RWF_CA209-76K

A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy with Nivolumab versus Placebo after Complete Resection of Stage IIB/C Melanoma

The purpose of this study is to determine the effectiveness of nivolumab adjuvant immunotherapy compared to placebo in adults and pediatric participants after complete resection of Stage IIB/C melanoma with no evidence of disease (NED) who are at high risk for recurrence.

Inclusion Criteria:
• Had a negative sentinel lymph node biopsy
• Participant has not been previously treated for melanoma
• Participants must have been diagnosed with histologically confirmed, Resected, Stage IIB/C cutaneous melanoma
• Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or agents that target IL-2 pathways, T-cell stimulators, or checkpoint pathways

Exclusion Criteria:
• History of ocular or mucosal melanoma.
• Participants with active known or suspected autoimmune disease
• Known history of allergy or hypersensitivity to study drug components.
Other protocol defined inclusion/exclusion criteria could apply.
Phase III
NCT04099251
Oncology
Cutaneous (skin)
Brendan Curti, M.D.
BMS (Bristol-Myers Squibb)
Chris Fountain
  • Providence Cancer Institute Franz Clinic