170
Participants
Start Date
December 4, 2015
Primary Completion Date
June 16, 2028
Study Completion Date
June 16, 2029
young TIL
Day 0: Cells will be administered intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Pembrolizumab
(Cohort 1, Arm 2 ,Cohort 2 and Cohort 3, Arm 2) On day -2, and days 21 (+/- 2 days), 42 (+/- 2 days), and 63 (+/- 2 days) following cell infusion: Pembrolizumab 2mg/kg IV over approximately 30 minutes.
Aldesleukin
Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 4 days (maximum 12 doses).
Fludarabine
Days -7 to -3, Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days.
Cyclophosphamide
Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day over 1 hour X 2 days.
RECRUITING
National Institutes of Health Clinical Center, Bethesda
National Cancer Institute (NCI)
NIH