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Prior placebo-controlled studies have shown a recurrence-free survival (RFS) benefit for patients with stage III melanoma who receive adjuvant immunotherapies, including the CTLA-4 inhibitor ipilimumab (NEJM JW Oncol Hematol Dec 2016 and N Engl J Med 2016; 375:1845) and the PD-1 inhibitor pembrolizumab (N Engl J Med 2018; 378:1789). In addition, the PD-1 inhibitor nivolumab was shown to improve RFS and lower the rate of adverse events compared with ipilimumab in patients with stage III or IV melanoma. (N Engl J Med 2017; 377:1824).
To evaluate the efficacy and safety of combining a CTLA-4 inhibitor with a PD-1 inhibitor in this setting, investigators in Germany have conducted an industry-funded, randomized, double-blind, placebo-controlled, …