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

Primary Purpose

Metastatic Melanoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lifileucel (LN-144)
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Melanoma focused on measuring LN-144, Non-uveal melanoma, Lifileucel (LN-144), 22-322

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Metastatic melanoma with asymptomatic brain metastases 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 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) History of hypersensitivity to any component or excipient of lifileucel or other treatment regimen drugs Symptomatic brain metastases 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 Patients who cannot receive gadolinium-enhanced MRI.

Sites / Locations

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants with Melanoma Brain Metastases

Arm Description

Participants have melanoma brain metastases who will undergo surgical excision to generate LN-144.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 28, 2022
Last Updated
August 22, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Iovance Biotherapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05640193
Brief Title
A Study of LN-144 in People With Metastatic Melanoma to the Brain
Official Title
Pilot Trial of Lifileucel (LN-144) for Patients With Asymptomatic Melanoma Brain Metastases and Progression on Prior PD1 Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2022 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Iovance Biotherapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Melanoma
Keywords
LN-144, Non-uveal melanoma, Lifileucel (LN-144), 22-322

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants with Melanoma Brain Metastases
Arm Type
Experimental
Arm Description
Participants have melanoma brain metastases who will undergo surgical excision to generate LN-144.
Intervention Type
Biological
Intervention Name(s)
Lifileucel (LN-144)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of treatment with LN-144 in patients with asymptomatic Metastatic Melanoma to the Brain (MMB)
Description
measured by the number of patients who undergo surgery and successfully undergo LN-144 infusion
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Metastatic melanoma with asymptomatic brain metastases 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 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) History of hypersensitivity to any component or excipient of lifileucel or other treatment regimen drugs Symptomatic brain metastases 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 Patients who cannot receive gadolinium-enhanced MRI.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Shoushtari, MD
Phone
646-888-4161
Email
shoushta@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Adam Schoenfeld, MD
Phone
646-608-4042
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Shoushtari, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Shoushtari, MD
Phone
646-888-4161
First Name & Middle Initial & Last Name & Degree
Adam Schoenfeld, MD
Phone
646-608-4042

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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