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
NCT ID: NCT04665843
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
123 participants
INTERVENTIONAL
2021-03-02
2025-08-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Atezolizumab + Tiragolumab
Participants will receive atezolizumab followed by tiragolumab every three weeks (Q3W) on Day 1 of each 21-day cycle.
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.
Tiragolumab
Tiragolumab at a fixed dose of 600 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Atezolizumab + Placebo
Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle.
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.
Placebo
Placebo will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Interventions
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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.
Tiragolumab
Tiragolumab at a fixed dose of 600 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Placebo
Placebo will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Known results from human papillomavirus (HPV) status test for oropharyngeal carcinoma
* No prior systemic therapy for metastatic and/or recurrent SCCHN
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Tumor PD-L1 expression as determined by PD-L1 immunohistochemistry assay
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Life expectancy \>=12 weeks
Exclusion Criteria
* Progressive or recurrent disease within 6 months of the last dose of curative intent systemic treatment for locally advanced SCCHN
* Rapidly progressing disease in the opinion of the treating investigator
* Grade \>=2 unresolved toxicity related to surgery or other prior therapies
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* History of leptomeningeal disease
* Active or history of autoimmune disease or immune deficiency
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
* History of additional malignancy other than SCCHN within 5 years prior to randomization
* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-TIGIT, anti-PD-L1, and anti-PD-1 therapeutic antibodies
* Treatment with systemic immunostimulatory agents or systemic immunosuppressive medication
* Pregnancy or breastfeeding
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Countries
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Other Identifiers
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2020-002852-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BO42533
Identifier Type: -
Identifier Source: org_study_id
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