A RANDOMIZED, PHASE 3, OPEN-LABEL STUDY OF NEOADJUVANT DAROVASERTIB IN SUBJECTS WITH PRIMARY NON-METASTATIC UVEAL MELANOMA (OptimUM-10)
Cohort 1: To demonstrate that the proportion of subjects with vision loss is lower for subjects in the Treatment Arm vs the Control Arm. Cohort 2: To demonstrate the ability to salvage the eye and prevent enucleation in the Treatment Arm
Why this Research Matters
This is a Phase 3, randomized, multicenter, open-label study of neoadjuvant darovasertib in 2 cohorts. Cohort 1 will be comprised of subjects who are considered for PB and Cohort 2 will be comprised of subjects who are considered for enucleation.
Who can Participate
Inclusion: -At high risk of metastasis defined by at least one of the following: Monosomy 3 Class 2 GEP Stage 3 by AJCC Exclusion: -Previous treatment for UM -Evidence of metastatic UM -Tumor originating from the iris Detailed eligibility criteria is available on clinicaltrials.gov. These requirements will be discussed with your doctor and/or study representative. Click the NCT number link below to learn more about this study on ClinicalTrials.gov
Study ID
Protocol Number: 25-2370
More information available at ClinicalTrials.gov: NCT07015190
Meet the Team
Principal Investigator