RecruitingPhase 3NCT07015190
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)
Sponsor
IDEAYA Biosciences
Enrollment
520 participants
Start Date
Jan 25, 2026
Study Type
INTERVENTIONAL
Conditions
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)
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria5
- 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
Interventions
DRUGDarovasertib
Dosed orally, twice daily (28-day/ cycle
PROCEDUREPrimary Local Therapy
Plaque Brachytherapy or Enucleation
Locations(87)
View Full Details on ClinicalTrials.gov
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NCT07015190
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