Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Alain Algazi
Headshot of Alain Algazi
Alain Algazi

Description

Summary

The purpose of this study is to determine whether pembrolizumab, when given after salvage surgery, is effective in increasing the time a person with squamous cell cancer of the head and neck remains disease-free following locoregional disease recurrence.

Official Title

An Open-Label, Phase 2 Efficacy Study With Window of Opportunity Immune Assessment of Pembrolizumab in Relapsed, Locally Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Details

The purpose of this study is to determine whether pembrolizumab, when given after salvage surgery, is effective in increasing the time a person with squamous cell cancer of the head and neck remains disease-free following locoregional disease recurrence.

This is a prospective, multi-center, open label, phase II study with a window of opportunity component in patients with recurrent squamous cell carcinoma of the head and neck (SCCHN) treated with adjuvant pembrolizumab following salvage surgery. Forty-five (45) patients will participate in this study to determine disease-free survival probability at 12 months. Secondary objectives include assessments of disease-free survival probability at 2 years, overall survival, adverse events and toxicity, and immune and molecular correlatives. For the window of opportunity component, patients will be randomized 3:1 in favor of receiving pembrolizumab 200 mg administered intravenously (IV) every three weeks for a maximum of two doses, versus placebo prior to salvage surgery. Approximately three to six weeks following the first dose of pembrolizumab, patients will undergo salvage surgery. Tumor tissue and blood will be collected at the time of surgery for immune correlative studies.

Keywords

Squamous Cell Carcinoma of the Head and Neck, squamous cell carcinoma head and neck, pembrolizumab, cancer, SCCHN, Carcinoma, Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck

Eligibility

Locations

  • UCSF
    San Francisco California 94115 United States
  • University of California Los Angeles
    Torrance California 90505 United States
  • UCSD Moores Cancer Center
    La Jolla California 92093 United States

Lead Scientist at UCSF

  • Alain Algazi
    Dr. Alain Algazi is a specialist in medical treatment – such as chemotherapy and immunotherapy – for patients with head and neck cancers, including head and neck squamous cell carcinoma, thyroid cancers and salivary gland cancers. He leads UCSF's program in medical therapy for head and neck cancers, and chairs the head and neck cancer research committee.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Assuntina G. Sacco, MD
ID
NCT02769520
Phase
Phase 2 research study
Study Type
Interventional
Participants
About 27 people participating
Last Updated