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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

Trial Status: Active

The purpose of this study is to investigate treatment with nivolumab in combination with trametinib with or without ipilimumab in participants with previously treated cancer of the colon or rectum that has spread.

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

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Mansoor N. Saleh
Phone: 205-996-1403
Email: mns@uab.edu

California

Los Angeles
Los Angeles County-USC Medical Center
Status: ACTIVE
Contact: Charlean Ketchens
Phone: 323-865-3035
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Rabia Rehman
Phone: 323-865-0460
Newport Beach
Hoag Memorial Hospital
Status: ACTIVE
Contact: Leila D. Andres
Phone: 949-764-8092
San Francisco
UCSF Medical Center-Mount Zion
Status: CLOSED_TO_ACCRUAL

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: ACTIVE

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: ACTIVE

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Bristol-Myers Squibb

  • Primary ID CA209-9N9
  • Secondary IDs NCI-2018-00091, 2017-001830-24
  • Clinicaltrials.gov ID NCT03377361