Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

332

Participants

Timeline

Start Date

August 26, 2010

Primary Completion Date

December 27, 2028

Study Completion Date

December 27, 2029

Conditions
Metastatic Colorectal CancerMetastatic Pancreatic CancerMetastatic Ovarian CancerMetastatic Breast CarcinomaMetastatic Endocrine Tumors/ Neuroendocrine Tumors
Interventions
DRUG

Pembrolizumab (Keytruda)

"Arm 3 or 5: Pembrolizumab 2mg/kg IV over approximately 30 minutes on Days -2, 21, 42, and 63 Arm 4: Pembrolizumab 2mg/kg IV over approximately 30 minutes (for patients who meet progressive disease per RECIST criteria and have resolved major toxicities after cell infusion or anytime during the post-treatment~evaluation period; starting within 4 weeks of progression; may receive up to 8 doses every 3 weeks)."

DRUG

Fludarabine

Days -7 to -3: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.

DRUG

Cyclophosphamide

Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X2 days over 1 hr.

DRUG

Aldesleukin

Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 4 days (maximum 12 doses.)

BIOLOGICAL

Young TIL

Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes (one to four days after the last dose of fludarabine).

Trial Locations (1)

20892

RECRUITING

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH