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Recruiting

An Investigational Immuno-therapy Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Patients With Previously Treated Cancer of the Colon or Rectum That Has Spread - CA209-9N9

Updated: 08 October, 2018   |   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 Participants 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

  • 40

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Previously Treated Metastatic Colorectal Cancer Doublet
Drug: Trametinib Biological: Nivolumab
Experimental: Previously Treated Metastatic Colorectal Cancer Triplet
Biological: Ipilimumab Drug: Trametinib Biological: Nivolumab

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Must have previously treated metastatic colorectal cancer - Must have RAS mutation and microsatellite stability status results as part of medical history - Must agree to provide archival or newly obtained tumor tissue sample prior to the start of treatment in this study - Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 - Ability to swallow pills or capsules - Adequate organ functions - Ability to comply with study visits, treatment, procedures, PK and PD sample collection, and required study follow-up Exclusion Criteria: - BRAF V600 mutant colorectal cancer - Active brain metastases or leptomeningeal metastases - Active, known or suspected autoimmune disease - Histology other than adenocarcinoma - 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 MEK inhibitors - History of allergy to study treatments or any of its components of the study arm that participant is enrolling Other protocol defined inclusion/exclusion criteria could apply

Have questions? Call 855-907-3286 or Email Us

Have questions?
Call 855-907-3286 or Email Us