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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 20, 2023

Interventions

  • Drug: Atezolizumab
    • Atezolizumab at a fixed dose of 1200 mg will be administered by intravenous (IV) infusion Q3W on Day 1 of each 21-day cycle.
  • Drug: Tiragolumab
    • Tiragolumab at a fixed dose of 600 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
  • Drug: Placebo
    • Placebo will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.

Arms, Groups and Cohorts

  • Experimental: Atezolizumab + Tiragolumab
    • Participants will receive atezolizumab followed by tiragolumab every three weeks (Q3W) on Day 1 of each 21-day cycle.
  • Placebo Comparator: Atezolizumab + Placebo
    • Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle.

Clinical Trial Outcome Measures

Primary Measures

  • Confirmed Objective Response Rate (ORR)
    • Time Frame: Up to approximately 43 months

Secondary Measures

  • 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

Participating in This Clinical Trial

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 – 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hoffmann-La Roche
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Trials, Study Director, Hoffmann-La Roche

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