NCT07288203

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

A Phase 2, Multicenter, Open-label Study of Lifileucel (Tumor-infiltrating Lymphocytes [TIL]) in Participants With Previously Treated Advanced Melanoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Iovance Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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 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

Conditions

• Melanoma (Skin Cancer)
• Unresectable Melanoma
• Metastatic Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	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.

Timeline

• Start date: 2025-11-28
• Primary completion: 2032-12-01
• Completion: 2033-12-01
• First posted: 2025-12-17
• Last updated: 2026-01-12

Locations

5 sites across 4 countries: United States, Australia, Canada, United Kingdom

Regulatory

• FDA-regulated drug study