Melanoma (Skin Cancer)Phase 2NCT07288203
A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Melanoma
A Phase 2 study testing Lifileucel in people with Melanoma (Skin Cancer) and Unresectable Melanoma, run by Iovance Biotherapeutics, Inc. at 5 sites in 4 countries.
Trial summary
This is a Phase 2, multicenter, open-label study of lifileucel (tumor-infiltrating lymphocytes [TIL]) in participants with previously treated advanced melanoma Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Melanoma (Skin Cancer), Unresectable Melanoma, Metastatic Melanoma
- What is being tested?
- Lifileucel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 28 Nov 2025to Jun 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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 or choose lifileucel as an alternative option to 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.
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- 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.
Who cannot join
- 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.)
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- 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.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Canada2 sites
Centre Hospitalier de l'Universite de Montreal
Montral, Quebec, Canada, H2X 0A9
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
United States1 site
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
About this study
Official title: 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
Read the 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 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
- Being tested
- Lifileucel
- 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
- Medical subject headings
- Melanoma, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifileucelBiological
Also called LN-144
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Lifileucel Receives: Biological: Lifileucel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
To evaluate the efficacy of lifileucel as measured by ORR per RECIST v1.1 as assessed by the investigators
Measured: 12 months
Secondary outcomes (6)
Complete Response Rate
To evaluate the efficacy of lifileucel as measured by CR rate per RECIST v1.1 as assessed by the investigators
Measured: 12 months
Duration of Response
To evaluate the efficacy of lifileucel as measured by DOR per RECIST v1.1 as assessed by the investigators
Measured: 12 months
Disease Control Rate
To evaluate the efficacy of lifileucel as measured by DCR per RECIST v1.1 as assessed by the investigators
Measured: 12 months
Progression-Free Survival
To evaluate the efficacy of lifileucel as measured by PFS per RECIST v1.1 as assessed by the investigators
Measured: 12 months
Overall Survival
To evaluate the efficacy of lifileucel as measured by OS
Measured: 18 months
Adverse Events
To demonstrate safety and tolerability of lifileucel
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start28 Nov 2025
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin Cancer)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iovance Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288203
- Sponsor's protocol ID
- IOV-MEL-202
- Other IDs
- 2025-522054-40-00, 2025
- Status last verified
- Sep 2026
- First submitted
- 9 Dec 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No