prostate Adenocarcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with prostate adenocarcinoma.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '21.9'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '6.8', 'upperLimit': '40.7'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '14.2'}, {'value': '30.4', 'groupId': 'OG003', 'lowerLimit': '13.2', 'upperLimit': '52.9'}, {'value': '17.4', 'groupId': 'OG004', 'lowerLimit': '5.0', 'upperLimit': '38.8'}, {'value': '16.0', 'groupId': 'OG005', 'lowerLimit': '4.5', 'upperLimit': '36.1'}, {'value': '6.3', 'groupId': 'OG006', 'lowerLimit': '0.2', 'upperLimit': '30.2'}, {'value': '12.0', 'groupId': 'OG007', 'lowerLimit': '2.5', 'upperLimit': '31.2'}, {'value': '11.5', 'groupId': 'OG008', 'lowerLimit': '2.4', 'upperLimit': '30.2'}, {'value': '13.0', 'groupId': 'OG009', 'lowerLimit': '2.8', 'upperLimit': '33.6'}, {'value': '16.7', 'groupId': 'OG010', 'lowerLimit': '4.7', 'upperLimit': '37.4'}, {'value': '5.6', 'groupId': 'OG011', 'lowerLimit': '0.1', 'upperLimit': '27.3'}, {'value': '34.8', 'groupId': 'OG012', 'lowerLimit': '16.4', 'upperLimit': '57.3'}, {'value': '20.0', 'groupId': 'OG013', 'lowerLimit': '6.8', 'upperLimit': '40.7'}, {'value': '13.6', 'groupId': 'OG014', 'lowerLimit': '2.9', 'upperLimit': '34.9'}, {'value': '11.5', 'groupId': 'OG015', 'lowerLimit': '2.4', 'upperLimit': '30.2'}, {'value': '25.9', 'groupId': 'OG016', 'lowerLimit': '11.1', 'upperLimit': '46.3'}, {'value': '8.0', 'groupId': 'OG017', 'lowerLimit': '1.0', 'upperLimit': '26.0'}, {'value': '4.2', 'groupId': 'OG018', 'lowerLimit': '0.1', 'upperLimit': '21.1'}, {'value': '13.0', 'groupId': 'OG019', 'lowerLimit': '2.8', 'upperLimit': '33.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 86 months', 'description': 'Overall response rate (ORR) was defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by the investigator.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all participants who received at least 1 dose of study treatment, had a baseline scan with measurable disease per modified RECIST 1.1 and had the intended indication. Per protocol, participants were analyzed according to disease type.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '475', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab (MK-3475) 10 mg/kg', 'description': 'Participants received pembrolizumab 10 mg/kg intravenously (IV) over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. Per protocol participants were presented by treatment received in the single arm study.'}], 'classes': [{'categories': [{'measurements': [{'value': '456', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 28 months', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one AE was assessed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all allocated participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Discontinued From Study Treatment Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '475', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab (MK-3475) 10 mg/kg', 'description': 'Participants received pembrolizumab 10 mg/kg intravenously (IV) over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. Per protocol participants were presented by treatment received in the single arm study.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 25 months', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued treatment due to an AE was assessed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all allocated participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}, {'value': '26', 'groupId': 'OG008'}, {'value': '23', 'groupId': 'OG009'}, {'value': '24', 'groupId': 'OG010'}, {'value': '18', 'groupId': 'OG011'}, {'value': '23', 'groupId': 'OG012'}, {'value': '25', 'groupId': 'OG013'}, {'value': '22', 'groupId': 'OG014'}, {'value': '26', 'groupId': 'OG015'}, {'value': '27', 'groupId': 'OG016'}, {'value': '25', 'groupId': 'OG017'}, {'value': '24', 'groupId': 'OG018'}, {'value': '23', 'groupId': 'OG019'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1: Colon or Rectal Adenocarcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with colon or rectal adenocarcinoma.'}, {'id': 'OG001', 'title': 'Cohort A2: Anal Canal Squamous Cell Carcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with anal canal squamous cell carcinoma.'}, {'id': 'OG002', 'title': 'Cohort A3: Pancreas Adenocarcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with pancreas adenocarcinoma.'}, {'id': 'OG003', 'title': 'Cohort A4: Esophageal Squamous Cell Carcinoma or Adenocarcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with esophageal squamous cell carcinoma or adenocarcinoma (including gastroesophageal (GE) junction).'}, {'id': 'OG004', 'title': 'Cohort A5: Biliary Tract Adenocarcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with biliary tract adenocarcinoma (gallbladder and biliary tree, but excluding ampulla of vater cancers).'}, {'id': 'OG005', 'title': 'Cohort A6: Carcinoid Tumors', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with carcinoid tumors.'}, {'id': 'OG006', 'title': 'Cohort A7: Neuroendocrine Carcinomas', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with neuroendocrine carcinomas (well or moderately differentiated pancreatic neuroendocrine tumor).'}, {'id': 'OG007', 'title': 'Cohort B1: ER Positive HER2 Negative Breast Cancer', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with ER positive HER2 negative breast cancer.'}, {'id': 'OG008', 'title': 'Cohort B2: Ovarian Epithelial, Fallopian Tube or Primary Peritoneal Carcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with ovarian epithelial, fallopian tube or primary peritoneal carcinoma.'}, {'id': 'OG009', 'title': 'Cohort B3: Endometrial Carcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with endometrial carcinoma'}, {'id': 'OG010', 'title': 'Cohort B4: Cervical Squamous Cell Cancer', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with cervical squamous cell cancer.'}, {'id': 'OG011', 'title': 'Cohort B5: Vulvar Squamous Cell Carcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with vulvar squamous cell carcinoma.'}, {'id': 'OG012', 'title': 'Cohort C1: Small Cell Lung Cancer', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with small cell lung cancer.'}, {'id': 'OG013', 'title': 'Cohort C2: Mesothelioma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with mesothelioma (malignant pleural mesothelioma).'}, {'id': 'OG014', 'title': 'Cohort D1: Thyroid Cancer', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with thyroid cancer (papillary or follicular subtype).'}, {'id': 'OG015', 'title': 'Cohort D2: Salivary Gland Carcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with salivary gland carcinoma.'}, {'id': 'OG016', 'title': 'Cohort D3: Nasopharyngeal Carcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with nasopharyngeal carcinoma.'}, {'id': 'OG017', 'title': 'Cohort E1: Glioblastoma Multiforme', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with glioblastoma multiforme.'}, {'id': 'OG018', 'title': 'Cohort E2: Leiomyosarcoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with leiomyosarcoma.'}, {'id': 'OG019', 'title': 'Cohort E3: Prostate Adenocarcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with prostate adenocarcinoma.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '1.8'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '6.2'}, {'value': '1.7', 'groupId': 'OG002', 'lowerLimit': '1.5', 'upperLimit': '1.8'}, {'value': '1.8', 'groupId': 'OG003', 'lowerLimit': '1.7', 'upperLimit': '2.9'}, {'value': '1.8', 'groupId': 'OG004', 'lowerLimit': '1.4', 'upperLimit': '2.1'}, {'value': '5.5', 'groupId': 'OG005', 'lowerLimit': '3.5', 'upperLimit': '10.7'}, {'value': '4.5', 'groupId': 'OG006', 'lowerLimit': '3.5', 'upperLimit': '13.9'}, {'value': '1.8', 'groupId': 'OG007', 'lowerLimit': '1.4', 'upperLimit': '3.6'}, {'value': '1.9', 'groupId': 'OG008', 'lowerLimit': '1.8', 'upperLimit': '3.5'}, {'value': '1.8', 'groupId': 'OG009', 'lowerLimit': '1.6', 'upperLimit': '2.7'}, {'value': '1.8', 'groupId': 'OG010', 'lowerLimit': '1.6', 'upperLimit': '3.2'}, {'value': '2.5', 'groupId': 'OG011', 'lowerLimit': '1.4', 'upperLimit': '3.7'}, {'value': '1.8', 'groupId': 'OG012', 'lowerLimit': '1.7', 'upperLimit': '5.8'}, {'value': '5.5', 'groupId': 'OG013', 'lowerLimit': '3.5', 'upperLimit': '8.2'}, {'value': '8.2', 'groupId': 'OG014', 'lowerLimit': '2.2', 'upperLimit': '14.4'}, {'value': '3.6', 'groupId': 'OG015', 'lowerLimit': '1.8', 'upperLimit': '5.1'}, {'value': '6.4', 'groupId': 'OG016', 'lowerLimit': '3.5', 'upperLimit': '13.4'}, {'value': '2.8', 'groupId': 'OG017', 'lowerLimit': '1.9', 'upperLimit': '8.1'}, {'value': '2.0', 'groupId': 'OG018', 'lowerLimit': '1.7', 'upperLimit': '5.3'}, {'value': '3.5', 'groupId': 'OG019', 'lowerLimit': '1.7', 'upperLimit': '6.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 86 months', 'description': 'PFS was defined as the time from the date of allocation to the date of the first documentation of disease progression, as determined by investigator per modified RECIST 1.1 or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeter \\[mm\\]) in the sum of diameter of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all participants who received at least 1 dose of study treatment, had a baseline scan with measurable disease per modified RECIST 1.1 and had the intended indication. Per protocol, participants were analyzed according to disease type.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}, {'value': '26', 'groupId': 'OG008'}, {'value': '24', 'groupId': 'OG009'}, {'value': '24', 'groupId': 'OG010'}, {'value': '18', 'groupId': 'OG011'}, {'value': '23', 'groupId': 'OG012'}, {'value': '25', 'groupId': 'OG013'}, {'value': '22', 'groupId': 'OG014'}, {'value': '26', 'groupId': 'OG015'}, {'value': '27', 'groupId': 'OG016'}, {'value': '26', 'groupId': 'OG017'}, {'value': '24', 'groupId': 'OG018'}, {'value': '23', 'groupId': 'OG019'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1: Colon or Rectal Adenocarcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with colon or rectal adenocarcinoma.'}, {'id': 'OG001', 'title': 'Cohort A2: Anal Canal Squamous Cell Carcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with anal canal squamous cell carcinoma.'}, {'id': 'OG002', 'title': 'Cohort A3: Pancreas Adenocarcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with Pancreas Adenocarcinoma.'}, {'id': 'OG003', 'title': 'Cohort A4: Esophageal Squamous Cell Carcinoma or Adenocarcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with esophageal squamous cell carcinoma or adenocarcinoma (including gastroesophageal (GE) junction).'}, {'id': 'OG004', 'title': 'Cohort A5: Biliary Tract Adenocarcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with biliary tract adenocarcinoma (gallbladder and biliary tree, but excluding ampulla of vater cancers).'}, {'id': 'OG005', 'title': 'Cohort A6: Carcinoid Tumors', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with carcinoid tumors.'}, {'id': 'OG006', 'title': 'Cohort A7: Neuroendocrine Carcinomas', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with neuroendocrine carcinomas (well or moderately differentiated pancreatic neuroendocrine tumor).'}, {'id': 'OG007', 'title': 'Cohort B1: HR Positive HER2 Negative Breast Cancer', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with ER positive HER2 negative breast cancer.'}, {'id': 'OG008', 'title': 'Cohort B2: Ovarian Epithelial, Fallopian Tube or Primary Peritoneal Carcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with ovarian epithelial, fallopian tube or primary peritoneal carcinoma.'}, {'id': 'OG009', 'title': 'Cohort B3: Endometrial Carcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with endometrial carcinoma.'}, {'id': 'OG010', 'title': 'Cohort B4: Cervical Squamous Cell Cancer', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with cervical squamous cell cancer.'}, {'id': 'OG011', 'title': 'Cohort B5: Vulvar Squamous Cell Carcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with vulvar squamous cell carcinoma.'}, {'id': 'OG012', 'title': 'Cohort C1: Small Cell Lung Cancer', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with small cell lung cancer.'}, {'id': 'OG013', 'title': 'Cohort C2: Mesothelioma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with mesothelioma (malignant pleural mesothelioma).'}, {'id': 'OG014', 'title': 'Cohort D1: Thyroid Cancer', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with thyroid cancer (papillary or follicular subtype).'}, {'id': 'OG015', 'title': 'Cohort D2: Salivary Gland Carcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with salivary gland carcinoma.'}, {'id': 'OG016', 'title': 'Cohort D3: Nasopharyngeal Carcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with nasopharyngeal carcinoma.'}, {'id': 'OG017', 'title': 'Cohort E1: Glioblastoma Multiforme', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with glioblastoma multiforme.'}, {'id': 'OG018', 'title': 'Cohort E2: Leiomyosarcoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with leiomyosarcoma.'}, {'id': 'OG019', 'title': 'Cohort E3: Prostate Adenocarcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with prostate adenocarcinoma.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '10.9'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '5.8', 'upperLimit': '16.2'}, {'value': '3.9', 'groupId': 'OG002', 'lowerLimit': '2.8', 'upperLimit': '5.5'}, {'value': '7.1', 'groupId': 'OG003', 'lowerLimit': '4.3', 'upperLimit': '17.7'}, {'value': '5.7', 'groupId': 'OG004', 'lowerLimit': '3.1', 'upperLimit': '9.8'}, {'value': '16.2', 'groupId': 'OG005', 'lowerLimit': '7.6', 'upperLimit': '22.4'}, {'value': '37.8', 'comment': 'NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.', 'groupId': 'OG006', 'lowerLimit': '20.2', 'upperLimit': 'NA'}, {'value': '8.0', 'groupId': 'OG007', 'lowerLimit': '6.5', 'upperLimit': '10.3'}, {'value': '13.1', 'groupId': 'OG008', 'lowerLimit': '7.3', 'upperLimit': '18.8'}, {'value': '13.6', 'groupId': 'OG009', 'lowerLimit': '2.2', 'upperLimit': '25.2'}, {'value': '10.8', 'groupId': 'OG010', 'lowerLimit': '3.8', 'upperLimit': '15.4'}, {'value': '3.7', 'groupId': 'OG011', 'lowerLimit': '3.1', 'upperLimit': '7.7'}, {'value': '9.3', 'groupId': 'OG012', 'lowerLimit': '4.1', 'upperLimit': '10.6'}, {'value': '18.0', 'groupId': 'OG013', 'lowerLimit': '10.3', 'upperLimit': '24.4'}, {'value': '39.7', 'groupId': 'OG014', 'lowerLimit': '29.7', 'upperLimit': '65.0'}, {'value': '12.3', 'groupId': 'OG015', 'lowerLimit': '6.0', 'upperLimit': '30.1'}, {'value': '16.5', 'groupId': 'OG016', 'lowerLimit': '10.1', 'upperLimit': '31.9'}, {'value': '13.1', 'groupId': 'OG017', 'lowerLimit': '8.0', 'upperLimit': '26.6'}, {'value': '12.0', 'groupId': 'OG018', 'lowerLimit': '7.7', 'upperLimit': '18.3'}, {'value': '7.9', 'groupId': 'OG019', 'lowerLimit': '6.5', 'upperLimit': '15.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 86 months', 'description': 'OS was defined as the time from the date of allocation to the date of death due to any cause. Participants who were lost to follow-up and those who were alive at the end of the trial were censored at the date of last assessment.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all participants who received at least 1 dose of study treatment, had a baseline scan with measurable disease per modified RECIST 1.1 and had the intended indication. Per protocol, participants were analyzed according to disease type.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '8', 'groupId': 'OG012'}, {'value': '5', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '3', 'groupId': 'OG015'}, {'value': '7', 'groupId': 'OG016'}, {'value': '2', 'groupId': 'OG017'}, {'value': '1', 'groupId': 'OG018'}, {'value': '3', 'groupId': 'OG019'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A1: Colon or Rectal Adenocarcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with colon or rectal adenocarcinoma.'}, {'id': 'OG001', 'title': 'Cohort A2: Anal Canal Squamous Cell Carcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with anal canal squamous cell carcinoma.'}, {'id': 'OG002', 'title': 'Cohort A3: Pancreas Adenocarcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with Pancreas Adenocarcinoma.'}, {'id': 'OG003', 'title': 'Cohort A4: Esophageal Squamous Cell Carcinoma or Adenocarcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with esophageal squamous cell carcinoma or adenocarcinoma (including gastroesophageal (GE) junction).'}, {'id': 'OG004', 'title': 'Cohort A5: Biliary Tract Adenocarcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with biliary tract adenocarcinoma (gallbladder and biliary tree, but excluding ampulla of vater cancers).'}, {'id': 'OG005', 'title': 'Cohort A6: Carcinoid Tumors', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with carcinoid tumors.'}, {'id': 'OG006', 'title': 'Cohort A7: Neuroendocrine Carcinomas', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with neuroendocrine carcinomas (well or moderately differentiated pancreatic neuroendocrine tumor).'}, {'id': 'OG007', 'title': 'Cohort B1: ER Positive HER2 Negative Breast Cancer', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with ER positive HER2 negative breast cancer.'}, {'id': 'OG008', 'title': 'Cohort B2: Ovarian Epithelial, Fallopian Tube or Primary Peritoneal Carcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with ovarian epithelial, fallopian tube or primary peritoneal carcinoma.'}, {'id': 'OG009', 'title': 'Cohort B3: Endometrial Carcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled endometrial carcinoma.'}, {'id': 'OG010', 'title': 'Cohort B4: Cervical Squamous Cell Cancer', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled cervical squamous cell cancer.'}, {'id': 'OG011', 'title': 'Cohort B5: Vulvar Squamous Cell Carcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with vulvar squamous cell carcinoma.'}, {'id': 'OG012', 'title': 'Cohort C1: Small Cell Lung Cancer', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with small cell lung cancer.'}, {'id': 'OG013', 'title': 'Cohort C2: Mesothelioma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with mesothelioma (malignant pleural mesothelioma).'}, {'id': 'OG014', 'title': 'Cohort D1: Thyroid Cancer', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with thyroid cancer (papillary or follicular subtype).'}, {'id': 'OG015', 'title': 'Cohort D2: Salivary Gland Carcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with salivary gland carcinoma.'}, {'id': 'OG016', 'title': 'Cohort D3: Nasopharyngeal Carcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with nasopharyngeal carcinoma.'}, {'id': 'OG017', 'title': 'Cohort E1: Glioblastoma Multiforme', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with glioblastoma multiforme.'}, {'id': 'OG018', 'title': 'Cohort E2: Leiomyosarcoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with leiomyosarcoma.'}, {'id': 'OG019', 'title': 'Cohort E3: Prostate Adenocarcinoma', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. This cohort represents all participants who enrolled with prostate adenocarcinoma.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA = Median, upper limit, lower limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '28.9', 'comment': 'NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': 'NA'}, {'value': '14.5', 'comment': 'NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.', 'groupId': 'OG003', 'lowerLimit': '5.6', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Median, upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.', 'groupId': 'OG004', 'lowerLimit': '6.0', 'upperLimit': 'NA'}, {'value': '10.1', 'comment': 'NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.', 'groupId': 'OG005', 'lowerLimit': '6.9', 'upperLimit': 'NA'}, {'value': '25.1', 'groupId': 'OG006', 'lowerLimit': '25.1', 'upperLimit': '25.1'}, {'value': '12.0', 'groupId': 'OG007', 'lowerLimit': '7.4', 'upperLimit': '15.9'}, {'value': '37.0', 'comment': 'NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.', 'groupId': 'OG008', 'lowerLimit': '34.4', 'upperLimit': 'NA'}, {'value': '68.5', 'comment': 'NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.', 'groupId': 'OG009', 'lowerLimit': '17.5', 'upperLimit': 'NA'}, {'value': '5.4', 'groupId': 'OG010', 'lowerLimit': '4.1', 'upperLimit': '7.5'}, {'value': '3.9', 'groupId': 'OG011', 'lowerLimit': '3.9', 'upperLimit': '3.9'}, {'value': 'NA', 'comment': 'NA = Median, upper limit, lower limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.', 'groupId': 'OG012', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '12.0', 'groupId': 'OG013', 'lowerLimit': '3.7', 'upperLimit': '44.4'}, {'value': '8.4', 'groupId': 'OG014', 'lowerLimit': '4.6', 'upperLimit': '20.3'}, {'value': '3.9', 'groupId': 'OG015', 'lowerLimit': '3.5', 'upperLimit': '20.6'}, {'value': '15.0', 'groupId': 'OG016', 'lowerLimit': '4.8', 'upperLimit': '34.0'}, {'value': '15.6', 'groupId': 'OG017', 'lowerLimit': '8.3', 'upperLimit': '22.8'}, {'value': '12.4', 'groupId': 'OG018', 'lowerLimit': '12.4', 'upperLimit': '12.4'}, {'value': '14.2', 'groupId': 'OG019', 'lowerLimit': '13.5', 'upperLimit': '31.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 86 months', 'description': 'For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per modified RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per modified RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. DOR assessments were based on investigator with confirmation. The DOR according to modified RECIST 1.1 for all participants who experienced a confirmed CR or PR was reported. Per protocol, participants were analyzed according to disease type.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all participants who received at least 1 dose of study treatment, had a baseline scan with measurable disease per modified RECIST 1.1, had the intended indication, and experienced a response. Per protocol-specified definition, DOR could not be analyzed in arms which did not have a confirmed response of CR or PR.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pembrolizumab 10 mg/kg', 'description': "Participants received pembrolizumab 10 mg/kg intravenously (IV) over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. Qualified participants who completed the first course of pembrolizumab treatment but progressed after discontinuation were eligible for a second course of pembrolizumab at 10 mg/kg IV Q2W for up to \\~1 additional year, at the Investigator's discretion. Per protocol participants were presented by treatment received in the single arm study."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '477'}]}, {'type': 'Treated During First Course', 'achievements': [{'groupId': 'FG000', 'numSubjects': '475'}]}, {'type': 'Treated During Second Course', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '477'}]}], 'dropWithdraws': [{'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '391'}]}]}], 'recruitmentDetails': 'Participants with a histologically- or cytologically-confirmed diagnosis of 20 advanced (unresectable and/or metastatic) solid tumors, were recruited into a single arm.', 'preAssignmentDetails': 'Per protocol, response/progression or adverse events during the second pembrolizumab course were not counted towards efficacy outcome measures or safety outcome measures respectively.\n\nPer protocol, analyses of disease type cohort was planned and conducted for efficacy outcome measures only.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '475', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pembrolizumab (MK-3475) 10 mg/kg', 'description': "Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \\~2 years. Qualified participants who completed the first course of pembrolizumab treatment but progressed after discontinuation were eligible for a second course of pembrolizumab at 10 mg/kg IV Q2W for up to \\~1 additional year, at the Investigator's discretion. Per protocol participants were presented by treatment received in the single arm study."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.7', 'spread': '11.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '281', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '194', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '380', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '77', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '99', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '280', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '73', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The analysis population consisted of all allocated participants who received at least one dose of study drug. Per protocol, Baseline Characteristics were summarized by treatment dose.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-28', 'size': 2381251, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-04-19T14:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 477}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-06', 'studyFirstSubmitDate': '2014-02-03', 'resultsFirstSubmitDate': '2022-04-19', 'studyFirstSubmitQcDate': '2014-02-03', 'lastUpdatePostDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-06', 'studyFirstPostDateStruct': {'date': '2014-02-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'Up to approximately 86 months', 'description': 'Overall response rate (ORR) was defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by the investigator.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Experienced an Adverse Event (AE)', 'timeFrame': 'Up to approximately 28 months', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one AE was assessed.'}, {'measure': 'Number of Participants Who Discontinued From Study Treatment Due to an AE', 'timeFrame': 'Up to approximately 25 months', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued treatment due to an AE was assessed.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Up to approximately 86 months', 'description': 'PFS was defined as the time from the date of allocation to the date of the first documentation of disease progression, as determined by investigator per modified RECIST 1.1 or death due to any cause (whichever occurred first). Disease progression was defined as at least 20 percent (%) increase (including an absolute increase of at least 5 millimeter \\[mm\\]) in the sum of diameter of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 86 months', 'description': 'OS was defined as the time from the date of allocation to the date of death due to any cause. Participants who were lost to follow-up and those who were alive at the end of the trial were censored at the date of last assessment.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to approximately 86 months', 'description': 'For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per modified RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per modified RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. DOR assessments were based on investigator with confirmation. The DOR according to modified RECIST 1.1 for all participants who experienced a confirmed CR or PR was reported. Per protocol, participants were analyzed according to disease type.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Programmed Cell Death-1 (PD1, PD-1)', 'Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)', 'Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)'], 'conditions': ['Solid Tumor']}, 'referencesModule': {'references': [{'pmid': '28291584', 'type': 'RESULT', 'citation': 'Alley EW, Lopez J, Santoro A, Morosky A, Saraf S, Piperdi B, van Brummelen E. Clinical safety and activity of pembrolizumab in patients with malignant pleural mesothelioma (KEYNOTE-028): preliminary results from a non-randomised, open-label, phase 1b trial. Lancet Oncol. 2017 May;18(5):623-630. doi: 10.1016/S1470-2045(17)30169-9. Epub 2017 Mar 11.'}, {'pmid': '28453692', 'type': 'RESULT', 'citation': 'Ott PA, Piha-Paul SA, Munster P, Pishvaian MJ, van Brummelen EMJ, Cohen RB, Gomez-Roca C, Ejadi S, Stein M, Chan E, Simonelli M, Morosky A, Saraf S, Emancipator K, Koshiji M, Bennouna J. Safety and antitumor activity of the anti-PD-1 antibody pembrolizumab in patients with recurrent carcinoma of the anal canal. Ann Oncol. 2017 May 1;28(5):1036-1041. doi: 10.1093/annonc/mdx029.'}, {'pmid': '28837405', 'type': 'RESULT', 'citation': 'Hsu C, Lee SH, Ejadi S, Even C, Cohen RB, Le Tourneau C, Mehnert JM, Algazi A, van Brummelen EMJ, Saraf S, Thanigaimani P, Cheng JD, Hansen AR. Safety and Antitumor Activity of Pembrolizumab in Patients With Programmed Death-Ligand 1-Positive Nasopharyngeal Carcinoma: Results of the KEYNOTE-028 Study. J Clin Oncol. 2017 Dec 20;35(36):4050-4056. doi: 10.1200/JCO.2017.73.3675. Epub 2017 Aug 24.'}, {'pmid': '28813164', 'type': 'RESULT', 'citation': 'Ott PA, Elez E, Hiret S, Kim DW, Morosky A, Saraf S, Piperdi B, Mehnert JM. Pembrolizumab in Patients With Extensive-Stage Small-Cell Lung Cancer: Results From the Phase Ib KEYNOTE-028 Study. J Clin Oncol. 2017 Dec 1;35(34):3823-3829. doi: 10.1200/JCO.2017.72.5069. Epub 2017 Aug 16.'}, {'pmid': '29116900', 'type': 'RESULT', 'citation': 'Doi T, Piha-Paul SA, Jalal SI, Saraf S, Lunceford J, Koshiji M, Bennouna J. Safety and Antitumor Activity of the Anti-Programmed Death-1 Antibody Pembrolizumab in Patients With Advanced Esophageal Carcinoma. J Clin Oncol. 2018 Jan 1;36(1):61-67. doi: 10.1200/JCO.2017.74.9846. Epub 2017 Nov 8.'}, {'pmid': '29095678', 'type': 'RESULT', 'citation': "Frenel JS, Le Tourneau C, O'Neil B, Ott PA, Piha-Paul SA, Gomez-Roca C, van Brummelen EMJ, Rugo HS, Thomas S, Saraf S, Rangwala R, Varga A. Safety and Efficacy of Pembrolizumab in Advanced, Programmed Death Ligand 1-Positive Cervical Cancer: Results From the Phase Ib KEYNOTE-028 Trial. J Clin Oncol. 2017 Dec 20;35(36):4035-4041. doi: 10.1200/JCO.2017.74.5471. Epub 2017 Nov 2."}, {'pmid': '29284010', 'type': 'RESULT', 'citation': "O'Neil BH, Wallmark JM, Lorente D, Elez E, Raimbourg J, Gomez-Roca C, Ejadi S, Piha-Paul SA, Stein MN, Abdul Razak AR, Dotti K, Santoro A, Cohen RB, Gould M, Saraf S, Stein K, Han SW. Safety and antitumor activity of the anti-PD-1 antibody pembrolizumab in patients with advanced colorectal carcinoma. PLoS One. 2017 Dec 28;12(12):e0189848. doi: 10.1371/journal.pone.0189848. eCollection 2017."}, {'pmid': '29462123', 'type': 'RESULT', 'citation': 'Cohen RB, Delord JP, Doi T, Piha-Paul SA, Liu SV, Gilbert J, Algazi AP, Damian S, Hong RL, Le Tourneau C, Day D, Varga A, Elez E, Wallmark J, Saraf S, Thanigaimani P, Cheng J, Keam B. Pembrolizumab for the Treatment of Advanced Salivary Gland Carcinoma: Findings of the Phase 1b KEYNOTE-028 Study. Am J Clin Oncol. 2018 Nov;41(11):1083-1088. doi: 10.1097/COC.0000000000000429.'}, {'pmid': '29559561', 'type': 'RESULT', 'citation': 'Rugo HS, Delord JP, Im SA, Ott PA, Piha-Paul SA, Bedard PL, Sachdev J, Le Tourneau C, van Brummelen EMJ, Varga A, Salgado R, Loi S, Saraf S, Pietrangelo D, Karantza V, Tan AR. Safety and Antitumor Activity of Pembrolizumab in Patients with Estrogen Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer. Clin Cancer Res. 2018 Jun 15;24(12):2804-2811. doi: 10.1158/1078-0432.CCR-17-3452. Epub 2018 Mar 20.'}, {'pmid': '28489510', 'type': 'RESULT', 'citation': 'Ott PA, Bang YJ, Berton-Rigaud D, Elez E, Pishvaian MJ, Rugo HS, Puzanov I, Mehnert JM, Aung KL, Lopez J, Carrigan M, Saraf S, Chen M, Soria JC. Safety and Antitumor Activity of Pembrolizumab in Advanced Programmed Death Ligand 1-Positive Endometrial Cancer: Results From the KEYNOTE-028 Study. J Clin Oncol. 2017 Aug 1;35(22):2535-2541. doi: 10.1200/JCO.2017.72.5952. Epub 2017 May 10.'}, {'pmid': '30522700', 'type': 'RESULT', 'citation': 'Varga A, Piha-Paul S, Ott PA, Mehnert JM, Berton-Rigaud D, Morosky A, Yang P, Ruman J, Matei D. Pembrolizumab in patients with programmed death ligand 1-positive advanced ovarian cancer: Analysis of KEYNOTE-028. Gynecol Oncol. 2019 Feb;152(2):243-250. doi: 10.1016/j.ygyno.2018.11.017. Epub 2018 Dec 3.'}, {'pmid': '35101941', 'type': 'DERIVED', 'citation': 'Cristescu R, Aurora-Garg D, Albright A, Xu L, Liu XQ, Loboda A, Lang L, Jin F, Rubin EH, Snyder A, Lunceford J. Tumor mutational burden predicts the efficacy of pembrolizumab monotherapy: a pan-tumor retrospective analysis of participants with advanced solid tumors. J Immunother Cancer. 2022 Jan;10(1):e003091. doi: 10.1136/jitc-2021-003091.'}, {'pmid': '33496357', 'type': 'DERIVED', 'citation': 'Reardon DA, Kim TM, Frenel JS, Simonelli M, Lopez J, Subramaniam DS, Siu LL, Wang H, Krishnan S, Stein K, Massard C. Treatment with pembrolizumab in programmed death ligand 1-positive recurrent glioblastoma: Results from the multicohort phase 1 KEYNOTE-028 trial. Cancer. 2021 May 15;127(10):1620-1629. doi: 10.1002/cncr.33378. Epub 2021 Jan 26.'}, {'pmid': '32359091', 'type': 'DERIVED', 'citation': 'Piha-Paul SA, Oh DY, Ueno M, Malka D, Chung HC, Nagrial A, Kelley RK, Ros W, Italiano A, Nakagawa K, Rugo HS, de Braud F, Varga AI, Hansen A, Wang H, Krishnan S, Norwood KG, Doi T. Efficacy and safety of pembrolizumab for the treatment of advanced biliary cancer: Results from the KEYNOTE-158 and KEYNOTE-028 studies. Int J Cancer. 2020 Oct 15;147(8):2190-2198. doi: 10.1002/ijc.33013. Epub 2020 May 2.'}, {'pmid': '32320048', 'type': 'DERIVED', 'citation': "Mehnert JM, Bergsland E, O'Neil BH, Santoro A, Schellens JHM, Cohen RB, Doi T, Ott PA, Pishvaian MJ, Puzanov I, Aung KL, Hsu C, Le Tourneau C, Hollebecque A, Elez E, Tamura K, Gould M, Yang P, Stein K, Piha-Paul SA. Pembrolizumab for the treatment of programmed death-ligand 1-positive advanced carcinoid or pancreatic neuroendocrine tumors: Results from the KEYNOTE-028 study. Cancer. 2020 Jul 1;126(13):3021-3030. doi: 10.1002/cncr.32883. Epub 2020 Apr 22."}, {'pmid': '30832606', 'type': 'DERIVED', 'citation': 'Mehnert JM, Varga A, Brose MS, Aggarwal RR, Lin CC, Prawira A, de Braud F, Tamura K, Doi T, Piha-Paul SA, Gilbert J, Saraf S, Thanigaimani P, Cheng JD, Keam B. Safety and antitumor activity of the anti-PD-1 antibody pembrolizumab in patients with advanced, PD-L1-positive papillary or follicular thyroid cancer. BMC Cancer. 2019 Mar 4;19(1):196. doi: 10.1186/s12885-019-5380-3.'}, {'pmid': '30557521', 'type': 'DERIVED', 'citation': "Ott PA, Bang YJ, Piha-Paul SA, Razak ARA, Bennouna J, Soria JC, Rugo HS, Cohen RB, O'Neil BH, Mehnert JM, Lopez J, Doi T, van Brummelen EMJ, Cristescu R, Yang P, Emancipator K, Stein K, Ayers M, Joe AK, Lunceford JK. T-Cell-Inflamed Gene-Expression Profile, Programmed Death Ligand 1 Expression, and Tumor Mutational Burden Predict Efficacy in Patients Treated With Pembrolizumab Across 20 Cancers: KEYNOTE-028. J Clin Oncol. 2019 Feb 1;37(4):318-327. doi: 10.1200/JCO.2018.78.2276. Epub 2018 Dec 13."}, {'pmid': '29992241', 'type': 'DERIVED', 'citation': 'Hansen AR, Massard C, Ott PA, Haas NB, Lopez JS, Ejadi S, Wallmark JM, Keam B, Delord JP, Aggarwal R, Gould M, Yang P, Keefe SM, Piha-Paul SA. Pembrolizumab for advanced prostate adenocarcinoma: findings of the KEYNOTE-028 study. Ann Oncol. 2018 Aug 1;29(8):1807-1813. doi: 10.1093/annonc/mdy232.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the efficacy and safety of pembrolizumab (MK-3475) administered to participants with incurable advanced biomarker-positive solid tumors that have not responded to current therapy or for which current therapy is not appropriate.\n\nThe study hypothesis is that administration of pembrolizumab to participants with some types of solid tumors will result in a clinically meaningful response rate.', 'detailedDescription': "Qualified participants who complete up to \\~2 years of pembrolizumab treatment but progress after discontinuation may be eligible for a second course of pembrolizumab for up to \\~1 additional year, at the Investigator's discretion. Per protocol, response or progression during this second course will not count towards efficacy outcome measures and adverse events during this second course will not count towards safety outcome measures."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically documented locally-advanced and/or metastatic solid malignancy that is incurable, and has failed prior standard therapy or for which standard therapy is not appropriate\n* Have biomarker-positive solid tumor\n* Have measurable disease based on Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1)\n* Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1\n* Adequate organ function\n* Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication\n* Male participants of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study medication through 120 days after the last dose of study medication\n\nExclusion Criteria:\n\n* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment\n* Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment\n* Prior anti-cancer therapy with a monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or not recovered from adverse events due to mAbs administered more than 4 weeks earlier\n* Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks (12 weeks for measurable sites of central nervous system \\[CNS\\] disease) prior to study Day 1 or not recovered from adverse events due to a previously administered agent\n* Known additional malignancy that is progressing or requires active treatment excepting basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer\n* Known active CNS metastases and/or carcinomatous meningitis\n* Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n* Has evidence of interstitial lung disease or a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n* Active infection requiring systemic therapy\n* Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n* Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment\n* Has previously participated in any other pembrolizumab (MK-3475) trial, or received prior therapy with an anti-PD-1, anti-PD-L1, and anti-PD-L2 (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)\n* Known history of human immunodeficiency virus (HIV)\n* Known active Hepatitis B or Hepatitis C\n* Has received a live vaccine within 30 days of planned start of study medication. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist®) are live attenuated vaccines and are not allowed.'}, 'identificationModule': {'nctId': 'NCT02054806', 'briefTitle': 'Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-028/KEYNOTE-28)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Phase IB Study of Pembrolizumab (MK-3475) in Subjects With Select Advanced Solid Tumors', 'orgStudyIdInfo': {'id': '3475-028'}, 'secondaryIdInfos': [{'id': '142515', 'type': 'REGISTRY', 'domain': 'JAPIC-CTI'}, {'id': 'MK-3475-028', 'type': 'OTHER', 'domain': 'Merck'}, {'id': 'KEYNOTE-28', 'type': 'OTHER', 'domain': 'Merck'}, {'id': '2013-004507-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pembrolizumab', 'description': 'Participants receive pembrolizumab 10 mg/kg, intravenously (IV), once every 2 weeks (Q2W) for up to \\~2 years', 'interventionNames': ['Biological: Pembrolizumab']}], 'interventions': [{'name': 'Pembrolizumab', 'type': 'BIOLOGICAL', 'otherNames': ['MK-3475', 'KEYTRUDA®'], 'description': 'IV infusion', 'armGroupLabels': ['Pembrolizumab']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}