A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread

Completed · Phase 2

Conditions studied: Microsatellite Unstable Colorectal Cancer, Microsatellite Stable Colorectal Cancer, Mismatch Repair Proficient Colorectal Cancer, Mismatch Repair Deficient Colorectal Cancer

In brief

The purpose of this study is to examine if Nivolumab by itself, or Nivolumab in combination with other anti-cancer drugs, will result in meaningful tumor size reduction, in participants with colon cancer that has come back or has spread, and who have a specific biomarker in their tumors.

Key facts

Study ID

NCT02060188

Run by

Bristol-Myers Squibb

People needed

385

Starts

2014-03-12

Expected to finish

2024-10-22

Last updated by the study team

2025-11-06

Who can join

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

You may qualify if…

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
• Histologically confirmed recurrent or metastatic colorectal cancer
• Measurable disease per RECIST v1.1
• Microsatellite instability expression detected by an accredited laboratory
• Participants enrolled into the C3 Cohort must have not had treatment for their metastatic disease

You may not qualify if…

• Active brain metastases or leptomeningeal metastases are not allowed
• Prior treatment with an anti-Programmed Death Receptor (PD)-1, anti-PD-L1, anti-PD-L2, anti-Cytotoxic T-Cell Lymphoma-4 Antigen (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
• Prior malignancy active within the previous 3 years except for locally curable cancers
• Participants with active, known or suspected autoimmune disease
• Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• Local Institution - 0028 — Gilbert, Arizona, United States
• Local Institution - 0004 — Los Angeles, California, United States
• Local Institution - 0001 — San Francisco, California, United States
• Local Institution - 0008 — Atlanta, Georgia, United States
• Local Institution - 0002 — Boston, Massachusetts, United States
• Local Institution - 0036 — Boston, Massachusetts, United States
• Local Institution - 0034 — Minneapolis, Minnesota, United States
• Local Institution - 0024 — Durham, North Carolina, United States
• Local Institution - 0029 — Winston-Salem, North Carolina, United States
• Local Institution - 0005 — Portland, Oregon, United States
• Local Institution - 0041 — Allentown, Pennsylvania, United States
• Local Institution - 0013 — Pittsburgh, Pennsylvania, United States
• Local Institution - 0006 — Nashville, Tennessee, United States
• Local Institution - 0003 — Houston, Texas, United States
• Local Institution - 0040 — Westmead, New South Wales, Australia
• Local Institution - 0039 — Southport, Queensland, Australia
• Local Institution - 0037 — Melbourne, Victoria, Australia
• Local Institution - 0019 — Brussels, Belgium
• Local Institution - 0018 — Brussels, Belgium
• Local Institution - 0020 — Leuven, Belgium
• Local Institution - 0027 — Edmonton, Alberta, Canada
• Local Institution - 0016 — Toronto, Ontario, Canada
• Local Institution - 0025 — Paris, France
• Local Institution - 0022 — Dublin, Ireland
• Local Institution - 0023 — Dublin, Ireland

Full record on ClinicalTrials.gov

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