Conference Proceedings
Pembrolizumab versus placebo after complete resection of high-risk stage III melanoma: Efficacy and safety results from the EORTC 1325-MG/Keynote 054 double-blinded phase III trial
Alexander M Eggermont, Christian U Blank, Mario Mandala, Georgina V Long, Victoria Atkinson, Stephane Dalle, Andrew Haydon, Mikhail Lichinitser, Adnan Khattak, Matteo S Carlino, Shahneen Sandhu, James Larkin, Susana Puig, Paolo A Ascierto, Piotr Rutkowski, Dirk Schadendorf, Rutger Koornstra, Leonel Hernandez-Aya, Michele Maio, Alfonsus J van den Eertwegh Show all
CANCER RESEARCH | AMER ASSOC CANCER RESEARCH | Published : 2018
Abstract
Abstract Background: The checkpoint inhibitors ipilimumab and nivolumab are approved by FDA as adjuvant therapy for patients with resected high-risk stage III melanoma. We conducted the phase 3 double-blind EORTC 1325/KEYNOTE-054 trial to evaluate pembrolizumab vs placebo in patients with resected high-risk stage III melanoma. Methods: Eligible patients included those ≥18 years of age with complete resection of cutaneous melanoma metastatic to lymph node(s), classified as stage IIIA (excluding lymph node metastasis ≤1 mm), IIIB or IIIC (excluding those with in-transit metastasis). A total of 1019 patients were randomized (stratification by stage and region) to p..
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