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

April 17, 2026 updated by: Iovance Biotherapeutics, Inc.

A Phase 2, Multicenter, Open-label Study of Lifileucel (Tumor-infiltrating Lymphocytes [TIL]) in Participants With Previously Treated Advanced Melanoma

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 2 study of the lifileucel treatment regimen in participants who previously received treatment for unresectable or metastatic (advanced) melanoma with 1 prior line of an anti-programmed cell death protein-1 (PD-1) or anti-programmed death ligand 1 (PD-L1) agent or whose melanoma progressed during and/or within ≤ 12 weeks after adjuvant anti-PD-(L)1 treatment (early relapse). Participants who have BRAF V600 mutation positive melanoma may have received or refused 1 additional prior line treatment with a BRAF inhibitor

± a MEK inhibitor

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • Australia
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
        • Greenslopes Private Hospital
  • Canada
    • Ontario, Canada
      • Toronto, Ontario, Canada, Canada, M5G 2M9
        • Princess Margaret Cancer Centre
    • Quebec, Canada
      • Montral, Quebec, Canada, Canada, H2X 0A9
        • Centre Hospitalier de l'Université de Montréal
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital
  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Other protocol defined inclusion/exclusion criteria could apply.

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?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm
Lifileucel
Biological: Lifileucel
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.
Other Names:
  • LN-144

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: 5 years
To evaluate the efficacy of lifileucel as measured by ORR per RECIST v1.1 as assessed by the IRC
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response Rate
Time Frame: 5 years
To evaluate the efficacy of lifileucel as measured by CR rate per RECIST v1.1 as assessed by the IRC
5 years
Duration of Response
Time Frame: 5 years
To evaluate the efficacy of lifileucel as measured by DOR per RECIST v1.1 as assessed by the IRC
5 years
Disease Control Rate
Time Frame: 5 years
To evaluate the efficacy of lifileucel as measured by DCR per RECIST v1.1 as assessed by the IRC
5 years
Progression-Free Survival
Time Frame: 5 years
To evaluate the efficacy of lifileucel as measured by PFS per RECIST v1.1 as assessed by the IRC
5 years
Objective Response Rate
Time Frame: 5 years
To evaluate the efficacy of lifileucel as measured by ORR per RECIST v1.1 as assessed by the investigators
5 years
Complete Response Rate
Time Frame: 5 years
To evaluate the efficacy of lifileucel as measured CR rate per RECIST v1.1 as assessed by the investigators
5 years
Duration of Response
Time Frame: 5 years
To evaluate the efficacy of lifileucel as measured by DOR per RECIST v1.1 as assessed by the investigators
5 years
Disease Control Rate
Time Frame: 5 years
To evaluate the efficacy of lifileucel as measured by DCR per RECIST v1.1 as assessed by the investigators
5 years
Progression-Free Survival
Time Frame: 5 years
To evaluate the efficacy of lifileucel as measured by PFS per RECIST v1.1 as assessed by the investigators
5 years
Overall Survival
Time Frame: 5 years
To evaluate the efficacy of lifileucel as measured by OS
5 years
Adverse Events
Time Frame: 5 years
To demonstrate safety and tolerability of lifileucel
5 years

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 Major Dates

Study Start (Actual)

November 28, 2025

Primary Completion (Estimated)

December 1, 2032

Study Completion (Estimated)

December 1, 2033

Study Registration Dates

First Submitted

December 9, 2025

First Submitted That Met QC Criteria

December 15, 2025

First Posted (Actual)

December 17, 2025

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOV-MEL-202
  • 2025-522054-40-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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