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 (SKYSCRAPER-09)

Roche

Status and phase: Active, not recruiting; Phase 2

Conditions: Squamous Cell Carcinoma of Head and Neck

Treatments: Drug: Placebo; Drug: Tiragolumab; Drug: Atezolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04665843

2020-002852-19 (EudraCT Number)

BO42533

Details and patient eligibility

About

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.

Enrollment: 123 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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123 participants in 2 patient groups, including a placebo group

Atezolizumab + Tiragolumab

Experimental group

Description:

Participants will receive atezolizumab followed by tiragolumab every three weeks (Q3W) on Day 1 of each 21-day cycle.

Treatment:

Drug: Atezolizumab

Drug: Tiragolumab

Atezolizumab + Placebo

Placebo Comparator group

Description:

Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle.

Treatment:

Drug: Atezolizumab

Drug: Placebo