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

A Phase 2 Clinical Trial of Nivolumab, or Nivolumab Combinations in Recurrent and Metastatic Microsatellite Instability High (MSI-H) and Non-MSI-H Colon Cancer

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.

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:

• 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