Neoadjuvant Darovasertib in Primary Uveal Melanoma

Summary

This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10)

Detailed Description

The study is divided into 2 cohorts of patients with primary uveal melanoma requiring either plaque brachytherapy or enucleation. In cohort 1, patients in the treatment arm will receive neoadjuvant darovasertib followed by plaque brachytherapy compared to immediate plaque brachytherapy (control arm). In cohort 2, the treatment arm will receive neoadjuvant darovasertib followed by definitive primary local therapy (i.e., plaque brachytherapy, proton beam radiation, or enucleation). Subjects in the control arm will go onto immediate enucleation. Subjects will then receive primary local therapy following neoadjuvant darovasertib. All patients will be followed for up to 3 years to assess longer term outcomes such as vision and tumor recurrence.

Eligibility Criteria

Interventions