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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
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

Full criteria on ClinicalTrials.gov

Sites (36)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Masarykuv Onkologicky Ustav
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Brno-StredCzechiaCompleted
Hospital Germans Trias i Pujol
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BadalonaSpainCompleted
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainCompleted
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainCompleted
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceCompleted
Centre Francois Baclesse
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Caen Cedex 5FranceCompleted
Centre Leon Berard
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LyonFranceCompleted
Institut Regional Du Cancer De Montpellier
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Montpellier Cedex 5FranceCompleted
Institut Curie
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ParisFranceCompleted
Institut de cancérologie de Lorraine
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Vandoeuvre Les Nancy_ CedexFranceCompleted
Velindre Cancer Centre
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CardiffUnited KingdomUnknown status
Beatson West of Scotland Cancer Centre
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GlasgowUnited KingdomUnknown status
Guys and St Thomas NHS Foundation Trust, Guys Hospital
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LondonUnited KingdomUnknown status
Royal Marsden NHS Foundation Trust
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SuttonUnited KingdomUnknown status
University General Hospital Attikon
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AthensGreeceCompleted
University of Pecs
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PécsHungaryCompleted
Asst Degli Spedali Civili Di Brescia
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BresciaItalyUnknown status
Azienda Ospedaliero-Universitaria Careggi
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FlorenceItalyUnknown status
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Auckland City Hospital, Cancer and Blood Research
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AucklandNew ZealandUnknown status
Uniwersyteckie Centrum Kliniczne
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GdanskPolandCompleted
Ramathibodi Hospital
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BangkokThailandUnknown status
Songklanagarind Hospital
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SongkhlaThailandUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
National Taiwan University Hospital
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Zhongzheng Dist.TaiwanUnknown status
Johns Hopkins Hospital
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BaltimoreUnited StatesUnknown status
MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
Moores Cancer Center at UC San Diego Health
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La JollaUnited StatesUnknown status
UCLA
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Los AngelesUnited StatesUnknown status
Tennessee Oncology - Nashville
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NashvilleUnited StatesUnknown status
Washington University School of Medicine
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St LouisUnited StatesUnknown status
SCRI Florida Cancer Specialists PAN
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TallahasseeUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.