Neoadjuvant Darovasertib in Primary Uveal Melanoma
This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10)
Inclusion Criteria
- Primary non-metastatic uveal melanoma
- Able and willing to provide written, informed consent before initiation of any study-related procedures, and in the opinion of the Investigator, to comply with all study requirements
- ECOG 0 or 1
- Adequate organ function
Exclusion Criteria
- Previous treatment for UM
- Evidence of metastatic UM
- Attributes that necessitate enucleation regardless of response to therapy
- Evidence of progressive secondary underlying ocular disease that would confound longitudinal VA assessments
- Presence of a malignant disease other than the one being treated in this study
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07015190.
Locations matching your search criteria
United States
Arizona
Scottsdale
California
La Jolla
Orange
Palo Alto
Colorado
Aurora
Florida
Jacksonville
Minnesota
Rochester
Nebraska
Omaha
New York
New York
Ohio
Columbus
Pennsylvania
Philadelphia
Pittsburgh
Texas
Dallas
Houston
Wisconsin
Madison
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.
Trial PhasePhase III
Trial Typetreatment
Lead OrganizationIDEAYA Biosciences
- Primary IDIDE196-010
- Secondary IDsNCI-2025-08784
- ClinicalTrials.gov IDNCT07015190