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A Prospective, Multicenter, Open-label, Randomized, Actively Controlled, Parallel-group Phase 3 Clinical Trial to Evaluate Efficacy, Safety, and Tolerability of IMA203 Versus Investigator's Choice of Treatment in Patients With Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (ACTengine® IMA203-301)

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Trial Profile

A Prospective, Multicenter, Open-label, Randomized, Actively Controlled, Parallel-group Phase 3 Clinical Trial to Evaluate Efficacy, Safety, and Tolerability of IMA203 Versus Investigator's Choice of Treatment in Patients With Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (ACTengine® IMA203-301)

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 28 Apr 2025

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At a glance

  • Drugs IMA-203 (Primary) ; Carboplatin; Dacarbazine; Ipilimumab; Lifileucel; Nivolumab; Nivolumab/relatlimab; Paclitaxel; Pembrolizumab; Temozolomide
  • Indications Acral lentiginous melanoma; Malignant melanoma; Skin cancer; Uveal melanoma
  • Focus Registrational; Therapeutic Use
  • Acronyms SUPRAME
  • Sponsors Immatics US

Most Recent Events

  • 23 Apr 2025 According to an Immatics media release, Company will present data from SUPRAME study at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting to be held from May 30-June 3, 2025, in Chicago, Illinois.
  • 27 Mar 2025 According to an Immatics media release, A pre-specified interim data analysis is planned for in 1Q 2026, the final analysis is planned for 4Q 2026 and company aims to submit a Biologics License Application (BLA) in 1Q 2027 for full approval and to launch IMA203 in 3Q 2027.
  • 16 Jan 2025 Status changed from not yet recruiting to recruiting.

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