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A Randomized, Open-label Phase III Study in Patients With Previously Treated Unresectable or Metastatic NRAS Mutant Cutaneous Melanoma Comparing the Combination of Naporafenib + Trametinib to Physician's Choice of Therapy (Dacarbazine, Temozolomide or Trametinib Monotherapy) With a Dose Optimization lead-in [SEACRAFT-2]

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Trial Profile

A Randomized, Open-label Phase III Study in Patients With Previously Treated Unresectable or Metastatic NRAS Mutant Cutaneous Melanoma Comparing the Combination of Naporafenib + Trametinib to Physician's Choice of Therapy (Dacarbazine, Temozolomide or Trametinib Monotherapy) With a Dose Optimization lead-in [SEACRAFT-2]

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 25 Mar 2025

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At a glance

  • Drugs Naporafenib (Primary) ; Dacarbazine; Temozolomide; Trametinib
  • Indications Acral lentiginous melanoma; Malignant melanoma; Skin cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms SEACRAFT-2
  • Sponsors Erasca

Most Recent Events

  • 20 Mar 2025 According to an Erasca media release, data from this trial expected in H2 2025.
  • 24 Oct 2024 According to an Erasca media release, the company is looking forward to randomized dose optimization data from Stage 1 of this trial, which is expected in 2025
  • 18 Jun 2024 According to an Erasca media release, the company announced that the Stage 2, which incorporates feedback from the United States Food and Drug Administration (FDA) and European health authorities, is designed for regulatory approval and will compare the combination against physicians choice of chemotherapy or a single agent MEK inhibitor using dual primary endpoints of progression free survival (PFS) and overall survival (OS).

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