Prolonged survival in stage III melanoma with ipilimumab adjuvant therapy

BackgroundOn the basis of data from a phase 2 trial that compared the checkpoint inhibitor ipilimumabat doses of 0.3 mg, 3 mg, and 10 mg per kilogramof body weight in patients with advanced melanoma, this phase 3 trial evaluated ipilimumabat a dose of 10 mg per kilogramin patients who had undergone complete resection of stage III melanoma. MethodsAfter patients had undergone complete resection of stage III cutaneous melanoma, we randomly assigned them to receive ipilimumabat a dose of 10 mg per kilogram(475 patients) or placebo (476) every 3 weeks for four doses, then every 3 months for up to 3 years or until disease recurrence or an unacceptable level of toxic effects occurred. Recurrence-free survival was the primary end point. Secondary end points included overall survival, distant metastasis–free survival, and safety. ResultsAt a median follow-up of 5.3 years, the 5-year rate of recurrence-free survival was 40.8% in the ipilimumabgroup, as compared with 30.3% in the placebo group (hazard ratio ...