Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma

PHASE2CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

December 12, 2013

Primary Completion Date

October 14, 2021

Study Completion Date

July 6, 2022

Conditions
Metastatic Melanoma
Interventions
DRUG

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).

DRUG

Fludarabine

25 mg/m\^2/day intravenous piggy-back (IVPB) daily for 5 days

DRUG

Fludarabine

30 mg/kg/day intravenous piggy-back (IVPB) daily for 3 days.

DRUG

Cyclophosphamide

60 mg/kg/day X 2 days intravenous (IV)

DRUG

Cyclophosphamide

Days -5 to -3 (low-dose arm):30 mg/kg IV over 60 minutes for 2 days

DRUG

Cyclophosphamide

Days -5 to -3 (low-dose arm): 300 mg/m\^2 IV over 60 minutes.

BIOLOGICAL

Young TIL

Day 0: Cells will be infused intravenously (IV)

DRUG

Pembrolizumab

2 mg/kg intravenous (IV) on Days -2, 21 (+/- 2 days), 42 (+/- 2 days), and 63 (+/- 2 days).

Trial Locations (1)

20892

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT01993719 - Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma | Biotech Hunter | Biotech Hunter