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An investigator sponsor clinical trial of Darovasertib in adjuvant uveal melanoma (UM)

Trial Profile

An investigator sponsor clinical trial of Darovasertib in adjuvant uveal melanoma (UM)

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 29 Sep 2024

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At a glance

  • Drugs Darovasertib (Primary)
  • Indications Uveal melanoma
  • Focus Therapeutic Use

Most Recent Events

  • 23 Sep 2024 According to an IDEAYA Biosciences media release, the company announced successful FDA Type C meeting on registrational trial design for regulatory approval in neoadjuvant Uveal melanoma. Targeting to initiate Phase 3 randomized registrational trial in neoadjuvant UM following finalization of the clinical protocol with FDA.
  • 23 Sep 2024 According to an IDEAYA Biosciences media release, the company announced positive interim Phase 2 clinical trial data for darovasertib in neoadjuvant uveal melanoma
  • 13 May 2024 we are targeting to provide a clinical data update from our company-sponsored Phase 2 neoadjuvant UM trial and receive FDA regulatory guidance for a potential registrational path in the neoadjuvant uveal melanoma indication in the second half of 2024.

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