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Clinical Trials

Clinical Trial Detail

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)

Complete title: 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

Research Study Number 20171087
 
Principal Investigator Cristina Rodriguez
 
Phase III

Research Study Description

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).

Eligibility Criteria (must meet the following to participate in this study)

** For Eligibility information, please click on the "Look up trial at NIH" link above. **

Other eligibility criteria may apply.

Research Study Number 20171087
 
Contact Seattle Cancer Care Alliance Intake Office
 
Telephone 800-804-8824 / 206-606-1024
 

Keywords: Head and Neck Cancer; Solid Tumors; Carcinoma, Squamous Cell; Neoplasms, Glandular and Epithelial; Carcinoma; Immunotherapy

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