Phase 2
Completed N=299
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
Colorectal Cancer · Colorectal Tumors · Colorectal Carcinoma · Colorectal Neoplasm
Source: ClinicalTrials.gov NCT03377361 ↗
Enrolled (actual)
299
Serious AEs
57.9%
Results posted
Dec 2025
Primary outcomePrimary: Dose Limiting Toxicities in Part 1 and Part 1A — 0; 0; 1; 1 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose Limiting Toxicities in Part 1 and Part 1A |
0; 0; 1; 1; 0; 0 | — |
| PRIMARY Safety Related Events in Part 1 and Part 1 A |
3; 3; 6; 7; 3; 3 | — |
| PRIMARY Clinical Laboratory Abnormalities in Part 1 and Part 1A: Specific Thyroid Tests |
2; 1; 1; 3; 1; 3 | — |
| PRIMARY Clinical Laboratory Abnormalities in Part 1 and Part 1A: Specific Liver Tests |
0; 0; 2; 1; 1; 0 | — |
| PRIMARY Overal Response Rate in Part 1B and Part 2 |
9.8; 1.6; 1.6 | — |
| SECONDARY Objective Response Rate in Part 1 and Part 1A |
0; 0; 0; 28.6; 33.3; 0 | — |
| SECONDARY Disease Control Rate in Part 1 and Part 1A |
66.7; 33.3; 50.0; 57.1; 33.3; 66.7 | — |
| SECONDARY Duration of Response in Part 1 and Part 1A |
9.46; 19.42 | — |
| SECONDARY Time to Response in Part 1 and Part 1A |
5.63; 1.54 | — |
| SECONDARY Progression Free Survival in Part 1 and Part 1A |
3.58; 1.91; 2.66; 7.36; 1.74; 4.14 | — |
| SECONDARY Overall Survival in Part 1 and Part 1A |
8.99; 18.50; 9.61; 42.09; 19.02; 11.33 | — |
| SECONDARY Safety Related Events in Part 1B and Part 2 |
82; 121; 57; 80; 116; 52 | — |
| SECONDARY Clinical Laboratory Abnormalities in Part 1B and Part 2: Specific Thyroid Tests |
13; 31; 21; 9; 18; 16 | — |
| SECONDARY Clinical Laboratory Abnormalities in Part 1B and Part 2: Specific Liver Tests |
18; 38; 11; 8; 19; 8 | — |
Eligibility Criteria
Inclusion Criteria
- 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
- 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
- Must have measurable disease per RECIST 1.1. Participants with lesions in a previously irradiated field as the sole site of measurable disease will be permitted to enroll provided the lesion(s) have demonstrated clear progression and can be measured accurately
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 at screening and on cycle 1 day 1 (C1D1)
Exclusion Criteria
- BRAF V600 mutant colorectal cancer
- Active brain metastases or leptomeningeal metastases
- Active, known or suspected autoimmune disease
- Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
- History of interstitial lung disease or pneumonitis
- Prior treatment with immune checkpoint inhibitors and mitogen-activated protein kinase enzymes (MEK) inhibitors
- History of allergy or hypersensitivity to study drug components
Other protocol defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT03377361). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.