20
Participants
Start Date
October 11, 2017
Primary Completion Date
February 13, 2021
Study Completion Date
June 9, 2023
Tumor-infiltrating Lymphocytes (TIL)
Tumor harvest for TIL growth in the lab: A sample of the participant's tumor will be collected and sent to the lab for TIL growth. TIL will be prepared and cryopreserved.
Nivolumab
Nivolumab will be administered intravenously at a fixed dose of 240 mg for 4 doses every 2 weeks prior to TIL. Nivolumab dose will be fixed at 480 mg every 4 weeks up to 12 months after TIL.
Cyclophosphamide
Cyclophosphamide will be administered at 60 mg/kg/day IV in 250 mL normal saline (NS) over approximately 2 hours. Cyclophosphamide will be initiated seven days prior to the anticipated TIL transfer, and the precise timing will depend on the rate of in vitro TIL growth. The dose will be based on the patient's body weight, but to prevent undue toxicity, it will not exceed a dose greater than 140% of the maximum ideal body weight per Metropolitan Life Insurance Company, Height and Weight Table.
Fludarabine
After administration of Cyclophosphamide, Fludarabine will then be infused at 25 mg/m\^2 intravenous piggyback (IVPB) daily over approximately 30 minutes starting 5 days prior to TIL transfer. To prevent undue toxicity with fludarabine, the dose will be based on body surface area (BSA), but will not exceed a dose calculated on surface areas based on body weights greater than 140% of the maximum ideal body weight per Metropolitan Life Insurance Company Height and Weight Tables.
Tumor-infiltrating Lymphocyte Therapy
On day 0, all patients will receive TIL administered according to the current Moffitt Cell Therapy TIL Standard Operating Procedure (SOP). Eight (8) to twelve (12) hours after completing the TIL infusion, all participants will begin intermediate-dose decrescendo interleukin-2 (IL-2).
Interleukin-2 (IL2)
Interleukin-2 (IL-2) - a drug used to help the body's response to treatment on the immune system. A high dose regimen of IL-2 will be given after the infusion of the T-cells.
University of Florida Health Cancer Center., Gainesville
H. Lee Moffitt Cancer Center and Research Institute, Tampa
Collaborators (2)
Bristol-Myers Squibb
INDUSTRY
Prometheus Inc.
INDUSTRY
Stand Up To Cancer
OTHER
Iovance Biotherapeutics, Inc.
INDUSTRY
H. Lee Moffitt Cancer Center and Research Institute
OTHER