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(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma

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Trial Profile

(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 03 Apr 2025

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At a glance

  • Drugs Darovasertib (Primary)
  • Indications Uveal melanoma
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms NADOM
  • Sponsors IDEAYA Biosciences

Most Recent Events

  • 31 Mar 2025 According to an IDEAYA Biosciences media release, company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for darovasertib supported by updated interim clinical data from an ongoing Phase 2 open-label trial (NCT05907954).
  • 31 Mar 2025 According to an IDEAYA Biosciences media release, company to present the updated Phase 2 clinical data in neoadjuvant UM that was provided as part of the BTD application at multiple medical conferences in 2025.
  • 13 Feb 2025 According to a IDEAYA Biosciences media release, a clinical update in over 75 patients in the Company-sponsored Phase 2 trial and regulatory update(s) is targeted for the first half of 2025, including vision data in plaque brachytherapy patients. 95 patients enrolled as of December 31, 2024 in the Company-sponsored Phase 2 trial.

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