A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Melanoma (NCT07288203) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Melanoma
United States, Australia, Canada100 participantsStarted 2025-11-28
Plain-language summary
This is a Phase 2, multicenter, open-label study of lifileucel (tumor-infiltrating lymphocytes \[TIL\]) in participants with previously treated advanced melanoma
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 melan…