Tests darovasertib before surgery or radiation for uveal melanoma
Tests darovasertib given before primary local therapy in adults with uveal melanoma.
Key facts
- Who runs it
- IDEAYA Biosciences
- Where
- Graz, Innsbruck, and Vienna, AustriaSee the 3 sitesAlso in 20 other countries, 88 sites
- Trial code
- Registry title
- Neoadjuvant Darovasertib in Primary Uveal Melanoma
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 520 people, planned
- Started
- 25 Jan 2026
- Expected to end
- Mar 2031
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Darovasertib
- Primary Local Therapy
- Record updated
- 6 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with uveal melanoma (a cancer of the eye) that has not spread, who have not yet been treated for it.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Primary uveal melanoma that has not spread (non-metastatic).
- Earlier treatment
- No previous treatment for uveal melanoma.
Main reasons for not taking part
- Previous treatment for uveal melanoma
- Signs that the uveal melanoma has spread
- Eye problems that mean the eye must be removed whatever the response to therapy
- Another worsening eye disease that would confuse the vision tests
- Another cancer besides the one treated in this trial
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Austria
Also in 20 other countries, 88 sites
- Medical University of GrazGraz, AustriaTaking people
- Medizinische Universitaet InnsbruckInnsbruck, AustriaTaking people
- Medical University of ViennaVienna, AustriaTaking people
About the trial
What the trial wants to find out
This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10)
The 2 groups in the trial
- Treatment ArmTreatment being tested
Darovasetib followed by definitive primary local therapy (i.e., PB, proton beam radiation, or enucleation)
Treatment: Darovasertib
- Control ArmExisting treatment, for comparison
Immediate Primary Local therapy
Treatment: Primary Local Therapy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Randomized, Phase 3, Open-label Study of Neoadjuvant Darovasertib in Subjects With Primary Non-metastatic Uveal Melanoma (OptimUM-10)
- Plain-language title
- Tests darovasertib before surgery or radiation for uveal melanomaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 6 May 2026