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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 - CA209-9N9

Updated: 5 February, 2021   |   ClinicalTrials.gov

Print Friendly Summary

Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1/Phase 2


  • Gender(s)

  • 18+

    Age Range

  • 25


  • Recruiting

Treatment Options

Study Arms
Experimental: Part 1 Cohort 1 3rd Line (3L): nivolumab + trametinib
Drug: Trametinib Biological: Nivolumab
Experimental: Part 1A Cohort 2 2nd Line (2L): nivolumab + ipilimumab + trametinib
Drug: Trametinib Biological: Nivolumab Biological: Ipilimumab
Experimental: Part 1A Cohort 3 (2L): nivolumab + ipilimumab + trametinib
Biological: Nivolumab Drug: Trametinib Biological: Ipilimumab
Experimental: Part 1B Cohort 6 (2L): nivolumab + ipilimumab + trametinib
Drug: Trametinib Biological: Nivolumab Biological: Ipilimumab
Experimental: Part 2 Cohort 4 (3L): nivolumab + ipilimumab + trametinib
Biological: Ipilimumab Drug: Trametinib Biological: Nivolumab
Experimental: Part 2 Cohort 5 (3L): Regorafenib
Drug: Regorafenib

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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

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Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

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