Uveal Melanoma
Conditions
Keywords
Uveal Melanoma, Plaque Brachytherapy, Enucleation, Neoadjuvant, Darovasertib, IDE 196, Ocular Melanoma, Choroidal Melanoma, Ophthalmology, Ocular Oncology, Melanoma, Protein Kinase C, GNAQ, GNA11
Brief summary
This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10)
Detailed description
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.
Interventions
DRUGDarovasertib
Dosed orally, twice daily (28-day/ cycle
PROCEDUREPrimary Local Therapy
Plaque Brachytherapy or Enucleation
Sponsors
IDEAYA Biosciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1: To demonstrate that the proportion of subjects with vision loss is lower for subjects in the Treatment Arm vs the Control Arm | Approximately 3 years | Loss of Best Corrected Visual Acuity (BCVA) of ≥ 15 letters using Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA |
| Cohort 2: To demonstrate the ability to salvage the eye and prevent enucleation in the Treatment Arm | Approximately 2 years | Eye preservation rate |
Countries
Australia, Austria, Belgium, Canada, Czechia, Denmark, Estonia, France, Germany, Greece, Israel, Italy, Netherlands, New Zealand, Poland, Slovakia, Slovenia, Spain, Switzerland, United Kingdom, United States
Contacts
CONTACTIDEAYA Clinical Trials
CONTACTMwe Mwe Chao, MD
Outcome results
None listed