Status:
COMPLETED
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
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Novartis
Conditions:
Colorectal Cancer
Colorectal Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 tha...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2024
Estimated Enrollment :
325 Patients enrolled
Trial Details
Trial ID
NCT03377361
Start Date
January 31 2018
End Date
November 4 2024
Last Update
December 3 2025
Active Locations (47)
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1
Local Institution - 0022
Birmingham, Alabama, United States, 35249
2
Local Institution - 0027
Los Angeles, California, United States, 90033
3
Local Institution - 0067
Los Angeles, California, United States, 90089
4
Local Institution - 0001
San Francisco, California, United States, 94158