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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
123
Atezolizumab at a fixed dose of 1200 mg will be administered by intravenous (IV) infusion Q3W on Day 1 of each 21-day cycle.
Tiragolumab at a fixed dose of 600 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Placebo will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Moores Cancer Center at UC San Diego Health
La Jolla, California, United States
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
St Louis, Missouri, United States
Confirmed Objective Response Rate (ORR)
Time frame: Up to approximately 43 months
Duration of Response (DOR)
Time frame: Up to approximately 43 months
Progression-Free Survival (PFS)
Time frame: Up to approximately 43 months
Overall Survival (OS)
Time frame: Up to approximately 43 months
Progression-Free Survival Rate at 6 Months
Time frame: Month 6
Overall Survival Rate at 6 Months and 12 Months
Time frame: Month 6, Month 12
Time to Confirmed Deterioration (TTCD) in Patient-Reported Physical Functioning
Time frame: Up to approximately 43 months
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to approximately 43 months
Minimum Serum Concentration (Cmin) of Atezolizumab
Time frame: 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
Time frame: 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
Time frame: 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
Cmax of Tiragolumab
Time frame: 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
Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Time frame: From baseline up to approximately 43 months
Number of Participants With ADAs to Tiragolumab
Time frame: From baseline up to approximately 43 months
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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 Králové, Czechia
Fakultni nemocnice v Motole
Prague, Czechia
...and 37 more locations