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

Part of paid clinical trials in La Jolla, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT04665843
Phase
PHASE2
Status
Completed

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Atezolizumab at a fixed dose of 1200 mg will be administered by intravenous (IV) infusion Q3W on Day 1 of each 21-day cycle.
  • Tiragolumab — DRUG
    Tiragolumab at a fixed dose of 600 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
  • Placebo — DRUG
    Placebo will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.

Study Details

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.

Key Dates

Start date
Mar 2, 2021
Status verified
Apr 2026
Primary completion
Sep 20, 2023
Completion
Aug 27, 2025

Study Design

Enrollment
123 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab + Tiragolumab
    Participants will receive atezolizumab followed by tiragolumab every three weeks (Q3W) on Day 1 of each 21-day cycle.
  • Placebo Comparator: Atezolizumab + Placebo
    Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle.

Primary Outcome Measure

Percentage of Participants With Confirmed Objective Response, as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [ Time Frame: Up to approximately 30.6 months ]

Locations (7)

FacilityCityStateZIP
Moores Cancer Center at UC San Diego HealthLa JollaCalifornia92093
UCLALos AngelesCalifornia90095
SCRI Florida Cancer Specialists PANTallahasseeFlorida32308
Johns Hopkins HospitalBaltimoreMaryland21287
Washington University School of MedicineSt LouisMissouri63108
Tennessee Oncology - NashvilleNashvilleTennessee37203
MD Anderson Cancer CenterHoustonTexas77030

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Moores Cancer Center at UC San Diego Health· La Jolla, CAUCLA· Los Angeles, CASCRI Florida Cancer Specialists PAN· Tallahassee, FLJohns Hopkins Hospital· Baltimore, MDWashington University School of Medicine· St Louis, MOTennessee Oncology - Nashville· Nashville, TN

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