NCT03452137

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

A Phase III, Multicenter, 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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 406 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Interventions

Type	Name	Description
DRUG	Atezolizumab	Atezolizumab intravenous infusion will be administered at a fixed dose on Day 1 of each 21-day cycle for 16 cycles.
DRUG	Placebo	Placebo intravenous infusion will be administered a fixed dose on Day 1 of each 21-day cycle for 16 cycles.

Timeline

• Start date: 2018-04-03
• Primary completion: 2023-09-27
• Completion: 2024-03-06
• First posted: 2018-03-02
• Last updated: 2024-10-09
• Results posted: 2024-10-09

Locations

135 sites across 23 countries: United States, Australia, Belgium, Brazil, Canada, China, France, Germany, Hungary, India, Italy, Japan, Poland, Portugal, Russia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study