NCT04665843CompletedPhase 2
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
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
Source: ClinicalTrials.gov · Last updated 5 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 123 (actual)
- First submitted
- 7 Dec 2020
- Start date
- 2 Mar 2021
- Primary completion date
- 20 Sept 2023
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Head and neck cancer
- NCT number
- NCT04665843
- EU CT number
- 2023-509449-10-00
- EudraCT number
- 2020-002852-19
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 123
- From 2 Mar 2021 to the primary completion date, 20 Sept 2023
- 36 sites in 13 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Grade \>=2 unresolved toxicity related to surgery or other prior therapies
- 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
Other illness
- Disease suitable for local therapy with curative intent
- 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
- 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
Other
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- Pregnancy or breastfeeding
Who the study is looking for
- Histologically or cytologically confirmed recurrent/metastatic SCCHN involving the oropharynx, oral cavity, larynx, or hypopharynx, that is considered incurable by local therapies
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (36)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Masarykuv Onkologicky Ustav Coordinator of this site? Confirm its status | Brno-Stred | Czechia | Completed |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Completed |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Completed |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Completed |
| Centre Francois Baclesse Coordinator of this site? Confirm its status | Caen Cedex 5 | France | Completed |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Completed |
| Institut Regional Du Cancer De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Completed |
| Institut Curie Coordinator of this site? Confirm its status | Paris | France | Completed |
| Institut de cancérologie de Lorraine Coordinator of this site? Confirm its status | Vandoeuvre Les Nancy_ Cedex | France | Completed |
| Velindre Cancer Centre Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| Beatson West of Scotland Cancer Centre Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Guys and St Thomas NHS Foundation Trust, Guys Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal Marsden NHS Foundation Trust Coordinator of this site? Confirm its status | Sutton | United Kingdom | Unknown status |
| University General Hospital Attikon Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| University of Pecs Coordinator of this site? Confirm its status | Pécs | Hungary | Completed |
| Asst Degli Spedali Civili Di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Unknown status |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Auckland City Hospital, Cancer and Blood Research Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Completed |
| Ramathibodi Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Songklanagarind Hospital Coordinator of this site? Confirm its status | Songkhla | Thailand | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Zhongzheng Dist. | Taiwan | Unknown status |
| Johns Hopkins Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Moores Cancer Center at UC San Diego Health Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| UCLA Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Tennessee Oncology - Nashville Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| SCRI Florida Cancer Specialists PAN Coordinator of this site? Confirm its status | Tallahassee | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.