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COMPLETED
NCT04665843
PHASE2

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Official title: A Phase II, Randomized, Double Blind Study of Atezolizumab Plus Tiragolumab and Atezolizumab Plus Placebo as First-Line Treatment in Patients With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

123

Start Date

2021-03-02

Completion Date

2025-08-27

Last Updated

2026-05-05

Healthy Volunteers

No

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.

Locations (47)

Moores Cancer Center at UC San Diego Health

La Jolla, California, United States

UCLA

Los Angeles, California, United States

SCRI Florida Cancer Specialists PAN

Tallahassee, Florida, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Washington University School of Medicine

St Louis, Missouri, United States

Tennessee Oncology - Nashville

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

Masarykuv onkologicky ustav

Brno, Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, Czechia

Fakultni nemocnice v Motole

Prague, Czechia

CHU Bordeaux

Bordeaux, France

Centre Francois Baclesse

Caen, France

Centre Leon Berard

Lyon, France

Institut régional du Cancer Montpellier

Montpellier, France

Institut Curie

Paris, France

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

Anticancer Hospital Ag Savas

Athens, Greece

Attiko Hospital University of Athens

Athens, Greece

Periph. University General Hospital of Heraklion Crete

Heraklion, Greece

Euromedical General Clinic of Thessaloniki

Thessaloniki, Greece

Gy?r-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház

Gy?r, Hungary

Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont

Kecskemét, Hungary

Pécsi Tudományegyetem

Pécs, Hungary

Asst Degli Spedali Civili Di Brescia

Brescia, Lombardy, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy, Italy

Azienda Ospedaliero-Universitaria Careggi

Florence, Tuscany, Italy

Auckland City Hospital, Cancer and Blood Research

Auckland, New Zealand

Beskidzkie Centrum Onkologii- Szpital Miejski

Bielsko-Biala, Poland

Uniwersyteckie Centrum Kliniczne

Gda?sk, Poland

Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna

Lodz, Poland

Centrum Onkologii Ziemi Lubelskiej Im. ?W. Jana Z Dukli

Lublin, Poland

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Poland

Seoul National University Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Institut Catala d Oncologia Hospital Duran i Reynals

Barcelona, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

China Medical University Hospital

Taichung, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

National Taiwan University Hospital

Zhongzheng Dist., Taiwan

Ramathibodi Hospital

Bangkok, Thailand

Songklanagarind Hospital

Songkhla, Thailand

Velindre Cancer Centre

Cardiff, United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Guys and St Thomas NHS Foundation Trust, Guys Hospital

London, United Kingdom

Royal Marsden NHS Foundation Trust

Sutton, United Kingdom