Summary

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

Description

Summary

This study will evaluate the efficacy and safety of atezolizumab compared with placebo as adjuvant therapy after definitive local therapy in patients with high-risk locally advanced squamous cell carcinoma of the head and neck (SCCHN)

Official Title

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab (Anti−Pd-L1 Antibody) as Adjuvant Therapy After Definitive Local Therapy in Patients With High-Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Keywords

Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Antibodies Antibodies, Monoclonal Atezolizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histologically or cytologically confirmed Squamous Cell Carcinoma of the Head and Neck(SCCHN)
  • Human Papilloma Virus (HPV) status
  • Completed definitive local therapy and have scans, 10−12 weeks after completion of definitive local therapy confirming either Complete Response (CR), Partial Response(PR), or Stable Disease (SD). If salvage neck dissection or salvage laryngectomy is not performed, patients must initiate study treatment within 4 weeks of the screening scans and within 16 weeks after completion of the definitive local therapy. If salvage neck dissection or salvage laryngectomy is performed, patients must initiate study treatment within 4 weeks of screening scans and within 20 weeks after completion of definitive local therapy.
  • Absence of metastatic disease as documented by radiographic scans
  • Adequate hematologic and end-organ function
  • For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
  • For women of childbearing potential: agreement to remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 5 months after the last dose of study treatment

You CAN'T join if...

  • Patients who have received surgery alone or radiotherapy alone as definitive local therapy
  • Squamous cell carcinoma of the nasopharynx
  • Evidence of disease progression or metastatic disease during or following definitive local therapy documented in the 10- to 12-week post-definitive local therapy scans
  • Uncontrolled or symptomatic hypercalcemia
  • Active or history of autoimmune disease or immune deficiency
  • Active tuberculosis
  • Significant cardiovascular disease
  • History of malignancy, including prior SCCHN primary tumors within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
  • Prior allogeneic stem cell or solid organ transplantation
  • Current treatment with anti-viral therapy for Hepatitis B Virus (HBV)
  • Treatment with systemic immunostimulatory agents
  • Treatment with systemic immunosuppressive medication
  • History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
  • Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the last dose of study treatment
  • Patients who have received a non-FDA or non-EMA approved anti-EGFR agent or any other non-FDA or non-EMA approved agent as part of concurrent radiotherapy

Locations

  • University of California San Diego Medical Center; Moores Cancer Center not yet accepting patients
    La Jolla California 92093 United States
  • Kaiser Permanente - Bellflower accepting new patients
    Bellflower California 90706 United States
  • City of Hope National Medical Center accepting new patients
    Duarte California 91010 United States
  • UCLA Hematology/Oncology not yet accepting patients
    Santa Monica California 90404 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT03452137
Phase
Phase 3
Study Type
Interventional
Last Updated
July 23, 2018