Spots Global Cancer Trial Database for SBRT +/- Pembrolizumab in Patients With Local-Regionally Recurrent or Second Primary Head and Neck Carcinoma
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Trial Identification
Brief Title: SBRT +/- Pembrolizumab in Patients With Local-Regionally Recurrent or Second Primary Head and Neck Carcinoma
Official Title: 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
Study ID: NCT03546582
Study Description
Brief Summary: This phase II trial with a safety run-in component will evaluate whether the addition of pembrolizumab to Stereotactic Body Radiation Therapy (SBRT) re-irradiation will improve the progression-free survival for patients with recurrent or new second primary Head and Neck Squamous Cell Carcinoma (HNSCC).
Detailed Description: 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 second 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. OUTLINE: Safety Run-In: Patients receive SBRT over 2 weeks and then receive pembrolizumab every 3 weeks for up to 2 years. Phase II: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive SBRT over 2 weeks and then receive pembrolizumab every 3 weeks for up to 2 years. ARM II: Patients receive SBRT over 2 weeks. Arm II patients who experience progressive disease within 2 years after the start of SBRT will be allowed to cross over to receive pembrolizumab for up to 2 years. After the completion of study treatment, patients are followed up every 6 months for 3 years.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arizona Cancer Center - North Campus, Tucson, Arizona, United States
Moffitt Cancer Center, Tampa, Florida, United States
Cleveland Clinic - Weston, Weston, Florida, United States
University of Louisville, James Graham Brown Cancer Center, Louisville, Kentucky, United States
Boston Medical Center, Boston, Massachusetts, United States
Henry Ford Hospital, Detroit, Michigan, United States
Washington University St. Louis, Saint Louis, Missouri, United States
Northwell Health, Lake Success, New York, United States
University of Cincinnati Cancer Center - UC Medical Center, Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
Ohio State University, Columbus, Ohio, United States
Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center Shadyside, Pittsburgh, Pennsylvania, United States
University of Texas Southwestern, Dallas, Texas, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Cross Cancer Institute, Edmonton, Alberta, Canada
Centre Hospitalier de l'université de Montréal, Montréal, Quebec, Canada
McGill University, Montréal, Quebec, Canada
CHU de Quebec - Universite Laval, Québec, Quebec, Canada
Contact Details
Name: Stuart J. Wong, MD
Affiliation: RTOG Foundation
Role: PRINCIPAL_INVESTIGATOR
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