RecruitingPHASE3INTERVENTIONAL

Neoadjuvant Darovasertib in Primary Uveal Melanoma

This study, called OptimUM-10, is for people with early-stage uveal melanoma, a type of eye cancer that hasn't spread. We're testing a new medication called darovasertib. In some cases, patients will receive darovasertib before their standard treatment, which could be a special type of radiation (plaque brachytherapy) or surgery to remove the eye (enucleation). Other patients will have their standard treatment right away. We want to compare these approaches to see if starting with darovasertib can lead to better results. Everyone in the study will be followed for up to three years to check their vision and if the cancer comes back.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

IDEAYA Biosciences

Enrolment target

520

Start

25 Jan 2026

Estimated completion

01 Mar 2031

Uveal Melanoma

What is this study about?

This research study is focused on a specific type of eye cancer called uveal melanoma that hasn't spread to other parts of the body. We're investigating whether a new drug, darovasertib, given before standard treatments, can make a difference for patients. Standard treatments for uveal melanoma include a special kind of radiation therapy (plaque brachytherapy) or, in some cases, surgery to remove the eye (enucleation). The study aims to see if using darovasertib first could improve how well these standard treatments work or lead to better long-term outcomes.

The study is divided into two groups, depending on the type of treatment usually recommended for a patient's uveal melanoma. In one group, we're comparing people who get darovasertib before plaque brachytherapy to those who receive plaque brachytherapy straight away. In the second group, we're comparing people who get darovasertib before their planned primary treatment (which could be plaque brachytherapy, another type of radiation called proton beam, or enucleation) to those who have enucleation straight away.

All patients will be carefully monitored for up to three years after their treatment. During this time, the research team will check their vision and look for any signs that the cancer has returned. This will help us understand the long-term effects of darovasertib and whether it could become a valuable new step in treating uveal melanoma.

Key takeaways

This study evaluates a new drug (darovasertib) for early-stage eye cancer (uveal melanoma).
It aims to see if darovasertib before standard treatment improves outcomes.
Patients will be randomly assigned to different treatment groups.
The study lasts up to three years, monitoring vision and cancer recurrence.
It's for uveal melanoma that has not spread to other body parts.

Who may be eligible?

To join this study, you must have a type of eye cancer called uveal melanoma that hasn't spread to other parts of your body. You also need to be 18 years old or older. It's important that you are generally well enough to take part in the study, which means your body's organs are working properly, and you are able to sign a consent form and follow all the study instructions.

You would not be able to join this study if you have already had treatment for your uveal melanoma, or if there's evidence that your cancer has spread. Also, if there are other eye conditions that would make it difficult to properly check your vision, or if you have another type of cancer, you wouldn't be able to participate. Finally, if for some reason surgery to remove the eye is definitely needed, regardless of other treatments, then this study might not be suitable.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have uveal melanoma that hasn't spread?
Are you 18 years old or older?
Are you generally well and able to participate in a study?
Have you *not* had previous treatment for your uveal melanoma?
Do you *not* have another active cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first sign an informed consent form. Depending on which group you're in, you might take the study medication, darovasertib, for a period of time before your main treatment (either radiation or surgery). During this time, and after your main treatment, you'll have regular hospital visits. These visits will involve various tests and check-ups to monitor your health, how the medication is working, and progress of your eye condition. We'll be checking things like your vision and looking for any changes in the cancer. You will be followed up for a total of three years to assess long-term outcomes. The study team will explain the full schedule of visits and assessments in detail if you are considering joining.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to a new treatment that isn't yet widely available, and close medical monitoring. However, there are also potential risks, including side effects from the study medication or procedures, which will be fully explained by the study team. Remember, you can withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (94)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Mayo Clinic Scottsdale - PPDS
Verified postcode
Scottsdale, United States· Recruiting
UCSD Moores Cancer Center
Verified postcode
La Jolla, United States· Not yet recruiting
Jules Stein Eye Institute
Verified postcode
Los Angeles, United States· Not yet recruiting
USC Norris Comprehensive Cancer Center
Verified postcode
Los Angeles, United States· Not yet recruiting
University of California Irvine Medical Center
Verified postcode
Orange, United States· Not yet recruiting
Stanford Comprehensive Cancer Center
Verified postcode
Palo Alto, United States· Recruiting
Kaiser Permanente-Riverside Medical Center
Verified postcode
Riverside, United States· Recruiting
UCSF Wayne and Gladys Valley Center for Vision
Verified postcode
San Francisco, United States· Not yet recruiting
University of Colorado Hospital
Verified postcode
Aurora, United States· Recruiting
The Melanoma and Skin Cancer Institute
Verified postcode
Englewood, United States· Not yet recruiting
Mayo Clinic Jacksonville
Verified postcode
Jacksonville, United States· Recruiting
USF Health Eye Institute
Verified postcode
Tampa, United States· Not yet recruiting

Common questions

What is uveal melanoma?

Uveal melanoma is a rare type of cancer that develops in the eye. This study is specifically for cases that have not spread to other parts of the body.

What is darovasertib?

Darovasertib is a new medication being tested to see if it can help treat uveal melanoma by affecting how the cancer cells grow.

What does 'neoadjuvant' mean?

'Neoadjuvant' means that the treatment (in this case, darovasertib) is given before the main, more definitive treatment like surgery or radiation.

Will I definitely get the new drug?

Not necessarily. This is a randomised study, meaning some participants will receive darovasertib before their standard treatment, while others will have their standard treatment straight away. Your doctor will explain which group you might be in.

How long will I be involved in the study?

If you join the study, you will be followed for up to three years to monitor your health and the long-term effects of the treatments.

How to find out more

IDEAYA Clinical Trials

ideayaclinicaltrials@ideayabio.com +1-855-433-2246 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.