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Neoadjuvant Darovasertib in Primary Uveal Melanoma
Trial Status: active
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.
