A 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
- Conditions
- Squamous cell carcinoma of the head and neck (SCCHN)MedDRA version: 27.0Level: LLTClassification code: 10082179Term: Squamous cell carcinoma of head and neck metastatic Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-509449-10-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 115
Known results from human papillomavirus status test 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 status test are required for oropharyngeal carcinoma, No prior systemic therapy for metastatic and/or recurrent SCCHN, Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1, Tumor PD-L1 expression as determined by PD-L1 IHC assay in either a previously obtained archival tumor tissue or tissue obtained from a biopsy at prescreening/screening, Eastern Cooperative Oncology Group Performance Status of 0 or 1, Adequate hematologic and end-organ function
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 metastases, History of leptomeningeal disease, Active or history of autoimmune disease or immune deficiency
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method