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A Phase 3, Multicenter, Randomized, Open-label, Parallel Group, Treatment Study to Assess the Efficacy and Safety of the Lifileucel (LN-144, Autologous Tumor Infiltrating Lymphocytes [TIL]) Regimen in Combination With Pembrolizumab Compared With Pembrolizumab Monotherapy in Participants With Untreated, Unresectable or Metastatic Melanoma

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A Phase 3, Multicenter, Randomized, Open-label, Parallel Group, Treatment Study to Assess the Efficacy and Safety of the Lifileucel (LN-144, Autologous Tumor Infiltrating Lymphocytes [TIL]) Regimen in Combination With Pembrolizumab Compared With Pembrolizumab Monotherapy in Participants With Untreated, Unresectable or Metastatic Melanoma

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 04 Apr 2025

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At a glance

  • Drugs Lifileucel (Primary) ; Pembrolizumab (Primary) ; Cyclophosphamide; Fludarabine; Lifileucel
  • Indications Malignant melanoma
  • Focus Registrational; Therapeutic Use
  • Acronyms TILVANCE-301
  • Sponsors Iovance Biotherapeutics

    • Most Recent Events

    • 23 May 2024 According to an Iovance Biotherapeutics media release, company plans to conduct an early interim analysis of ORR as the potential basis for regulatory submission and approvals.
    • 09 May 2024 According to an Iovance Biotherapeutics media release, an oral presentation of updated clinical data from Cohort 1A of the IOV-COM-202 trial, which strongly supports the rationale for TILVANCE-301 and the frontline melanoma opportunity, will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting on May 31, 2024
    • 10 Apr 2024 Trial design presented at the 115th Annual Meeting of the American Association for Cancer Research

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