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

Titre officiel

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

Sommaire:

Cette étude vise à évaluer l’efficacité et l’innocuité de l’atézolizumab comparativement au placebo comme traitement adjuvant après un traitement local définitif chez des patients atteints d’un carcinome épidermoïde de la tête et du cou localement avancé et à haut risque

Description de l'essai

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

Voir cet essai sur ClinicalTrials.gov