for people ages 18 years and up (full criteria)
study started
estimated completion



The purpose of this study is to investigate treatment with Nivolumab in combination with Trametinib with or without Ipilimumab in patients with previously treated cancer of the colon or rectum that has spread.

Official Title

A Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Metastatic Colorectal Cancers


Colorectal Cancer Colorectal Tumors Colorectal Carcinoma Colorectal Neoplasm Colorectal Neoplasms Nivolumab Ipilimumab Trametinib


For people ages 18 years and up

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit

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


  • University of California San Francisco (UCSF)
    San Francisco California 94158 United States
  • USC Norris Comprehensive Cancer Center
    Los Angeles California 90033 United States
  • Usc
    Los Angeles California 90033 United States


in progress, not accepting new patients
Start Date
Completion Date
Bristol-Myers Squibb
BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Phase 1/2
Study Type
Last Updated