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American Journal of Clinical Nutrition, 108(1), 13-22

Ipilimumab Evidence (ipilimumab): The open-label, three-arm, North American Intergroup trial E1609 (NCT01274338) compared two doses of ipilimumab with HDI as adjuvant therapy in high-risk patients with melanoma.[23] A total of 1,670 patients with resected disease (defined by the American Joint Committee on Cancer, 7th edition, as stage IIIB, IIIC, M1a, or M1b) were randomly assigned (1:1:1) to ipi3 or ipi10 every 3 weeks for four doses (induction), followed by the same dose every 12 weeks for four doses (maintenance), or HDI 20 million units/m2 per day, 5 days per week for 4 weeks (induction), followed by 10 million units/m2 daily subcutaneously every other day, 3 days per week for 48 weeks (maintenance).[23][Level of evidence A1] The trial was designed with two coprimary end points, RFS and OS, with a hierarchic analysis to evaluate ipi3 versus HDI followed by ipi10 versus HDI