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

Iovance Biotherapeutics

Status and phase

Enrolling

Phase 2

Conditions

Melanoma (Skin Cancer)

Metastatic Melanoma

Unresectable Melanoma

Treatments

Biological: Lifileucel

Study type

Interventional

Funder types

Industry

Identifiers

NCT07288203

2025-522054-40-00 (EU Trial (CTIS) Number)

IOV-MEL-202

Details and patient eligibility

About

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

Full 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

Enrollment

100 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.