Clinical trial · Interventional
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Carcinoma of Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| Tiragolumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Atezolizumab + Tiragolumab
- description
- Participants will receive atezolizumab followed by tiragolumab every three weeks (Q3W) on Day 1 of each 21-day cycle.
- interventionNames
- Drug: Atezolizumab
- Drug: Tiragolumab
- type
- PLACEBO_COMPARATOR
- label
- Atezolizumab + Placebo
- description
- Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle.
- interventionNames
- Drug: Atezolizumab
- Drug: Placebo
Primary outcomes (1)
- measure
- Percentage of Participants With Confirmed Objective Response, as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available