NCT07015190

Neoadjuvant Darovasertib in Primary Uveal Melanoma

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 520 (estimated)
• Sponsor: IDEAYA Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The study is divided into 2 cohorts of patients with primary uveal melanoma requiring either plaque brachytherapy or enucleation. In cohort 1, patients in the treatment arm will receive neoadjuvant darovasertib followed by plaque brachytherapy compared to immediate plaque brachytherapy (control arm). In cohort 2, the treatment arm will receive neoadjuvant darovasertib followed by definitive primary local therapy (i.e., plaque brachytherapy, proton beam radiation, or enucleation). Subjects in the control arm will go onto immediate enucleation. Subjects will then receive primary local therapy following neoadjuvant darovasertib. All patients will be followed for up to 3 years to assess longer term outcomes such as vision and tumor recurrence.

Conditions

• Uveal Melanoma

Interventions

Type	Name	Description
DRUG	Darovasertib	Dosed orally, twice daily (28-day/ cycle
PROCEDURE	Primary Local Therapy	Plaque Brachytherapy or Enucleation

Timeline

• Start date: 2026-01-25
• Primary completion: 2030-10-01
• Completion: 2031-03-01
• First posted: 2025-06-11
• Last updated: 2026-02-18

Locations

87 sites across 21 countries: United States, Australia, Austria, Belgium, Canada, Czechia, Denmark, Estonia, France, Germany, Greece, Israel, Italy, Netherlands, New Zealand, Poland, Slovakia, Slovenia, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study