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Clinical Trials in the UK / NCT07288203
Active, not recruiting Phase 2

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

NCT07288203 · tracked via the Priya Life Science UK tracker
Sponsor
Iovance Biotherapeutics, Inc.
Phase
Phase 2
Started
2025-11-28
Last updated
2026-04-20

Condition(s) studied

Melanoma (Skin Cancer)Unresectable MelanomaMetastatic Melanoma

Investigational drug(s) / intervention(s)

Lifileucel

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.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Sarah Cannon Research Institute Nashville Tennessee
Greenslopes Private Hospital Greenslopes Queensland
Princess Margaret Cancer Centre Toronto Ontario, Canada
Centre Hospitalier de l'Universite de Montreal Montral Quebec, Canada
Royal Marsden Hospital London United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07288203 on ClinicalTrials.gov ↗ ← All trials in the UK