Testing a New Drug (Darovasertib) to Help Prevent Eye Cancer from Spreading

In Plain English

This trial is testing whether a new drug called darovasertib can help protect you from uveal melanoma coming back or spreading to other parts of your body. Here's how it works: you'll take this drug by mouth for up to 12 months *before* you have your main eye cancer treatment (either surgery to remove your eye or radiation therapy). The goal is to start fighting the cancer cells early, before your doctor removes the tumor or treats it with radiation. After your main treatment, you may continue taking the drug for another 6 months to keep working against any cancer cells that might be hiding. Doctors will then follow you for up to 3 years to watch for any signs that the cancer has come back or spread. This is a Phase 2 trial, which means the drug has already been tested in a small group of people and showed some promise—now doctors want to see if it really works and is safe in more patients like you. You'll be closely monitored throughout, with regular check-ups to make sure the drug is helping and not causing serious side effects. This trial offers a chance to try a new approach that might give you better odds of staying cancer-free.

What This Trial Does

Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma

How It Works

Phase 2 multi-center open-label IDE196 study in patients with primary uveal melanoma (UM) requiring either enucleation or plaque brachytherapy. Patients will be treated in neoadjuvant setting up to 12 months (or maximum benefit) followed by primary local therapy. An additional 6 months of adjuvant treatment may be given to some patients. All patients will have long term follow-up (up to 3 years) to assess visual outcome, disease recurrence, and development of metastatic disease.

Who Can Join

Treatments