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A 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
Overall Recruitment Status: Active, currently enrolling
 
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
 
Region Sponsors
California - Northern
Genentech
Hoffmann-La Roche Ltd.
 
Acronym KP IRB No.
1311849
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Adults with locally advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are at high risk for disease recurrence or progression following definitive local therapy.
 
Purpose
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).
 
Detailed Description
Study WO40242 is a global Phase III, multicenter, randomized, double-blind, placebo-controlled study of atezolizumab as adjuvant therapy after definitive local therapy in patients with locally advanced SCCHN who are at high risk for disease recurrence or progression following definitive local therapy. The study is designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of adjuvant treatment with atezolizumab compared with placebo in patients with locally advanced SCCHN who have not progressed after receiving definitive local therapy. Male and female patients >/= 18 years of age who have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 and histologically confirmed SCCHN involving the oral cavity, oropharynx, larynx, or hypopharynx, and who have received definitive local therapy and are classified as being at high risk for recurrence or progression are eligible for study participation.
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • Histologically or cytologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN)
  • Human Papilloma Virus (HPV) status
  • Completed 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. Women must refrain from donating eggs during this same period.
  • Confirmed response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) to definitive local therapy documented by CT with contrast or MRI with contract to head and neck region done >/= 8 weeks after completion of definitive local therapy and within 28 days prior to initiation of study drug.
  • Please contact the study team for more inclusion criteria.
 
Exclusion Criteria
  • Patients who have received surgery alone or radiotherapy alone as definitive local therapy
  • Squamous cell carcinoma of the nasopharynx or paranasal sinuses or non-squamous histology
  • Evidence of disease progression or metastatic disease during or following definitive local therapy documented in post-definitive local therapy screening 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 definitive local therapy.
  • Any systemic therapy in the adjuvant setting such as after surgery, radiation, or concurrent CRT
  • Please contact the study team for more exclusion criteria.

 
Keywords and/or Specific Medical Conditions
  • Antibodies
  • Neoplasms
  • Antibodies, Monoclonal
  • Neoplasms by Histologic Type
  • Antineoplastic Agents
  • Neoplasms by Site
  • Atezolizumab
  • Neoplasms, Glandular and Epithelial
  • Carcinoma
  • Neoplasms, Squamous Cell
  • Carcinoma, Squamous Cell
  • Physiological Effects of Drugs
  • Head and Neck Neoplasms
  • SCCHN
  • High-Risk
  • Squamous Cell Carcinoma of the Head and Neck
  • Immunologic Factors
  • Oncology (Adult)
  • Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)
 
KP Clinical Facility
  • Hayward Medical Center
  • Oakland Medical Center
  • Roseville Medical Center
  • Sacramento Medical Center
  • San Francisco Medical Center
  • Santa Clara Medical Center-Homestead
  • Santa Teresa Medical Center-San Jose
  • South San Francisco Medical Center
  • Vallejo Medical Center
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Jennifer Marie Suga, MD
Contact Information:
- Desiree Goldstein
-Desiree.Goldstein@kp.org
-Vallejo Medical Center


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