Phase 2
N=123
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
Squamous Cell Carcinoma of Head and Neck
Bottom Line
View on ClinicalTrials.gov: NCT04665843 ↗Enrolled (actual)
123
Serious AEs
31.1%
Results posted
May 2026
Primary outcome: Primary: 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) — 15.4; 21.3 percentage of participants — p=0.3886
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Atezolizumab (Drug); Tiragolumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
15.4; 21.3 | 0.3886 |
| SECONDARY Duration of Response (DOR) |
NA; 14.75 | — |
| SECONDARY Progression-free Survival (PFS) |
2.99; 4.14 | 0.5983 |
| SECONDARY Overall Survival (OS) |
13.57; 16.23 | 0.4457 |
| SECONDARY PFS Rate at 6 Months |
35.90; 42.10 | 0.5150 |
| SECONDARY OS Rate at 6 Months and 12 Months |
76.92; 83.37; 53.05; 64.84 | 0.4176 |
| SECONDARY Time to Confirmed Deterioration (TTCD) in Participant-reported Physical Functioning (PF), as Measured by the Patient-reported Outcomes Measurement Information System (PROMIS) Item Bank Version 2.0 (v2.0)-PF-Short Form 10b |
9.00; 11.76 | 0.8230 |
| SECONDARY Number of Participants With Adverse Events (AEs) |
30; 76 | — |
| SECONDARY Serum Concentration of Atezolizumab at Specified Timepoints |
NA; NA; 262; 285; 80.4; 84.3 | — |
| SECONDARY Serum Concentration of Tiragolumab at Specified Timepoints |
NA; 147; 44.6; 65.7; 80.2; 89.8 | — |
| SECONDARY Number of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab |
8; 11 | — |
| SECONDARY Number of Participants With ADAs to Tiragolumab |
— | — |
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.
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
- 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
Data sourced from ClinicalTrials.gov (NCT04665843). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.