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Brief Title: Pembrolizumab in Combination With Cisplatin and Intensity Modulated Radiotherapy (IMRT) in Head and Neck Cancer
Official Title: Randomized, Phase II Study Evaluating Concurrent or Sequential Fixed-Dose Pembrolizumab in Combination With Cisplatin and Intensity Modulated Radiotherapy in Intermediate or High Risk, Previously Untreated, Locally Advanced Head and Neck Cancer
Study ID: NCT02777385
Brief Summary: The study regimen consists of cisplatin and radiation for all patients, the standard treatment for head and neck cancer. All patients will also receive pembrolizumab (the study drug), and will be randomized to two treatment schedules: either pembrolizumab with cisplatin-radiation, or pembrolizumab after completing cisplatin-radiation. The goal of this research study is to learn which therapy order (adding pembrolizumab during vs. after cisplatin and radiation) may be more effective in treating head and neck cancer, as well as learn the side effects of these combinations.Pembrolizumab is an immune therapy, a drug that stimulates the immune system to fight cancer, and is FDA approved in lung cancer and melanoma. It is not currently FDA approved for head and neck cancer.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Name: Dan Zandberg, MD
Affiliation: UPMC Hillman Cancer Center
Role: PRINCIPAL_INVESTIGATOR