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

October 9, 2023 updated by: Iovance Biotherapeutics, Inc.

An Expanded Access Program of Lifileucel, Autologous Tumor Infiltrating Lymphocytes (TIL; LN-144), for Patients With Unresectable or Metastatic Melanoma

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

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

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.

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population
  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • HonorHealth Research and Innovation Institute
    • Florida
      • Orlando, Florida, United States, 32806
        • Orlando Health Cancer Institute
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville - Brown Cancer Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine - Siteman Cancer Center
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • The University of Tennessee Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iovance Biotherapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

May 26, 2022

First Submitted That Met QC Criteria

May 31, 2022

First Posted (Actual)

June 1, 2022

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOV-EAP-401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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