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Randomized, Ph3 Clinical Study Comparing Vusolimogene Oderparepvec in Combination With Nivolumab Vs Treatment of Physician's Choice in Patients With Advanced Melanoma That Progressed on Anti-PD-1 and Anti-CTLA-4 Containing Treatment

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Trial Profile

Randomized, Ph3 Clinical Study Comparing Vusolimogene Oderparepvec in Combination With Nivolumab Vs Treatment of Physician's Choice in Patients With Advanced Melanoma That Progressed on Anti-PD-1 and Anti-CTLA-4 Containing Treatment

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 27 May 2025

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At a glance

  • Drugs Nivolumab (Primary) ; Vusolimogene oderparepvec (Primary) ; Dacarbazine; Paclitaxel; Pembrolizumab; Relatlimab; Temozolomide
  • Indications Malignant melanoma; Skin cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms IGNYTE-3
  • Sponsors Replimune

Most Recent Events

  • 22 May 2025 According to a Replimune media release, data from this study will be presented at American Society of Clinical Oncology (ASCO) 2025 Annual Meeting being held May 30-June 3, 2025.
  • 21 Jan 2025 According to a Replimune media release, IGNYTE-3, is currently underway with over 100 sites planned globally.
  • 21 Nov 2024 According to a Replimune media release, company announced that it has submitted a biologics license application (BLA) to the FDA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of adult patients with advanced melanoma who have previously received an anti-PD1 containing regimen. The submission was made under the Accelerated Approval pathway.

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