NCT07015190 · IDEAYA Biosciences
Neoadjuvant Darovasertib in Primary Uveal Melanoma
What this study is about
This is a Phase 3, randomly assigned, multi-center, where both patients and doctors know the treatment given study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10)
View original scientific 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)
Interventions
DRUG
Darovasertib
Dosed orally, twice daily (28-day/ cycle
PROCEDURE
Primary Local Therapy
Plaque Brachytherapy or Enucleation
Primary outcome measures
Cohort 1: To demonstrate that the proportion of subjects with vision loss is lower for subjects in the Treatment Arm vs the Control Arm
Time frame: Approximately 3 years
Loss of Best Corrected Visual Acuity (BCVA) of ≥ 15 letters using Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA
Cohort 2: To demonstrate the ability to salvage the eye and prevent enucleation in the Treatment Arm
Time frame: Approximately 2 years
Eye preservation rate
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Scottsdale, Arizona
- La Jolla, California
- Los Angeles, California
- Orange, California
- Palo Alto, California
- Riverside, California
- San Francisco, California
- Aurora, Colorado
- Englewood, Colorado
- Jacksonville, Florida
- Tampa, Florida
- Baltimore, Maryland
And 17 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 6, 2026 · Source of record for eligibility and locations