RTOG Foundation Study 3507

Study 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 NameCityState/Country
Boston Medical CenterBostonMA
Centre Hospitalier de l’Université de MontréalMontréalQC
Cleveland ClinicClevelandOH
Cross Cancer InstituteEdmontonAB
Fox Chase Cancer CenterPhiladelphiaPA
Henry Ford HospitalDetroitMI
James Graham Brown Cancer Center at the University of LouisvilleLouisvilleKY
McGill UniversityMontrealQC
Medical College of WisconsinMilwaukeeWI
Moffitt Cancer CenterTampaFL
Northwell HealthLake SuccessNY
Ohio State UniversityColumbusOH
Penn State Milton S. Hershey Medical CenterHersheyPA
University Hospitals Cleveland Medical CenterClevelandOH
University of Arizona Cancer CenterTucsonAZ
University of CincinnatiCincinnatiOH
University of Pittsburgh Medical CenterPittsburghPA
Washington UniversitySt. LouisMO