Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2026-01-05 @ 5:40 PM
Study NCT ID:
NCT05394350
Status:
TERMINATED
Last Update Posted:
2024-11-08
First Post:
2022-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of MK-1088 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (MK-1088-002)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}}}}, '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': 'If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The decision to close study enrollment was based on review of data from the dose escalation phase and Sponsor prioritization. The decision to stop enrollment was not due to any safety concerns, and there were no safety signals observed during the study.'}}, 'adverseEventsModule': {'timeFrame': 'Death and adverse events up to ~13 months', 'description': 'Every participant is counted a single time for each applicable serious adverse event. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.', 'eventGroups': [{'id': 'EG000', 'title': 'MK-1088 100 mg', 'description': 'Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'MK-1088 200 mg', 'description': 'Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'MK-1088 400 mg', 'description': 'Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 4, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'MK-1088 600 mg', 'description': 'Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'MK 1088 100 mg + Pembrolizumab', 'description': 'Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \\~24 months)', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'MK-1088 200 mg + Pembrolizumab', 'description': 'Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \\~24 months)', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'MK-1088 100 mg + Pembrolizumab Swicthover', 'description': 'Participants who progressed by radiographic evaluation on monotherapy with MK-1088 and switched over to combination therapy received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \\~24 months)', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, 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{'term': 'Early satiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'General physical health 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'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Localised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Mucosal 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Ureteric stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Experiencing a Dose-limiting Toxicity (DLT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1088 100 mg', 'description': 'Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG001', 'title': 'MK-1088 200 mg', 'description': 'Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG002', 'title': 'MK-1088 400 mg', 'description': 'Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG003', 'title': 'MK-1088 600 mg', 'description': 'Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG004', 'title': 'MK-1088 100 mg + Pembrolizumab', 'description': 'Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG005', 'title': 'MK-1088 200 mg + Pembrolizumab', 'description': 'Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG006', 'title': 'MK-1088 100 mg + Pembrolizumab Switchover', 'description': 'Participants who progressed by radiographic evaluation on monotherapy with MK-1088 and switched over to combination therapy received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '9.09', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 21 days', 'description': 'A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0). Per protocol participants who switched over from MK-1088 monotherapy into MK-1088 100 mg + Pembrolizumab combination therapy completed the DLT evaluation period in the monotherapy arm assigned. Percentage of participants who experienced a DLT are presented.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study intervention and met the criteria for DLT evaluability'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Experiencing an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1088 100 mg', 'description': 'Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG001', 'title': 'MK-1088 200 mg', 'description': 'Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG002', 'title': 'MK-1088 400 mg', 'description': 'Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG003', 'title': 'MK-1088 600 mg', 'description': 'Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG004', 'title': 'MK-1088 100 mg + Pembrolizumab', 'description': 'Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG005', 'title': 'MK-1088 200 mg + Pembrolizumab', 'description': 'Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG006', 'title': 'MK-1088 100 mg + Pembrolizumab Switchover', 'description': 'Participants who progressed by radiographic evaluation on monotherapy with MK-1088 and switched over to combination therapy received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}, {'value': '100.0', 'groupId': 'OG005'}, {'value': '100.0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to ~13 months', 'description': "An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. Safety data from participants who experienced disease progression in the monotherapy arm and crossed over into the combination arm are summarized in their initial monotherapy dose group until the time of cross over and are summarized separately thereafter. The percentage of participants who experienced an AE are presented.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study intervention'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Discontinuing Study Treatment Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1088 100 mg', 'description': 'Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG001', 'title': 'MK-1088 200 mg', 'description': 'Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG002', 'title': 'MK-1088 400 mg', 'description': 'Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG003', 'title': 'MK-1088 600 mg', 'description': 'Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG004', 'title': 'MK-1088 100 mg + Pembrolizumab', 'description': 'Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG005', 'title': 'MK-1088 200 mg + Pembrolizumab', 'description': 'Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG006', 'title': 'MK-1088 100 mg + Pembrolizumab Switchover', 'description': 'Participants who progressed by radiographic evaluation on monotherapy with MK-1088 and switched over to combination therapy received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '9.1', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '66.7', 'groupId': 'OG004'}, {'value': '75.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to ~10 months', 'description': "An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. Safety data from participants who experienced disease progression in the monotherapy arm and crossed over into the combination arm are summarized in their initial monotherapy dose group until the time of cross over and are summarized separately thereafter. The percentage of participants who discontinued study treatment due to an AE is presented.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study intervention'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Curve (AUC) of MK-1088', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1088 100 mg', 'description': 'Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG001', 'title': 'MK-1088 200 mg', 'description': 'Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG002', 'title': 'MK-1088 400 mg', 'description': 'Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG003', 'title': 'MK-1088 600 mg', 'description': 'Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG004', 'title': 'MK-1088 100 mg + Pembrolizumab', 'description': 'Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG005', 'title': 'MK-1088 200 mg + Pembrolizumab', 'description': 'Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG006', 'title': 'MK-1088 100 mg + Pembrolizumab Switchover', 'description': 'Participants who progressed by radiographic evaluation on monotherapy with MK-1088 and switched over to combination therapy received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '31.9', 'spread': '105.2', 'groupId': 'OG000'}, {'value': '26.1', 'spread': '95.1', 'groupId': 'OG001'}, {'value': '98.4', 'spread': '38.5', 'groupId': 'OG002'}, {'value': '99.4', 'spread': '43.9', 'groupId': 'OG003'}, {'value': '21.8', 'spread': '51.2', 'groupId': 'OG004'}, {'value': '49.3', 'spread': '50.8', 'groupId': 'OG005'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '39.0', 'spread': '46.6', 'groupId': 'OG000'}, {'value': '39.5', 'spread': '145.4', 'groupId': 'OG001'}, {'value': '197.0', 'spread': '46.4', 'groupId': 'OG002'}, {'value': '188.0', 'spread': '90.6', 'groupId': 'OG003'}, {'value': '29.7', 'spread': '97.1', 'groupId': 'OG004'}, {'value': '102.0', 'spread': '17.6', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 1, 2, 4, and 8 hours post-dose on Cycle 1 Day 1 and Cycle 2 Day 1; Pre-dose on Cycle 1 Day 2 and Cycle 2 Day 2; Pre-dose on Cycle 3, Cycle 4 and every 4 cycles up to ~3.5 months. Each cycle = 21 days', 'description': 'AUC of MK-1088 determined by blood samples collected pre-dose and at designated timepoints post-dose are presented.', 'unitOfMeasure': 'hr*μmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that their data will be likely to show the effects of treatment, according to the underlying scientific model. Only the per protocol analysis set (excluding the data from the participants after switching over to MK-1088 100 mg and Pembrolizumab) were analyzed for pharmacokinetic (PK) data.'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentration (Cmax) of MK-1088', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1088 100 mg', 'description': 'Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG001', 'title': 'MK-1088 200 mg', 'description': 'Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG002', 'title': 'MK-1088 400 mg', 'description': 'Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG003', 'title': 'MK-1088 600 mg', 'description': 'Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG004', 'title': 'MK-1088 100 mg + Pembrolizumab', 'description': 'Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG005', 'title': 'MK-1088 200 mg + Pembrolizumab', 'description': 'Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG006', 'title': 'MK-1088 100 mg + Pembrolizumab Switchover', 'description': 'Participants who progressed by radiographic evaluation on monotherapy with MK-1088 and switched over to combination therapy received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '2.58', 'spread': '61.8', 'groupId': 'OG000'}, {'value': '2.17', 'spread': '50.8', 'groupId': 'OG001'}, {'value': '6.63', 'spread': '36.7', 'groupId': 'OG002'}, {'value': '7.70', 'spread': '46.4', 'groupId': 'OG003'}, {'value': '1.41', 'spread': '62.4', 'groupId': 'OG004'}, {'value': '3.29', 'spread': '83.1', 'groupId': 'OG005'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '2.82', 'spread': '31.9', 'groupId': 'OG000'}, {'value': '3.27', 'spread': '92.0', 'groupId': 'OG001'}, {'value': '11.6', 'spread': '31.8', 'groupId': 'OG002'}, {'value': '11.6', 'spread': '79.9', 'groupId': 'OG003'}, {'value': '1.80', 'spread': '117.4', 'groupId': 'OG004'}, {'value': '6.32', 'spread': '30.2', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 1, 2, 4, and 8 hours post-dose on Cycle 1 Day 1 and Cycle 2 Day 1; Pre-dose on Cycle 1 Day 2 and Cycle 2 Day 2; Pre-dose on Cycle 3, Cycle 4 and every 4 cycles up to ~3.5 months. Each cycle = 21 days', 'description': 'Cmax of MK-1088 determined by blood samples collected pre-dose and at designated timepoints post-dose are presented.', 'unitOfMeasure': 'μmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that their data will be likely to show the effects of treatment, according to the underlying scientific model. Only the per protocol analysis set (excluding the data from the participants after switching over to MK-1088 100 mg and Pembrolizumab) were analyzed for pharmacokinetic (PK) data.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or Prostate Cancer Working Group (PCWG)-Modified RECIST 1.1 as Assessed by Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1088 100 mg', 'description': 'Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG001', 'title': 'MK-1088 200 mg', 'description': 'Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG002', 'title': 'MK-1088 400 mg', 'description': 'Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG003', 'title': 'MK-1088 600 mg', 'description': 'Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG004', 'title': 'MK-1088 100 mg + Pembrolizumab', 'description': 'Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG005', 'title': 'MK-1088 200 mg + Pembrolizumab', 'description': 'Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'OG006', 'title': 'MK-1088 100 mg + Pembrolizumab Switchover', 'description': 'Participants who progressed by radiographic evaluation on monotherapy with MK-1088 and switched over to combination therapy received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '84.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '70.8'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '28.5'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '70.8'}, {'value': '33.3', 'groupId': 'OG004', 'lowerLimit': '0.8', 'upperLimit': '90.6'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '84.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to ~13 months', 'description': 'ORR is defined as the percentage of participants who have 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) per RECIST 1.1 or Prostate Cancer Working Group (PCWG)-modified RECIST 1.1 as assessed by investigator. Efficacy data from participants who experienced disease progression in the monotherapy arm and crossed over into the combination arm will be summarized in their initial monotherapy dose group until the time of cross over and will be summarized separately thereafter. The percentage of participants who experience a CR or PR as assessed by the investigator based on RECIST 1.1 is presented.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "All participants with a screening/baseline scan that showed measurable disease by the investigator's assessment, and received at least 1 dose of study intervention"}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MK-1088 100 mg', 'description': 'Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'FG001', 'title': 'MK-1088 200 mg', 'description': 'Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'FG002', 'title': 'MK-1088 400 mg', 'description': 'Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'FG003', 'title': 'MK-1088 600 mg', 'description': 'Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'FG004', 'title': 'MK-1088 100 mg + Pembrolizumab', 'description': 'Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'FG005', 'title': 'MK-1088 200 mg + Pembrolizumab', 'description': 'Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'Switch Over to MK-1088 100 mg + Pembrolizumab', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'The study was closed to enrollment on 04-MAY-2023 for all participants, and no participants remain on treatment with MK-1088. Part 2 of the study was not initiated.', 'preAssignmentDetails': "Per protocol two participants who progressed by radiographic evaluation on monotherapy with MK-1088 at the investigator's discretion and after consultation with the Sponsor, switched over to combination treatment arm of MK-1088 and pembrolizumab."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '27', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'MK-1088 100 mg', 'description': 'Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'BG001', 'title': 'MK-1088 200 mg', 'description': 'Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'BG002', 'title': 'MK-1088 400 mg', 'description': 'Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'BG003', 'title': 'MK-1088 600 mg', 'description': 'Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'BG004', 'title': 'MK-1088 100 mg + Pembrolizumab', 'description': 'Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'BG005', 'title': 'MK-1088 200 mg + Pembrolizumab', 'description': 'Participants received MK-1088 daily (QD) orally at 200 mg on days 1-21 of each 21-day cycle plus pembrolizumab at 200 mg intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of each 21-day cycle for up to 35 cycles (up to \\~24 months)'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'spread': '13.6', 'groupId': 'BG000'}, {'value': '58.7', 'spread': '24.8', 'groupId': 'BG001'}, {'value': '59.5', 'spread': '13.5', 'groupId': 'BG002'}, {'value': '62.7', 'spread': '4.9', 'groupId': 'BG003'}, {'value': '61.0', 'spread': '10.1', 'groupId': 'BG004'}, {'value': '55.8', 'spread': '11.6', 'groupId': 'BG005'}, {'value': '60.1', 'spread': '12.9', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-29', 'size': 938567, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-19T09:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'whyStopped': 'Business Reasons', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-07', 'studyFirstSubmitDate': '2022-05-23', 'resultsFirstSubmitDate': '2024-08-19', 'studyFirstSubmitQcDate': '2022-05-23', 'lastUpdatePostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-25', 'studyFirstPostDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Experiencing a Dose-limiting Toxicity (DLT)', 'timeFrame': 'Up to 21 days', 'description': 'A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0). Per protocol participants who switched over from MK-1088 monotherapy into MK-1088 100 mg + Pembrolizumab combination therapy completed the DLT evaluation period in the monotherapy arm assigned. Percentage of participants who experienced a DLT are presented.'}, {'measure': 'Percentage of Participants Experiencing an Adverse Event (AE)', 'timeFrame': 'Up to ~13 months', 'description': "An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. Safety data from participants who experienced disease progression in the monotherapy arm and crossed over into the combination arm are summarized in their initial monotherapy dose group until the time of cross over and are summarized separately thereafter. The percentage of participants who experienced an AE are presented."}, {'measure': 'Percentage of Participants Discontinuing Study Treatment Due to an AE', 'timeFrame': 'Up to ~10 months', 'description': "An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. Safety data from participants who experienced disease progression in the monotherapy arm and crossed over into the combination arm are summarized in their initial monotherapy dose group until the time of cross over and are summarized separately thereafter. The percentage of participants who discontinued study treatment due to an AE is presented."}], 'secondaryOutcomes': [{'measure': 'Area Under the Plasma Concentration-time Curve (AUC) of MK-1088', 'timeFrame': 'Pre-dose and 1, 2, 4, and 8 hours post-dose on Cycle 1 Day 1 and Cycle 2 Day 1; Pre-dose on Cycle 1 Day 2 and Cycle 2 Day 2; Pre-dose on Cycle 3, Cycle 4 and every 4 cycles up to ~3.5 months. Each cycle = 21 days', 'description': 'AUC of MK-1088 determined by blood samples collected pre-dose and at designated timepoints post-dose are presented.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of MK-1088', 'timeFrame': 'Pre-dose and 1, 2, 4, and 8 hours post-dose on Cycle 1 Day 1 and Cycle 2 Day 1; Pre-dose on Cycle 1 Day 2 and Cycle 2 Day 2; Pre-dose on Cycle 3, Cycle 4 and every 4 cycles up to ~3.5 months. Each cycle = 21 days', 'description': 'Cmax of MK-1088 determined by blood samples collected pre-dose and at designated timepoints post-dose are presented.'}, {'measure': 'Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or Prostate Cancer Working Group (PCWG)-Modified RECIST 1.1 as Assessed by Investigator', 'timeFrame': 'Up to ~13 months', 'description': 'ORR is defined as the percentage of participants who have 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) per RECIST 1.1 or Prostate Cancer Working Group (PCWG)-modified RECIST 1.1 as assessed by investigator. Efficacy data from participants who experienced disease progression in the monotherapy arm and crossed over into the combination arm will be summarized in their initial monotherapy dose group until the time of cross over and will be summarized separately thereafter. The percentage of participants who experience a CR or PR as assessed by the investigator based on RECIST 1.1 is presented.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumors']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com/', 'label': 'Merck Clinical Trials Information'}, {'url': 'https://msd.trialsummaries.com/Study/StudyDetails?id=26166&tenant=MT_MSD_9011', 'label': 'Plain Language Summary'}]}, 'descriptionModule': {'briefSummary': 'The study will evaluate the safety, tolerability, and pharmacokinetics (PK) of MK-1088 in monotherapy and in combination with pembrolizumab in participants with advanced solid tumors who have not responded to conventional therapy. The effect of MK-1088 on tumor size will also be examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Has a histologically- or cytologically-confirmed diagnosis of advanced/metastatic solid tumor by pathology report and have received, have been intolerant to, or have been ineligible for treatment known to confer clinical benefit\n* For metastatic castrate-resistant prostate cancer (mCRPC) only: (1) Must have previously received docetaxel, prior treatment with one other chemotherapy is allowed as well as up to 2 second-generation hormonal manipulations and (2) have prostate cancer progression within 6 months before screening, as determined by the investigator\n* If human immunodeficiency virus (HIV) positive, has well-controlled HIV on anti-retroviral therapy (ART)\n\nExclusion Criteria:\n\n* Has had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study intervention\n* Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years\n* Has clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis\n* Has an active infection requiring therapy\n* Has a history of interstitial lung disease\n* Has a history of (noninfectious) pneumonitis that required steroids or current pneumonitis\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years\n* Has concurrent active Hepatitis B and Hepatitis C virus infection\n* Has HIV with a history of Kaposi\'s sarcoma and/or Multicentric Castleman\'s Disease\n* Has not fully recovered from any effects of major surgery without significant detectable infection\n* Has a history or current evidence of a gastrointestinal (GI) condition or impaired liver function or diseases that in the opinion of the investigator may significantly alter the absorption or metabolism of oral medications\n* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Health Association (NYHA) Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability\n* Has a corrected QT interval using Fridericia\'s Correction Formula (QTcF) \\>470 msec\n* Has history of an allogeneic stem cell transplant or a solid organ transplant.\n* Has received prior systemic anticancer therapy including investigational agents within 4 weeks before allocation\n* Has received prior radiotherapy within 2 weeks of start of study intervention, or had radiation-related toxicities requiring corticosteroids\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention\n* Has a "superscan" bone scan'}, 'identificationModule': {'nctId': 'NCT05394350', 'briefTitle': 'A Study of MK-1088 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (MK-1088-002)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 1/Phase 2 Study to Evaluate the Safety and Tolerability of MK-1088 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': '1088-002'}, 'secondaryIdInfos': [{'id': 'MK-1088-002', 'type': 'OTHER', 'domain': 'Merck'}, {'id': '2022-502288-40-00', 'type': 'REGISTRY', 'domain': 'CTIS (EU)'}, {'id': '2021-006712-93', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MK-1088 100 mg', 'description': 'Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months).', 'interventionNames': ['Drug: MK-1088']}, {'type': 'EXPERIMENTAL', 'label': 'MK-1088 200 mg', 'description': 'Participants received MK-1088 (QD) orally at 200 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)', 'interventionNames': ['Drug: MK-1088']}, {'type': 'EXPERIMENTAL', 'label': 'MK-1088 400 mg', 'description': 'Participants received MK-1088 (QD) orally at 400 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)', 'interventionNames': ['Drug: MK-1088']}, {'type': 'EXPERIMENTAL', 'label': 'MK-1088 600 mg', 'description': 'Participants received MK-1088 (QD) orally at 600 mg on days 1-21 of each 21-day cycle for up to 35 cycles (up to \\~24 months)', 'interventionNames': ['Drug: MK-1088']}, {'type': 'EXPERIMENTAL', 'label': 'MK-1088 100 mg + Pembrolizumab', 'description': 'Participants received MK-1088 daily (QD) orally at 100 mg on days 1-21 of each 21-day cycle 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