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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Darovasertib
DrugDosed orally, twice daily (28-day/ cycle
Primary Local Therapy
Procedure/SurgeryPlaque Brachytherapy or Enucleation
Treatment groups
520 Participants
are divided into 2 treatment groupsGroup A: Treatment ArmExperimental treatment 1 intervention
Group B: Control ArmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cohort 1: To demonstrate that the proportion of subjects with vision loss is lower for subjects in the Treatment Arm vs the Control Arm
Loss of Best Corrected Visual Acuity (BCVA) of ≥ 15 letters using Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA
Time frame
Approximately 3 years2
Cohort 2: To demonstrate the ability to salvage the eye and prevent enucleation in the Treatment Arm
Eye preservation rate
Time frame
Approximately 2 yearsSponsors and contacts
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Source ClinicalTrials.gov