Skip to main content

Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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

Keywords

Colorectal Cancer Colorectal Tumors Colorectal Carcinoma Colorectal Neoplasm Colorectal Neoplasms Nivolumab Trametinib Antibodies, Monoclonal

Eligibility

For people ages 18 years and up

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

Locations

  • University of California San Francisco (UCSF) accepting new patients
    San Francisco, California, 94158, United States
  • Local Institution not yet accepting patients
    Los Angeles, California, 90033, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
ID
NCT03377361
Phase
Phase 1/2
Study Type
Interventional
Last Updated
May 8, 2018
I’m interested in this study!