Phase 3 Study of Oral Darovasertib Before Local Therapy in Patients with Primary Non-Metastatic Uveal Melanoma

What this Trial Is About

This research aims to evaluate the use of neoadjuvant darovasertib in adults with primary non-metastatic uveal melanoma. The study is a Phase 3, randomized, open-label trial conducted at multiple centers, focusing on patients who require either plaque brachytherapy or enucleation. It investigates whether adding darovasertib before primary local therapy can improve vision preservation and eye salvage compared to immediate local therapy alone. Participants are divided into two groups based on treatment needs. In cohort 1, patients receive darovasertib orally twice daily before plaque brachytherapy and are compared to those receiving immediate plaque brachytherapy without darovasertib. In cohort 2, the treatment group receives darovasertib before primary local therapies such as plaque brachytherapy, proton beam radiation, or enucleation, while the control group undergoes immediate enucleation. After initial treatments, all patients continue with their assigned local therapies. During the study, participants will be followed for up to three years to monitor outcomes including vision loss and tumor recurrence. Assessments include evaluations of vision and the ability to preserve the eye. Researchers will measure the proportion of patients experiencing vision loss in cohort 1 and the success of eye salvage in cohort 2. This long-term follow-up helps understand the effects of neoadjuvant darovasertib combined with local therapies on patient outcomes.

Neoadjuvant Darovasertib in Primary Uveal Melanoma