11
Participants
Start Date
March 8, 2016
Primary Completion Date
August 30, 2020
Study Completion Date
August 30, 2020
Nivolumab
Participants entering the study after the first 6 participants only: Treatment with nivolumab prior to removal of tumor sample for TIL growth. About 2 weeks after their tumor sample has been taken, these participants may receive additional infusions of nivolumab.
Surgery to Remove Tumor for Growth of TIL
All participants: Tumor sample taken for growth of TILs. Growing the TILs takes about 4-8 weeks.
CD137
All participants: Anti-CD137 agonistic antibody as an agent to augment T cell proliferation in vitro. The growth of the TIL will be accelerated by the use of CD137 activating antibody in the laboratory.
Cyclophosphamide
All participants: Lymphodepleting chemotherapy intravenously, beginning 3 to 6 weeks after tumor collection for TIL growth.
Fludarabine
All participants: Lymphodepleting chemotherapy intravenously, beginning after first 2 days of cyclophosphamide.
TIL Infusion
After completing one week of lymphodepleting chemotherapy, all participants will be admitted back into the hospital for IV infusion of the TIL cells.
Interleukin-2
After TIL infusion, in-patient high dose IL-2 treatment.
H. Lee Moffitt Cancer Center and Research Institute, Tampa
Collaborators (2)
Bristol-Myers Squibb
INDUSTRY
Prometheus Inc.
INDUSTRY
Iovance Biotherapeutics, Inc.
INDUSTRY
H. Lee Moffitt Cancer Center and Research Institute
OTHER