Active, Not Recruiting
A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection - CA209-6GE
Updated: 18 August, 2023 | ClinicalTrials.gov
Phase
Gender(s)
Age Range
Active, Not Recruiting
Inclusion Criteria: - Stage IIIA/B/C/D or Stage IV melanoma and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins - Complete resection performed within 12 weeks prior to randomization or treatment assignment - Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 Exclusion Criteria: - History of uveal or mucosal melanoma - Untreated/unresected CNS metastases or leptomeningeal metastases - Active, known or suspected autoimmune disease - Serious or uncontrolled medical disorder 4 weeks prior to screening - Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization or treatment assignment. Participants with history of prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are eligible - Prior immunotherapy treatments for any prior malignancies are not permitted Other protocol-defined inclusion/exclusion criteria apply
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