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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 of Pembrolizumab (KEYTRUDA®) Plus non-surgical radiation therapy Versus non-surgical radiation therapy alone for Recurrent or Second Primary Head and Neck Cancer. This study is evaluating the safety of the addition of pembrolizumab to non-surgical radiation therapy.

The purpose of this voluntary research study is to compare any good and bad effects of using the study drug, pembrolizumab, plus radiation therapy to using radiation therapy alone. The addition of the study drug to radiation could shrink your cancer/prevent it from returning but it could also cause side effects.

Yes
 
Mitchell Machtay
igeier@pennstatehealth.psu.edu
Medicine: Hematology and Medical Oncology (HERSHEY)
 
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18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03546582
STUDY00017112
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Inclusion Criteria:
Confirmed diagnosis of recurrent or any new primary squamous cell carcinoma of the head and neck
Patients for whom resection would be medically contraindicated and/or would impose excessive surgical risk
Patients must have had prior radiation to the head and neck
Exclusion Criteria:
Patients with distant metastases
Tumors that involve more than 180 degrees of the carotid artery
Patients with tumor ulceration through the skin
Disease that requires two or more discontiguous target volumes will be ineligible.
Cancer
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See this study on ClinicalTrials.gov
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Location Contacts
Hershey, PA ,