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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT03215810
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tumor-infiltrating Lymphocytes (TIL) — PROCEDURE
    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 — DRUG
    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 — DRUG
    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 — DRUG
    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 — OTHER
    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) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 11, 2017
Status verified
Jul 2023
Primary completion
Feb 13, 2021
Completion
Jun 9, 2023

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TIL+ Nivolumab
    Tumor-infiltrating Lymphocyte Therapy (TIL) + Nivolumab Treatment Plan: Tumor harvest, Tumor-infiltrating Lymphocytes growth, 4 cycles of nivolumab, cytoreductive chemotherapy with cyclophosphamide and fludarabine, TIL infusion, Interleukin-2 treatment.

Primary Outcome Measure

Rate of Dose Limiting Toxicity (DLT) [ Time Frame: Up to 40 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of Florida Health Cancer Center.GainesvilleFlorida32608-
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-

Find similar trials in Gainesville, FL

By condition
Lung cancerSkin cancer
By specialty
OncologyLung oncologyLung diseaseSkin cancerDermatology
By research site
University of Florida Health Cancer Center.· Gainesville, FLH. Lee Moffitt Cancer Center and Research Institute· Tampa, FL

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