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

Completed · Phase 1/Phase 2

Conditions studied: Colorectal Cancer, Colorectal Tumors, Colorectal Carcinoma, Colorectal Neoplasm

In brief

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.

Key facts

Study ID

NCT03377361

Run by

Bristol-Myers Squibb

People needed

325

Starts

2018-01-31

Expected to finish

2024-11-04

Last updated by the study team

2025-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Local Institution - 0022 — Birmingham, Alabama, United States
• Local Institution - 0027 — Los Angeles, California, United States
• Local Institution - 0067 — Los Angeles, California, United States
• Local Institution - 0001 — San Francisco, California, United States
• Local Institution - 0107 — Gainesville, Florida, United States
• Local Institution - 0111 — Miami, Florida, United States
• Local Institution - 0028 — Baltimore, Maryland, United States
• Local Institution - 0116 — Hattiesburg, Mississippi, United States
• Local Institution - 0103 — St Louis, Missouri, United States
• Local Institution - 0104 — New York, New York, United States
• Local Institution - 0029 — Charlotte, North Carolina, United States
• Local Institution - 0100 — Lancaster, Pennsylvania, United States
• Local Institution - 0003 — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University - Clinical Research Institute — Philadelphia, Pennsylvania, United States
• Local Institution - 0101 — Temple, Texas, United States
• Local Institution - 0002 — Madison, Wisconsin, United States
• Local Institution - 0120 — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
• Local Institution - 0123 — Buenos Aires, Distrito Federal, Argentina
• Local Institution - 0122 — Buenos Aires, Distrito Federal, Argentina
• Local Institution - 0119 — Buenos Aires, Argentina
• Local Institution - 0044 — Blacktown, New South Wales, Australia
• Local Institution - 0043 — Southport, Queensland, Australia
• Local Institution - 0068 — Elizabeth Vale, South Australia, Australia
• Local Institution - 0055 — Clayton, Victoria, Australia
• Local Institution - 0069 — Heidelberg, Victoria, Australia

Full record on ClinicalTrials.gov

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