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A Study of Atezolizumab Plus Tiragolumab and Atezolizumab Plus Placebo as First-Line Treatment in Participants With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck

NCT04665843 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2026-05-05

Study results available
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Summary

The primary objective of this study is to evaluate the efficacy of atezolizumab plus tiragolumab and atezolizumab plus placebo as first-line (1L) treatment in recurrent/metastatic PD-L1-positive squamous cell carcinoma of the head and neck (SCCHN) on the basis of confirmed objective response rate. In addition, safety, pharmacokinetics, immunogenicity of atezolizumab and tiragolumab will be evaluated.

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Interventions

DRUG

Atezolizumab

Atezolizumab at a fixed dose of 1200 mg will be administered by intravenous (IV) infusion Q3W on Day 1 of each 21-day cycle.

DRUG

Tiragolumab

Tiragolumab at a fixed dose of 600 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.

DRUG

Placebo

Placebo will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.

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
2021-03-02
Primary Completion
2023-09-20
Completion
2025-08-27
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • France
  • Greece
  • Hungary
  • Italy
  • New Zealand
  • Poland
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • 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 NCT04665843 on ClinicalTrials.gov