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
- Are there results?
- Not yet: the study is under way
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.
Show all 9Show fewer
- 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.)
Show all 9Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Open-label Study of Lifileucel (Tumor-infiltrating Lymphocytes [TIL]) in Participants With Previously Treated Advanced Melanoma
- ClinicalTrials.gov ID
- NCT07288203
- Acronym / sponsor ID
- IOV-MEL-202
- Keywords
- Tumor Infiltrating Lymphocytes, TIL, Metastatic Melanoma, Unresectable Melanoma, Cell Therapy, Cellular Immuno-therapy, IL-2, Non-myeloablative lymphodepletion (NMALD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Iovance Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Nov 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2, multicenter, open-label study of lifileucel (tumor-infiltrating lymphocytes [TIL]) in participants with previously treated advanced melanoma
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Biological: LifileucelLifileucel |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LifileucelAlso: LN-144A 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. | Biological | Single Arm |
Primary outcome
Objective Response Rate
Time frame: 12 months
To evaluate the efficacy of lifileucel as measured by ORR per RECIST v1.1 as assessed by the investigators
6 secondary outcomes
Complete Response Rate
Time frame: 12 months
Duration of Response
Time frame: 12 months
Disease Control Rate
Time frame: 12 months
Progression-Free Survival
Time frame: 12 months
Overall Survival
Time frame: 18 months
Adverse Events
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
Related trials for Melanoma (Skin Cancer)
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada, United States, Australia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.