Projekt
Merck EORTC 1325 / MK-3475-054 - Adjuvant immunotherapy with anti-PD-1 monoclonal anti-body Pembrolizumab (MK-3475) versus placebo after complete resection of high-risk Stage III melanoma: A ran-domized, double- blind Phase 3 trial of the EORTC Mela-noma Group
Automatisch geschlossen · 2016 bis 2020
Fehr Martin
Art
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Bereiche
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Ende
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Kurzbeschreibung/Zielsetzung
This is an international, double-blinded, placebo-controlled randomized phase III trial. Enrollment will be a multi-step process. Randomization (placebo vs. pembrolizumab) will be performed centrally and will be stratified for the following factors: stage (IIIA (> 1 mm metastasis) vs. IIIB vs. IIIC 1-3 positive lymph nodes vs. IIIC ≥ 4 positive lymph nodes) and region (North America, European countries, Australia and other countries as designated)).
Data will be unblinded in case of recurrence and at any time during the trial in case of a safety concern affecting an individual patient.