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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 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

NCT04665843

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Squamous Cell Carcinoma of Head and Neck

Interventions: Atezolizumab, Tiragolumab, Placebo

Countries: United States, Czechia, France, Greece, Hungary, Italy, New Zealand, Poland

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria:

* 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

Key Exclusion Criteria:

* 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
* 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
Locations (47)
  • La Jolla, California, United States
  • Los Angeles, California, United States
  • Tallahassee, Florida, United States
  • Baltimore, Maryland, United States
  • St Louis, Missouri, United States
  • Nashville, Tennessee, United States
  • Houston, Texas, United States
  • Brno, Czechia
  • Hradec Králové, Czechia
  • Prague, Czechia
  • Bordeaux, France
  • Caen, France
  • Lyon, France
  • Montpellier, France
  • Paris, France
  • Vandœuvre-lès-Nancy, France
  • Athens, Greece
  • Athens, Greece
  • Heraklion, Greece
  • Thessaloniki, Greece
  • Gy?r, Hungary
  • Kecskemét, Hungary
  • Pécs, Hungary
  • Brescia, Lombardy, Italy
  • Milan, Lombardy, Italy
  • Florence, Tuscany, Italy
  • Auckland, New Zealand
  • Bielsko-Biala, Poland
  • Gda?sk, Poland
  • Lodz, Poland
  • + 17 more on CT.gov