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)

Official 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 (KEYNOTE-412)

Summary:

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).

Trial Description

Primary Outcome:

• Event-free Survival (EFS)

• Overall Survival (OS)
• Adverse Events (AEs)
• Treatment Discontinuations Due to AEs
• Change From Baseline in Global Health Status/Quality of Life (GHS/QoL)
• Change From Baseline in Swallowing, Speech, and Pain Symptoms
• Change From Baseline in Physical Functioning

View this trial on ClinicalTrials.gov