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A Study of Darovasertib Before Surgery or Radiation Therapy for Patients with Early-Stage Uveal Melanoma That Has Not Spread

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at uveal melanoma, which is a type of cancer that develops in the eye. The study will test a treatment called IDE196, also known by its code name darovasertib, which is given as a tablet by mouth. The medication is designed to be given before the standard treatment for this type of eye cancer. The purpose of the study is to see if giving this medication before surgery or radiation therapy can help preserve vision and prevent the need to remove the eye.

The study has two groups of patients based on the size and thickness of their tumor. The first group includes patients whose tumors are planned to be treated with plaque brachytherapy, which is a type of radiation therapy where a small radioactive device is placed near the tumor. The second group includes patients whose tumors are larger and would normally require enucleation, which means surgical removal of the eye. Some patients will receive the study medication before their planned treatment, while others will receive the standard treatment without the study medication first. For the first group, the study will measure how many patients experience vision loss and develop macular edema, which is swelling in the central part of the eye that affects vision. For the second group, the study will measure how many patients are able to keep their eye instead of having it removed.

During the study, patients will be monitored regularly with eye examinations and imaging tests to check the size of the tumor and assess vision using standard eye charts. The study will also track any side effects that patients experience and measure changes in the tumor size using ultrasound and eye photographs. The study will follow patients for several years after treatment to see how well the tumor responds and whether the cancer returns or spreads to other parts of the body. The study will also assess the amount of radiation that reaches important structures in the eye when the medication is given before radiation therapy.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Random assignment to treatment group

    Upon joining the study, you will be randomly assigned to one of two groups. This process is similar to flipping a coin and determines whether you will receive the study medication before your standard treatment or proceed directly to standard treatment.

    If you are in Cohort 1, you may be assigned to receive darovasertib before plaque brachytherapy (radiation therapy using a small device placed near the tumor) or proceed directly to plaque brachytherapy without darovasertib.

    If you are in Cohort 2, you may be assigned to receive darovasertib before potential eye-preserving treatment or proceed directly to the originally planned treatment.

  2. Step 2

    Treatment with darovasertib (if assigned to treatment group)

    If you are assigned to the treatment group, you will take darovasertib, which is an oral medication in tablet form.

    The medication is taken by mouth.

    The specific dosage, frequency, and duration of treatment will be determined by the study protocol and your medical team.

  3. Step 3

    Standard treatment (plaque brachytherapy or alternative)

    After completing darovasertib treatment (if applicable), or immediately after randomization (if assigned to the control group), you will receive your standard treatment.

    For Cohort 1, this involves plaque brachytherapy, a type of radiation therapy where a radioactive device is temporarily placed near the tumor in your eye. The type of plaque used (ruthenium or iodine) depends on standard practice in your geographic region.

    For Cohort 2, the treatment approach will be determined based on whether darovasertib has reduced the tumor size sufficiently to allow eye-preserving treatment instead of enucleation (surgical removal of the eye).

  4. Step 4

    Regular monitoring and assessments

    Throughout the study, you will undergo regular assessments to monitor your vision, tumor size, and overall health.

    Vision testing will be performed using the Early Treatment Diabetic Retinopathy Study method, which measures your best corrected visual acuity (the clearest vision you can achieve with corrective lenses).

    Imaging tests will include ultrasound to measure tumor size and thickness, fundus photography to take pictures of the back of your eye, and optical coherence tomography to examine the layers of your retina.

    Your medical team will monitor for any side effects or complications, including macular edema (swelling in the central part of the retina that can affect vision) and other radiation-related effects on your eye.

    Blood tests, electrocardiograms (tests that measure the electrical activity of your heart), and vital signs measurements will be performed to assess your overall health.

  5. Step 5

    Follow-up assessments

    After completing your standard treatment, you will continue to have follow-up visits at regular intervals.

    These visits will occur at specific time points including 6, 12, 18, 24, 30, and 36 months after plaque brachytherapy.

    During these visits, your vision will be assessed, and your medical team will check for any long-term effects of the treatment on your eye structures, including the macula (central part of the retina responsible for detailed vision), optic disc and nerve (where the nerve connecting your eye to your brain begins), and lens.

    Your medical team will also monitor for any signs of tumor growth, disease progression, or spread of the cancer to other parts of your body.

  6. Step 6

    Long-term monitoring

    The study will continue to track your health status over an extended period to assess the long-term effectiveness of the treatment.

    This monitoring includes checking for any recurrence of the tumor, either locally in the eye or at distant sites in the body.

    Your overall survival and time without disease progression will be recorded as part of the study outcomes.

Who can join the trial?

10 criteria

  • You must be at least 18 years of age or older
  • You must be able and willing to sign a consent form before any study procedures begin, and be able to follow all study requirements
  • Your uveal melanoma, which is a type of eye cancer, must be at high risk of spreading to other parts of the body. This is determined by at least one of these findings: having monosomy 3, which means missing one copy of chromosome 3 in the cancer cells; having Class 2 GEP, which is a genetic test showing higher risk; or being Stage 3 by AJCC, which is a cancer staging system
  • For Cohort 1, which is the group receiving plaque brachytherapy (a type of radiation treatment placed directly on the eye): You must have a diagnosis of primary uveal melanoma and be considered for plaque brachytherapy treatment. Your tumor must meet specific size requirements depending on the type of radiation plaque used in your region. If ruthenium plaque is used, your tumor thickness must be between 4 and 6 millimeters and the base diameter up to 16 millimeters. If iodine plaque is used, your tumor thickness must be between 4 and 10 millimeters and the base diameter up to 16 millimeters. You must have at least 20/80 vision in the affected eye, which means you can see at 20 feet what people with normal vision can see at 80 feet. The planned radiation dose must be at least 30 Gray to the macula, which is the central part of your retina responsible for sharp vision, or to the optic disc or nerve, which connects your eye to your brain
  • For Cohort 2, which is the group being considered for enucleation (surgical removal of the eye): You must have a diagnosis of primary uveal melanoma and be considered for eye removal. Your tumor must meet specific size requirements depending on your region. If ruthenium plaque is standard treatment in your area, your tumor thickness must be greater than 6 millimeters but not more than 10 millimeters, with base diameter up to 16 millimeters. If iodine plaque is standard treatment in your area, your tumor thickness must be greater than 10 millimeters but not more than 15 millimeters, with base diameter up to 16 millimeters
  • You must be able to safely swallow medication by mouth
  • You must have an ECOG performance status of 0 or 1, which means you are fully active or able to carry out light work with only minor symptoms
  • Your organs, including liver, kidneys, and bone marrow, must be functioning adequately based on screening tests
  • If you are a woman who can become pregnant and are sexually active with a male partner who has not been sterilized, you must use highly effective birth control methods during the study and for 6 months after your last dose of study treatment. Birth control pills or hormonal methods should always be used together with a barrier method such as a male condom
  • If you are a male participant, you must either be surgically sterilized or agree to use double-barrier birth control methods from the time you sign the consent form, throughout the treatment, and for 3 months after your last dose of study treatment

Who cannot join the trial?

1 criterion

  • The study did not provide specific reasons why patients cannot participate in this clinical trial
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Investigated drugs

Darovasertib is an investigational medication being studied as a treatment given before surgery (called neoadjuvant treatment) for uveal melanoma, which is a type of cancer that occurs in the eye. In this study, darovasertib is being tested to see if it can help preserve vision and potentially save the eye from removal in patients with this type of melanoma that has not spread to other parts of the body.

What is already known about the treatment

Darovasertib – Darovasertib is an investigational medication currently being studied in clinical trials for the treatment of uveal melanoma, a rare type of eye cancer that develops in the pigmented cells of the eye. This drug is being tested as a neoadjuvant therapy, meaning it is given before the main treatment to help shrink tumors and preserve vision. Darovasertib works at the molecular level by blocking specific proteins that help cancer cells grow and survive, particularly targeting pathways that are commonly altered in uveal melanoma. The medication belongs to a class of drugs known as protein kinase inhibitors, which interfere with signals that tell cancer cells to multiply and spread.

Investigated diseases

Uveal Melanoma – Uveal melanoma is a type of cancer that develops in the uvea, which is the middle layer of the eye wall. The uvea contains three parts: the iris (colored part of the eye), the ciliary body (which helps the eye focus), and the choroid (a layer of blood vessels that nourishes the eye). This cancer occurs when pigment-producing cells called melanocytes in the uvea begin to grow abnormally and uncontrollably. As the tumor grows, it can affect vision by distorting the shape of the eye or blocking light from reaching the retina. The disease may progress locally within the eye and can potentially spread to other parts of the body. Uveal melanoma is considered a rare disease and is the most common type of eye cancer in adults.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522387-32-00Protocol codeIDE196-010Estimated enrolment554 patientsSponsorIdeaya Biosciences Inc.

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