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A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Treatment of Patients With Metastatic Melanoma

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Trial Profile

A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Treatment of Patients With Metastatic Melanoma

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 16 Oct 2025

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At a glance

  • Drugs Lifileucel (Primary) ; Aldesleukin; Cyclophosphamide; Fludarabine
  • Indications Malignant melanoma
  • Focus Registrational; Therapeutic Use
  • Acronyms innovaTIL-01
  • Sponsors Iovance Biotherapeutics

Most Recent Events

  • 18 Oct 2025 According to an Iovance Biotherapeutics media release, company announced Health Canada has issued a Notice of Compliance with Conditions (NOC/c) for Amtagvi (lifileucel), for the treatment of adult patients with unresectable or metastatic melanoma that has progressed.
  • 02 Jun 2025 According to an Iovance Biotherapeutics media release, data from this study published in the Journal of Clinical Oncology and five-year follow-up results are being simultaneously presented during an oral session today at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
  • 22 May 2025 According to an Iovance Biotherapeutics media release, the U.S. Food and Drug Administration granted accelerated approval to Amtagvi for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.

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