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: 22.0Level: LLTClassification code 10082179Term: Squamous cell carcinoma of head and neck metastaticSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-002852-19-FR
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
• Age >= 18 years
• Participants 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 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
• Progressive or recurrent disease within 6 months of the last dose of curative intent systemic treatment for locally advanced SCCHN
• 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
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
• History of additional malignancy other than SCCHN within 5 years prior to randomization, with the exception of malignancies with a negligible risk of metastasis or death
• Severe infection within 4 weeks prior to initiation of study treatment
• Current treatment with anti-viral therapy for HBV or HCV
• Treatment with investigational therapy within 28 days prior to initiation of study treatment
• Prior treatment with CD137 agonists or immune checkpoint blockade therapies
• Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives prior to initiation of study treatment
• Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment.
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