Melanoma Clinical Trial

Expanded Access Program of Lifileucel (LN-144) in Patients With Unresectable or Metastatic Melanoma

Summary

This is an open label, multi-center expanded access treatment protocol evaluating lifileucel (LN-144) in patients with unresectable or metastatic melanoma.

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Full Description

Lifileucel (LN-144) is an autologous Tumor Infiltrating Lymphocytes (TIL) cell therapy that utilizes a 22-day centralized GMP process for the treatment of patients with advanced melanoma. Lifileucel is infused as part of a treatment regimen that includes preparative NMA-LD, followed by one-time autologous TIL infusion, and a short course of high-dose IL-2.

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Eligibility Criteria

Inclusion Criteria:

Unresectable or metastatic melanoma (Stages IIIC/IIID/IV per AJCC 8th edition)
Progressed on or did not achieve a response or were intolerant due to toxicity following 1-4 prior lines of systemic therapy including PD-1/ PD-L1 blocking antibody.
May have received adjuvant PD-1/PD-L1 blocking antibody if recurred within 6 months of discontinuation of therapy or while on therapy
At least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to generate TIL
Must be ≥ 18 years of age at time of consent
ECOG performance status of 0-1 and estimated life expectancy of ≥ 3 months
Adequate hematologic parameters and organ function
There is no alternative therapy

Exclusion Criteria:

Received organ allograft, except kidney transplant, or prior cell transfer therapy including TIL and CAR-T therapies
Ongoing grade 2-4 toxicity from prior immunotherapy (excluding endocrine, ocular toxicity or vitiligo)
Melanoma of uveal/ocular origin
History of hypersensitivity to any component or excipient of lifileucel or other treatment regimen drugs
Symptomatic and/or untreated brain metastases, unless definitively treated and stable for ≥ 14 days prior to beginning NMA LD preparative regimen
Chronic systemic steroid therapy of > 10 mg/day
Active medical illness(es) that would pose increased risk for protocol participation
Must have negative syphilis assay and be seronegative for HIV, positive serology for HBV must have corresponding PCR assay and may be enrolled if viral load by PCR is undetectable
Primary immunodeficiency
Received live or attenuated vaccine within 28 days prior to beginning NMA-LD
Pregnant or breastfeeding

Study is for people with:

Melanoma

Study ID:

NCT05398640

Recruitment Status:

Available

Sponsor:

Iovance Biotherapeutics, Inc.

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There are 5 Locations for this study

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Orlando Health Cancer Institute
Orlando Florida, 32806, United States
University of Louisville - Brown Cancer Center
Louisville Kentucky, 40202, United States
Washington University School of Medicine - Siteman Cancer Center
Saint Louis Missouri, 63110, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
The University of Tennessee Medical Center
Knoxville Tennessee, 37920, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Study ID:

NCT05398640

Recruitment Status:

Available

Sponsor:


Iovance Biotherapeutics, Inc.

How clear is this clinincal trial information?

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