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Darovasertib before local treatment for primary uveal melanoma

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

Phase 3 Interventional IDEAYA Biosciences · NCT07015190

This trial tests whether giving darovasertib before surgery or radiation helps people with primary non-metastatic uveal melanoma.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment520 (estimated)
Ages18 Years and up
SexAll
SponsorIDEAYA Biosciences Industry-sponsored
Drugs / interventionsradiation
Locations94 sites (Scottsdale, Arizona and 93 other locations)
Trial IDNCT07015190 on ClinicalTrials.gov

What this trial studies

This Phase 3, randomized, multicenter, open-label trial enrolls patients with primary non-metastatic uveal melanoma and assigns them to receive neoadjuvant darovasertib or immediate local therapy. The study is split into two cohorts: one compares darovasertib followed by plaque brachytherapy versus immediate plaque brachytherapy, and the other compares darovasertib followed by definitive local therapy versus immediate enucleation. After neoadjuvant therapy participants receive planned local treatment and are followed for up to three years to track vision, tumor control, and recurrence. Key outcomes include eye preservation rates, visual acuity changes, and longer-term tumor recurrence.

Who should consider this trial

Good fit: Adults with primary non-metastatic uveal melanoma who are ECOG 0–1, have adequate organ function, no prior UM treatment, and whose tumors do not require immediate enucleation are ideal candidates.

Not a fit: Patients with metastatic disease, prior treatment for uveal melanoma, tumors that mandate enucleation regardless of shrinkage, or other ocular conditions that prevent reliable vision assessment are unlikely to benefit.

Why it matters

Potential benefit: If successful, pre-treatment with darovasertib could shrink tumors to increase the chance of saving the eye and preserving vision while lowering recurrence risk.

How similar studies have performed: Early-phase trials of darovasertib and other PKC inhibitors have shown tumor shrinkage signals and tolerable safety but no definitive survival benefit yet, making this a promising but not proven approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* Previous treatment for UM
* Evidence of metastatic 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

Where this trial is running

Scottsdale, Arizona and 93 other locations

+44 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Uveal MelanomaPlaque BrachytherapyEnucleationNeoadjuvantDarovasertibIDE 196Ocular MelanomaChoroidal Melanoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.