Abstract CT125: A phase III randomized trial comparing FDA approved standard of care adjuvant therapy to one year of pembrolizumab in patients with high risk resected melanoma. SWOG 1404

Background: Adjuvant therapy for melanoma has centered on high dose interferon for now almost 20 years. Recently, the FDA approved ipilimumab dosed at 10 mg/kg (10/kg ipi) for use in high risk resected melanoma. Though these two treatment options are available they still have limits in terms of efficacy with approximately 1 year of relapse free survival benefit (HDI and 10/kg ipi) and a modest overall survival benefit (HDI). Toxicity remains an issue as well with both therapies. S1404 is a Phase III, open label trial which seeks to compare currently available FDA approved treatments to one year of pembrolizumab in patients at high risk of relapse and death after surgery. Study Design: 1,378 patients will be randomized 1:1 to an FDA approved standard therapy, or pembrolizumab. Stratification factors include PD-L1 staining status, clinical stage, and pre-randomization selected standard treatment option. Patients: Patients must be 18 or older, and have Stage IIIA (n2), IIIB, IIIC or IV (M1a, b and c) resected melanoma to be eligible. Exclusion factors include brain metastases, ocular primary, and auto-immune disease. Prior therapy is not allowed, but radiation as adjuvant treatment is considered an option available to patients prior to treatment. Current status: As of January 2016, 30 sites are registered and 5 patients are randomized. An amendment to include 10 mg/kg ipilimumab as a treatment option is under review and will likely be finalized by the time of the meeting. Support: NIH/NCI NCTN grants CA180888, CA180819, CA180818, CA180826, CA180858, CA180820, CA180844 Citation Format: Kenneth F. Grossmann, Vernon K. Sondak, Megan Othus, Ahmad Tarhini, Sapna Patel, John M. Kirkwood, Antoni Ribas, James Moon. A phase III randomized trial comparing FDA approved standard of care adjuvant therapy to one year of pembrolizumab in patients with high risk resected melanoma. SWOG 1404. [abstract]. In: Proceedings of the 107th Annual Meeting of the American Association for Cancer Research; 2016 Apr 16-20; New Orleans, LA. Philadelphia (PA): AACR; Cancer Res 2016;76(14 Suppl):Abstract nr CT125.