A Randomized Phase III Study of Pembrolizumab Given Concomitantly With Chemoradiation and as Maintenance Therapy Versus Chemoradiation Alone in Subjects With Locally Advanced Head and Neck Squamous Cell Carcinoma (KEYNOTE-412)
A Randomized Phase III Study of Pembrolizumab Given Concomitantly With Chemoradiation and as Maintenance Therapy Versus Chemoradiation Alone in Subjects With Locally Advanced Head and Neck Squamous Cell Carcinoma (KEYNOTE-412)
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).
Inclusion Criteria:
Exclusion Criteria:
Baton Rouge, Louisiana 70809, United States
Worcester, Massachusetts 01655, United States
Ann Arbor, Michigan 48109, United States
Springfield, Missouri 65804, United States
Rochester, New York 14642, United States
Eugene, Oregon 97401, United States
Seattle, Washington 98109, United States
Spokane, Washington 99208, United States
Blacktown, New South Wales 2148, Australia
Vienna/Wien, 1090, Austria
Salvador, Estado de Bahia 40050-410, Brazil
Rio de Janeiro, 20230-130, Brazil
Sherbrooke, Quebec J1H 5N4, Canada
Kita-gun, Kagawa-ken 761-0793, Japan
Wellington, Newtown 6021, New Zealand
Adana, 01250, Turkey (Türkiye)
Norwich, Norfolk NR4 7UY, United Kingdom
Stoke-on-Trent, Staffordshire ST4 6QG, United Kingdom
Southampton, SO16 6YD, United Kingdom