RTOG Foundation Study 3507

Status Date:  November 14, 2018  | Status:  Open to Accrual


A Randomized Phase II Study of Pembrolizumab (KEYTRUDA®) Plus Stereotactic Re-irradiation versus SBRT Alone for Locoregionally Recurrent or Second Primary Head and Neck Carcinoma

Principal Investigator

Stuart J. Wong, MD

Primary Objective

Safety Run-In:  To evaluate the safety of the addition of pembrolizumab (anti PD-1 immunotherapy) to re-irradiation with SBRT for patients with recurrent or new secondary primary head and neck squamous cell carcinoma (HNSCC). Phase II:  To compare progression-free survival (PFS) for patients with recurrent or new second primary head and neck squamous cell carcinoma with SBRT re-irradiation with or without pembrolizumab.

Patient Population

Locoregional recurrent or any new primary squamous cell carcinoma of the head and neck that is not amenable to curative resection.

Participating Sites

Institution Name City State/Country
Boston Medical Center Boston MA
Centre Hospitalier de l’Université de Montréal Montréal QC
Cleveland Clinic Cleveland OH
Cross Cancer Institute Edmonton AB
Fox Chase Cancer Center Philadelphia PA
Henry Ford Hospital Detroit MI
James Graham Brown Cancer Center at the University of Louisville Louisville KY
McGill University Montreal QC
Medical College of Wisconsin Milwaukee WI
Moffitt Cancer Center Tampa FL
Northwell Health Lake Success NY
Ohio State University Columbus OH
Penn State Milton S. Hershey Medical Center Hershey PA
University Hospitals Cleveland Medical Center Cleveland OH
University of Arizona Cancer Center Tucson AZ
University of Cincinnati Cincinnati OH
University of Pittsburgh Medical Center Pittsburgh PA
Washington University St. Louis MO

Participate in RTOG Research

To participate as an RTOG study investigator, your organization must be part of the RTOG Foundation network. Patients who wish to participate in a study must be under the care of an RTOG participating investigator. For additional information, email info@rtog.org or call 1-215-574-3173.

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