Summary

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

Description

Summary

This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC CRT alone in front-line treatment of patients with locally advanced head and neck cancer.

Official Title

A Randomized Double-blind Phase 3 Study Of Avelumab In Combination With Standard Of Care Chemoradiotherapy (Cisplatin Plus Definitive Radiation Therapy) Versus Standard Of Care Chemoradiotherapy In The Front-line Treatment Of Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck

Keywords

Squamous Cell Carcinoma of the Head and Neck Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Cisplatin Antibodies, Monoclonal Avelumab Chemoradiation

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histological diagnosis of squamous cell carcinoma of the oral cavity, oropharynx,hypopharynx, or larynx
  • HPV negative disease, Stage III, IVa, IVb; non-oropharyngeal HPV positive disease Stage III, IVa, IVb, HPV positive oropharyngeal disease T4 or N2c or N3
  • No prior therapy for advanced stage SCCHN; eligible for definitive CRT with curative intent.
  • Available tumor samples for submission or willing to undergo further tumor biopsies:
  • Age ≥18 years (≥19 in Korea;20 years in Japan and Taiwan).
  • ECOG Performance Status 0 or 1
  • Adequate bone marrow function
  • Adequate renal function
  • Adequate liver function
  • Pregnancy test (for patients of childbearing potential) negative at screening

You CAN'T join if...

  • Prior immunotherapy with an anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti CTLA 4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways.
  • Major surgery 4 weeks prior to randomization.
  • Prior malignancy requiring tumor-directed therapy within the last 2 years prior to enrollment, or concurrent malignancy associated with clinical instability. Exceptions for disease within the 2 years are superficial esophageal cancer (TIS or T1a) fully resected by endoscopy, prostate cancer (Gleason score 6) either curatively treated or deemed to not require treatment, ductal IS carcinoma of the breast that has completed curative treatment, adequately treated basal cell or squamous cell skin cancer.
  • Active autoimmune disease
  • Any of the following in the 6 months prior to randomization: myocardial infarction,severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism.
  • Active infection requiring systemic therapy.
  • Use of immunosuppressive medication at time of randomization
  • Prior organ transplantation including allogenic stem-cell transplantation.
  • Diagnosis of prior immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness.
  • Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  • Vaccination within 4 weeks prior to randomization.
  • Current use of or anticipated need for treatment with other anti-cancer drugs.
  • Pregnant female patients, breastfeeding female patients, and male patients able to father children and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in the protocol for the duration of the study and for at least 6 months after the last dose of cisplatin and 60 days after the last dose of avelumab/placebo (whichever is later).

Locations

  • UC San Diego Moores Cancer Center- Investigational Drug Services accepting new patients
    La Jolla California 92037-0845 United States
  • UC San Diego Medical Center- La Jolla (Thornton Hospital) accepting new patients
    La Jolla California 92037 United States
  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • UC San Diego Medical Center- Hillcrest accepting new patients
    San Diego California 92103 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT02952586
Phase
Phase 3
Study Type
Interventional
Last Updated
August 12, 2018