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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: 09 Dec 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

  • 06 Nov 2025 According to an Iovance Biotherapeutics media release, company announced that potential approvals of Amtagvi are anticipated in the United Kingdom and Australia in the first half of 2026 and Switzerland in 2027.
  • 06 Nov 2025 According to an Iovance Biotherapeutics media release, company announced that in August 2025, Health Canada granted the first Amtagvi approval outside the U.S. for patients with previously treated advanced melanoma.
  • 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.

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