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.

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.

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).

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.

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.

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.