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
Inclusion Criteria:
- 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
EXCLUSION CRITERIA
Exclusion Criteria:
- 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
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
Contition
Microsatellite Unstable Colorectal Cancer,Microsatellite Stable Colorectal Cancer,Mismatch Repair Proficient Colorectal Cancer,Mismatch Repair Deficient Colorectal Cancer
Age (in years)
18+
Phase
Phase 2
Participants needed
385
Est. Completion Date
Dec 14, 2024
Treatment type
Interventional
Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov identifier
NCT02060188
Study number
CA209142
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