Last updated on April 2019

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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St. Joseph Heritage Healthcare ( Site 0254)

Santa Rosa, CA United States

Indiana University ( Site 0264)

Indianapolis, IN United States

Oncology Hematology Care, Inc. ( Site 8003)

Cincinnati, OH United States

Texas Oncology PA ( Site 8001)

Longview, TX United States

University of Virginia Health System ( Site 0261)

Charlottesville, VA United States

UZ Gent ( Site 0650)

Gent, Belgium

FN Brno. ( Site 0703)

Brno, Czechia

Institut Claudius Regaud ( Site 0754)

Toulouse Cedex 09, France

Rambam MC ( Site 0903)

Haifa, Israel

Rabin Medical Center ( Site 0904)

Petah Tikva, Israel

Sheba MC ( Site 0901)

Ramat Gan, Israel

Chungbuk National University Hospital ( Site 0454)

Cheongju si, Korea, Republic of

Samsung Medical Center ( Site 0450)

Seoul, Korea, Republic of

VU Medisch Centrum ( Site 1352)

Amsterdam, Netherlands

UMCG ( Site 1351)

Groningen, Netherlands

Hospital Duran i Reynals ( Site 1053)

Hospitalet de Llobregat, Spain

UCLA Medical Center ( Site 0273)

Los Angeles, CA United States

Liverpool Hospital ( Site 0301)

Liverpool, Australia

Ipswich Hospital ( Site 1207)

Ipswich, United Kingdom

University of California San Francisco ( Site 0274)

San Francisco, CA United States

Mary Bird Perkins Cancer Center ( Site 0281)

Baton Rouge, LA United States

UMC St. Radboud ( Site 1356)

Nijmegen, Netherlands

Texas Oncology-Arlington North ( Site 8005)

Arlington, TX United States

Recruitment Status: Closed

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