Nivolumab and Tumor Infiltrating Lymphocytes (TIL) in Advanced Non-Small Cell Lung Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 11, 2017

Primary Completion Date

February 13, 2021

Study Completion Date

June 9, 2023

Conditions
Non-Small Cell Lung CancerMetastatic Non-small Cell Lung CancerSquamous Cell CarcinomaAdvanced NSCLCAdenosquamous CarcinomaAdenocarcinomas
Interventions
PROCEDURE

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.

DRUG

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.

DRUG

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.

DRUG

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.

OTHER

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).

DRUG

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.

Trial Locations (2)

32608

University of Florida Health Cancer Center., Gainesville

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

Prometheus Inc.

INDUSTRY

collaborator

Stand Up To Cancer

OTHER

collaborator

Iovance Biotherapeutics, Inc.

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER

NCT03215810 - Nivolumab and Tumor Infiltrating Lymphocytes (TIL) in Advanced Non-Small Cell Lung Cancer | Biotech Hunter | Biotech Hunter