For Healthcare Professionals

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


About the study

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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

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


Exclusion Criteria:

  1. Active brain metastases or leptomeningeal metastases are not allowed
  2. 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
  3. Prior malignancy active within the previous 3 years except for locally curable cancers
  4. Participants with active, known or suspected autoimmune disease
  5. 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

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Microsatellite Unstable Colorectal Cancer,Microsatellite Stable Colorectal Cancer,Mismatch Repair Proficient Colorectal Cancer,Mismatch Repair Deficient Colorectal Cancer

Age (in years)



Phase 2

Participants needed


Est. Completion Date

Dec 14, 2024

Treatment type



Bristol-Myers Squibb identifier


Study number


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