Phase II Study of IMRT Re-Irradiation With Concurrent/Adjuvant Nivolumab In Patients With Locoregionally Recurrent Or Second Primary Squamous Cell Cancer Of The Head And Neck

Protocol No
WINSHIP-4221-17
Principal Investigator
Stuart Wong
Phase
II
Summary
The purpose of this study is to test the effect of an immunotherapy drug called nivolumab when added to radiation therapy on controlling your cancer. Nivolumab has been approved by the FDA in the treatment of advanced head and neck cancer that cannot be controlled with radiation or surgery and that has failed the standard chemotherapy used to treat head and neck cancer. This study is testing nivolumab in a different situation. Your doctors are recommending repeat radiation for your cancer. Often this is given as the only treatment. In this trial we will be combining nivolumab with radiation therapy to treat your cancer and we will give you nivolumab for a total of one year after finishing radiation therapy. This study will test whether nivolumab can help treat your cancer more effectively and reduce the chance of your cancer coming back compared to our prior cure rates with radiation alone. While nivolumab is FDA approved for the treatment of head and neck cancer, it has not been used in patients who need repeated radiation to treat head and neck cancer (like yourself). We therefore do not know what effect, if any, nivolumab will have on reducing the chance of your disease coming back.
Description
Intensity-Modulated Radiation Therapy & Nivolumab for Recurrent or Second Primary Head & Neck Squamous Cell Cancer
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL
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