A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Melanoma

NCT07288203 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: IOV-MEL-2022025-522054-40-00
• Study Type: interventional
• Target: 100
• Locations: 4 countries
• Sites: 5

Brief Summary

This is a Phase 2, multicenter, open-label study of lifileucel (tumor-infiltrating lymphocytes \[TIL\]) in participants with previously treated advanced melanoma

Conditions

Melanoma (Skin Cancer); Unresectable Melanoma; Metastatic Melanoma

Keywords

Tumor Infiltrating Lymphocytes; TIL; Metastatic Melanoma; Unresectable Melanoma; Cell Therapy; Cellular Immuno-therapy; IL-2; Non-myeloablative lymphodepletion (NMALD); Melanoma; Lifileucel; Skin Cancer; LN-144; BRAF v600; BRAF/MEK

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  To evaluate the efficacy of lifileucel as measured by ORR per RECIST v1.1 as assessed by the IRC

  5 years

Secondary Outcomes (11)

• Complete Response Rate

  5 years

• Duration of Response

  5 years

• Disease Control Rate

  5 years

• Progression-Free Survival

  5 years

• Objective Response Rate

  5 years

Study Arms (1)

Single Arm

EXPERIMENTAL

Lifileucel

Biological: Lifileucel

Interventions

Lifileucel BIOLOGICAL

A tumor sample is resected from each patient for lifileucel manufacturing. Patients will first receive the preparative non-myeloablative lymphodepletion (NMA-LD) regimen. They will then receive the lifileucel infusion, followed by an abbreviated course of aldesleukin.

Also known as: LN-144

Single Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has a histologically or pathologically confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma.
• The participant has an ECOG performance status of 0 or 1 and an estimated life expectancy of \> 6 months.
• The participant must have experienced radiographic disease progression on: 1 prior line of an anti-PD-(L)1 treatment (as a monotherapy or as part of a combination) for advanced melanoma and/or during or within ≤ 12 weeks after adjuvant anti-PD-(L)1 treatment (as a monotherapy or as part of a combination). Participants who have BRAF V600 mutation positive melanoma may have received 1 additional prior line of treatment with a BRAF inhibitor ± a MEK inhibitor.
• Participant is assessed as having at least one resectable lesion (or aggregate lesions) for lifileucel generation.
• Participant must have at least one measurable disease as defined by RECIST 1.1 following tumor resection.
• Participants who are \> 70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.
• Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control.
• Participants must have adequate organ function.
• Participant is willing to receive optimal supportive care, including intensive care, from enrollment until the first post-treatment tumor assessment.

You may not qualify if:

• Participant has melanoma of uveal/ocular origin.
• Participant has symptomatic untreated brain metastases.
• Participant has active uveitis that requires active treatment.
• Participant has an active medical illness(es) that, in the opinion of the investigator, would pose increased risks for study participation, such as systemic infections; seizure disorders; coagulation disorders; or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.
• Participant has any form of primary or acquired immunodeficiency (eg, SCID or AIDS).
• Participant had another primary malignancy within the previous 3 years (except for those that do not require treatment or were curatively treated \>1 year ago, and in the judgment of the investigator do not pose a significant risk of recurrence.)
• Participant has a history of allogeneic cell or organ transplant.
• Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.

Sponsors & Collaborators

• Iovance Biotherapeutics, Inc.: lead

Study Sites (5)

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Greenslopes Private Hospital

Greenslopes, Queensland, 4120, Australia

Location

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9, Canada

Location

Centre Hospitalier de l'Universite de Montreal

Montral, Quebec, Canada, H2X 0A9, Canada

Location

Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Location

MeSH Terms

Conditions

Melanoma; Skin Neoplasms

Interventions

lifileucel

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 17, 2025
• Study Start: November 28, 2025
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 1, 2033
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

US (1); GB (1); CA (2); AU (1)