Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Darovasertib · 2 trials · 1 indication
Loss of Best Corrected Visual Acuity (BCVA) of ≥ 15 letters using Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA
Eye preservation rate
Treatment emergent adverse events will be summarized by all AEs, all Grade 3-4-5 AEs, all treatment related AEs, all AEs leading to study drug modifications or discontinuations, all SAEs. Lab results will be summarized by change from baseline values, frequency of newly occurring on-treatment Grade 3 or 4 events; worst on-treatment value compared to baseline.
Rate of eye salvage as determined by the ocular oncologist based on tumor response to neoadjuvant therapy
Change in modeled radiation dose at critical eye structures before and after neoadjuvant therapy
Proportion of patients with clinical benefit rate (CBR) defined as complete response (CR) + partial response (PR) + stable disease (SD) for ≥ 12 weeks per UM response criteria
| Arm | Type | Description |
|---|---|---|
| Treatment Arm | EXPERIMENTAL | Darovasetib followed by definitive primary local therapy (i.e., PB, proton beam radiation, or enucleation) |
| Control Arm | ACTIVE_COMPARATOR | Immediate Primary Local therapy |
| darovasertib | EXPERIMENTAL | IDE196 (darovasertib) oral open label |
| Name | Type | Description |
|---|---|---|
| Darovasertib | DRUG | Dosed orally, twice daily (28-day/ cycle |
| Primary Local Therapy | PROCEDURE | Plaque Brachytherapy or Enucleation |
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 Cri...