This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib
in subjects with primary non-metastatic uveal melanoma (OptimUM-10)
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07015190.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Approved
Name Not Available
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
