Last updated on October 2018

Study of Pembrolizumab (MK-3475) or Placebo With Chemoradiation in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-412/KEYNOTE-412)


Brief description of study

The purpose of this study is to determine the efficacy and safety of pembrolizumab given concomitantly with chemoradiation (CRT) and as maintenance therapy versus placebo plus CRT in participants with locally advanced head and neck squamous cell carcinoma (LA HNSCC). The primary hypothesis is that pembrolizumab in combination with CRT is superior to placebo in combination with CRT with respect to event-free survival (EFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR).

Clinical Study Identifier: NCT03040999

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Study Coordinator

Hospital Nossa Senhora da Conceicao ( Site 0001)
Porto Alegre, Brazil
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Study Coordinator

Hospital de Clinicas de Porto Alegre ( Site 0011)
Porto Alegre, Brazil
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