A Study of Atezolizumab (Anti-Pd-L1 Antibody) as Adjuvant Therapy After Definitive Local Therapy in Patients With High-Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Official Title

A Phase III, Multicentre, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab (Anti-Pd-L1 Antibody) as Adjuvant Therapy After Definitive Local Therapy in Patients With High-Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Summary:

This study will evaluate the efficacy and safety of atezolizumab compared with placebo as adjuvant therapy after definitive local therapy in patients with high-risk locally advanced squamous cell carcinoma of the head and neck (SCCHN)

Trial Description

Primary Outcome:

• Investigator-assessed Event Free Survival (EFS)
• Overall Survival (OS) after Randomization

• Independent Review Facility-assessed Event Free Survival (IRF-assessed EFS)
• Percentage of Participants with Adverse Events
• Serum Concentration of Atezolizumab
• Change from baseline in physical function and Quality of Life Global Health Status/Quality of Life Scales of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire

View this trial on ClinicalTrials.gov