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

• Status: Recruiting
• Trial end date: 2024-08-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Atezolizumab

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

• 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