Neoadjuvant Darovasertib in Primary Uveal Melanoma
ConditionUveal Melanoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorIDEAYA Biosciences
About this trial
This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10)
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Darovasertib
- Primary Local Therapy
Treatment groups
520 Participants
are divided into 2 treatment groupsLocations
94Australia
Gallipoli Medical Research FoundationQLD 4120, GreenslopesQueensland, Australia
The Queen Elizabeth Hospital5011, Woodville SouthSouth Australia, Australia
The Alfred Hospital3004, MelbourneVictoria, Australia
The Crown Princess Mary Cancer Centre (Westmead Hospital), NSW 214NSW 2145, Westmead Australia
Sponsors and collaborators
IDEAYA Biosciences
Lead sponsor
Source ClinicalTrials.gov