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Taking peoplePhase 3

Tests darovasertib before surgery or radiation for uveal melanoma

Tests darovasertib given before primary local therapy in adults with uveal melanoma.

Plain-language title generated from the registry record
Registry title: Neoadjuvant Darovasertib in Primary Uveal Melanoma

Key facts

Where
Ljubljana, SloveniaSee the site
Phase
Phase 3

Where in Slovenia

  • Institute of Oncology LjubljanaLjubljana, SloveniaNot yet recruiting

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
IDEAYA Biosciences
Trial code
NCT07015190EU 2025-522387-32-00
Record updated
6 May 2026
Original description
This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10)Read full original descriptionShow less

A Randomized, Phase 3, Open-label Study of Neoadjuvant Darovasertib in Subjects With Primary Non-metastatic Uveal Melanoma (OptimUM-10)

This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10)

Inclusion: Primary non-metastatic uveal melanoma; Able and willing to provide written, informed consent before initiation of any study-related procedures, and in the opinion of the Investigator, to comply with all study requirements; ECOG 0 or 1; Adequate organ function.

Exclusion: Previous treatment for UM; Attributes that necessitate enucleation regardless of response to therapy; Evidence of progressive secondary underlying ocular disease that would confound longitudinal VA assessments; Presence of a malignant disease other than the one being treated in this study; Evidence of metastatic UM.

ClinicalTrials.gov NCT07015190 · EU CTIS 2025-522387-32-00