Active, Not Recruiting
A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread - CA209-142
Updated:
13 December, 2023
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ClinicalTrials.gov
Phase
Gender(s)
Age Range
Active, Not Recruiting
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
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