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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 9:37 PM

Ignite Modification Date: 2025-12-25 @ 7:20 PM

Study NCT ID: NCT03400332

Status: ACTIVE_NOT_RECRUITING

Last Update Posted: 2025-07-25

First Post: 2018-01-12

Is NOT Gene Therapy: False

Has Adverse Events: True

Brief Title: A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Chile'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000709704', 'term': 'HuMax-IL8'}, {'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'D000074324', 'term': 'Ipilimumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'phone': 'Please Email', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 74 months). SAEs and Other AEs were assessed from first dose to 100 days post the last dose (up to approximately 65 months).', 'description': 'The population for all-cause mortality is all randomized participants. SAEs and Other AEs represents all participants who received at least one dose of study treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1: 600 Q4W', 'description': '600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 16, 'seriousNumAtRisk': 16, 'deathsNumAffected': 14, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Part 1: 1200 Q4W', 'description': '1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 14, 'seriousNumAtRisk': 15, 'deathsNumAffected': 15, 'seriousNumAffected': 10}, {'id': 'EG002', 'title': 'Part 1: 2400 Q4W', 'description': '2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 18, 'seriousNumAtRisk': 18, 'deathsNumAffected': 17, 'seriousNumAffected': 13}, {'id': 'EG003', 'title': 'Part 1: 1200 Q2W', 'description': '1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 11, 'seriousNumAtRisk': 12, 'deathsNumAffected': 10, 'seriousNumAffected': 7}, {'id': 'EG004', 'title': 'Part 1: 2400 Q2W', 'description': '2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 59, 'seriousNumAtRisk': 63, 'deathsNumAffected': 53, 'seriousNumAffected': 31}, {'id': 'EG005', 'title': 'Part 1: 3600 Q2W', 'description': '3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 19, 'seriousNumAtRisk': 20, 'deathsNumAffected': 13, 'seriousNumAffected': 12}, {'id': 'EG006', 'title': 'Part 1: 3600Q2W + Nivo + Ipi', 'description': '3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'deathsNumAffected': 8, 'seriousNumAffected': 9}, {'id': 'EG007', 'title': 'Part 2 Arm A: BMS+Nivo+Ipi', 'description': 'BMS-986253 3600 mg Q2W + nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W for 12 weeks; BMS-986253 3600 mg Q2W + nivolumab 480 mg Q4W thereafter', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 61, 'seriousNumAtRisk': 62, 'deathsNumAffected': 30, 'seriousNumAffected': 44}, {'id': 'EG008', 'title': 'Part 2 Arm B: Placebo+Nivo+Ipi', 'description': 'Placebo Q2W + nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W for 12 weeks; BMS-986253 3600 mg Q2W + nivolumab 480 mg Q4W thereafter', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 60, 'otherNumAffected': 54, 'seriousNumAtRisk': 57, 'deathsNumAffected': 17, 'seriousNumAffected': 42}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 21}, {'groupId': 'EG008', 'numAtRisk': 57, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 8}, {'groupId': 'EG008', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Neutrophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 57, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Bundle branch block bilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 57, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 57, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 57, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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{'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Experiencing Adverse Events (AEs) - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 600 Q4W', 'description': '600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG001', 'title': 'Part 1: 1200 Q4W', 'description': '1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG002', 'title': 'Part 1: 2400 Q4W', 'description': '2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG003', 'title': 'Part 1: 1200 Q2W', 'description': '1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG004', 'title': 'Part 1: 2400 Q2W', 'description': '2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG005', 'title': 'Part 1: 3600 Q2W', 'description': '3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG006', 'title': 'Part 1: 3600Q2W + Nivo + Ipi', 'description': '3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '60', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose up to 100 days after last dose (up to 65 months)', 'description': 'An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.\n\nThis endpoint was prespecified in the protocol to include only participants in Part 1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1'}, {'type': 'PRIMARY', 'title': 'Number of Participants Experiencing Serious Adverse Events (SAEs) - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 600 Q4W', 'description': '600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG001', 'title': 'Part 1: 1200 Q4W', 'description': '1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG002', 'title': 'Part 1: 2400 Q4W', 'description': '2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG003', 'title': 'Part 1: 1200 Q2W', 'description': '1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG004', 'title': 'Part 1: 2400 Q2W', 'description': '2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG005', 'title': 'Part 1: 3600 Q2W', 'description': '3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG006', 'title': 'Part 1: 3600Q2W + Nivo + Ipi', 'description': '3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose up to 100 days after last dose (up to 65 months)', 'description': 'A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.\n\nThis endpoint was prespecified in the protocol to include only participants in Part 1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1'}, {'type': 'PRIMARY', 'title': 'Number of Participants Experiencing Dose Limiting Toxicities (DLTs) - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 600 Q4W', 'description': '600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG001', 'title': 'Part 1: 1200 Q4W', 'description': '1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG002', 'title': 'Part 1: 2400 Q4W', 'description': '2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG003', 'title': 'Part 1: 1200 Q2W', 'description': '1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG004', 'title': 'Part 1: 2400 Q2W', 'description': '2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG005', 'title': 'Part 1: 3600 Q2W', 'description': '3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG006', 'title': 'Part 1: 3600Q2W + Nivo + Ipi', 'description': '3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose up to 100 days after last dose (up to 65 months)', 'description': 'Dose-Limiting Toxicities (DLTs) are effects of a treatment that are serious enough to prevent an increase in dose of that treatment, as advised by the Dose Review Team. DLTs will be defined based on the incidence, intensity, and duration of AEs that are possibly related to study treatment. DLTs will include gastrointestinal, hepatic, hematologic, dermatologic, and other AEs.\n\nThis endpoint was prespecified in the protocol to include only participants in Part 1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1'}, {'type': 'PRIMARY', 'title': 'Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 600 Q4W', 'description': '600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG001', 'title': 'Part 1: 1200 Q4W', 'description': '1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG002', 'title': 'Part 1: 2400 Q4W', 'description': '2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG003', 'title': 'Part 1: 1200 Q2W', 'description': '1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG004', 'title': 'Part 1: 2400 Q2W', 'description': '2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG005', 'title': 'Part 1: 3600 Q2W', 'description': '3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG006', 'title': 'Part 1: 3600Q2W + Nivo + Ipi', 'description': '3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose up to 100 days after last dose (up to 65 months)', 'description': 'Number of participants with any grade adverse events (AEs) leading to discontinuation of study treatment. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.\n\nThis endpoint was prespecified in the protocol to include only participants in Part 1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Died - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 600 Q4W', 'description': '600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG001', 'title': 'Part 1: 1200 Q4W', 'description': '1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG002', 'title': 'Part 1: 2400 Q4W', 'description': '2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG003', 'title': 'Part 1: 1200 Q2W', 'description': '1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG004', 'title': 'Part 1: 2400 Q2W', 'description': '2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG005', 'title': 'Part 1: 3600 Q2W', 'description': '3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG006', 'title': 'Part 1: 3600Q2W + Nivo + Ipi', 'description': '3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose up to 100 days after last dose (up to 65 months)', 'description': 'The number of participants who died due to any cause are summarized. This endpoint was prespecified in the protocol to include only participants in Part 1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1'}, {'type': 'PRIMARY', 'title': 'Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 600 Q4W', 'description': '600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG001', 'title': 'Part 1: 1200 Q4W', 'description': '1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG002', 'title': 'Part 1: 2400 Q4W', 'description': '2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG003', 'title': 'Part 1: 1200 Q2W', 'description': '1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG004', 'title': 'Part 1: 2400 Q2W', 'description': '2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG005', 'title': 'Part 1: 3600 Q2W', 'description': '3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG006', 'title': 'Part 1: 3600Q2W + Nivo + Ipi', 'description': '3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W'}], 'classes': [{'title': 'Hemoglobin - Grade 3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}]}, {'title': 'Alanine aminotransferase - Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'Alkaline phosphatase - Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'Aspartate aminotransferase - Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Phosphate - Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Sodium - Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'Lipase - Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'Lipase - Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'Amylase - Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'Amylase - Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Albumin - Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose up to 30 days after last dose (up to 63 months)', 'description': 'Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Laboratory tests are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.\n\nThis endpoint was prespecified in the protocol to include only participants in Part 1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '63', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 600 Q4W', 'description': '600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG001', 'title': 'Part 1: 1200 Q4W', 'description': '1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG002', 'title': 'Part 1: 2400 Q4W', 'description': '2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG003', 'title': 'Part 1: 1200 Q2W', 'description': '1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG004', 'title': 'Part 1: 2400 Q2W', 'description': '2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG005', 'title': 'Part 1: 3600 Q2W', 'description': '3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG006', 'title': 'Part 1: 3600Q2W + Nivo + Ipi', 'description': '3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '30.2'}, {'value': '6.7', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '31.9'}, {'value': '16.7', 'groupId': 'OG002', 'lowerLimit': '3.6', 'upperLimit': '41.4'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '26.5'}, {'value': '3.2', 'groupId': 'OG004', 'lowerLimit': '0.4', 'upperLimit': '11.0'}, {'value': '10.0', 'groupId': 'OG005', 'lowerLimit': '1.2', 'upperLimit': '31.7'}, {'value': '13.3', 'groupId': 'OG006', 'lowerLimit': '1.7', 'upperLimit': '40.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 74 months)', 'description': 'Objective Response Rate per investigator is the percentage of participants who have a confirmed complete or partial best overall response (BOR) among participants who have measurable disease at baseline. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to =\\< 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Baseline was defined as evaluations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations. This endpoint was prespecified in the protocol to include only participants in Part 1.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 600 Q4W', 'description': '600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG001', 'title': 'Part 1: 1200 Q4W', 'description': '1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG002', 'title': 'Part 1: 2400 Q4W', 'description': '2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG003', 'title': 'Part 1: 1200 Q2W', 'description': '1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG004', 'title': 'Part 1: 2400 Q2W', 'description': '2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG005', 'title': 'Part 1: 3600 Q2W', 'description': '3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG006', 'title': 'Part 1: 3600Q2W + Nivo + Ipi', 'description': '3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '3.7'}, {'value': '28.9', 'groupId': 'OG001', 'lowerLimit': '28.9', 'upperLimit': '28.9'}, {'value': '44.6', 'groupId': 'OG002', 'lowerLimit': '8.4', 'upperLimit': '44.6'}, {'value': '21.09', 'groupId': 'OG004', 'lowerLimit': '4.0', 'upperLimit': '21.1'}, {'value': '3.4', 'groupId': 'OG005', 'lowerLimit': '3.4', 'upperLimit': '3.4'}, {'value': 'NA', 'comment': 'Median not calculated due to insufficient number of events', 'groupId': 'OG006', 'lowerLimit': '3.7', 'upperLimit': '24.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 74 months)', 'description': 'DOR for a participant with a best overall response (BOR) of CR or PR is defined as the date of first response up to the date of the first objectively documented tumor progression by the investigator per RECIST v1.1 or death, whichever occurs first. Analysis computed using Kaplan-Meier method.\n\nComplete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to =\\< 10 mm.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.\n\nProgressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of at least 5 mm.\n\nThis endpoint was prespecified in the protocol to include only participants in Part 1.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All confirmed responders in Part 1'}, {'type': 'SECONDARY', 'title': 'Maximum Concentration (Cmax) - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 600 Q4W', 'description': '600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG001', 'title': 'Part 1: 1200 Q4W', 'description': '1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG002', 'title': 'Part 1: 2400 Q4W', 'description': '2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG003', 'title': 'Part 1: 1200 Q2W', 'description': '1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG004', 'title': 'Part 1: 2400 Q2W', 'description': '2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG005', 'title': 'Part 1: 3600 Q2W', 'description': '3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG006', 'title': 'Part 1: 3600Q2W + Nivo + Ipi', 'description': '3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W'}], 'classes': [{'categories': [{'measurements': [{'value': '142.91', 'spread': '52.1', 'groupId': 'OG000'}, {'value': '352.12', 'spread': '62.7', 'groupId': 'OG001'}, {'value': '779.90', 'spread': '43.1', 'groupId': 'OG002'}, {'value': '325.67', 'spread': '24.0', 'groupId': 'OG003'}, {'value': '919.44', 'spread': '32.8', 'groupId': 'OG004'}, {'value': '1227.67', 'spread': '23.3', 'groupId': 'OG005'}, {'value': '999.60', 'spread': '29.4', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1', 'description': 'Cmax is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered and before the administration of a second dose.\n\n1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1 who have evaluable concentration-time data.'}, {'type': 'SECONDARY', 'title': 'AUC(0-T)-Area Under Curve From Time Zero up to Last Quantifiable Concentration - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 600 Q4W', 'description': '600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG001', 'title': 'Part 1: 1200 Q4W', 'description': '1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG002', 'title': 'Part 1: 2400 Q4W', 'description': '2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG003', 'title': 'Part 1: 1200 Q2W', 'description': '1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG004', 'title': 'Part 1: 2400 Q2W', 'description': '2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG005', 'title': 'Part 1: 3600 Q2W', 'description': '3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG006', 'title': 'Part 1: 3600Q2W + Nivo + Ipi', 'description': '3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W'}], 'classes': [{'categories': [{'measurements': [{'value': '19594.22', 'spread': '52.7', 'groupId': 'OG000'}, {'value': '44821.39', 'spread': '44.5', 'groupId': 'OG001'}, {'value': '105171.46', 'spread': '29.7', 'groupId': 'OG002'}, {'value': '42835.41', 'spread': '28.1', 'groupId': 'OG003'}, {'value': '112123.35', 'spread': '34.2', 'groupId': 'OG004'}, {'value': '148321.77', 'spread': '32.0', 'groupId': 'OG005'}, {'value': '118041.10', 'spread': '40.3', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Cycle 1 Day 1', 'description': 'AUC (0-T) represents the observed exposure to a drug (area under the concentration curve) from first exposure until the last quantifiable concentration. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.\n\n1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)', 'unitOfMeasure': 'h*ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1 who have evaluable concentration-time data'}, {'type': 'SECONDARY', 'title': 'AUC(TAU)-Area Under Curve in 1 Dosing Interval - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 600 Q4W', 'description': '600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG001', 'title': 'Part 1: 1200 Q4W', 'description': '1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG002', 'title': 'Part 1: 2400 Q4W', 'description': '2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG003', 'title': 'Part 1: 1200 Q2W', 'description': '1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG004', 'title': 'Part 1: 2400 Q2W', 'description': '2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG005', 'title': 'Part 1: 3600 Q2W', 'description': '3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG006', 'title': 'Part 1: 3600Q2W + Nivo + Ipi', 'description': '3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W'}], 'classes': [{'categories': [{'measurements': [{'value': '21301.74', 'spread': '49.5', 'groupId': 'OG000'}, {'value': '48664.06', 'spread': '42.9', 'groupId': 'OG001'}, {'value': '106916.11', 'spread': '27.3', 'groupId': 'OG002'}, {'value': '43844.97', 'spread': '24.8', 'groupId': 'OG003'}, {'value': '113969.47', 'spread': '30.8', 'groupId': 'OG004'}, {'value': '153791.84', 'spread': '27.9', 'groupId': 'OG005'}, {'value': '137809.44', 'spread': '29.5', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1', 'description': 'Area under the concentration-time curve in 1 dosing interval. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.\n\n1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)', 'unitOfMeasure': 'h*ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1 who have evaluable concentration-time data'}, {'type': 'SECONDARY', 'title': 'Observed Serum Concentration at the End of a Dosing Interval (Ctau) - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 600 Q4W', 'description': '600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG001', 'title': 'Part 1: 1200 Q4W', 'description': '1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG002', 'title': 'Part 1: 2400 Q4W', 'description': '2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG003', 'title': 'Part 1: 1200 Q2W', 'description': '1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG004', 'title': 'Part 1: 2400 Q2W', 'description': '2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG005', 'title': 'Part 1: 3600 Q2W', 'description': '3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG006', 'title': 'Part 1: 3600Q2W + Nivo + Ipi', 'description': '3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W'}], 'classes': [{'categories': [{'measurements': [{'value': '6.81', 'spread': '173.8', 'groupId': 'OG000'}, {'value': '14.92', 'spread': '144.4', 'groupId': 'OG001'}, {'value': '23.68', 'spread': '692.4', 'groupId': 'OG002'}, {'value': '55.82', 'spread': '53.0', 'groupId': 'OG003'}, {'value': '141.89', 'spread': '42.6', 'groupId': 'OG004'}, {'value': '181.84', 'spread': '46.3', 'groupId': 'OG005'}, {'value': '175.29', 'spread': '46.6', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1', 'description': 'BMS-986253 observed serum concentration at the end of a dosing interval (Ctau). Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.\n\n1 cycle=28 days for all Arms/Groups except Cycles 1 and 2 (1 cycle=42 days) in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1 who have evaluable concentration-time data'}, {'type': 'SECONDARY', 'title': 'Total Body Clearance (CLT) - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 600 Q4W', 'description': '600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG001', 'title': 'Part 1: 1200 Q4W', 'description': '1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG002', 'title': 'Part 1: 2400 Q4W', 'description': '2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG003', 'title': 'Part 1: 1200 Q2W', 'description': '1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG004', 'title': 'Part 1: 2400 Q2W', 'description': '2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG005', 'title': 'Part 1: 3600 Q2W', 'description': '3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG006', 'title': 'Part 1: 3600Q2W + Nivo + Ipi', 'description': '3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W'}], 'classes': [{'categories': [{'measurements': [{'value': '28.17', 'spread': '49.5', 'groupId': 'OG000'}, {'value': '24.66', 'spread': '42.9', 'groupId': 'OG001'}, {'value': '22.45', 'spread': '27.3', 'groupId': 'OG002'}, {'value': '27.37', 'spread': '24.8', 'groupId': 'OG003'}, {'value': '21.06', 'spread': '30.8', 'groupId': 'OG004'}, {'value': '23.41', 'spread': '27.9', 'groupId': 'OG005'}, {'value': '26.12', 'spread': '29.5', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1', 'description': 'Clearance is the rate of elimination of BMS-986253 from the blood calculated as the rate of elimination divided by serum concentration. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.\n\n1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)', 'unitOfMeasure': 'mL/h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1 who have evaluable concentration-time data'}, {'type': 'SECONDARY', 'title': 'Average Serum Concentration Over a Dosing Interval (Css-avg) - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 600 Q4W', 'description': '600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG001', 'title': 'Part 1: 1200 Q4W', 'description': '1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG002', 'title': 'Part 1: 2400 Q4W', 'description': '2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG003', 'title': 'Part 1: 1200 Q2W', 'description': '1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG004', 'title': 'Part 1: 2400 Q2W', 'description': '2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG005', 'title': 'Part 1: 3600 Q2W', 'description': '3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG006', 'title': 'Part 1: 3600Q2W + Nivo + Ipi', 'description': '3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W'}], 'classes': [{'title': 'C2D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '182.48', 'spread': '26.6', 'groupId': 'OG003'}, {'value': '487.85', 'spread': '32.4', 'groupId': 'OG004'}, {'value': '658.06', 'spread': '26.2', 'groupId': 'OG005'}, {'value': '397.96', 'spread': '32.7', 'groupId': 'OG006'}]}]}, {'title': 'C3D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '59.03', 'spread': '47.1', 'groupId': 'OG000'}, {'value': '66.87', 'spread': '74.2', 'groupId': 'OG001'}, {'value': '181.94', 'spread': '19.0', 'groupId': 'OG002'}]}]}, {'title': 'C4D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '115.89', 'groupId': 'OG001'}, {'value': '238.51', 'spread': '20.1', 'groupId': 'OG003'}, {'value': '535.44', 'spread': '37.4', 'groupId': 'OG004'}, {'value': '590.45', 'spread': '37.5', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1', 'description': 'BMS-986253 Average concentration over a dosing interval (\\\\\\[AUC(TAU)/tau\\\\\\] (Css-avg) at steady state. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.\n\n1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)\n\nNote: C2D1, C3D1, C4D1 were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1 who have evaluable concentration-time data'}, {'type': 'SECONDARY', 'title': 'AUC Accumulation Index (AI_AUC) - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 600 Q4W', 'description': '600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG001', 'title': 'Part 1: 1200 Q4W', 'description': '1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG002', 'title': 'Part 1: 2400 Q4W', 'description': '2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG003', 'title': 'Part 1: 1200 Q2W', 'description': '1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG004', 'title': 'Part 1: 2400 Q2W', 'description': '2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG005', 'title': 'Part 1: 3600 Q2W', 'description': '3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG006', 'title': 'Part 1: 3600Q2W + Nivo + Ipi', 'description': '3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W'}], 'classes': [{'title': 'C2D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1.45', 'spread': '10.3', 'groupId': 'OG003'}, {'value': '1.40', 'spread': '22.8', 'groupId': 'OG004'}, {'value': '1.34', 'spread': '20.6', 'groupId': 'OG005'}, {'value': '1.19', 'spread': '6.6', 'groupId': 'OG006'}]}]}, {'title': 'C3D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1.47', 'spread': '37.4', 'groupId': 'OG000'}, {'value': '1.07', 'spread': '16.8', 'groupId': 'OG001'}, {'value': '1.08', 'spread': '15.7', 'groupId': 'OG002'}]}]}, {'title': 'C4D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1.30', 'groupId': 'OG001'}, {'value': '1.77', 'spread': '20.0', 'groupId': 'OG003'}, {'value': '1.64', 'spread': '17.2', 'groupId': 'OG004'}, {'value': '1.43', 'spread': '7.1', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1', 'description': 'AUC Accumulation Index is defined as the ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.\n\n1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)\n\nNote: C2D1, C3D1, C4D1 were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1 who have evaluable concentration-time data'}, {'type': 'SECONDARY', 'title': 'Cmax Accumulation Index (AI_Cmax) - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 600 Q4W', 'description': '600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG001', 'title': 'Part 1: 1200 Q4W', 'description': '1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG002', 'title': 'Part 1: 2400 Q4W', 'description': '2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG003', 'title': 'Part 1: 1200 Q2W', 'description': '1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG004', 'title': 'Part 1: 2400 Q2W', 'description': '2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG005', 'title': 'Part 1: 3600 Q2W', 'description': '3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG006', 'title': 'Part 1: 3600Q2W + Nivo + Ipi', 'description': '3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W'}], 'classes': [{'title': 'C2D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1.15', 'spread': '16.7', 'groupId': 'OG003'}, {'value': '1.11', 'spread': '36.5', 'groupId': 'OG004'}, {'value': '1.21', 'spread': '18.6', 'groupId': 'OG005'}, {'value': '1.15', 'spread': '28.3', 'groupId': 'OG006'}]}]}, {'title': 'C3D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0.90', 'spread': '81.6', 'groupId': 'OG000'}, {'value': '1.05', 'spread': '16.9', 'groupId': 'OG001'}, {'value': '0.86', 'spread': '35.5', 'groupId': 'OG002'}]}]}, {'title': 'C4D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1.58', 'groupId': 'OG000'}, {'value': '1.19', 'groupId': 'OG001'}, {'value': '1.63', 'spread': '46.0', 'groupId': 'OG003'}, {'value': '1.36', 'spread': '26.3', 'groupId': 'OG004'}, {'value': '0.98', 'spread': '30.9', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1', 'description': 'BMS-986253 Cmax accumulation index (AI\\_Cmax). Ratio of an exposure measure at steady state to that after the first dose. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.\n\n1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)\n\nNote: C2D1, C3D1, C4D1 were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1 who have evaluable concentration-time data'}, {'type': 'SECONDARY', 'title': 'Ctau Accumulation Index (AI_Ctau) - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 600 Q4W', 'description': '600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG001', 'title': 'Part 1: 1200 Q4W', 'description': '1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG002', 'title': 'Part 1: 2400 Q4W', 'description': '2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG003', 'title': 'Part 1: 1200 Q2W', 'description': '1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG004', 'title': 'Part 1: 2400 Q2W', 'description': '2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG005', 'title': 'Part 1: 3600 Q2W', 'description': '3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG006', 'title': 'Part 1: 3600Q2W + Nivo + Ipi', 'description': '3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W'}], 'classes': [{'title': 'C2D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1.90', 'spread': '22.7', 'groupId': 'OG003'}, {'value': '1.51', 'spread': '38.0', 'groupId': 'OG004'}, {'value': '1.39', 'spread': '30.7', 'groupId': 'OG005'}, {'value': '1.10', 'spread': '21.2', 'groupId': 'OG006'}]}]}, {'title': 'C3D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1.33', 'spread': '91.0', 'groupId': 'OG000'}, {'value': '1.29', 'spread': '6.5', 'groupId': 'OG001'}, {'value': '0.90', 'spread': '53.5', 'groupId': 'OG002'}]}]}, {'title': 'C4D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1.35', 'groupId': 'OG001'}, {'value': '1.97', 'spread': '31.5', 'groupId': 'OG003'}, {'value': '2.01', 'spread': '35.5', 'groupId': 'OG004'}, {'value': '1.37', 'spread': '45.2', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1', 'description': 'Ctau is the observed serum concentration at the end of a dosing interval. Ctau accumulation index (AI\\_Ctau) is the ratio of an exposure measure at steady state to that after the first dose. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint. Ctau was reported on non-compartmental analysis day, which is on Cycle 1 Day1, Cycle 2 Day 1, Cycle 3 Day 1, or Cycle 4 Day 1 based on data available.\n\n1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)\n\nNote: C2D1, C3D1, C4D1 were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1 who have evaluable concentration-time data'}, {'type': 'SECONDARY', 'title': 'Effective Elimination (T-HALFeff) - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 600 Q4W', 'description': '600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG001', 'title': 'Part 1: 1200 Q4W', 'description': '1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG002', 'title': 'Part 1: 2400 Q4W', 'description': '2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG003', 'title': 'Part 1: 1200 Q2W', 'description': '1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG004', 'title': 'Part 1: 2400 Q2W', 'description': '2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG005', 'title': 'Part 1: 3600 Q2W', 'description': '3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG006', 'title': 'Part 1: 3600Q2W + Nivo + Ipi', 'description': '3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W'}], 'classes': [{'title': 'C2D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '200.10', 'spread': '39.12', 'groupId': 'OG003'}, {'value': '202.89', 'spread': '76.38', 'groupId': 'OG004'}, {'value': '185.51', 'spread': '71.51', 'groupId': 'OG005'}, {'value': '145.15', 'spread': '51.41', 'groupId': 'OG006'}]}]}, {'title': 'C3D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '410.31', 'spread': '275.42', 'groupId': 'OG000'}, {'value': '222.95', 'spread': '92.65', 'groupId': 'OG001'}, {'value': '240.94', 'spread': '92.57', 'groupId': 'OG002'}]}]}, {'title': 'C4D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '317.87', 'groupId': 'OG001'}, {'value': '283.97', 'spread': '84.38', 'groupId': 'OG003'}, {'value': '247.68', 'spread': '73.44', 'groupId': 'OG004'}, {'value': '189.42', 'spread': '22.08', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1', 'description': 'BMS-986253 effective elimination (T-HALFeff) that explains the degree of accumulation observed for a specific exposure measure. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.\n\n1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)\n\nNote: C2D1, C3D1, C4D1 were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1 who have evaluable concentration-time data'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Concentration (Tmax) - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 600 Q4W', 'description': '600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG001', 'title': 'Part 1: 1200 Q4W', 'description': '1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG002', 'title': 'Part 1: 2400 Q4W', 'description': '2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG003', 'title': 'Part 1: 1200 Q2W', 'description': '1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG004', 'title': 'Part 1: 2400 Q2W', 'description': '2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG005', 'title': 'Part 1: 3600 Q2W', 'description': '3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG006', 'title': 'Part 1: 3600Q2W + Nivo + Ipi', 'description': '3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W'}], 'classes': [{'categories': [{'measurements': [{'value': '3.95', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '24.0'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '4.1'}, {'value': '3.81', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '6.1'}, {'value': '4.00', 'groupId': 'OG003', 'lowerLimit': '0.9', 'upperLimit': '4.2'}, {'value': '4.00', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '23.5'}, {'value': '2.18', 'groupId': 'OG005', 'lowerLimit': '1.9', 'upperLimit': '21.1'}, {'value': '1.99', 'groupId': 'OG006', 'lowerLimit': '1.9', 'upperLimit': '21.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 1', 'description': 'Tmax is defined as the time it takes for a drug to reach the maximum concentration (Cmax) after administration of a drug.\n\n1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1 who have evaluable concentration-time data'}, {'type': 'SECONDARY', 'title': 'Serum Trough Concentration (Ctrough) - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 600 Q4W', 'description': '600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG001', 'title': 'Part 1: 1200 Q4W', 'description': '1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG002', 'title': 'Part 1: 2400 Q4W', 'description': '2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG003', 'title': 'Part 1: 1200 Q2W', 'description': '1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG004', 'title': 'Part 1: 2400 Q2W', 'description': '2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG005', 'title': 'Part 1: 3600 Q2W', 'description': '3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG006', 'title': 'Part 1: 3600Q2W + Nivo + Ipi', 'description': '3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W'}], 'classes': [{'title': 'C1D15 - Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '59518.0', 'spread': '49.4', 'groupId': 'OG003'}, {'value': '149309.4', 'spread': '37.0', 'groupId': 'OG004'}, {'value': '221414.7', 'spread': '26.0', 'groupId': 'OG005'}, {'value': '166358.6', 'spread': '43.2', 'groupId': 'OG006'}]}]}, {'title': 'C1D29 - Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '242843.4', 'spread': '65.2', 'groupId': 'OG006'}]}]}, {'title': 'C2D1 - Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '10711.8', 'spread': '124.6', 'groupId': 'OG000'}, {'value': '14450.3', 'spread': '177.5', 'groupId': 'OG001'}, {'value': '45153.8', 'spread': '50.4', 'groupId': 'OG002'}, {'value': '85596.2', 'spread': '38.1', 'groupId': 'OG003'}, {'value': '187079.9', 'spread': '47.5', 'groupId': 'OG004'}, {'value': '272401.3', 'spread': '54.1', 'groupId': 'OG005'}, {'value': '194945.1', 'spread': '35.3', 'groupId': 'OG006'}]}]}, {'title': 'C2D15 - Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '98349.7', 'spread': '46.0', 'groupId': 'OG003'}, {'value': '226385.2', 'spread': '44.5', 'groupId': 'OG004'}, {'value': '299360.3', 'spread': '44.3', 'groupId': 'OG005'}, {'value': '112012.1', 'spread': '37.6', 'groupId': 'OG006'}]}]}, {'title': 'C2D29 - Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '160198.5', 'spread': '38.2', 'groupId': 'OG006'}]}]}, {'title': 'C3D1 - Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '12124.7', 'spread': '82.5', 'groupId': 'OG000'}, {'value': '21260.6', 'spread': '131.9', 'groupId': 'OG001'}, {'value': '58149.8', 'spread': '31.5', 'groupId': 'OG002'}, {'value': '92359.7', 'spread': '35.7', 'groupId': 'OG003'}, {'value': '224533.3', 'spread': '54.9', 'groupId': 'OG004'}, {'value': '260971.3', 'spread': '63.9', 'groupId': 'OG005'}, {'value': '113514.3', 'spread': '12.4', 'groupId': 'OG006'}]}]}, {'title': 'C4D1 - Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '27124.2', 'spread': '99.1', 'groupId': 'OG000'}, {'value': '15763.7', 'spread': '219.2', 'groupId': 'OG001'}, {'value': '54841.7', 'spread': '43.6', 'groupId': 'OG002'}, {'value': '86790.7', 'spread': '41.8', 'groupId': 'OG003'}, {'value': '271535.1', 'spread': '44.9', 'groupId': 'OG004'}, {'value': '327146.5', 'spread': '55.7', 'groupId': 'OG005'}, {'value': '145940.5', 'spread': '19.8', 'groupId': 'OG006'}]}]}, {'title': 'C4D15 - Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '127803.1', 'spread': '24.5', 'groupId': 'OG003'}, {'value': '258413.8', 'spread': '48.1', 'groupId': 'OG004'}, {'value': '356070.0', 'spread': '56.9', 'groupId': 'OG005'}]}]}, {'title': 'C5D1 - Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '34491.0', 'groupId': 'OG001'}, {'value': '125274.8', 'spread': '27.4', 'groupId': 'OG003'}, {'value': '161340.5', 'spread': '551.8', 'groupId': 'OG004'}, {'value': '312899.5', 'spread': '65.2', 'groupId': 'OG005'}]}]}, {'title': 'C7D1 - Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '29506.0', 'groupId': 'OG000'}, {'value': '51155.0', 'groupId': 'OG001'}, {'value': '76154.6', 'spread': '26.5', 'groupId': 'OG002'}]}]}, {'title': 'C9D1 - Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '48706.0', 'groupId': 'OG002'}, {'value': '182098.0', 'spread': '43.0', 'groupId': 'OG003'}, {'value': '263195.0', 'spread': '56.6', 'groupId': 'OG004'}, {'value': '281410.5', 'spread': '85.2', 'groupId': 'OG005'}]}]}, {'title': 'C10D1 - Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '94273.0', 'groupId': 'OG002'}]}]}, {'title': 'C14D1 - Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '95722.0', 'groupId': 'OG001'}, {'value': '102905.0', 'groupId': 'OG002'}, {'value': '200795.9', 'spread': '27.5', 'groupId': 'OG003'}, {'value': '298491.4', 'spread': '50.2', 'groupId': 'OG004'}, {'value': '361774.6', 'spread': '41.4', 'groupId': 'OG005'}]}]}, {'title': 'C20D1 - Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '72607.0', 'groupId': 'OG001'}, {'value': '116745.0', 'groupId': 'OG002'}, {'value': '81342.0', 'groupId': 'OG003'}, {'value': '424725.7', 'spread': '23.5', 'groupId': 'OG004'}, {'value': '427000.0', 'groupId': 'OG005'}]}]}, {'title': 'C26D1 - Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '56040.0', 'groupId': 'OG001'}, {'value': '143209.5', 'spread': '14.8', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'C1D15, C1D29, C2D1, C2D9, C2D15, C3D1, C4D1, C4D15, C5D1, C7D1, C9D1, C10D1, C14D1, C20D1, and C26D1', 'description': 'A serum trough concentration (Ctrough) is the concentration reached by a drug immediately before the next dose is administered. Serum trough concentrations (Ctrough) of BMS-986253 will be summarized with descriptive statistics by treatment and visit.\n\n1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)\n\nNote: The timepoints listed were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1 who have evaluable concentration-time data'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-Drug Antibodies (ADA) - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 600 Q4W', 'description': '600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG001', 'title': 'Part 1: 1200 Q4W', 'description': '1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG002', 'title': 'Part 1: 2400 Q4W', 'description': '2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG003', 'title': 'Part 1: 1200 Q2W', 'description': '1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG004', 'title': 'Part 1: 2400 Q2W', 'description': '2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG005', 'title': 'Part 1: 3600 Q2W', 'description': '3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG006', 'title': 'Part 1: 3600Q2W + Nivo + Ipi', 'description': '3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W'}], 'classes': [{'title': 'Baseline ADA positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'ADA Positive-Overall', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'ADA Persistent Positive (PP)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'ADA Positive-Not PP last sample positive', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'ADA Positive-other positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'ADA Negative', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'C1D1, C1D2, C1D8, C1D15, C1D22, C2D1, C2D2, C2D8, C2D15, C3D1, C4D1, C4D2, C4D8, C4D15, C4D22, C5D1, C9D1, C14D1, C20D1, C26D1, C32D1, C38D1, 30-day follow-up, 100-day follow-up', 'description': 'Blood samples were evaluated for development of Anti-Drug Antibody (ADA) by a validated electrochemiluminescent (ECL) immunoassay. Baseline is defined as first dose.\n\nADA-positive subject: A subject with at least one ADA positive-sample relative to baseline at any time after initiation of treatment.\n\nPersistent Positive (PP): ADA-positive sample at 2 or more consecutive time points, where the first and last ADA-positive samples are at least 16 weeks apart\n\nNot PP-Last Sample Positive: Not persistent positive with ADA-positive sample at the last sampling time point\n\nOther Positive: Not persistent positive but some ADA-positive samples with the last sample being negative\n\nNeutralizing Positive: At least one ADA-positive sample with neutralizing antibodies detected\n\nADA-negative subject: A subject with no ADA-positive sample after the initiation of treatment.\n\n1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1 with baseline and at least one post-baseline evaluable ADA assessment'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Interleukin 8 (IL-8)- Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '61', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: 600 Q4W', 'description': '600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG001', 'title': 'Part 1: 1200 Q4W', 'description': '1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG002', 'title': 'Part 1: 2400 Q4W', 'description': '2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'OG003', 'title': 'Part 1: 1200 Q2W', 'description': '1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG004', 'title': 'Part 1: 2400 Q2W', 'description': '2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG005', 'title': 'Part 1: 3600 Q2W', 'description': '3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'OG006', 'title': 'Part 1: 3600Q2W + Nivo + Ipi', 'description': '3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W'}], 'classes': [{'title': 'Cycle 1 Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '59', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-96.9', 'groupId': 'OG000', 'lowerLimit': '-891.0', 'upperLimit': '-24.3'}, {'value': '-37.3', 'groupId': 'OG001', 'lowerLimit': '-105.6', 'upperLimit': '-7.0'}, {'value': '-66.3', 'groupId': 'OG002', 'lowerLimit': '-377.0', 'upperLimit': '-5.8'}, {'value': '-48.2', 'groupId': 'OG003', 'lowerLimit': '-115.5', 'upperLimit': '-21.6'}, {'value': '-48.5', 'groupId': 'OG004', 'lowerLimit': '-141.5', 'upperLimit': '-4.4'}, {'value': '-82.8', 'groupId': 'OG005', 'lowerLimit': '-509.6', 'upperLimit': '-8.2'}, {'value': '-76.1', 'groupId': 'OG006', 'lowerLimit': '-268.2', 'upperLimit': '-18.6'}]}]}, {'title': 'Cycle 1 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '61', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-78.2', 'groupId': 'OG000', 'lowerLimit': '-857.0', 'upperLimit': '-5.0'}, {'value': '-31.4', 'groupId': 'OG001', 'lowerLimit': '-94.0', 'upperLimit': '-6.2'}, {'value': '-58.6', 'groupId': 'OG002', 'lowerLimit': '-350.0', 'upperLimit': '-4.8'}, {'value': '-40.3', 'groupId': 'OG003', 'lowerLimit': '-107.0', 'upperLimit': '-17.2'}, {'value': '-69.8', 'groupId': 'OG004', 'lowerLimit': '-1569.6', 'upperLimit': '2.2'}, {'value': '-48.1', 'groupId': 'OG005', 'lowerLimit': '-121.0', 'upperLimit': '-5.0'}, {'value': '-71.9', 'groupId': 'OG006', 'lowerLimit': '-246.0', 'upperLimit': '-6.0'}]}]}, {'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '58', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-66.2', 'groupId': 'OG000', 'lowerLimit': '-769.0', 'upperLimit': '11.0'}, {'value': '-24.4', 'groupId': 'OG001', 'lowerLimit': '-79.0', 'upperLimit': '3.0'}, {'value': '-34.3', 'groupId': 'OG002', 'lowerLimit': '-87.0', 'upperLimit': '-0.3'}, {'value': '-23.6', 'groupId': 'OG003', 'lowerLimit': '-63.0', 'upperLimit': '-11.0'}, {'value': '-38.0', 'groupId': 'OG004', 'lowerLimit': '-123.2', 'upperLimit': '89.0'}, {'value': '-65.8', 'groupId': 'OG005', 'lowerLimit': '-502.5', 'upperLimit': '-1.0'}, {'value': '-33.5', 'groupId': 'OG006', 'lowerLimit': '-120.0', 'upperLimit': '-3.0'}]}]}, {'title': 'Cycle 1 Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-48.0', 'groupId': 'OG000', 'lowerLimit': '-561.0', 'upperLimit': '24.0'}, {'value': '17.4', 'groupId': 'OG001', 'lowerLimit': '-30.8', 'upperLimit': '277.0'}, {'value': '-41.6', 'groupId': 'OG002', 'lowerLimit': '-240.0', 'upperLimit': '11.8'}, {'value': '-33.0', 'groupId': 'OG003', 'lowerLimit': '-77.0', 'upperLimit': '-18.6'}, {'value': '-71.3', 'groupId': 'OG004', 'lowerLimit': '-1559.0', 'upperLimit': '1.7'}, {'value': '-68.1', 'groupId': 'OG005', 'lowerLimit': '-507.2', 'upperLimit': '-8.2'}, {'value': '-34.3', 'groupId': 'OG006', 'lowerLimit': '-104.0', 'upperLimit': '-6.0'}]}]}, {'title': 'Cycle 1 Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-23.2', 'groupId': 'OG006', 'lowerLimit': '-62.9', 'upperLimit': '-4.0'}]}]}, {'title': 'Cycle 1 Day 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-29.1', 'groupId': 'OG006', 'lowerLimit': '-66.8', 'upperLimit': '-10.2'}]}]}, {'title': 'Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '-67.0', 'upperLimit': '50.0'}, {'value': '43.5', 'groupId': 'OG001', 'lowerLimit': '-28.0', 'upperLimit': '427.0'}, {'value': '-20.3', 'groupId': 'OG002', 'lowerLimit': '-73.0', 'upperLimit': '32.8'}, {'value': '-25.3', 'groupId': 'OG003', 'lowerLimit': '-58.0', 'upperLimit': '-5.0'}, {'value': '-40.2', 'groupId': 'OG004', 'lowerLimit': '-127.8', 'upperLimit': '4.0'}, {'value': '-78.3', 'groupId': 'OG005', 'lowerLimit': '-506.1', 'upperLimit': '-9.0'}, {'value': '-21.3', 'groupId': 'OG006', 'lowerLimit': '-65.5', 'upperLimit': '23.0'}]}]}, {'title': 'Cycle 2 Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-42.5', 'groupId': 'OG003', 'lowerLimit': '-84.0', 'upperLimit': '-21.6'}, {'value': '-47.3', 'groupId': 'OG004', 'lowerLimit': '-139.4', 'upperLimit': '0.0'}, {'value': '-48.2', 'groupId': 'OG005', 'lowerLimit': '-127.1', 'upperLimit': '-8.2'}, {'value': '-31.5', 'groupId': 'OG006', 'lowerLimit': '-68.6', 'upperLimit': '-7.7'}]}]}, {'title': 'Cycle 2 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-35.6', 'groupId': 'OG003', 'lowerLimit': '-77.0', 'upperLimit': '-18.6'}, {'value': '-44.2', 'groupId': 'OG004', 'lowerLimit': '-136.8', 'upperLimit': '0.6'}, {'value': '-77.4', 'groupId': 'OG005', 'lowerLimit': '-508.2', 'upperLimit': '-8.2'}, {'value': '-26.1', 'groupId': 'OG006', 'lowerLimit': '-68.0', 'upperLimit': '-5.5'}]}]}, {'title': 'Cycle 2 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-22.6', 'groupId': 'OG000', 'lowerLimit': '-99.0', 'upperLimit': '-3.0'}, {'value': '-13.8', 'groupId': 'OG001', 'lowerLimit': '-30.8', 'upperLimit': '3.0'}, {'value': '-30.0', 'groupId': 'OG002', 'lowerLimit': '-70.0', 'upperLimit': '6.8'}, {'value': '-31.0', 'groupId': 'OG003', 'lowerLimit': '-63.0', 'upperLimit': '-17.4'}, {'value': '-70.8', 'groupId': 'OG004', 'lowerLimit': '-1569.1', 'upperLimit': '3.1'}, {'value': '-74.6', 'groupId': 'OG005', 'lowerLimit': '-501.3', 'upperLimit': '-7.4'}, {'value': '9.1', 'groupId': 'OG006', 'lowerLimit': '-22.2', 'upperLimit': '56.0'}]}]}, {'title': 'Cycle 2 Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-18.7', 'groupId': 'OG006', 'lowerLimit': '-29.4', 'upperLimit': '-2.8'}]}]}, {'title': 'Cycle 2 Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-22.7', 'groupId': 'OG006', 'lowerLimit': '-26.9', 'upperLimit': '-18.0'}]}]}, {'title': 'Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '-82.0', 'upperLimit': '44.0'}, {'value': '-4.0', 'groupId': 'OG001', 'lowerLimit': '-25.0', 'upperLimit': '30.0'}, {'value': '-16.4', 'groupId': 'OG002', 'lowerLimit': '-49.0', 'upperLimit': '21.0'}, {'value': '-25.1', 'groupId': 'OG003', 'lowerLimit': '-38.0', 'upperLimit': '-8.0'}, {'value': '-86.7', 'groupId': 'OG004', 'lowerLimit': '-1569.6', 'upperLimit': '2.3'}, {'value': '-93.5', 'groupId': 'OG005', 'lowerLimit': '-508.2', 'upperLimit': '-8.1'}, {'value': '-14.4', 'groupId': 'OG006', 'lowerLimit': '-21.0', 'upperLimit': '4.0'}]}]}, {'title': 'Cycle 3 Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-24.9', 'groupId': 'OG004', 'lowerLimit': '-24.9', 'upperLimit': '-24.9'}]}]}, {'title': 'Cycle 3 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-36.3', 'groupId': 'OG000', 'lowerLimit': '-113.0', 'upperLimit': '-7.0'}, {'value': '-24.5', 'groupId': 'OG001', 'lowerLimit': '-34.5', 'upperLimit': '-15.0'}, {'value': '-37.0', 'groupId': 'OG002', 'lowerLimit': '-77.0', 'upperLimit': '-13.2'}]}]}, {'title': 'Cycle 3 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-44.3', 'groupId': 'OG000', 'lowerLimit': '-117.0', 'upperLimit': '-2.0'}, {'value': '-20.8', 'groupId': 'OG001', 'lowerLimit': '-31.7', 'upperLimit': '-14.0'}, {'value': '-24.3', 'groupId': 'OG002', 'lowerLimit': '-46.8', 'upperLimit': '-5.0'}]}]}, {'title': 'Cycle 3 Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-53.5', 'groupId': 'OG000', 'lowerLimit': '-107.0', 'upperLimit': '0.0'}, {'value': '-15.4', 'groupId': 'OG001', 'lowerLimit': '-27.0', 'upperLimit': '-2.0'}, {'value': '-16.9', 'groupId': 'OG002', 'lowerLimit': '-43.0', 'upperLimit': '23.0'}]}]}, {'title': 'Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-30.3', 'groupId': 'OG000', 'lowerLimit': '-101.0', 'upperLimit': '18.0'}, {'value': '-8.8', 'groupId': 'OG001', 'lowerLimit': '-26.0', 'upperLimit': '13.0'}, {'value': '-15.5', 'groupId': 'OG002', 'lowerLimit': '-28.4', 'upperLimit': '3.5'}, {'value': '-18.5', 'groupId': 'OG003', 'lowerLimit': '-38.9', 'upperLimit': '1.0'}, {'value': '-102.9', 'groupId': 'OG004', 'lowerLimit': '-1568.8', 'upperLimit': '2.0'}, {'value': '-29.6', 'groupId': 'OG005', 'lowerLimit': '-86.0', 'upperLimit': '9.0'}, {'value': '-23.8', 'groupId': 'OG006', 'lowerLimit': '-26.4', 'upperLimit': '-21.1'}]}]}, {'title': 'Cycle 4 Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-35.7', 'groupId': 'OG001', 'lowerLimit': '-35.7', 'upperLimit': '-35.7'}, {'value': '-32.0', 'groupId': 'OG003', 'lowerLimit': '-41.7', 'upperLimit': '-21.3'}, {'value': '-33.5', 'groupId': 'OG004', 'lowerLimit': '-81.6', 'upperLimit': '0.5'}, {'value': '-44.0', 'groupId': 'OG005', 'lowerLimit': '-96.9', 'upperLimit': '-13.6'}]}]}, {'title': 'Cycle 4 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-32.1', 'groupId': 'OG001', 'lowerLimit': '-32.1', 'upperLimit': '-32.1'}, {'value': '-30.3', 'groupId': 'OG003', 'lowerLimit': '-40.9', 'upperLimit': '-19.6'}, {'value': '-32.7', 'groupId': 'OG004', 'lowerLimit': '-81.6', 'upperLimit': '3.8'}, {'value': '-43.8', 'groupId': 'OG005', 'lowerLimit': '-92.1', 'upperLimit': '-8.2'}]}]}, {'title': 'Cycle 4 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-29.0', 'groupId': 'OG001', 'lowerLimit': '-29.0', 'upperLimit': '-29.0'}, {'value': '-26.7', 'groupId': 'OG003', 'lowerLimit': '-38.6', 'upperLimit': '-17.6'}, {'value': '-34.5', 'groupId': 'OG004', 'lowerLimit': '-122.5', 'upperLimit': '6.0'}, {'value': '-46.4', 'groupId': 'OG005', 'lowerLimit': '-90.6', 'upperLimit': '-8.2'}]}]}, {'title': 'Cycle 4 Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-26.0', 'groupId': 'OG001', 'lowerLimit': '-26.0', 'upperLimit': '-26.0'}, {'value': '-28.8', 'groupId': 'OG003', 'lowerLimit': '-38.5', 'upperLimit': '-19.1'}, {'value': '-30.6', 'groupId': 'OG004', 'lowerLimit': '-81.1', 'upperLimit': '2.7'}, {'value': '-43.8', 'groupId': 'OG005', 'lowerLimit': '-94.5', 'upperLimit': '-7.6'}]}]}, {'title': 'Cycle 5 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '38.0', 'groupId': 'OG000', 'lowerLimit': '38.0', 'upperLimit': '38.0'}, {'value': '-27.3', 'groupId': 'OG003', 'lowerLimit': '-36.0', 'upperLimit': '-17.7'}, {'value': '-28.2', 'groupId': 'OG004', 'lowerLimit': '-80.3', 'upperLimit': '4.9'}, {'value': '-46.8', 'groupId': 'OG005', 'lowerLimit': '-91.7', 'upperLimit': '-8.2'}]}]}, {'title': 'Cycle 7 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-111.0', 'groupId': 'OG000', 'lowerLimit': '-111.0', 'upperLimit': '-111.0'}, {'value': '-8.0', 'groupId': 'OG001', 'lowerLimit': '-25.0', 'upperLimit': '9.0'}, {'value': '-14.6', 'groupId': 'OG002', 'lowerLimit': '-29.7', 'upperLimit': '-1.7'}, {'value': '-29.3', 'groupId': 'OG003', 'lowerLimit': '-38.5', 'upperLimit': '-20.0'}, {'value': '-33.0', 'groupId': 'OG004', 'lowerLimit': '-80.8', 'upperLimit': '-13.6'}, {'value': '-36.9', 'groupId': 'OG005', 'lowerLimit': '-86.6', 'upperLimit': '-8.2'}]}]}, {'title': 'Cycle 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-21.8', 'groupId': 'OG002', 'lowerLimit': '-21.8', 'upperLimit': '-21.8'}]}]}, {'title': 'Cycle 9 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-17.0', 'groupId': 'OG002', 'lowerLimit': '-17.0', 'upperLimit': '-17.0'}, {'value': '-28.2', 'groupId': 'OG003', 'lowerLimit': '-38.5', 'upperLimit': '-18.6'}, {'value': '-27.8', 'groupId': 'OG004', 'lowerLimit': '-48.3', 'upperLimit': '-13.6'}, {'value': '-9.1', 'groupId': 'OG005', 'lowerLimit': '-11.0', 'upperLimit': '-7.1'}]}]}, {'title': 'Cycle 10 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-14.2', 'groupId': 'OG002', 'lowerLimit': '-32.3', 'upperLimit': '0.7'}]}]}, {'title': 'Cycle 11 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-16.0', 'groupId': 'OG001', 'lowerLimit': '-28.0', 'upperLimit': '-4.0'}, {'value': '-30.7', 'groupId': 'OG003', 'lowerLimit': '-37.7', 'upperLimit': '-21.4'}, {'value': '-24.4', 'groupId': 'OG004', 'lowerLimit': '-39.5', 'upperLimit': '-13.6'}, {'value': '-7.6', 'groupId': 'OG005', 'lowerLimit': '-7.6', 'upperLimit': '-7.6'}]}]}, {'title': 'Cycle 14 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-16.1', 'groupId': 'OG001', 'lowerLimit': '-36.2', 'upperLimit': '4.0'}, {'value': '-2.2', 'groupId': 'OG002', 'lowerLimit': '-2.2', 'upperLimit': '-2.2'}, {'value': '-1.6', 'groupId': 'OG003', 'lowerLimit': '-36.8', 'upperLimit': '48.0'}, {'value': '-22.2', 'groupId': 'OG004', 'lowerLimit': '-38.2', 'upperLimit': '-13.6'}]}]}, {'title': 'Cycle 16 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'groupId': 'OG002', 'lowerLimit': '-1.6', 'upperLimit': '-1.6'}]}]}, {'title': 'Cycle 17 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-32.2', 'groupId': 'OG001', 'lowerLimit': '-32.2', 'upperLimit': '-32.2'}, {'value': '-17.3', 'groupId': 'OG002', 'lowerLimit': '-30.5', 'upperLimit': '-4.1'}, {'value': '-38.0', 'groupId': 'OG003', 'lowerLimit': '-38.0', 'upperLimit': '-38.0'}, {'value': '-14.2', 'groupId': 'OG004', 'lowerLimit': '-14.8', 'upperLimit': '-13.6'}]}]}, {'title': 'Cycle 20 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-30.7', 'groupId': 'OG001', 'lowerLimit': '-30.7', 'upperLimit': '-30.7'}, {'value': '-32.5', 'groupId': 'OG002', 'lowerLimit': '-32.5', 'upperLimit': '-32.5'}, {'value': '-34.4', 'groupId': 'OG003', 'lowerLimit': '-34.4', 'upperLimit': '-34.4'}, {'value': '-17.1', 'groupId': 'OG004', 'lowerLimit': '-23.6', 'upperLimit': '-13.6'}]}]}, {'title': 'Cycle 23 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-28.9', 'groupId': 'OG001', 'lowerLimit': '-28.9', 'upperLimit': '-28.9'}, {'value': '-27.1', 'groupId': 'OG002', 'lowerLimit': '-32.2', 'upperLimit': '-22.0'}, {'value': '-22.6', 'groupId': 'OG004', 'lowerLimit': '-22.6', 'upperLimit': '-22.6'}]}]}, {'title': 'Cycle 26 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-30.8', 'groupId': 'OG001', 'lowerLimit': '-30.8', 'upperLimit': '-30.8'}, {'value': '-10.0', 'groupId': 'OG002', 'lowerLimit': '-22.6', 'upperLimit': '2.5'}]}]}, {'title': 'End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '-44.0', 'groupId': 'OG000', 'lowerLimit': '-105.0', 'upperLimit': '17.0'}, {'value': '-49.5', 'groupId': 'OG002', 'lowerLimit': '-66.0', 'upperLimit': '-29.0'}, {'value': '-24.6', 'groupId': 'OG003', 'lowerLimit': '-37.0', 'upperLimit': '-10.0'}, {'value': '-34.5', 'groupId': 'OG004', 'lowerLimit': '-125.0', 'upperLimit': '20.0'}, {'value': '-149.1', 'groupId': 'OG005', 'lowerLimit': '-503.2', 'upperLimit': '-16.0'}, {'value': '-50.9', 'groupId': 'OG006', 'lowerLimit': '-65.0', 'upperLimit': '-36.8'}]}]}, {'title': 'Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG002', 'lowerLimit': '9.0', 'upperLimit': '26.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'C1D2, C1D8, C1D15, C1D22, C1D29, C1D36, C2D1, C2D2, C2D8, C2D15, C2D22, C2D29, C3D1, C3D2, C3D8, C4D1, C4D2, C4D8, C4D15, C4D22, C5D1, C7D1, C8D1, C9D1, C10D1, C11D1, C14D1, C16D1, C17D1, C20D1, C23D1, C26D1, at last dose, and 100 days post last dose', 'description': 'Change from baseline in IL-8 measured in pg/mL. Baseline is defined as first dose.\n\n1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)\n\nNote: Some timepoints were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1 with available biomarker data'}, {'type': 'PRIMARY', 'title': 'Objective Response Rate (ORR) - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Arm A: BMS+Nivo+Ipi', 'description': 'BMS-986253 3600 mg Q2W + nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W for 12 weeks; BMS-986253 3600 mg Q2W + nivolumab 480 mg Q4W thereafter'}, {'id': 'OG001', 'title': 'Part 2 Arm B: Placebo+Nivo+Ipi', 'description': 'Placebo Q2W + nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W for 12 weeks; BMS-986253 3600 mg Q2W + nivolumab 480 mg Q4W thereafter'}], 'classes': [{'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '25.8'}, {'value': '11.7', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '22.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 22 months)', 'description': 'Objective Response Rate per blinded independent central review (BICR) is the percentage of participants who have a confirmed complete or partial best overall response (BOR) among participants who have measurable disease at baseline. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to =\\< 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Baseline was defined as evaluations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations. This endpoint was prespecified in the protocol to include only participants in Part 2.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in Part 2'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS) - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Arm A: BMS+Nivo+Ipi', 'description': 'BMS-986253 3600 mg Q2W + nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W for 12 weeks; BMS-986253 3600 mg Q2W + nivolumab 480 mg Q4W thereafter'}, {'id': 'OG001', 'title': 'Part 2 Arm B: Placebo+Nivo+Ipi', 'description': 'Placebo Q2W + nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W for 12 weeks; BMS-986253 3600 mg Q2W + nivolumab 480 mg Q4W thereafter'}], 'classes': [{'categories': [{'measurements': [{'value': '2.103', 'groupId': 'OG000', 'lowerLimit': '1.873', 'upperLimit': '3.778'}, {'value': '3.318', 'groupId': 'OG001', 'lowerLimit': '1.906', 'upperLimit': '3.745'}]}]}], 'analyses': [{'pValue': '0.7416', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.61', 'ciUpperLimit': '1.45', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 22 months)', 'description': 'Progression free survival (PFS) is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by BICR or death due to any cause, whichever is earlier.\n\nProgressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.\n\nThis endpoint was prespecified in the protocol to include only participants in Part 2.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in Part 2'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Adverse Events (AEs) - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Arm A: BMS+Nivo+Ipi', 'description': 'BMS-986253 3600 mg Q2W + nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W for 12 weeks; BMS-986253 3600 mg Q2W + nivolumab 480 mg Q4W thereafter'}, {'id': 'OG001', 'title': 'Part 2 Arm B: Placebo+Nivo+Ipi', 'description': 'Placebo Q2W + nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W for 12 weeks; BMS-986253 3600 mg Q2W + nivolumab 480 mg Q4W thereafter'}], 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose up to 100 days after last dose (up to 25 months)', 'description': 'An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.\n\nThis endpoint was prespecified in the protocol to include only participants in Part 2.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 2'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Serious Adverse Events (SAEs) - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Arm A: BMS+Nivo+Ipi', 'description': 'BMS-986253 3600 mg Q2W + nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W for 12 weeks; BMS-986253 3600 mg Q2W + nivolumab 480 mg Q4W thereafter'}, {'id': 'OG001', 'title': 'Part 2 Arm B: Placebo+Nivo+Ipi', 'description': 'Placebo Q2W + nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W for 12 weeks; BMS-986253 3600 mg Q2W + nivolumab 480 mg Q4W thereafter'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose up to 100 days after last dose (up to 25 months)', 'description': 'A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 2'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Arm A: BMS+Nivo+Ipi', 'description': 'BMS-986253 3600 mg Q2W + nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W for 12 weeks; BMS-986253 3600 mg Q2W + nivolumab 480 mg Q4W thereafter'}, {'id': 'OG001', 'title': 'Part 2 Arm B: Placebo+Nivo+Ipi', 'description': 'Placebo Q2W + nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W for 12 weeks; BMS-986253 3600 mg Q2W + nivolumab 480 mg Q4W thereafter'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose up to 100 days after last dose (up to 25 months)', 'description': 'Number of participants with any grade adverse events (AEs) leading to discontinuation of study treatment. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 2'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Died - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Arm A: BMS+Nivo+Ipi', 'description': 'BMS-986253 3600 mg Q2W + nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W for 12 weeks; BMS-986253 3600 mg Q2W + nivolumab 480 mg Q4W thereafter'}, {'id': 'OG001', 'title': 'Part 2 Arm B: Placebo+Nivo+Ipi', 'description': 'Placebo Q2W + nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W for 12 weeks; BMS-986253 3600 mg Q2W + nivolumab 480 mg Q4W thereafter'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose up to 100 days after last dose (up to 25 months)', 'description': 'The number of participants who died due to any cause are summarized.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 2'}, {'type': 'SECONDARY', 'title': 'Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Arm A: BMS+Nivo+Ipi', 'description': 'BMS-986253 3600 mg Q2W + nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W for 12 weeks; BMS-986253 3600 mg Q2W + nivolumab 480 mg Q4W thereafter'}, {'id': 'OG001', 'title': 'Part 2 Arm B: Placebo+Nivo+Ipi', 'description': 'Placebo Q2W + nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W for 12 weeks; BMS-986253 3600 mg Q2W + nivolumab 480 mg Q4W thereafter'}], 'classes': [{'title': 'Alanine aminotransferase - Grade 3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Alanine aminotransferase - Grade 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate aminotransferase - Grade 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate aminotransferase - Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Phosphate - Grade 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Sodium - Grade 3', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Sodium - Grade 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lipase - Grade 3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Lipase - Grade 4', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Amylase - Grade 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose up to 30 days after last dose (up to 23 months)', 'description': 'Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Laboratory tests are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.\n\nThis endpoint was prespecified in the protocol to include only participants in Part 2.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 2'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1: 600 Q4W', 'description': '600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'FG001', 'title': 'Part 1: 1200 Q4W', 'description': '1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'FG002', 'title': 'Part 1: 2400 Q4W', 'description': '2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'FG003', 'title': 'Part 1: 1200 Q2W', 'description': '1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'FG004', 'title': 'Part 1: 2400 Q2W', 'description': '2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'FG005', 'title': 'Part 1: 3600 Q2W', 'description': '3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'FG006', 'title': 'Part 1: 3600Q2W + Nivo + Ipi', 'description': '3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W'}, {'id': 'FG007', 'title': 'Part 2 Arm A: BMS+Nivo+Ipi', 'description': 'BMS-986253 3600 mg Q2W + nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W for 12 weeks; BMS-986253 3600 mg Q2W + nivolumab 480 mg Q4W thereafter'}, {'id': 'FG008', 'title': 'Part 2 Arm B: Placebo+Nivo+Ipi', 'description': 'Placebo Q2W + nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W for 12 weeks; BMS-986253 3600 mg Q2W + nivolumab 480 mg Q4W thereafter'}], 'periods': [{'title': 'Pre-Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '63'}, {'groupId': 'FG005', 'numSubjects': '20'}, {'groupId': 'FG006', 'numSubjects': '15'}, {'groupId': 'FG007', 'numSubjects': '62'}, {'groupId': 'FG008', 'numSubjects': '60'}]}, {'type': 'Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '62'}, {'groupId': 'FG008', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'comment': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '63'}, {'groupId': 'FG005', 'numSubjects': '20'}, {'groupId': 'FG006', 'numSubjects': '15'}, {'groupId': 'FG007', 'numSubjects': '62'}, {'groupId': 'FG008', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}]}, {'type': 'No longer met study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}]}]}, {'title': 'Treatment', 'milestones': [{'type': 'STARTED', 'comment': 'Started=Received study treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '63'}, {'groupId': 'FG005', 'numSubjects': '20'}, {'groupId': 'FG006', 'numSubjects': '15'}, {'groupId': 'FG007', 'numSubjects': '62'}, {'groupId': 'FG008', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'comment': 'Completed=continuing in study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '51'}, {'groupId': 'FG005', 'numSubjects': '14'}, {'groupId': 'FG006', 'numSubjects': '11'}, {'groupId': 'FG007', 'numSubjects': '58'}, {'groupId': 'FG008', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Participant withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}]}, {'type': 'Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '6'}]}]}], 'preAssignmentDetails': '281 participants were randomized and 278 received treatment.\n\nPart 1: 159 participants were directly treated and not blinded (open label).\n\nPart 2: 122 participants were double-blinded and randomized. 122 participants were randomized in the pre-treatment phase while 119 received treatment. 3 participants were randomized but did not receive treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}, {'value': '62', 'groupId': 'BG007'}, {'value': '60', 'groupId': 'BG008'}, {'value': '281', 'groupId': 'BG009'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1: 600 Q4W', 'description': '600 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'BG001', 'title': 'Part 1: 1200 Q4W', 'description': '1200 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'BG002', 'title': 'Part 1: 2400 Q4W', 'description': '2400 mg BMS-986253 Q4W + 480 mg nivolumab Q4W'}, {'id': 'BG003', 'title': 'Part 1: 1200 Q2W', 'description': '1200 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'BG004', 'title': 'Part 1: 2400 Q2W', 'description': '2400 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'BG005', 'title': 'Part 1: 3600 Q2W', 'description': '3600 mg BMS-986253 Q2W + 480 mg nivolumab Q4W'}, {'id': 'BG006', 'title': 'Part 1: 3600Q2W + Nivo + Ipi', 'description': '3600 mg BMS-986253 Q2W + nivolumab 1 mg/kg Q3W (480 mg Q4W after 12 Weeks) + ipilimumab 3 mg/kg Q3W'}, {'id': 'BG007', 'title': 'Part 2 Arm A: BMS+Nivo+Ipi', 'description': 'BMS-986253 3600 mg Q2W + nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W for 12 weeks; BMS-986253 3600 mg Q2W + nivolumab 480 mg Q4W thereafter'}, {'id': 'BG008', 'title': 'Part 2 Arm B: Placebo+Nivo+Ipi', 'description': 'Placebo Q2W + nivolumab 1 mg/kg Q3W + ipilimumab 3 mg/kg Q3W for 12 weeks; BMS-986253 3600 mg Q2W + nivolumab 480 mg Q4W thereafter'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.4', 'groupId': 'BG000', 'lowerLimit': '35.0', 'upperLimit': '86.0'}, {'value': '64.6', 'groupId': 'BG001', 'lowerLimit': '49.0', 'upperLimit': '83.0'}, {'value': '66.3', 'groupId': 'BG002', 'lowerLimit': '40.0', 'upperLimit': '82.0'}, {'value': '64.4', 'groupId': 'BG003', 'lowerLimit': '51.0', 'upperLimit': '87.0'}, {'value': '63.0', 'groupId': 'BG004', 'lowerLimit': '43.0', 'upperLimit': '86.0'}, {'value': '62.6', 'groupId': 'BG005', 'lowerLimit': '36.0', 'upperLimit': '78.0'}, {'value': '56.6', 'groupId': 'BG006', 'lowerLimit': '32.0', 'upperLimit': '79.0'}, {'value': '62.3', 'groupId': 'BG007', 'lowerLimit': '22.0', 'upperLimit': '89.0'}, {'value': '60.6', 'groupId': 'BG008', 'lowerLimit': '22.0', 'upperLimit': '83.0'}, {'value': '62.2', 'groupId': 'BG009', 'lowerLimit': '22.0', 'upperLimit': '89.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '22', 'groupId': 'BG007'}, {'value': '17', 'groupId': 'BG008'}, {'value': '88', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '40', 'groupId': 'BG007'}, {'value': '43', 'groupId': 'BG008'}, {'value': '193', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '42', 'groupId': 'BG007'}, {'value': '41', 'groupId': 'BG008'}, {'value': '201', 'groupId': 'BG009'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '20', 'groupId': 'BG007'}, {'value': '18', 'groupId': 'BG008'}, {'value': '72', 'groupId': 'BG009'}]}]}], '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': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}]}, {'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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '59', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '13', 'groupId': 'BG006'}, {'value': '56', 'groupId': 'BG007'}, {'value': '53', 'groupId': 'BG008'}, {'value': '256', 'groupId': 'BG009'}]}, {'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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '14', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All treated participants for Part 1 and all randomized participants for Part 2. Participants in Part 1 were not randomized.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-05-17', 'size': 7337538, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-16T13:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 281}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2018-01-12', 'resultsFirstSubmitDate': '2025-04-16', 'studyFirstSubmitQcDate': '2018-01-12', 'lastUpdatePostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-17', 'studyFirstPostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Experiencing Adverse Events (AEs) - Part 1', 'timeFrame': 'From first dose up to 100 days after last dose (up to 65 months)', 'description': 'An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.\n\nThis endpoint was prespecified in the protocol to include only participants in Part 1.'}, {'measure': 'Number of Participants Experiencing Serious Adverse Events (SAEs) - Part 1', 'timeFrame': 'From first dose up to 100 days after last dose (up to 65 months)', 'description': 'A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.\n\nThis endpoint was prespecified in the protocol to include only participants in Part 1.'}, {'measure': 'Number of Participants Experiencing Dose Limiting Toxicities (DLTs) - Part 1', 'timeFrame': 'From first dose up to 100 days after last dose (up to 65 months)', 'description': 'Dose-Limiting Toxicities (DLTs) are effects of a treatment that are serious enough to prevent an increase in dose of that treatment, as advised by the Dose Review Team. DLTs will be defined based on the incidence, intensity, and duration of AEs that are possibly related to study treatment. DLTs will include gastrointestinal, hepatic, hematologic, dermatologic, and other AEs.\n\nThis endpoint was prespecified in the protocol to include only participants in Part 1.'}, {'measure': 'Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation - Part 1', 'timeFrame': 'From first dose up to 100 days after last dose (up to 65 months)', 'description': 'Number of participants with any grade adverse events (AEs) leading to discontinuation of study treatment. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.\n\nThis endpoint was prespecified in the protocol to include only participants in Part 1.'}, {'measure': 'Number of Participants Who Died - Part 1', 'timeFrame': 'From first dose up to 100 days after last dose (up to 65 months)', 'description': 'The number of participants who died due to any cause are summarized. This endpoint was prespecified in the protocol to include only participants in Part 1.'}, {'measure': 'Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 1', 'timeFrame': 'From first dose up to 30 days after last dose (up to 63 months)', 'description': 'Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Laboratory tests are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.\n\nThis endpoint was prespecified in the protocol to include only participants in Part 1.'}, {'measure': 'Objective Response Rate (ORR) - Part 2', 'timeFrame': 'From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 22 months)', 'description': 'Objective Response Rate per blinded independent central review (BICR) is the percentage of participants who have a confirmed complete or partial best overall response (BOR) among participants who have measurable disease at baseline. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to =\\< 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Baseline was defined as evaluations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations. This endpoint was prespecified in the protocol to include only participants in Part 2.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR) - Part 1', 'timeFrame': 'From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 74 months)', 'description': 'Objective Response Rate per investigator is the percentage of participants who have a confirmed complete or partial best overall response (BOR) among participants who have measurable disease at baseline. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to =\\< 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Baseline was defined as evaluations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations. This endpoint was prespecified in the protocol to include only participants in Part 1.'}, {'measure': 'Duration of Response (DOR) - Part 1', 'timeFrame': 'From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 74 months)', 'description': 'DOR for a participant with a best overall response (BOR) of CR or PR is defined as the date of first response up to the date of the first objectively documented tumor progression by the investigator per RECIST v1.1 or death, whichever occurs first. Analysis computed using Kaplan-Meier method.\n\nComplete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to =\\< 10 mm.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.\n\nProgressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of at least 5 mm.\n\nThis endpoint was prespecified in the protocol to include only participants in Part 1.'}, {'measure': 'Maximum Concentration (Cmax) - Part 1', 'timeFrame': 'Cycle 1 Day 1', 'description': 'Cmax is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered and before the administration of a second dose.\n\n1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)'}, {'measure': 'AUC(0-T)-Area Under Curve From Time Zero up to Last Quantifiable Concentration - Part 1', 'timeFrame': '0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Cycle 1 Day 1', 'description': 'AUC (0-T) represents the observed exposure to a drug (area under the concentration curve) from first exposure until the last quantifiable concentration. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.\n\n1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)'}, {'measure': 'AUC(TAU)-Area Under Curve in 1 Dosing Interval - Part 1', 'timeFrame': 'Cycle 1 Day 1', 'description': 'Area under the concentration-time curve in 1 dosing interval. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.\n\n1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)'}, {'measure': 'Observed Serum Concentration at the End of a Dosing Interval (Ctau) - Part 1', 'timeFrame': 'Cycle 1 Day 1', 'description': 'BMS-986253 observed serum concentration at the end of a dosing interval (Ctau). Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.\n\n1 cycle=28 days for all Arms/Groups except Cycles 1 and 2 (1 cycle=42 days) in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group'}, {'measure': 'Total Body Clearance (CLT) - Part 1', 'timeFrame': 'Cycle 1 Day 1', 'description': 'Clearance is the rate of elimination of BMS-986253 from the blood calculated as the rate of elimination divided by serum concentration. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.\n\n1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)'}, {'measure': 'Average Serum Concentration Over a Dosing Interval (Css-avg) - Part 1', 'timeFrame': 'Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1', 'description': 'BMS-986253 Average concentration over a dosing interval (\\\\\\[AUC(TAU)/tau\\\\\\] (Css-avg) at steady state. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.\n\n1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)\n\nNote: C2D1, C3D1, C4D1 were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.'}, {'measure': 'AUC Accumulation Index (AI_AUC) - Part 1', 'timeFrame': 'Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1', 'description': 'AUC Accumulation Index is defined as the ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.\n\n1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)\n\nNote: C2D1, C3D1, C4D1 were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.'}, {'measure': 'Cmax Accumulation Index (AI_Cmax) - Part 1', 'timeFrame': 'Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1', 'description': 'BMS-986253 Cmax accumulation index (AI\\_Cmax). Ratio of an exposure measure at steady state to that after the first dose. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.\n\n1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)\n\nNote: C2D1, C3D1, C4D1 were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.'}, {'measure': 'Ctau Accumulation Index (AI_Ctau) - Part 1', 'timeFrame': 'Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1', 'description': 'Ctau is the observed serum concentration at the end of a dosing interval. Ctau accumulation index (AI\\_Ctau) is the ratio of an exposure measure at steady state to that after the first dose. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint. Ctau was reported on non-compartmental analysis day, which is on Cycle 1 Day1, Cycle 2 Day 1, Cycle 3 Day 1, or Cycle 4 Day 1 based on data available.\n\n1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)\n\nNote: C2D1, C3D1, C4D1 were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.'}, {'measure': 'Effective Elimination (T-HALFeff) - Part 1', 'timeFrame': 'Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1', 'description': 'BMS-986253 effective elimination (T-HALFeff) that explains the degree of accumulation observed for a specific exposure measure. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.\n\n1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)\n\nNote: C2D1, C3D1, C4D1 were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.'}, {'measure': 'Time to Maximum Concentration (Tmax) - Part 1', 'timeFrame': 'Cycle 1 Day 1', 'description': 'Tmax is defined as the time it takes for a drug to reach the maximum concentration (Cmax) after administration of a drug.\n\n1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)'}, {'measure': 'Serum Trough Concentration (Ctrough) - Part 1', 'timeFrame': 'C1D15, C1D29, C2D1, C2D9, C2D15, C3D1, C4D1, C4D15, C5D1, C7D1, C9D1, C10D1, C14D1, C20D1, and C26D1', 'description': 'A serum trough concentration (Ctrough) is the concentration reached by a drug immediately before the next dose is administered. Serum trough concentrations (Ctrough) of BMS-986253 will be summarized with descriptive statistics by treatment and visit.\n\n1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)\n\nNote: The timepoints listed were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.'}, {'measure': 'Number of Participants With Anti-Drug Antibodies (ADA) - Part 1', 'timeFrame': 'C1D1, C1D2, C1D8, C1D15, C1D22, C2D1, C2D2, C2D8, C2D15, C3D1, C4D1, C4D2, C4D8, C4D15, C4D22, C5D1, C9D1, C14D1, C20D1, C26D1, C32D1, C38D1, 30-day follow-up, 100-day follow-up', 'description': 'Blood samples were evaluated for development of Anti-Drug Antibody (ADA) by a validated electrochemiluminescent (ECL) immunoassay. Baseline is defined as first dose.\n\nADA-positive subject: A subject with at least one ADA positive-sample relative to baseline at any time after initiation of treatment.\n\nPersistent Positive (PP): ADA-positive sample at 2 or more consecutive time points, where the first and last ADA-positive samples are at least 16 weeks apart\n\nNot PP-Last Sample Positive: Not persistent positive with ADA-positive sample at the last sampling time point\n\nOther Positive: Not persistent positive but some ADA-positive samples with the last sample being negative\n\nNeutralizing Positive: At least one ADA-positive sample with neutralizing antibodies detected\n\nADA-negative subject: A subject with no ADA-positive sample after the initiation of treatment.\n\n1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)'}, {'measure': 'Change From Baseline in Interleukin 8 (IL-8)- Part 1', 'timeFrame': 'C1D2, C1D8, C1D15, C1D22, C1D29, C1D36, C2D1, C2D2, C2D8, C2D15, C2D22, C2D29, C3D1, C3D2, C3D8, C4D1, C4D2, C4D8, C4D15, C4D22, C5D1, C7D1, C8D1, C9D1, C10D1, C11D1, C14D1, C16D1, C17D1, C20D1, C23D1, C26D1, at last dose, and 100 days post last dose', 'description': 'Change from baseline in IL-8 measured in pg/mL. Baseline is defined as first dose.\n\n1 cycle=28 days for all Arms/Groups except in "Part 1: 3600Q2W + Nivo + Ipi" Arm/Group (1 cycle=42 days)\n\nNote: Some timepoints were partial samplings only as pre-specified in the protocol and did not include a sampling for each arm.'}, {'measure': 'Progression Free Survival (PFS) - Part 2', 'timeFrame': 'From the date of the first dose to the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurred first (up to approximately 22 months)', 'description': 'Progression free survival (PFS) is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by BICR or death due to any cause, whichever is earlier.\n\nProgressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.\n\nThis endpoint was prespecified in the protocol to include only participants in Part 2.'}, {'measure': 'Number of Participants Experiencing Adverse Events (AEs) - Part 2', 'timeFrame': 'From first dose up to 100 days after last dose (up to 25 months)', 'description': 'An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.\n\nThis endpoint was prespecified in the protocol to include only participants in Part 2.'}, {'measure': 'Number of Participants Experiencing Serious Adverse Events (SAEs) - Part 2', 'timeFrame': 'From first dose up to 100 days after last dose (up to 25 months)', 'description': 'A serious adverse event is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.'}, {'measure': 'Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation - Part 2', 'timeFrame': 'From first dose up to 100 days after last dose (up to 25 months)', 'description': 'Number of participants with any grade adverse events (AEs) leading to discontinuation of study treatment. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.'}, {'measure': 'Number of Participants Who Died - Part 2', 'timeFrame': 'From first dose up to 100 days after last dose (up to 25 months)', 'description': 'The number of participants who died due to any cause are summarized.'}, {'measure': 'Most Frequently Reported Grade 3 and Grade 4 Laboratory Test Results - Part 2', 'timeFrame': 'From first dose up to 30 days after last dose (up to 23 months)', 'description': 'Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Laboratory tests are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.\n\nThis endpoint was prespecified in the protocol to include only participants in Part 2.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer', 'Melanoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1\n* At least 1 lesion accessible for biopsy\n* Eastern Cooperative Oncology Group Performance Status of 0 or 1\n\nExclusion Criteria:\n\n* Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)\n* Participants with active, known or suspected autoimmune disease\n* Participants with conditions requiring systemic treatment with either corticosteroids (\\> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration\n* Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)\n* Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy\n\nOther protocol defined inclusion/exclusion criteria could apply'}, 'identificationModule': {'nctId': 'NCT03400332', 'briefTitle': 'A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers', 'orgStudyIdInfo': {'id': 'CA027-002'}, 'secondaryIdInfos': [{'id': '2023-509061-20', 'type': 'REGISTRY', 'domain': 'EU Trial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1A: BMS-986253 + nivolumab', 'interventionNames': ['Drug: BMS-986253', 'Biological: Nivolumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1B: BMS-986253 + nivolumab', 'interventionNames': ['Drug: BMS-986253', 'Biological: Nivolumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1C: BMS-986253 + nivolumab + ipilimumab', 'interventionNames': ['Drug: BMS-986253', 'Biological: Nivolumab', 'Biological: Ipilimumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2A: BMS-986253 + nivolumab + ipilimumab', 'interventionNames': ['Drug: BMS-986253', 'Biological: Nivolumab', 'Biological: Ipilimumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 2B: Placebo + nivolumab + ipilimumab', 'interventionNames': ['Biological: Nivolumab', 'Biological: Ipilimumab', 'Other: Placebo']}], 'interventions': [{'name': 'BMS-986253', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part 1A: BMS-986253 + nivolumab', 'Part 1B: BMS-986253 + nivolumab', 'Part 1C: BMS-986253 + nivolumab + ipilimumab', 'Part 2A: BMS-986253 + nivolumab + ipilimumab']}, {'name': 'Nivolumab', 'type': 'BIOLOGICAL', 'otherNames': ['BMS-936558', 'Opdivo'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part 1A: BMS-986253 + nivolumab', 'Part 1B: BMS-986253 + nivolumab', 'Part 1C: BMS-986253 + nivolumab + ipilimumab', 'Part 2A: BMS-986253 + nivolumab + ipilimumab', 'Part 2B: Placebo + nivolumab + ipilimumab']}, {'name': 'Ipilimumab', 'type': 'BIOLOGICAL', 'otherNames': ['BMS-734016', 'YERVOY'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part 1C: BMS-986253 + nivolumab + ipilimumab', 'Part 2A: BMS-986253 + nivolumab + ipilimumab', 'Part 2B: Placebo + nivolumab + ipilimumab']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part 2B: Placebo + nivolumab + ipilimumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72762', 'city': 'Springdale', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Local Institution - 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