RTOG Foundation Study 3507
Status Date: November 14, 2018 | Status: Open to Accrual
KEYSTROKE
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 |