33
Participants
Start Date
December 12, 2013
Primary Completion Date
October 14, 2021
Study Completion Date
July 6, 2022
Aldesleukin
720,000 IU/kg intravenous (IV) every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 4 days (maximum 12 doses).
Fludarabine
25 mg/m\^2/day intravenous piggy-back (IVPB) daily for 5 days
Fludarabine
30 mg/kg/day intravenous piggy-back (IVPB) daily for 3 days.
Cyclophosphamide
60 mg/kg/day X 2 days intravenous (IV)
Cyclophosphamide
Days -5 to -3 (low-dose arm):30 mg/kg IV over 60 minutes for 2 days
Cyclophosphamide
Days -5 to -3 (low-dose arm): 300 mg/m\^2 IV over 60 minutes.
Young TIL
Day 0: Cells will be infused intravenously (IV)
Pembrolizumab
2 mg/kg intravenous (IV) on Days -2, 21 (+/- 2 days), 42 (+/- 2 days), and 63 (+/- 2 days).
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda
National Cancer Institute (NCI)
NIH