Patients with resected stage IIB/C melanoma have high recurrence risk, similar to those with resected stage IIIA/B disease. The phase 3, double-blind CheckMate 76K trial assessed 790 patients with resected stage IIB/C melanoma randomized 2:1 (stratified by tumor category) to nivolumab 480 mg or placebo every 4 weeks for 12 months. The primary endpoint was investigator-assessed recurrence-free survival (RFS). Secondary endpoints included distant metastasis-free survival (DMFS) and safety. At 7.8 months of minimum follow-up, nivolumab significantly improved RFS versus placebo (hazard ratio (HR) = 0.42; 95% confidence interval (CI): 0.30-0.59; P < 0.0001), with 12-month RFS of 89.0% versus 79.4% and benefit observed across subgroups; DMFS was also improved (HR = 0.47; 95% CI: 0.30-0.72). Treatment-related grade 3/4 adverse events occurred in 10.3% (nivolumab) and 2.3% (placebo) of patients. One treatment-related death (0.2%) occurred with nivolumab. Nivolumab is an effective and generally well-tolerated adjuvant treatment in patients with resected stage IIB/C melanoma. ClinicalTrials.gov identifier: NCT04099251 .

Bristol Myers Squibb Princeton NJ USA

Charles University 3rd Faculty of Medicine and University Hospital Královské Vinohrady Prague Czech Republic

Cleveland Clinic Cleveland OH USA

Elbe Klinikum Buxtehude Buxtehude Germany

Fondazione IRCCS Istituto Nazionale dei Tumori Milan Italy

Hôpital de la Timone Marseille France

Hôpital Saint André Bordeaux France

Institute of Oncology Poznan University of Medical Sciences Poznan Poland

Istituto Nazionale Tumori IRCCS 'Fondazione G Pascale' Naples Italy

Istituto Oncologico Veneto IOV IRCCS Padova Italy

Maria Skłodowska Curie National Research Institute of Oncology Warsaw Poland

Medizinische Universität Wien Vienna Austria

Melanoma Institute Australia University of Sydney and Royal North Shore and Mater Hospitals Sydney NSW Australia

Nantes University Hospital Nantes France

NYU Langone Medical Center New York NY USA

University Medical Center Mainz Mainz Germany

University of Western Australia and Sir Charles Gairdner Hospital Perth WA Australia

UPMC Hillman Cancer Center Pittsburgh PA USA

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ClinicalTrials.gov
NCT04099251