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.
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
Drug | Synonyms | Arms |
---|
Atezolizumab | Tecentriq; RO5541267 | Atezolizumab + Placebo |
Tiragolumab | RO7092284 | Atezolizumab + Tiragolumab |
Placebo | | Atezolizumab + 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
Name | Type | Description | Interventions |
---|
Atezolizumab + Tiragolumab | Experimental | Participants will receive atezolizumab followed by tiragolumab every three weeks (Q3W) on Day 1 of each 21-day cycle. | |
Atezolizumab + Placebo | Placebo Comparator | Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle. | |
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: | Recruiting |
Lead Sponsor: | Hoffmann-La Roche |
Last Updated
August 25, 2021