A Phase II, Randomized, Double Blind 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

Hoffmann-La Roche47 sites in 13 countries123 target enrollmentMarch 2, 2021

ConditionsSquamous Cell Carcinoma of Head and Neck

InterventionsTiragolumab Atezolizumab Placebo

DrugsAtezolizumab Tiragolumab Placebo

Overview

Phase: Phase 2
Intervention: Tiragolumab
Conditions: Squamous Cell Carcinoma of Head and Neck
Sponsor: Hoffmann-La Roche
Enrollment: 123
Locations: 47
Primary Endpoint: Confirmed Objective Response Rate (ORR)
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2, 2021

End Date

August 27, 2025

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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

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

Arms & Interventions

Atezolizumab + Tiragolumab

Participants will receive atezolizumab followed by tiragolumab every three weeks (Q3W) on Day 1 of each 21-day cycle.

Intervention: Tiragolumab

Atezolizumab + Tiragolumab

Participants will receive atezolizumab followed by tiragolumab every three weeks (Q3W) on Day 1 of each 21-day cycle.

Intervention: Atezolizumab

Atezolizumab + Placebo

Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle.

Intervention: Atezolizumab

Atezolizumab + Placebo

Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle.

Intervention: Placebo

Outcomes

Primary Outcomes

Confirmed Objective Response Rate (ORR)

Time Frame: Up to approximately 43 months

Secondary Outcomes

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)
Overall Survival Rate at 6 Months and 12 Months(Month 6, Month 12)
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)