7
Participants
Start Date
October 9, 2017
Primary Completion Date
June 1, 2020
Study Completion Date
June 1, 2020
Cyclophosphamide
Cyclophosphamide 60 mg/kg is administered i.v. on day -7 and day -6.
Fludarabine
Fludarabine 25 mg/m2 is administered on day -5 to day -1.
TIL infusion
The maximum number of expanded TILs are infused over 30-45 minutes on day 0.
Interleukin-2
Interleukin-2 is administered as a daily low-dose subcutaneous injection of 2 MIU for a total of 14 days.
Ipilimumab
One dose of Ipilimumab 3 mg/kg is administered 14 days prior to surgical removal of tumor tissue for TIL expansion.
Nivolumab
Nivolumab 3 mg/kg is administered on day -2 before TIL infusion and every 2 weeks for a total of 4 doses.
Center for Cancer Immune Therapy Dept. of Hematology/oncology, Copenhagen
Inge Marie Svane
OTHER