Ignite Creation Date:
2025-12-24 @ 12:10 PM
Ignite Modification Date:
2025-12-24 @ 12:10 PM
Study NCT ID:
NCT03377361
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2017-12-14
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
An Investigational Immuno-therapy Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Cancer of the Colon or Rectum That Has Spread
Sponsor:
Organization:
Raw JSON
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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': 'Part 1: Approximately 5.5 Months Part 1A: Approximately 6.5 Months Part 1B and 2: Approximately 6.8 Months', 'description': 'The number at Risk for All-Cause Mortality represents all Randomized Participants. 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'sourceVocabulary': '27.1'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Extrinsic iliac vein compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dose Limiting Toxicities in Part 1 and Part 1A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Cohort 1', 'description': 'Trame 1.5mg Cont'}, {'id': 'OG001', 'title': 'Part 1 Cohort 1B', 'description': 'Trame 2 mg Int'}, {'id': 'OG002', 'title': 'Part 1 Cohort 1D', 'description': 'Trame 2mg Cont'}, {'id': 'OG003', 'title': 'Part 1A Cohort 2', 'description': 'Trame 1.5mg Cont'}, {'id': 'OG004', 'title': 'Part 1A Cohort 2A', 'description': 'Trame 1mg Cont'}, {'id': 'OG005', 'title': 'Part 1A Cohort 3', 'description': 'Trame 1.5mg Int'}, {'id': 'OG006', 'title': 'Part 1A Cohort 3B', 'description': 'Trame 2mg Int'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks for Doublet Reginmen and 8 weeks for triplet Regimen', 'description': 'Dose Limiting Toxicities are defined as adverse events have to be at least possibly related to study treatment, and not to disease progression, be clinically relevant and a clinically relevant shift from baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1 and Part 1A'}, {'type': 'PRIMARY', 'title': 'Safety Related Events in Part 1 and Part 1 A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Cohort 1', 'description': 'Trame 1.5mg Cont'}, {'id': 'OG001', 'title': 'Part 1 Cohort 1B', 'description': 'Trame 2 mg Int'}, {'id': 'OG002', 'title': 'Part 1 Cohort 1D', 'description': 'Trame 2mg Cont'}, {'id': 'OG003', 'title': 'Part 1A Cohort 2', 'description': 'Trame 1.5mg Cont'}, {'id': 'OG004', 'title': 'Part 1A Cohort 2A', 'description': 'Trame 1mg Cont'}, {'id': 'OG005', 'title': 'Part 1A Cohort 3', 'description': 'Trame 1.5mg Int'}, {'id': 'OG006', 'title': 'Part 1A Cohort 3B', 'description': 'Trame 2mg Int'}], 'classes': [{'title': 'Adverse Events (AEs)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}]}, {'title': 'Drug-Related AEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}]}, {'title': 'Serious Adverse Events (SAEs)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}]}, {'title': 'Drug-Related SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: Part 1: ~ 6.5 Months Part 1A: ~ 5.5 Months)', 'description': 'Safety-related events in clinical trials include Adverse Events (AEs), Serious Adverse Events (SAEs), and deaths. An AE is any new or worsening medical issue in a participant receiving the study drug, regardless of its relation to the drug. This includes abnormal lab results, symptoms, or diseases. An SAE is a more severe AE that results in death, is life-threatening, requires or prolongs hospitalization, causes significant disability, involves a birth defect, or is deemed medically important-potentially jeopardizing the participant or requiring intervention, even if not immediately life-threatening. These definitions help ensure consistent reporting and evaluation of safety during clinical studies.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1 and Part 1A'}, {'type': 'PRIMARY', 'title': 'Clinical Laboratory Abnormalities in Part 1 and Part 1A: Specific Thyroid Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Cohort 1', 'description': 'Trame 1.5mg Cont'}, {'id': 'OG001', 'title': 'Part 1 Cohort 1B', 'description': 'Trame 2 mg Int'}, {'id': 'OG002', 'title': 'Part 1 Cohort 1D', 'description': 'Trame 2mg Cont'}, {'id': 'OG003', 'title': 'Part 1A Cohort 2', 'description': 'Trame 1.5mg Cont'}, {'id': 'OG004', 'title': 'Part 1A Cohort 2A', 'description': 'Trame 1mg Cont'}, {'id': 'OG005', 'title': 'Part 1A Cohort 3', 'description': 'Trame 1.5mg Int'}, {'id': 'OG006', 'title': 'Part 1A Cohort 3B', 'description': 'Trame 2mg Int'}], 'classes': [{'title': 'TSH > ULN', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'TSH > ULN WITH TSH ≤ ULN AT BASELINE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES ≥ LLN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'TSH > ULN WITH FT3/FT4 TEST MISSING', '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': 'TSH < LLN', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'TSH <LLN WITH TSH ≥ LLN AT BASELINE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES ≤ ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'TSH < LLN WITH FT3/FT4 TEST MISSING', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: Part 1: ~ 6.5 Months Part 1A: ~ 5.5 Months)', 'description': 'Number of participants with clinical laboratory abnormalities in specific thyroid tests', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1 and Part 1A'}, {'type': 'PRIMARY', 'title': 'Clinical Laboratory Abnormalities in Part 1 and Part 1A: Specific Liver Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Cohort 1', 'description': 'Trame 1.5mg Cont'}, {'id': 'OG001', 'title': 'Part 1 Cohort 1B', 'description': 'Trame 2 mg Int'}, {'id': 'OG002', 'title': 'Part 1 Cohort 1D', 'description': 'Trame 2mg Cont'}, {'id': 'OG003', 'title': 'Part 1A Cohort 2', 'description': 'Trame 1.5mg Cont'}, {'id': 'OG004', 'title': 'Part 1A Cohort 2A', 'description': 'Trame 1mg Cont'}, {'id': 'OG005', 'title': 'Part 1A Cohort 3', 'description': 'Trame 1.5mg Int'}, {'id': 'OG006', 'title': 'Part 1A Cohort 3B', 'description': 'Trame 2mg Int'}], 'classes': [{'title': 'ALT OR AST > 3XULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'ALT OR AST> 5XULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'ALT OR AST> 10XULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}, {'title': 'ALT OR AST > 20XULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'TOTAL BILIRUBIN > 2XULN', 'categories': [{'measurements': [{'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': '1', 'groupId': 'OG006'}]}]}, {'title': 'ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY', 'categories': [{'measurements': [{'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': '1', 'groupId': 'OG006'}]}]}, {'title': 'ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS', 'categories': [{'measurements': [{'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': '1', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: Part 1: ~ 6.5 Months Part 1A: ~ 5.5 Months)', 'description': 'Number of participants with clinical laboratory abnormalities in specific liver tests.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1 and Part 1A with atleast 1 On-Treatment Liver Test Measurement'}, {'type': 'PRIMARY', 'title': 'Overal Response Rate in Part 1B and Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1B', 'description': 'Nivo 6 + Ipi 1 + Trame 1.5'}, {'id': 'OG001', 'title': 'Part 2 Treatment 1', 'description': 'Nivo 6 + Ipi 1 + Trame 1.5'}, {'id': 'OG002', 'title': 'Part 2 Treatment 2', 'description': 'Regorafenib 80/160'}], 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '18.3'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '5.7'}, {'value': '1.6', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Approximately up to 30 Months', 'description': 'ORR is defined as the proportion of all treated participants whose BOR is either confirmed complete response (CR) or confirmed partial response (PR).', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized Participants in Part 1B and Part 2'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate in Part 1 and Part 1A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Cohort 1', 'description': 'Trame 1.5mg Cont'}, {'id': 'OG001', 'title': 'Part 1 Cohort 1B', 'description': 'Trame 2 mg Int'}, {'id': 'OG002', 'title': 'Part 1 Cohort 1D', 'description': 'Trame 2mg Cont'}, {'id': 'OG003', 'title': 'Part 1A Cohort 2', 'description': 'Trame 1.5mg Cont'}, {'id': 'OG004', 'title': 'Part 1A Cohort 2A', 'description': 'Trame 1mg Cont'}, {'id': 'OG005', 'title': 'Part 1A Cohort 3', 'description': 'Trame 1.5mg Int'}, {'id': 'OG006', 'title': 'Part 1A Cohort 3B', 'description': 'Trame 2mg Int'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '70.8'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '70.8'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '45.9'}, {'value': '28.6', 'groupId': 'OG003', 'lowerLimit': '3.7', 'upperLimit': '71.0'}, {'value': '33.3', 'groupId': 'OG004', 'lowerLimit': '0.8', 'upperLimit': '90.6'}, {'value': '0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '70.8'}, {'value': '0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '41.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the first dosing date and the date of the initial objectively documented tumor progression or subsequent therapy date (Approximately up to 21 Months)', 'description': 'ORR is defined as the proportion of all treated participants whose BOR is either confirmed complete response (CR) or confirmed partial response (PR).', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1 and Part 1A'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate in Part 1 and Part 1A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Cohort 1', 'description': 'Trame 1.5mg Cont'}, {'id': 'OG001', 'title': 'Part 1 Cohort 1B', 'description': 'Trame 2 mg Int'}, {'id': 'OG002', 'title': 'Part 1 Cohort 1D', 'description': 'Trame 2mg Cont'}, {'id': 'OG003', 'title': 'Part 1A Cohort 2', 'description': 'Trame 1.5mg Cont'}, {'id': 'OG004', 'title': 'Part 1A Cohort 2A', 'description': 'Trame 1mg Cont'}, {'id': 'OG005', 'title': 'Part 1A Cohort 3', 'description': 'Trame 1.5mg Int'}, {'id': 'OG006', 'title': 'Part 1A Cohort 3B', 'description': 'Trame 2mg Int'}], 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '99.2'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '90.6'}, {'value': '50.0', 'groupId': 'OG002', 'lowerLimit': '11.8', 'upperLimit': '88.2'}, {'value': '57.1', 'groupId': 'OG003', 'lowerLimit': '18.4', 'upperLimit': '90.1'}, {'value': '33.3', 'groupId': 'OG004', 'lowerLimit': '0.8', 'upperLimit': '90.6'}, {'value': '66.7', 'groupId': 'OG005', 'lowerLimit': '9.4', 'upperLimit': '99.2'}, {'value': '28.6', 'groupId': 'OG006', 'lowerLimit': '3.7', 'upperLimit': '71.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the first dosing date and the date of the initial objectively documented tumor progression or subsequent therapy date (Approximately up to 21 Months)', 'description': 'The disease control rate (DCR) is defined as the percentage of participants whose BOR is either confirmed CR or confirmed PR or stable disease (SD)', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1 and Part 1A'}, {'type': 'SECONDARY', 'title': 'Duration of Response in Part 1 and Part 1A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Cohort 1', 'description': 'Trame 1.5mg Cont'}, {'id': 'OG001', 'title': 'Part 1 Cohort 1B', 'description': 'Trame 2 mg Int'}, {'id': 'OG002', 'title': 'Part 1 Cohort 1D', 'description': 'Trame 2mg Cont'}, {'id': 'OG003', 'title': 'Part 1A Cohort 2', 'description': 'Trame 1.5mg Cont'}, {'id': 'OG004', 'title': 'Part 1A Cohort 2A', 'description': 'Trame 1mg Cont'}, {'id': 'OG005', 'title': 'Part 1A Cohort 3', 'description': 'Trame 1.5mg Int'}, {'id': 'OG006', 'title': 'Part 1A Cohort 3B', 'description': 'Trame 2mg Int'}], 'classes': [{'categories': [{'measurements': [{'value': '9.46', 'comment': 'Insufficient number of events to calculate via KM Methodology.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '19.42', 'comment': 'Insufficient number of events to calculate via KM methodology.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Approximately up to 20 Months', 'description': 'DOR for a participant with a BOR of confirmed CR or PR, is defined as the time between the date of first confirmed response and the date of the first objectively documented tumor progression per RECIST 1.1 or death, whichever occurs first.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1 and Part 1A who had a response'}, {'type': 'SECONDARY', 'title': 'Time to Response in Part 1 and Part 1A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Cohort 1', 'description': 'Trame 1.5mg Cont'}, {'id': 'OG001', 'title': 'Part 1 Cohort 1B', 'description': 'Trame 2 mg Int'}, {'id': 'OG002', 'title': 'Part 1 Cohort 1D', 'description': 'Trame 2mg Cont'}, {'id': 'OG003', 'title': 'Part 1A Cohort 2', 'description': 'Trame 1.5mg Cont'}, {'id': 'OG004', 'title': 'Part 1A Cohort 2A', 'description': 'Trame 1mg Cont'}, {'id': 'OG005', 'title': 'Part 1A Cohort 3', 'description': 'Trame 1.5mg Int'}, {'id': 'OG006', 'title': 'Part 1A Cohort 3B', 'description': 'Trame 2mg Int'}], 'classes': [{'categories': [{'measurements': [{'value': '5.63', 'groupId': 'OG003', 'lowerLimit': '1.8', 'upperLimit': '9.5'}, {'value': '1.54', 'groupId': 'OG004', 'lowerLimit': '1.54', 'upperLimit': '1.54'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the first dosing date to the date of first documented CR or PR per RECIST 1.1. (Approximately on average 10 months)', 'description': 'Time to response (TTR) is defined for participants who had a confirmed CR or PR as the time from the first dosing date to the date of first documented CR or PR per RECIST 1.1.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1 and Part 1A who had a response'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival in Part 1 and Part 1A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Cohort 1', 'description': 'Trame 1.5mg Cont'}, {'id': 'OG001', 'title': 'Part 1 Cohort 1B', 'description': 'Trame 2 mg Int'}, {'id': 'OG002', 'title': 'Part 1 Cohort 1D', 'description': 'Trame 2mg Cont'}, {'id': 'OG003', 'title': 'Part 1A Cohort 2', 'description': 'Trame 1.5mg Cont'}, {'id': 'OG004', 'title': 'Part 1A Cohort 2A', 'description': 'Trame 1mg Cont'}, {'id': 'OG005', 'title': 'Part 1A Cohort 3', 'description': 'Trame 1.5mg Int'}, {'id': 'OG006', 'title': 'Part 1A Cohort 3B', 'description': 'Trame 2mg Int'}], 'classes': [{'categories': [{'measurements': [{'value': '3.58', 'comment': 'Insufficient number of participants with events to calculate via KM methodology', 'groupId': 'OG000', 'lowerLimit': '1.84', 'upperLimit': 'NA'}, {'value': '1.91', 'comment': 'Insufficient number of participants with events to calculate via KM methodology', 'groupId': 'OG001', 'lowerLimit': '1.74', 'upperLimit': 'NA'}, {'value': '2.66', 'comment': 'Insufficient number of participants with events to calculate via KM methodology', 'groupId': 'OG002', 'lowerLimit': '0.79', 'upperLimit': 'NA'}, {'value': '7.36', 'comment': 'Insufficient number of participants with events to calculate via KM methodology', 'groupId': 'OG003', 'lowerLimit': '1.84', 'upperLimit': 'NA'}, {'value': '1.74', 'comment': 'Insufficient number of participants with events to calculate via KM methodology', 'groupId': 'OG004', 'lowerLimit': '1.74', 'upperLimit': 'NA'}, {'value': '4.14', 'comment': 'Insufficient number of participants with events to calculate via KM methodology', 'groupId': 'OG005', 'lowerLimit': '1.84', 'upperLimit': 'NA'}, {'value': '1.81', 'comment': 'Insufficient number of participants with events to calculate via KM methodology', 'groupId': 'OG006', 'lowerLimit': '0.92', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from the first dosing date to the date of first objectively documented disease progression or death, whichever occurs first (Approximately up to 21 months)', 'description': 'PFS for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression per RECIST 1.1 (ie, radiologic) or death due to any cause, whichever occurs first.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1 and Part 1A'}, {'type': 'SECONDARY', 'title': 'Overall Survival in Part 1 and Part 1A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Cohort 1', 'description': 'Trame 1.5mg Cont'}, {'id': 'OG001', 'title': 'Part 1 Cohort 1B', 'description': 'Trame 2 mg Int'}, {'id': 'OG002', 'title': 'Part 1 Cohort 1D', 'description': 'Trame 2mg Cont'}, {'id': 'OG003', 'title': 'Part 1A Cohort 2', 'description': 'Trame 1.5mg Cont'}, {'id': 'OG004', 'title': 'Part 1A Cohort 2A', 'description': 'Trame 1mg Cont'}, {'id': 'OG005', 'title': 'Part 1A Cohort 3', 'description': 'Trame 1.5mg Int'}, {'id': 'OG006', 'title': 'Part 1A Cohort 3B', 'description': 'Trame 2mg Int'}], 'classes': [{'categories': [{'measurements': [{'value': '8.99', 'comment': 'Insufficient number of participants with events to calculate via KM methodology', 'groupId': 'OG000', 'lowerLimit': '8.80', 'upperLimit': 'NA'}, {'value': '18.50', 'comment': 'Insufficient number of participants with events to calculate via KM methodology', 'groupId': 'OG001', 'lowerLimit': '17.45', 'upperLimit': 'NA'}, {'value': '9.61', 'comment': 'Insufficient number of participants with events to calculate via KM methodology', 'groupId': 'OG002', 'lowerLimit': '0.89', 'upperLimit': 'NA'}, {'value': '42.09', 'comment': 'Insufficient number of participants with events to calculate via KM methodology', 'groupId': 'OG003', 'lowerLimit': '11.60', 'upperLimit': 'NA'}, {'value': '19.02', 'comment': 'Insufficient number of participants with events to calculate via KM methodology', 'groupId': 'OG004', 'lowerLimit': '8.80', 'upperLimit': 'NA'}, {'value': '11.33', 'comment': 'Insufficient number of participants with events to calculate via KM methodology', 'groupId': 'OG005', 'lowerLimit': '10.51', 'upperLimit': 'NA'}, {'value': '36.24', 'comment': 'Insufficient number of participants with events to calculate via KM methodology', 'groupId': 'OG006', 'lowerLimit': '2.23', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Approximately up to 69 Months', 'description': 'OS for a participant is defined as the time from the first dosing date to the date of death due to any cause. A participant who has not died will be censored at last known date alive.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants in Part 1 and Part 1A'}, {'type': 'SECONDARY', 'title': 'Safety Related Events in Part 1B and Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1B', 'description': 'Nivo 6 + Ipi 1 + Trame 1.5'}, {'id': 'OG001', 'title': 'Part 2 Treatment 1', 'description': 'Nivo 6 + Ipi 1 + Trame 1.5'}, {'id': 'OG002', 'title': 'Part 2 Treatment 2', 'description': 'Regorafenib 80/160'}], 'classes': [{'title': 'Adverse Events (AEs)', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}]}, {'title': 'Drug-Related AEs', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}]}, {'title': 'Serious Adverse Events (SAEs)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'Drug-Related SAEs', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: 6.8 Months)', 'description': 'Safety-related events in clinical trials include Adverse Events (AEs), Serious Adverse Events (SAEs), and deaths. An AE is any new or worsening medical issue in a participant receiving the study drug, regardless of its relation to the drug. This includes abnormal lab results, symptoms, or diseases. An SAE is a more severe AE that results in death, is life-threatening, requires or prolongs hospitalization, causes significant disability, involves a birth defect, or is deemed medically important-potentially jeopardizing the participant or requiring intervention, even if not immediately life-threatening. These definitions help ensure consistent reporting and evaluation of safety during clinical studies.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Participants in Part 1B and Part 2'}, {'type': 'SECONDARY', 'title': 'Clinical Laboratory Abnormalities in Part 1B and Part 2: Specific Thyroid Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1B', 'description': 'Nivo 6 + Ipi 1 + Trame 1.5'}, {'id': 'OG001', 'title': 'Part 2 Treatment 1', 'description': 'Nivo 6 + Ipi 1 + Trame 1.5'}, {'id': 'OG002', 'title': 'Part 2 Treatment 2', 'description': 'Regorafenib 80/160'}], 'classes': [{'title': 'TSH > ULN', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'TSH > ULN WITH TSH ≤ ULN AT BASELINE', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES ≥ LLN', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'TSH > ULN WITH FT3/FT4 TEST MISSING', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'TSH < LLN', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'TSH <LLN WITH TSH ≥ LLN AT BASELINE', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES ≤ ULN', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'TSH < LLN WITH FT3/FT4 TEST MISSING', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: 6.8 Months)', 'description': 'Number of participants with clinical laboratory abnormalities in specific thyroid tests', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Participants in Part 1B and Part 2 with atleast 1 On-Treatment TSH Measurement'}, {'type': 'SECONDARY', 'title': 'Clinical Laboratory Abnormalities in Part 1B and Part 2: Specific Liver Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1B', 'description': 'Nivo 6 + Ipi 1 + Trame 1.5'}, {'id': 'OG001', 'title': 'Part 2 Treatment 1', 'description': 'Nivo 6 + Ipi 1 + Trame 1.5'}, {'id': 'OG002', 'title': 'Part 2 Treatment 2', 'description': 'Regorafenib 80/160'}], 'classes': [{'title': 'ALT OR AST > 3XULN', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'ALT OR AST> 5XULN', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'ALT OR AST> 10XULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'ALT OR AST > 20XULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'TOTAL BILIRUBIN > 2XULN', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: 6.8 Months)', 'description': 'Number of participants with clinical laboratory abnormalities in specific liver tests.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Participants in Part 1B and Part 2 with atleast 1 On-Treatment Liver test Measurement'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1 Cohort 1', 'description': 'Trame 1.5mg Cont'}, {'id': 'FG001', 'title': 'Part 1 Cohort 1B', 'description': 'Trame 2 mg Int'}, {'id': 'FG002', 'title': 'Part 1 Cohort 1D', 'description': 'Trame 2mg Cont'}, {'id': 'FG003', 'title': 'Part 1A Cohort 2', 'description': 'Trame 1.5mg Cont'}, {'id': 'FG004', 'title': 'Part 1A Cohort 2A', 'description': 'Trame 1mg Cont'}, {'id': 'FG005', 'title': 'Part 1A Cohort 3', 'description': 'Trame 1.5mg Int'}, {'id': 'FG006', 'title': 'Part 1A Cohort 3B', 'description': 'Trame 2mg Int'}, {'id': 'FG007', 'title': 'Part 2 Treatment 1', 'description': 'Nivo 6 + Ipi 1 + Trame 1.5'}, {'id': 'FG008', 'title': 'Part 2 Treatment 2', 'description': 'Regorafenib 80/160'}, {'id': 'FG009', 'title': 'Part 1B', 'description': 'Nivo 6 + Ipi 1 + Trame 1.5'}], 'periods': [{'title': 'Pre-Treatment', 'milestones': [{'type': 'STARTED', 'comment': 'Part 1 directly treated participants Part 2 randomized participants', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '124'}, {'groupId': 'FG008', 'numSubjects': '61'}, {'groupId': 'FG009', 'numSubjects': '82'}]}, {'type': 'COMPLETED', 'comment': '= Will Receive Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '121'}, {'groupId': 'FG008', 'numSubjects': '57'}, {'groupId': 'FG009', 'numSubjects': '82'}]}, {'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': '3'}, {'groupId': 'FG008', 'numSubjects': '4'}, {'groupId': 'FG009', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Subject withdrew consent', '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': '3'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Not Reported', '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': '3'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '3'}, 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[{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '124', 'groupId': 'BG007'}, {'value': '61', 'groupId': 'BG008'}, {'value': '82', 'groupId': 'BG009'}, {'value': '299', 'groupId': 'BG010'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1 Cohort 1', 'description': 'Trame 1.5mg Cont'}, {'id': 'BG001', 'title': 'Part 1 Cohort 1B', 'description': 'Trame 2 mg Int'}, {'id': 'BG002', 'title': 'Part 1 Cohort 1D', 'description': 'Trame 2mg Cont'}, {'id': 'BG003', 'title': 'Part 1A Cohort 2', 'description': 'Trame 1.5mg Cont'}, {'id': 'BG004', 'title': 'Part 1A Cohort 2A', 'description': 'Trame 1mg Cont'}, {'id': 'BG005', 'title': 'Part 1A Cohort 3', 'description': 'Trame 1.5mg Int'}, {'id': 'BG006', 'title': 'Part 1A Cohort 3B', 'description': 'Trame 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'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '48', 'groupId': 'BG007'}, {'value': '30', 'groupId': 'BG008'}, {'value': '37', 'groupId': 'BG009'}, {'value': '129', 'groupId': 'BG010'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '76', 'groupId': 'BG007'}, {'value': '31', 'groupId': 'BG008'}, {'value': '45', 'groupId': 'BG009'}, {'value': '170', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', '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': '10', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}, {'value': '25', 'groupId': 'BG010'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '55', 'groupId': 'BG007'}, {'value': '27', 'groupId': 'BG008'}, {'value': '51', 'groupId': 'BG009'}, {'value': '163', 'groupId': 'BG010'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, 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{'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '10', 'groupId': 'BG010'}]}, {'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'}, {'value': '0', 'groupId': 'BG010'}]}, {'title': 'Black or African American', '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': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '119', 'groupId': 'BG007'}, {'value': '58', 'groupId': 'BG008'}, {'value': '74', 'groupId': 'BG009'}, {'value': '278', 'groupId': 'BG010'}]}, {'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'}, {'value': '0', 'groupId': 'BG010'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '8', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-03', 'size': 8548576, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-11-04T13:33', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 325}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2017-12-14', 'resultsFirstSubmitDate': '2025-11-04', 'studyFirstSubmitQcDate': '2017-12-14', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-20', 'studyFirstPostDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose Limiting Toxicities in Part 1 and Part 1A', 'timeFrame': '4 weeks for Doublet Reginmen and 8 weeks for triplet Regimen', 'description': 'Dose Limiting Toxicities are defined as adverse events have to be at least possibly related to study treatment, and not to disease progression, be clinically relevant and a clinically relevant shift from baseline.'}, {'measure': 'Safety Related Events in Part 1 and Part 1 A', 'timeFrame': 'Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: Part 1: ~ 6.5 Months Part 1A: ~ 5.5 Months)', 'description': 'Safety-related events in clinical trials include Adverse Events (AEs), Serious Adverse Events (SAEs), and deaths. An AE is any new or worsening medical issue in a participant receiving the study drug, regardless of its relation to the drug. This includes abnormal lab results, symptoms, or diseases. An SAE is a more severe AE that results in death, is life-threatening, requires or prolongs hospitalization, causes significant disability, involves a birth defect, or is deemed medically important-potentially jeopardizing the participant or requiring intervention, even if not immediately life-threatening. These definitions help ensure consistent reporting and evaluation of safety during clinical studies.'}, {'measure': 'Clinical Laboratory Abnormalities in Part 1 and Part 1A: Specific Thyroid Tests', 'timeFrame': 'Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: Part 1: ~ 6.5 Months Part 1A: ~ 5.5 Months)', 'description': 'Number of participants with clinical laboratory abnormalities in specific thyroid tests'}, {'measure': 'Clinical Laboratory Abnormalities in Part 1 and Part 1A: Specific Liver Tests', 'timeFrame': 'Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: Part 1: ~ 6.5 Months Part 1A: ~ 5.5 Months)', 'description': 'Number of participants with clinical laboratory abnormalities in specific liver tests.'}, {'measure': 'Overal Response Rate in Part 1B and Part 2', 'timeFrame': 'Approximately up to 30 Months', 'description': 'ORR is defined as the proportion of all treated participants whose BOR is either confirmed complete response (CR) or confirmed partial response (PR).'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate in Part 1 and Part 1A', 'timeFrame': 'From the first dosing date and the date of the initial objectively documented tumor progression or subsequent therapy date (Approximately up to 21 Months)', 'description': 'ORR is defined as the proportion of all treated participants whose BOR is either confirmed complete response (CR) or confirmed partial response (PR).'}, {'measure': 'Disease Control Rate in Part 1 and Part 1A', 'timeFrame': 'From the first dosing date and the date of the initial objectively documented tumor progression or subsequent therapy date (Approximately up to 21 Months)', 'description': 'The disease control rate (DCR) is defined as the percentage of participants whose BOR is either confirmed CR or confirmed PR or stable disease (SD)'}, {'measure': 'Duration of Response in Part 1 and Part 1A', 'timeFrame': 'Approximately up to 20 Months', 'description': 'DOR for a participant with a BOR of confirmed CR or PR, is defined as the time between the date of first confirmed response and the date of the first objectively documented tumor progression per RECIST 1.1 or death, whichever occurs first.'}, {'measure': 'Time to Response in Part 1 and Part 1A', 'timeFrame': 'From the first dosing date to the date of first documented CR or PR per RECIST 1.1. (Approximately on average 10 months)', 'description': 'Time to response (TTR) is defined for participants who had a confirmed CR or PR as the time from the first dosing date to the date of first documented CR or PR per RECIST 1.1.'}, {'measure': 'Progression Free Survival in Part 1 and Part 1A', 'timeFrame': 'from the first dosing date to the date of first objectively documented disease progression or death, whichever occurs first (Approximately up to 21 months)', 'description': 'PFS for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression per RECIST 1.1 (ie, radiologic) or death due to any cause, whichever occurs first.'}, {'measure': 'Overall Survival in Part 1 and Part 1A', 'timeFrame': 'Approximately up to 69 Months', 'description': 'OS for a participant is defined as the time from the first dosing date to the date of death due to any cause. A participant who has not died will be censored at last known date alive.'}, {'measure': 'Safety Related Events in Part 1B and Part 2', 'timeFrame': 'Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: 6.8 Months)', 'description': 'Safety-related events in clinical trials include Adverse Events (AEs), Serious Adverse Events (SAEs), and deaths. An AE is any new or worsening medical issue in a participant receiving the study drug, regardless of its relation to the drug. This includes abnormal lab results, symptoms, or diseases. An SAE is a more severe AE that results in death, is life-threatening, requires or prolongs hospitalization, causes significant disability, involves a birth defect, or is deemed medically important-potentially jeopardizing the participant or requiring intervention, even if not immediately life-threatening. These definitions help ensure consistent reporting and evaluation of safety during clinical studies.'}, {'measure': 'Clinical Laboratory Abnormalities in Part 1B and Part 2: Specific Thyroid Tests', 'timeFrame': 'Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: 6.8 Months)', 'description': 'Number of participants with clinical laboratory abnormalities in specific thyroid tests'}, {'measure': 'Clinical Laboratory Abnormalities in Part 1B and Part 2: Specific Liver Tests', 'timeFrame': 'Assessed from first dose date to 100 days after last dose of study therapy. (Approximately: 6.8 Months)', 'description': 'Number of participants with clinical laboratory abnormalities in specific liver tests.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer', 'Colorectal Tumors', 'Colorectal Carcinoma', 'Colorectal Neoplasm']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'http://www.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate treatment with nivolumab in combination with trametinib with or without ipilimumab in participants with previously treated cancer of the colon or rectum that has spread.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed previously treated metastatic colorectal cancer with adenocarcinoma histology and in Stage IV per American Joint Committee on Cancer (version 4.0) at study entry\n* Microsatellite status should be performed per local standard of practice, immunohistochemistry (IHC) and/or PCR. If IHC results are equivocal, PCR is required for determining microsatellite stable (MSS) status\n* Must have measurable disease per RECIST 1.1. 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