This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib
in subjects with primary non-metastatic uveal melanoma (OptimUM-10)
Additional locations may be listed on ClinicalTrials.gov for NCT07015190.
See trial information on ClinicalTrials.gov for a list of participating sites.
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.
Lead OrganizationIDEAYA Biosciences
