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Recruiting

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

CONSIDERING THIS TRIAL?
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

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 25

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
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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