Clareo Health | 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
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Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
