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
Purpose
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.
Conditions
- Colorectal Cancer
- Colorectal Tumors
- Colorectal Carcinoma
- Colorectal Neoplasm
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
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Experimental Part 1 Cohort 1 3rd Line (3L): nivolumab + trametinib |
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Experimental Part 1A Cohort 2 2nd Line (2L): nivolumab + ipilimumab + trametinib |
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Experimental Part 1A Cohort 3 (2L): nivolumab + ipilimumab + trametinib |
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Experimental Part 2 Cohort 4 (3L): nivolumab + ipilimumab + trametinib |
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Experimental Part 2 Cohort 5 (3L): Regorafenib |
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Experimental Part 1B Cohort 6 (2L): nivolumab + ipilimumab + trametinib |
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More Details
- Status
- Active, not recruiting
- Sponsor
- Bristol-Myers Squibb