54
Participants
Start Date
November 27, 2018
Primary Completion Date
June 30, 2026
Study Completion Date
December 31, 2027
Hypofractionated Radiation Therapy (HFRT)
The dose of HFRT will be 8 Gy x 3 fractions, given over a maximum of 7 days timespan.
Nivolumab
Nivolumab (1 mg/kg) will be administered as an IV infusion over 30 minutes, followed by ipilimumab (3 mg/kg) on the same day given as an IV infusion over 90 minutes. The two drugs will be given on day 1, then every 3 weeks for a total of four doses. After these 4 doses, the patient and investigator will decide to continue with nivolumab (240 mg) every 2 weeks or Nivolumab (480mg) every 4 weeks as monotherapy for up to one year as an IV infusion over 30 minutes.
Ipilimumab
Nivolumab (1 mg/kg) will be administered as an IV infusion over 30 minutes, followed by ipilimumab (3 mg/kg) on the same day given as an IV infusion over 90 minutes. The two drugs will be given on day 1, then every 3 weeks for a total of four doses.
RECRUITING
Lancaster General Hospital, Lancaster
RECRUITING
Abramson Cancer Center, Philadelphia
RECRUITING
Huntsman Cancer Institute at the University of Utah, Salt Lake City
National Cancer Institute (NCI)
NIH
Abramson Cancer Center at Penn Medicine
OTHER