A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Participants With Advanced Solid Tumors

Brief summary public domain (ClinicalTrials.gov)

The purpose of this study is to evaluate the safety profile, tolerability, drug levels, drug effects, and preliminary efficacy of BMS-813160 alone or in combination with either chemotherapy or nivolumab or chemotherapy plus nivolumab in participants with metastatic colorectal and pancreatic cancers.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Number of Participants Experiencing Adverse Events (AEs) [From first dose up to 100 days post last dose, up to approximately 3 years]. Count Of Participants, Participants. Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=10): 10; Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=8): 8; Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=10): 10; Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=11): 11; Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=8): 8; Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=7): 7; Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=7): 7; Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=11): 11; Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO (n=1): 1; Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO (n=2): 2; Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI (n=32): 32; Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI (n=32): 32; Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI (n=26): 25; Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB (n=35): 35; Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO (n=35): 35; Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB (n=32): 31; Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO (n=24): 23; Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO (n=33): 32.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Number of Participants Experiencing Serious Adverse Events (SAEs) [From first dose up to 100 days post last dose, up to approximately 3 years]. Count Of Participants, Participants. Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=10): 5; Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=8): 5; Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=10): 5; Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=11): 7; Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=8): 5; Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=7): 6; Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=7): 6; Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=11): 6; Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO (n=1): 1; Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO (n=2): 2; Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI (n=32): 12; Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI (n=32): 12; Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI (n=26): 6; Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB (n=35): 24; Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO (n=35): 22; Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB (n=32): 15; Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO (n=24): 17; Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO (n=33): 19.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) [From first dose up to 100 days post last dose, up to approximately 3 years]. Count Of Participants, Participants. Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=10): 0; Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=8): 0; Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=10): 2; Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=11): 2; Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=8): 0; Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=7): 0; Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=7): 0; Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=11): 0; Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO (n=1): 0; Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO (n=2): 0; Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI (n=32): 0; Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI (n=32): 0; Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI (n=26): 0; Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB (n=35): 0; Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO (n=35): 1; Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB (n=32): 0; Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO (n=24): 0; Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO (n=33): 0.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation [From first dose up to 100 days post last dose, up to approximately 3 years]. Count Of Participants, Participants. Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=10): 2; Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=8): 0; Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=10): 1; Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=11): 6; Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=8): 0; Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=7): 1; Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=7): 0; Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=11): 1; Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO (n=1): 0; Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO (n=2): 1; Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI (n=32): 10; Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI (n=32): 6; Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI (n=26): 2; Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB (n=35): 12; Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO (n=35): 8; Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB (n=32): 3; Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO (n=24): 4; Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO (n=33): 2.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Number of Participants Who Died [From first dose up to 100 days post last dose, up to approximately 3 years]. Count Of Participants, Participants. Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=10): 6; Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=8): 6; Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=10): 8; Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=11): 8; Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=8): 6; Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=7): 6; Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=7): 6; Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=11): 7; Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO (n=1): 1; Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO (n=2): 2; Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI (n=32): 26; Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI (n=32): 28; Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI (n=26): 17; Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB (n=35): 33; Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO (n=35): 34; Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB (n=32): 26; Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO (n=24): 20; Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO (n=33): 25.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Number of Participants Experiencing Laboratory Abnormalities [From first dose up to 100 days post last dose, up to approximately 3 years]. Count Of Participants, Participants. ALANINE AMINOTRANSFERASE (ALT), LOCAL LAB (U/L) - Abnormal High: Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=10): 2; Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=8): 4; Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=10): 5; Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=11): 7; Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=8): 2; Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=7): 1; Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=7): 3; Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=11): 6; Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO (n=1): 1; Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO (n=2): 1; Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI (n=32): 15; Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI (n=32): 9; Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI (n=26): 10; Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB (n=35): 24; Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO (n=35): 28; Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB (n=32): 24; Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO (n=24): 10; Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO (n=33): 13. ASPARTATE AMINOTRANSFERASE (AST), LOCAL LAB (U/L) - Abnormal High: Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=10): 2; Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=8): 4; Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=10): 5; Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=11): 7; Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=8): 3; Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=7): 3; Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=7): 5; Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=11): 5; Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO (n=1): 1; Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO (n=2): 1; Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI (n=32): 15; Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI (n=32): 12; Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI (n=26): 9; Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB (n=35): 21; Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO (n=35): 26; Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB (n=32): 24; Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO (n=24): 12; Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO (n=33): 19. Total Bilirubin (UMOL/L) - Abnormal High: Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=10): 2; Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=8): 4; Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=10): 5; Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=11): 2; Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=8): 1; Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=7): 1; Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=7): 4; Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=11): 3; P

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Vital Signs [From first dose to 100 days post last dose, up to approximately 3 years]. Mean, mmHg (Standard Deviation). Systolic Blood Pressure (mmHg) - End of Treatment: Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=1): 133.0 (NA) [Standard deviation not calculated due to insufficient number of events]; Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=3): 129.7 (6.7); Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=5): 130.2 (21.8); Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=4): 143.0 (34.0); Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=7): 114.0 (15.0); Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=3): 125.0 (6.1); Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=7): 140.3 (18.0); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=10): 124.0 (23.7); Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO (n=1): 151.0 (NA) [Standard deviation not calculated due to insufficient number of events]; Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO (n=1): 107.0 (NA) [Standard deviation not calculated due to insufficient number of events]; Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI (n=9): 126.0 (15.9); Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI (n=9): 113.0 (NA) [Standard deviation not calculated due to insufficient number of events]; Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI (n=5): 113.0 (NA) [Standard deviation not calculated due to insufficient number of events]; Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB (n=21): 123.2 (18.8); Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO (n=24): 128.9 (17.8); Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB (n=16): 118.8 (15.9); Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO (n=15): 112.6 (11.6); Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO (n=24): 123.1 (13.6). Systolic Blood Pressure (mmHg) - Follow-up: Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=1): 140.0 (8.5); Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=3): 124.5 (2.1); Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=5): 100.0 (NA) [Standard deviation not calculated due to insufficient number of events]; Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=4): 143.0 (34.0); Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=7): 140.0 (8.5); Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=3): 108.0 (NA) [Standard deviation not calculated due to insufficient number of events]; Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=7): 148.0 (NA) [Standard deviation not calculated due to insufficient number of events]; Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=10): 129.5 (29.0); Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI (n=9): 127.9 (13.2); Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI (n=9): 131.3 (20.6); Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI (n=5): 113.6 (8.1); Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB (n=21): 119.2 (15.1); Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO (n=24): 142.6 (16.0); Part 2-Arm B-Cohort 3C: 1L PC/

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Number of Participants With Out-of-Range Electrocardiograms (ECG) [From baseline up to 100 days post last dose]. Count Of Participants, Participants. QTcF INTERVAL (MSEC) < 450: Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=10): 7; Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=8): 8; Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=10): 10; Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=10): 8; Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=8): 8; Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=7): 7; Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=7): 7; Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=11): 10; Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO (n=1): 1; Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO (n=2): 2; Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI (n=32): 31; Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI (n=31): 27; Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI (n=25): 23; Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB (n=34): 26; Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO (n=34): 30; Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB (n=29): 26; Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO (n=24): 24; Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO (n=33): 31. QTcF INTERVAL (MSEC): 450 <= QTcF < 480: Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=10): 3; Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=8): 0; Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=10): 0; Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=10): 1; Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=8): 0; Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=7): 0; Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=7): 0; Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=11): 1; Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO (n=1): 0; Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO (n=2): 0; Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI (n=32): 0; Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI (n=31): 4; Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI (n=25): 2; Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB (n=34): 6; Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO (n=34): 4; Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB (n=29): 3; Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO (n=24): 0; Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO (n=33): 2. 480<=QTcF<500 (MSEC): Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=10): 0; Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=8): 0; Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=10): 0; Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=10): 1; Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=8): 0; Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=7): 0; Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=7): 0; Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=11): 0; Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO (n=1): 0; Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO (n=2): 0; Par

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Percent Change in Regulatory T Cells (Treg) in Tumor Samples [From first dose up to prespecified timepoints listed below (C0D7; C0D14; C1D1; C1D15; C1D16; C1D28; C2D1)]. Median, Percent change in Treg (Full Range). FOXP3 - C0D7: Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=6): 26.6 (-67 to 180); Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=4): -43.8 (-58 to -15); Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=3): -22.9 (-74 to -14); Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=3): 156.4 (-12 to 177); Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=5): 57.3 (-76 to 116); Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=5): -18.4 (-27 to -9); Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=4): -92.2 (-94 to 27); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=6): 96.4 (14 to 152); Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO (n=1): 101.0 (101 to 101). FOXP3 - C0D14: Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=6): 26.5 (-50 to 103); Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=4): -19.8 (-78 to 53); Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=3): 60.0 (60 to 60); Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=3): -41.6 (-67 to -16); Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=5): -41 (-41 to -41); Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=5): -26.5 (-57 to 249); Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=4): 180.2 (-60 to 421); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=6): -3.7 (-9 to 25). FOXP3 - C1D1: Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=5): 34.7 (-58 to 128); Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=5): 49 (49 to 49); Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=4): 147.4 (20 to 275); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=6): 33.0 (-51 to 338); Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO (n=1): 31.0 (31 to 31). FOXP3 - C1D15: Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=5): -25.9 (-48 to -6); Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=5): 14.5 (-90 to 322); Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=4): 39.1 (4 to 74); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=6): -33 (-33 to -33); Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI (n=3): -39.1 (-46 to -32); Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI (n=5): 60 (60 to 60); Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB (n=5): 113.6 (-1 to 228); Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB (n=3): 17.0 (-39 to 73); Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO (n=4): -64 (-64 to -64). FOXP3 - C1D16: Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI (n=6): -21 (-21 to -21). FOXP3 - C1D28: Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI (n=6): -7.4 (-26 to 113); Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI (n=3): -77.0 (-93 to -61); Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI (n=5): 12.0 (-73 to 152); Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB (n=5): -36.0 (-77 t

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Percent Change in Tumor-Associated Macrophages (TAMs) in Tumor Samples [From first dose up to prespecified timepoints listed below (C0D7; C0D14; C1D1; C1D15; C1D16; C1D28; C2D1)]. Median, Percent change in TAM (Full Range). CD163 Positive - C0D7: Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=4): 13.1 (2 to 808); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=5): -12.7 (-67 to 231). CD163 Positive - C0D14: Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=4): 95.4 (34 to 157); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=5): 133.6 (0 to 286). CD163 Positive - C1D1: Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=4): 477.5 (334 to 621); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=5): 22.1 (-28 to 520). CD163 Positive - C1D15: Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=4): 7.6 (-37 to 53); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=5): -93 (-93 to -93); Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI (n=3): 89.8 (35 to 132); Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI (n=4): -61 (-61 to -61); Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB (n=5): 145.7 (43 to 248); Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB (n=3): 60.3 (1 to 120). CD163 Positive - C1D16: Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI (n=6): 1369 (1369 to 1369). CD163 Positive - C1D28: Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI (n=6): -4.1 (-21 to 1072); Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI (n=3): -58.4 (-98 to -19); Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI (n=4): 106.3 (-67 to 511); Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB (n=5): -14.7 (-57 to 91); Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO (n=6): 65.5 (-31 to 666); Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB (n=3): 1.0 (-96 to 61). CD163 Positive - C2D1: Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI (n=6): -58.3 (-94 to -22); Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB (n=3): -41.3 (-61 to -33); Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO (n=2): 39.3 (-1 to 79). CD68 Positive - C0D7: Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=4): -70.2 (-91 to 107); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=5): -17.1 (-64 to -2). CD68 Positive - C0D14: Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=4): 57.7 (-12 to 128); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=5): 7.9 (-8 to 24). CD68 Positive - C1D1: Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=4): 294.2 (203 to 385); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=5): 17.8 (-39 to 102). CD68 Positive - C1D15: Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=4): 2.9 (-26 to 185); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=5): -26 (-26 to -26); Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI (n=3): -4.0 (-27 to 58); Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI (n=4): 81 (81 to 81); Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB (n=5): 162.4 (150 to 175); Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB (n=3): 92.5

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Objective Response Rate (ORR) [From first dose until disease progression, or the last response recorded (up to approximately 5 years)]. Number, Percent of participants (95% Confidence Interval). Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=10): 60.0 (26.2 to 87.8); Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=8): 25.0 (3.2 to 65.1); Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=10): 0 (0.0 to 30.8); Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=11): 18.2 (2.3 to 51.8); Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=8): 0 (0.0 to 36.9); Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=7): 0 (0.0 to 41.0); Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=7): 0 (0.0 to 41.0); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=11): 0 (0.0 to 28.5); Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO (n=1): 0 (0.0 to 97.5); Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO (n=2): 0 (0.0 to 84.2); Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI (n=32): 9.4 (2.0 to 25.0); Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI (n=32): 9.4 (2.0 to 25.0); Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI (n=26): 19.2 (6.6 to 39.4); Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB (n=35): 22.9 (10.4 to 40.1); Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO (n=35): 17.1 (6.6 to 33.6); Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB (n=32): 21.9 (9.3 to 40.0); Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO (n=24): 0 (0.0 to 14.2); Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO (n=24): 8.3 (1.0 to 27.0).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Duration of Response (DoR) [From first dose up to date of disease progression or death, whichever occurs first (up to approximately 5 years)]. Median, Weeks (95% Confidence Interval). Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=6): 159.00 (47.00 to NA) [Upper limit not calculated due to insufficient number of events]; Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=2): NA (16.43 to NA) [Median and upper limit not calculated due to insufficient number of events]; Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=2): NA (24.14 to NA) [Median and upper limit not calculated due to insufficient number of events]; Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI (n=3): 74.14 (32.14 to NA) [Upper limit not calculated due to insufficient number of events]; Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI (n=3): 56.57 (40.17 to NA) [Upper limit not calculated due to insufficient number of events]; Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI (n=5): 36.21 (16.14 to NA) [Upper limit not calculated due to insufficient number of events]; Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB (n=7): 32.14 (17.14 to 37.29); Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO (n=6): 37.14 (14.14 to NA) [Upper limit not calculated due to insufficient number of events]; Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB (n=7): 20.57 (14.29 to 31.00); Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO (n=2): NA (41.00 to NA) [Median and upper limit not calculated due to insufficient number of events].

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Progression Free Survival (PFS) Rate at 24 Weeks [From first dose up to Week 24]. Number, Proportion of Participants (95% Confidence Interval). Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=7): 0.778 (0.3648 to 0.9393); Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=4): NA (NA to NA) [Not calculated due to insufficient number of participants who reached threshold]; Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=5): 0.556 (0.2042 to 0.8045); Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=6): 0.800 (0.4087 to 0.9459); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=1): NA (NA to NA) [Not calculated due to insufficient number of participants who reached threshold]; Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI (n=7): 0.357 (0.1699 to 0.5490); Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI (n=14): 0.536 (0.3372 to 0.6996); Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI (n=13): 0.691 (0.4361 to 0.8478); Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB (n=17): 0.535 (0.3512 to 0.6888); Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO (n=21): 0.636 (0.4495 to 0.7746); Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB (n=13): 0.467 (0.2779 to 0.6358); Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO (n=3): NA (NA to NA) [Not calculated due to insufficient number of participants who reached threshold].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Maximim Concentration (Cmax) [From first dose up to the prespecified timepoints, C0D1, C0D14, and C2D1]. Mean, ng/mL (Standard Deviation). C0D1 - BMS-813160: Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=10): 620.4 (250.60); Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=7): 2204.1 (961.90); Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=10): 828.4 (458.03); Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=10): 2419.0 (1203.53); Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=8): 486.3 (137.69); Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=7): 1896.3 (1421.89); Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=7): 1179.1 (605.50); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=6): 276.28 (141.915); Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO (n=1): 1580.0 (NA) [Standard deviation not calculated due to insufficient number of events]; Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO (n=2): 807.0 (NA) [Standard deviation not calculated due to insufficient number of events]. C0D1 - BMS-939429: Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=10): 172.23 (103.837); Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=7): 435.6 (284.14); Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=10): 207.63 (142.559); Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=10): 545.7 (218.89); Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=8): 92.33 (50.015); Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=7): 539.1 (465.93); Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=7): 237.63 (188.286); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=6): 54.82 (23.716); Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO (n=1): 504.0 (NA) [Standard deviation not calculated due to insufficient number of events]; Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO (n=2): 72.50 (NA) [Standard deviation not calculated due to insufficient number of events]. C0D14 - BMS-813160: Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=10): 927.1 (513.88); Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=7): 4152.5 (2010.23); Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=10): 1060.3 (830.04); Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=10): 3274.0 (884.15); Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=8): 701.5 (284.59); Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=7): 1793.5 (1607.25); Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=7): 653.3 (298.08); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=6): 80.00 (19.408); Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO (n=1): 1370.0 (NA) [Standard deviation not calculated due to insufficient number of events]; Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO (n=2): 1680.0 (961.67). C0D14 - BMS-939429: Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=10): 317.90 (290.209); Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=7): 658.3 (143.17); Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=10): 409.63 (382.471); Part

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Time to Maximum Concentration (Tmax) [From first dose up to the prespecified timpoints, C0D1, C0D14, AND C2D1]. Median, Hours (Full Range). C0D1 - BMS-813160: Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=10): 2.000 (0.50 to 4.00); Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=7): 0.500 (0.47 to 4.00); Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=10): 3.017 (2.00 to 4.02); Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=10): 2.492 (0.73 to 5.98); Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=8): 2.492 (0.52 to 11.92); Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=7): 2.983 (0.58 to 8.92); Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=7): 3.00 (0.50 to 6.00); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=6): 1.992 (0.50 to 3.00); Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO (n=1): 2.0 (2 to 2); Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO (n=2): 3.950 (3.95 to 3.95). C0D1 - BMS-939429: Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=10): 3.500 (0.50 to 6.25); Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=7): 1.000 (0.50 to 4.00); Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=10): 3.508 (1.00 to 11.98); Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=10): 3.000 (0.73 to 5.98); Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=8): 3.000 (1.0 to 11.92); Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=7): 2.083 (1.08 to 8.92); Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=7): 3.000 (1.00 to 6.00); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=6): 2.000 (0.98 to 4.00); Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO (n=1): 2.0 (2 to 2); Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO (n=2): 1.950 (1.95 to 1.95). C0D14 - BMS-813160: Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=10): 3.000 (0.55 to 3.03); Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=7): 1.825 (0.50 to 3.00); Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=10): 2.917 (0.92 to 15.70); Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=10): 2.983 (0.50 to 4.00); Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=8): 2.875 (0.50 to 3.00); Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=7): 2.0 (1 to 3); Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=7): 2.000 (1.00 to 3.02); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=6): 1.00 (0.5 to 4.0); Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO (n=1): 2.02 (2.02 to 2.02); Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO (n=2): 2.542 (2.00 to 3.08). C0D14 - BMS-939429: Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=10): 3.000 (0.98 to 4.00); Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=7): 1.825 (0.50 to 3.00); Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=10): 3.000 (1.08 to 15.70); Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=10): 2.983 (1.00 to 4.00); Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=8): 2.875 (1.17 to 3.00); Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600Q

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Trough Observed Plasma Concentration (Ctrough) [From first dose up to prespecified timepoints, C0D1, C5D1, C0D1, C1D15, C5D1]. Mean, ng/mL (Standard Deviation). C0D1 - BMS-813160: Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=6): 283.70 (207.784); Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=3): 84.30 (46.169); Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=4): 292.0 (154.31); Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=4): 74.05 (72.127); Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=5): 157.28 (92.311); Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=1): 137.0 (NA) [Standard deviation not calculated due to insufficient number of events]; Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=2): 57.10 (54.871); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=2): 5.485 (2.4395); Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO (n=1): 77.40 (NA) [Standard deviation not calculated due to insufficient number of events]; Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO (n=2): 154.05 (139.936). C5D1 - BMS-813160: Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=6): 268.80 (216.882); Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=3): 129.40 (89.944); Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=4): 176.0 (NA) [Standard deviation not calculated due to insufficient number of events]; Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=4): 15.30 (NA) [Standard deviation not calculated due to insufficient number of events]; Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=5): 323.0 (NA) [Standard deviation not calculated due to insufficient number of events]. C0D1 - BMS-939429: Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=6): 172.63 (264.187); Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=3): 31.40 (10.689); Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=4): 180.88 (195.959); Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=4): 72.95 (55.542); Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=5): 47.60 (10.412); Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=1): 31.50 (NA) [Standard deviation not calculated due to insufficient number of events]; Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=2): 63.45 (60.175); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=2): 4.950 (2.3052); Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO (n=1): 90.30 (NA) [Standard deviation not calculated due to insufficient number of events]; Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO (n=2): 71.65 (55.649). C1D15 - BMS 939429: Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI (n=11): 191.33 (84.266); Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI (n=16): 24.106 (18.445); Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI (n=3): 275.7 (164.34); Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB (n=7): 116.04 (29.696); Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO (n=6): 145.00 (99.293); Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO (n=1): 283.0 (NA) [Standard deviation

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Area Under Curve (AUC) 0-8 [From first dose up to prespecified timepoints- C0D1, C2D1]. Mean, ug*h/mL (Standard Deviation). C0D1 - BMS-813160: Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=10): 2300.018 (976.4608); Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=7): 7069.265 (2452.4213); Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=10): 2725.390 (1365.3562); Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=10): 7884.381 (3968.4940); Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=8): 1534.932 (518.2172); Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=7): 6593.904 (3603.5286); Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=7): 3533.737 (1931.7752); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=6): 878.051 (535.3197); Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO (n=1): 4440.313 (NA) [Standard deviation not calculated due to insufficient number of events]; Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO (n=1): 3656.713 (NA) [Standard deviation not calculated due to insufficient number of events]. C0D1 - BMS-939429: Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=10): 652.848 (363.5925); Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=7): 1783.336 (856.0103); Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=10): 936.394 (826.5807); Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=10): 2302.092 (1023.3978); Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=8): 342.534 (157.1350); Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=7): 2147.888 (1415.6386); Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=7): 942.398 (620.1018); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=6): 210.938 (106.5352); Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO (n=1): 1919.228 (NA) [Standard deviation not calculated due to insufficient number of events]; Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO (n=1): 411.410 (NA) [Standard deviation not calculated due to insufficient number of events]. C2D1 - BMS-813160: Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=10): 5348.973 (2506.2558); Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=7): 11967.560 (4586.3823); Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI (n=9): 4838.264 (2750.7756); Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI (n=13): 1483.423 (1236.0374); Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB (n=14): 3821.887 (2221.2474). C2D1 - BMS-939429: Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=10): 1410.415 (837.4895); Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=7): 2403.182 (1144.3271).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Area Under Curve (AUC) 0-24 [From first dose up to prespecified timepoints-C0D1, C2D1]. Mean, ug*h/mL (Standard Deviation). C0D1 - BMS-813160: Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=7): 9383.385 (2842.8397); Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=9): 11726.669 (6439.1376); Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=5): 10447.179 (2995.9347); Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=7): 4829.881 (2696.4668); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=6): 1275.314 (799.8262); Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO (n=1): 7687.658 (NA) [Standard deviation not calculated due to insufficient number of events]. C0D1 - BMS-939429: Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=7): 2638.062 (977.2502); Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=9): 3991.522 (1636.3573); Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=5): 3905.941 (1852.8415); Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=7): 1660.159 (991.0121); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=6): 341.0396 (160.4425); Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO (n=1): 940.294 (NA) [Standard deviation not calculated due to insufficient number of events]. C2D1 - BMS-813160: Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=7): 17890.458 (9212.5646); Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI (n=11): 2050.804 (997.6990). C2D1 - BMS-939429: Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=7): 3958.779 (1632.3781).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Apparent Total Body Clearance (CLT/F) [From first dose up to prespecified timepoints-C0D1, C2D14]. Mean, mL/min (Standard Deviation). C0D14 - BMS-813160: Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=8): 1163.173 (588.1385); Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=5): 744.746 (361.5390); Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=7): 1521.863 (1277.8075); Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=4): 826.468 (300.1738); Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=6): 1602.009 (1123.8919); Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=2): 961.379 (235.4622); Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=3): 1688.813 (1022.7160); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=2): 4950.110 (781.0155); Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO (n=1): 1135.947 (NA) [Standard deviation not calculated due to insufficient number of events]; Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO (n=2): 1032.434 (850.2203). C2D1 - BMS-813160: Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=8): 956.446 (596.7553); Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=5): 683.958 (322.7045); Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI (n=9): 1115.087 (851.2513); Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI (n=13): 1813.987 (1920.2627); Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB (n=10): 1440.516 (733.5156).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Renal Clearance (CLR) [From first dose up to prespecified timepoints-C0D1, C0D14]. Mean, mL/min (Standard Deviation). C0D1 - BMS-813160: Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=7): 212.411 (191.8961); Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=4): 275.309 (277.2659); Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=6): 139.012 (107.2006); Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=3): 165.327 (77.8766); Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=7): 155.820 (119.3858); Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=3): 181.930 (9.1130); Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=5): 248.003 (82.6974); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=4): 236.781 (62.8689). C0D1 - BMS-939429: Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=7): 74.298 (44.8889); Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=4): 175.109 (187.5683); Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=6): 68.184 (52.1580); Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=3): 77.744 (34.8177); Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=7): 81.027 (65.1050); Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=3): 98.733 (6.2562); Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=5): 140.597 (41.7347); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=4): 128.943 (26.7782); Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO (n=1): 62.007. C0D14 - BMS-813160: Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=7): 185.926 (56.5866); Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=4): 124.400 (52.1454); Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=6): 260.786 (120.8954); Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=3): 168.274 (72.7581); Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=7): 158.238 (82.5905); Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=3): 194.009 (50.1111); Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=5): 283.842 (109.4518); Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=4): 149.271 (72.0204); Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO (n=1): 115.147. C0D14 - BMS-939429: Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=7): 101.042 (27.5043); Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=4): 76.285 (30.5071); Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=6): 145.662 (73.3215); Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=3): 91.490 (43.8006); Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=7): 87.068 (43.9667); Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=3): 111.649 (32.4552).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Participants Who Were Anti-Drug Antibody (ADA) Positive [From first dose up to prespecified timepoints-C1D1, C1D15, C2D1, C3D1, C5D1, C9D1]. Count Of Participants, Participants. Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI (n=10): 0; Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI (n=8): 0; Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB (n=10): 0; Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB (n=11): 0; Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO (n=8): 0; Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO (n=7): 0; Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO (n=7): 1; Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO (n=11): 0; Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO (n=1): 0; Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO (n=2): 0; Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI (n=32): 0; Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI (n=32): 0; Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI (n=26): 0; Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB (n=35): 0; Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO (n=35): 0; Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB (n=32): 0; Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO (n=24): 0; Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO (n=33): 0.