A Study of LN-144 in People With Metastatic Melanoma to the Brain

Pilot Trial of Lifileucel (LN-144) for Patients With Asymptomatic Melanoma Brain Metastases and Progression on Prior PD1 Therapy

This is an open label study evaluating lifileucel (LN-144) in patients with melanoma brain metastases.

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Melanoma
• Intervention / Treatment: Biological: Lifileucel (LN-144)

Detailed Description

Lifileucel (LN-144) is an autologous Tumor Infiltrating Lymphocytes (TIL) cell therapy that utilizes a 22-day centralized GMP process. 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: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Adam Schoenfeld, MD; Phone Number: 646-608-4042
• Study Contact Backup: Name: Alexander Shoushtari, MD; Phone Number: 646-888-4161; Email: shoushta@mskcc.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Metastatic melanoma with asymptomatic brain metastases
2. At least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to generate TIL
3. Must be ≥ 18 years of age at time of consent
4. ECOG performance status of 0-1 and estimated life expectancy of ≥ 3 months
5. Adequate hematologic parameters and organ function

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. History of hypersensitivity to any component or excipient of lifileucel or other treatment regimen drugs
4. Symptomatic brain metastases
5. Chronic systemic steroid therapy of > 10 mg/day
6. Active medical illness(es) that would pose increased risk for protocol participation
7. 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
8. Primary immunodeficiency
9. Received live or attenuated vaccine within 28 days prior to beginning NMA-LD
10. Pregnant or breastfeeding
11. Patients who cannot receive gadolinium-enhanced MRI.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants with Melanoma Brain Metastases; Participants have melanoma brain metastases who will undergo surgical excision to generate LN-144.	Biological: Lifileucel (LN-144); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of treatment with LN-144 in patients with asymptomatic Metastatic Melanoma to the Brain (MMB)	measured by the number of patients who undergo surgery and successfully undergo LN-144 infusion	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility measured by the number of patients who undergo surgery and successfully undergo LN-144 infusion	the number of patients who undergo surgery and successfully generate LN-144	1 year

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Iovance Biotherapeutics, Inc.
• Investigators: Principal Investigator: Alexander Shoushtari, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2022
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: LN-144; Non-uveal melanoma; Lifileucel (LN-144); 22-322
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Melanoma
• Other Study ID Numbers: 22-322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No