39
Participants
Start Date
November 12, 2018
Primary Completion Date
November 30, 2025
Study Completion Date
November 30, 2025
Re-irradiation (RT)
Re-RT will start on day 28 +/- 5 days for 5 fractions of 600cGy every other day over a 2-week period.
Bevacizumab
Bevacizumab if deemed beneficial by the investigator, will be started at the initiation of re-RT and continued for three doses in the medical arm. Patients in the surgical arm will omit the first bevacizumab dose to assure adequate wound healing after surgery and receive two doses. Bevacizumab will be dosed at 10mg/kg and given intravenously on day 28 (medical arm only), day 42 and day 56. Following day 56, further bevacizumab doses can be given every two weeks at the discretion of the treating physician.
Nivolumab
"Nivolumab will be started at enrollment and each patient will receive two doses of nivolumab prior to radiation.~Nivolumab will be dosed at 3mg/kg given intravenously before re-RT (day 1 +/- 5 and 14 +/- 5) and when given with bevacizumab if deemed beneficial by the investigator, (day 28 +/- 5 (medical arm only), day 42 +/- 5, and day 56 +/-5). Nivolumab will be dosed based on body weight while combined with re-radiation and bevacizumab for safety considerations to reduce adverse events. Single agent nivolumab will be given at 240mg flat dose every 2 weeks thereafter until disease progression, withdrawal, adverse event, or death."
Re-resection
Re-resection will be performed in the surgical arm at day 14 (+/- 5 days).
Memorial Sloan Kettering Cancer Center, New York
Memorial Sloan Kettering Westchester, Harrison
Memorial Sloan Kettering Nassau, Uniondale
Memorial Sloan Kettering Commack, Commack
Lehigh Valley Health Network (Data Collection Only), Allentown
Miami Cancer Institute Baptist Health South Florida (Data Collection Only), Miami
Indiana University (Data Collection Only), Indianapolis
Hartford Healthcare (Data Collection), Hartford
Memorial Sloan Kettering Basking Ridge, Basking Ridge
Memorial Sloan Kettering Monmouth, Middletown
Memorial Sloan Kettering Bergen, Montvale
University of Vermont Medical Center (Data Collection Only), Burlington
Memorial Sloan Kettering Cancer Center
OTHER