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Darovasertib for Primary Uveal Melanoma

This study is testing a drug called Darovasertib for people with primary uveal melanoma (a type of eye cancer that hasn't spread). It's a Phase 3 study, meaning it's comparing Darovasertib to standard treatments to see if it's better. The study aims to see if Darovasertib can help preserve your vision or prevent the need to remove your eye (enucleation). You might be able to join if you have uveal melanoma that hasn't spread, are at least 18 years old, and are generally in good health. The study plans to enroll 520 participants.

Study design
This is a Phase 3, randomized, multi-center, open-label study. It will compare Darovasertib plus standard treatment to standard treatment alone.
What's involved
You would take Darovasertib orally twice daily for 28-day cycles, followed by a procedure like plaque brachytherapy or enucleation. You will be followed for up to 3 years.
Compensation
Not stated in the trial record.
Follow-up
All participants will be followed for up to 3 years to check on their vision and if the tumor returns.

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NCT07015190

Neoadjuvant Darovasertib in Primary Uveal Melanoma

Recruiting
PHASE3Ages 18+InterventionalTreatment
IDEAYA Biosciences
~520 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:DarovasertibPrimary Local Therapy

At a glance

Recruiting sites
25 of 94 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cohort 1: To demonstrate that the proportion of subjects with vision loss is lower for subjects in the Treatment Arm vs the Control Arm
Measured over Approximately 3 years
+1 more outcome measured

Conditions

Uveal Melanoma

Explore related trials

Uveal Melanoma

Where it's being run

94 sites across 65 states
California7
Germany5
Texas4
Florida3
New York3
Austria3
Colorado2
Michigan2

Who to contact

IDEAYA Clinical Trials
[email protected]
+1-855-433-2246
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Cohort 1: To demonstrate that the proportion of subjects with vision loss is lower for subjects in the Treatment Arm vs the Control ArmApproximately 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 ArmApproximately 2 years

    Eye preservation rate