Neoadjuvant Darovasertib therapy in Primary Non metastatic Uveal Melanoma
Research type
Research Study
Full title
A Randomized, Phase 3, Open-label Study of Neoadjuvant Darovasertib in Subjects with Primary Non-metastatic Uveal Melanoma (OptimUM-10)
IRAS ID
1012966
Contact name
Candice Montagna
Contact email
Sponsor organisation
IDEAYA Biosciences, Inc.
Clinicaltrials.gov Identifier
Research summary
Uveal melanoma (UM) is a rare type of cancer vision that involves the pigmented layer of the eye called the uvea. UM is the most common primary malignant neoplasm of the adult eye arising from pigmented cells of the iris, ciliary body, or choroid. UMs that have not metastasised are treated with radiation therapy (medium sized tumors) or removal of the eye, also called enucleation, (large sized tumors); however, both therapies can lead to permanent vision loss.
This study will investigate a new drug darovasertib and its safety, tolerability, and effectiveness in the treatment of UM. This is an investigational drug, meaning it is not currently approved in the UK, or any other country.
The study plans to enroll ~ 520 participants globally. It involves two groups:
• Cohort 1: Patients eligible for plaque brachytherapy.
• Cohort 2: Patients eligible for eye removal surgery.Participants in cohort 1 and 2 will be randomly assigned (by chance, like flipping a coin) at a 2 to 1 ratio to the treatment arm and control arm, respectively:
• Treatment arm - Receive darovasertib before their main treatment (radiation or surgery)
• Control arm - Proceed immediately with their main treatment (no darovasertib).Participants who receive darovasertib will take the medication twice daily for up to 6 cycles (~ 6 months). Following this, they will undergo their main treatment (radiation therapy or surgery).
Participants will stay on the study for ~ 3.5 years, including treatment and follow-up visits. The total duration of the study will be ~ 5.5 years.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
26/NE/0058
Date of REC Opinion
6 May 2026
REC opinion
Further Information Favourable Opinion