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
Phase 2
Active, not recruiting
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Interventions
- Registration Number
- NCT04665843
- Lead Sponsor
- Hoffmann-La Roche
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 123
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Atezolizumab + Tiragolumab Tiragolumab Participants will receive atezolizumab followed by tiragolumab every three weeks (Q3W) on Day 1 of each 21-day cycle. Atezolizumab + Placebo Placebo Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle. Atezolizumab + Tiragolumab Atezolizumab Participants will receive atezolizumab followed by tiragolumab every three weeks (Q3W) on Day 1 of each 21-day cycle. Atezolizumab + Placebo Atezolizumab Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle.
- Primary Outcome Measures
Name Time Method Confirmed Objective Response Rate (ORR) Up to approximately 43 months
- Secondary Outcome Measures
Name Time Method Overall Survival Rate at 6 Months and 12 Months Month 6, Month 12 Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab From baseline up to approximately 43 months Number of Participants With ADAs to Tiragolumab From baseline up to approximately 43 months Cmax of Tiragolumab Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days), predose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit up to approximately 43 months Maximum Serum Concentration (Cmax) of Atezolizumab Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days), predose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit up to approximately 43 months Cmin of Tiragolumab Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days), predose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit up to approximately 43 months Duration of Response (DOR) Up to approximately 43 months Progression-Free Survival (PFS) Up to approximately 43 months Overall Survival (OS) Up to approximately 43 months Progression-Free Survival Rate at 6 Months Month 6 Time to Confirmed Deterioration (TTCD) in Patient-Reported Physical Functioning Up to approximately 43 months Percentage of Participants With Adverse Events (AEs) Up to approximately 43 months Minimum Serum Concentration (Cmin) of Atezolizumab Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days), predose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit up to approximately 43 months
Trial Locations
- Locations (43)
UCLA
🇺🇸Los Angeles, California, United States
SCRI Florida Cancer Specialists PAN
🇺🇸Tallahassee, Florida, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Tennessee Oncology - Nashville
🇺🇸Nashville, Tennessee, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Masarykuv onkologicky ustav
🇨🇿Brno, Czechia
Fakultni nemocnice Hradec Kralove
🇨🇿Hradec Kralove, Czechia
Fakultni nemocnice v Motole
🇨🇿Praha 5, Czechia
CHU Bordeaux
🇫🇷Bordeaux, France
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