Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

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.

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

Keywords

Squamous Cell Carcinoma of Head and Neck Carcinoma Carcinoma, Squamous Cell Atezolizumab Tiragolumab Atezolizumab + Tiragolumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • Moores Cancer Center at UC San Diego Health not yet accepting patients
    La Jolla California 92093 United States
  • UCLA accepting new patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT04665843
Phase
Phase 2
Study Type
Interventional
Last Updated