Trial results for a study investigating BMS-813160 in combination with chemotherapy or Nivolumab in participants with advanced solid tumors were posted on ClinicalTrials.gov on 2025-10-09. The study, NCT03184870, reported adverse event counts across various treatment arms and doses, with the number of participants experiencing adverse events ranging from 1 to 32.
Background
The study investigated Nivolumab in combination with BMS-813160 and various chemotherapies for advanced colorectal cancer and pancreatic cancer.
Trial design
The study (NCT03184870) was a Phase 1/Phase 2 trial that enrolled 332 participants. It investigated BMS-813160 alone or in combination with either chemotherapy or Nivolumab, or chemotherapy plus Nivolumab. The conditions studied were metastatic colorectal cancer and pancreatic cancer. Interventions included BMS-813160, Nivolumab, 5-fluorouracil (5-FU), nab-paclitaxel, and gemcitabine. The trial's purpose was to evaluate the safety profile, tolerability, drug levels, drug effects, and preliminary efficacy.
Key results
The trial reported the number of participants experiencing adverse events (AEs) across various treatment groups and doses. Key findings for the outcome 'Number of Participants Experiencing Adverse Events (AEs)' included:
- Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI: 10 Participants
- Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI: 8 Participants
- Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB: 10 Participants
- Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB: 11 Participants
- Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO: 8 Participants
- Part 1-Arm C-Cohort 2: 2/3L CRC MSS/BMS600QD + NIVO: 7 Participants
- Part 1-Arm C-Cohort 3: 2/3L CRC MSS/BMS300QD + NIVO: 7 Participants
- Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO: 11 Participants
- Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO: 1 Participant
- Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO: 2 Participants
- Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI: 32 Participants
- Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI: 32 Participants
What this means
The posted results provide data on the safety and tolerability profile of BMS-813160 in combination with chemotherapy or Nivolumab across various doses and cancer types. The reported counts of participants experiencing adverse events offer insights into the frequency of AEs within these specific cohorts, which is crucial for assessing the safety of these combination regimens in advanced colorectal cancer and pancreatic cancer patients. These data contribute to the overall understanding of the safety landscape for these investigational treatments.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03184870, titled 'A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Participants With Advanced Solid Tumors,' were posted on 2025-10-09 on clinicaltrials.gov.