Clinical Trials /

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

NCT04665843

Description:

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.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: BO42533
  • SECONDARY ID: 2020-002852-19
  • NCT ID: NCT04665843

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Interventions

DrugSynonymsArms
AtezolizumabTecentriq; RO5541267Atezolizumab + Placebo
TiragolumabRO7092284Atezolizumab + Tiragolumab
PlaceboAtezolizumab + Placebo

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Atezolizumab + TiragolumabExperimentalParticipants will receive atezolizumab followed by tiragolumab every three weeks (Q3W) on Day 1 of each 21-day cycle.
  • Atezolizumab
  • Tiragolumab
Atezolizumab + PlaceboPlacebo ComparatorParticipants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle.
  • Atezolizumab
  • Placebo

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Confirmed Objective Response Rate (ORR)
Time Frame:Up to approximately 43 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Duration of Response (DOR)
Time Frame:Up to approximately 43 months
Safety Issue:
Description:
Measure:Progression-Free Survival (PFS)
Time Frame:Up to approximately 43 months
Safety Issue:
Description:
Measure:Overall Survival (OS)
Time Frame:Up to approximately 43 months
Safety Issue:
Description:
Measure:Progression-Free Survival Rate at 6 Months
Time Frame:Month 6
Safety Issue:
Description:
Measure:Overall Survival Rate at 6 Months and 12 Months
Time Frame:Month 6, Month 12
Safety Issue:
Description:
Measure:Time to Confirmed Deterioration (TTCD) in Patient-Reported Physical Functioning
Time Frame:Up to approximately 43 months
Safety Issue:
Description:
Measure:Percentage of Participants With Adverse Events (AEs)
Time Frame:Up to approximately 43 months
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure:Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Time Frame:From baseline up to approximately 43 months
Safety Issue:
Description:
Measure:Number of Participants With ADAs to Tiragolumab
Time Frame:From baseline up to approximately 43 months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Hoffmann-La Roche

Last Updated

December 14, 2020