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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

NCT03452137 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2024-10-09

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-03
Primary Completion
2023-09-27
Completion
2024-03-06
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03452137 on ClinicalTrials.gov