Trial results for Nivolumab in combination with trametinib, with or without ipilimumab, for previously treated metastatic colorectal cancer were posted on ClinicalTrials.gov on 2025-12-03. The Phase 1/2 study (NCT03377361) investigated the safety of these combinations, reporting a maximum of 1 dose-limiting toxicity in any single cohort.
Background
The study aimed 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.
Trial design
The study (NCT03377361) was a Phase 1/2 trial that enrolled 325 participants with colorectal cancer, colorectal tumors, colorectal carcinoma, or colorectal neoplasm that had spread and was previously treated. The trial investigated various combinations of nivolumab, trametinib, and ipilimumab.
Key results
Key results from the trial focused on safety outcomes, including dose-limiting toxicities (DLTs) and safety-related events. For Dose Limiting Toxicities in Part 1 and Part 1A:
- In Part 1 Cohort 1, 0 Participants experienced DLTs.
- In Part 1 Cohort 1B, 0 Participants experienced DLTs.
- In Part 1 Cohort 1D, 1 Participant experienced DLTs.
- In Part 1A Cohort 2, 1 Participant experienced DLTs.
- In Part 1A Cohort 2A, 0 Participants experienced DLTs.
- In Part 1A Cohort 3, 0 Participants experienced DLTs.
- In Part 1A Cohort 3B, 0 Participants experienced DLTs.
For Safety Related Events in Part 1 and Part 1A:
- In Part 1 Cohort 1, 3 Participants experienced safety related events.
- In Part 1 Cohort 1B, 3 Participants experienced safety related events.
- In Part 1 Cohort 1D, 6 Participants experienced safety related events.
- In Part 1A Cohort 2, 7 Participants experienced safety related events.
- In Part 1A Cohort 2A, 3 Participants experienced safety related events.
What this means
The low number of dose-limiting toxicities observed across the various cohorts in this Phase 1/2 study suggests a manageable safety profile for nivolumab in combination with trametinib, with or without ipilimumab, in previously treated metastatic colorectal cancer. These early safety findings are important for guiding further development and potential dose optimization of these combination therapies.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03377361, titled "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," were posted on 2025-12-03 on clinicaltrials.gov.