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Trial record 1 of 1 for:    NCT05398640
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Expanded Access Program of Lifileucel (LN-144) in Patients With Unresectable or Metastatic Melanoma

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ClinicalTrials.gov Identifier: NCT05398640
Expanded Access Status : Available
First Posted : June 1, 2022
Last Update Posted : December 8, 2022
Information provided by (Responsible Party):
Iovance Biotherapeutics, Inc.

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

Condition or disease Intervention/treatment
Unresectable Melanoma Metastatic Melanoma Biological: Lifileucel

Detailed 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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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population, Treatment IND/Protocol
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: An Expanded Access Program of Lifileucel, Autologous Tumor Infiltrating Lymphocytes (TIL; LN-144), for Patients With Unresectable or Metastatic Melanoma

Intervention Details:
  • Biological: Lifileucel
    A portion of the patient's tumor is resected and serves as the starting material for manufacturing lifileucel. After preparative NMA-LD, patients are infused with their autologous TIL (lifileucel), followed by a short course of high-dose IL-2.
    Other Name: LN-144

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  1. Unresectable or metastatic melanoma (Stages IIIC/IIID/IV per AJCC 8th edition)
  2. 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.
  3. May have received adjuvant PD-1/PD-L1 blocking antibody if recurred within 6 months of discontinuation of therapy or while on therapy
  4. At least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to generate TIL
  5. Must be ≥ 18 years of age at time of consent
  6. ECOG performance status of 0-1 and estimated life expectancy of ≥ 3 months
  7. Adequate hematologic parameters and organ function
  8. There is no alternative therapy

Exclusion Criteria:

  1. Received organ allograft, except kidney transplant, or prior cell transfer therapy including TIL and CAR-T therapies
  2. Ongoing grade 2-4 toxicity from prior immunotherapy (excluding endocrine, ocular toxicity or vitiligo)
  3. Melanoma of uveal/ocular origin
  4. History of hypersensitivity to any component or excipient of lifileucel or other treatment regimen drugs
  5. Symptomatic and/or untreated brain metastases, unless definitively treated and stable for ≥ 14 days prior to beginning NMA LD preparative regimen
  6. Chronic systemic steroid therapy of > 10 mg/day
  7. Active medical illness(es) that would pose increased risk for protocol participation
  8. 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
  9. Primary immunodeficiency
  10. Received live or attenuated vaccine within 28 days prior to beginning NMA-LD
  11. Pregnant or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05398640

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Contact: Iovance Biotherapeutics Study Team 1 (866) 565-4410 clinical.inquiries@iovance.com

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United States, Arizona
HonorHealth Research and Innovation Institute Available
Scottsdale, Arizona, United States, 85258
United States, Florida
Orlando Health Cancer Institute Available
Orlando, Florida, United States, 32806
United States, Kentucky
University of Louisville - Brown Cancer Center Available
Louisville, Kentucky, United States, 40202
United States, Missouri
Washington University School of Medicine - Siteman Cancer Center Available
Saint Louis, Missouri, United States, 63110
United States, New York
Memorial Sloan Kettering Cancer Center Available
New York, New York, United States, 10065
United States, Tennessee
The University of Tennessee Medical Center Available
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
Iovance Biotherapeutics, Inc.
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Responsible Party: Iovance Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05398640    
Other Study ID Numbers: IOV-EAP-401
First Posted: June 1, 2022    Key Record Dates
Last Update Posted: December 8, 2022
Last Verified: December 2022
Keywords provided by Iovance Biotherapeutics, Inc.:
Adoptive Cell Therapy
Cell Therapy
Tumor Infiltrating Lymphocytes
Cutaneous Melanoma
Mucosal Melanoma
Acral Melanoma
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas