Multinational phase 3 trial of adjuvant nivolumab after resection of stage IIB or IIC melanoma

After resection of stage IIB of IIC melanoma, patients have a high recurrence risk. The multinational phase 3 CheckMate 76K trial evaluated adjuvant nivolumab for these patients. Patients were randomized to adjuvant nivolumab or placebo. The median recurrence-free survival (primary endpoint) was significantly improved with nivolumab versus placebo, as was the distant metastasis-free survival. The RFS benefit with nivolumab was seen across subgroups. Treatment-related grade 3 or 4 adverse events were seen in 10.3% of patients in the nivolumab group and 2.3% of patients in the placebo group, while one (0.2%) treatment-related death occurred with nivolumab. The authors conclude that nivolumab is an effective and generally well-tolerated adjuvant treatment after resection of stage IIB or IIC melanoma.