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

Summary

Investigators plan to study the safety, side effects, and benefits of tumor-infiltrating lymphocytes (TILs) when they are given with the drug nivolumab. Nivolumab is a type of immunotherapy - a drug that is used to boost the ability of the immune system to fight cancer, infection, and other diseases.

Conditions

• Non-Small Cell Lung Cancer
• Metastatic Non-small Cell Lung Cancer
• Squamous Cell Carcinoma
• Advanced NSCLC
• Adenosquamous Carcinoma
• Adenocarcinomas

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.

Sponsors & Collaborators

• Bristol-Myers Squibb

  collaborator INDUSTRY

• Prometheus Inc.

  collaborator INDUSTRY

• Stand Up To Cancer

  collaborator OTHER

• Iovance Biotherapeutics, Inc.

  collaborator INDUSTRY

• H. Lee Moffitt Cancer Center and Research Institute

  lead OTHER

Principal Investigators

• Ben Creelan, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-11

Primary Completion

2021-02-13

Completion

2023-06-09

FDA Drug

Yes

Countries

• United States

Study Locations