Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Darovasertib · 3 trials · 1 indication
Time to local recurrence or metastatic disease per Blinded Independent Central Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
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 | EXPERIMENTAL | Participant Group/Arm: Treatment combination dose of IDE196 + crizotinib will be tested |
| Observation | NO_INTERVENTION | Participant Group/Arm: Observation Standard of care observation \& follow-up (no treatment) |
| 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 | Oral, selectively targets key proteins |
| Crizotinib (Xalkori) | DRUG | Oral small molecule |
| Primary Local Therapy | PROCEDURE | Plaque Brachytherapy or Enucleation |
Inclusion Criteria: * Primary Uveal Melanoma, classified as high-risk of relapse (AJCC Stage II or Stage 3) * Completed primary local therapy (enucleation, proton beam therapy, plaque brachytherapy) * ECOG performance status of 0 or 1 * Adequate organ function * Age 18 or older * Written informed c...
Darovasertib is an investigational small molecule being studied for the treatment of uveal melanoma, a cancer of the eye. It is currently in Phase 3 clinical development as a neoadjuvant therapy for primary uveal melanoma, meaning it is given before the main treatment to shrink tumors. It has received Breakthrough Therapy designation from the FDA.
Darovasertib is a small molecule that targets protein kinase C (PKC), a key driver in uveal melanoma. By inhibiting PKC, it aims to block cancer cell growth and survival. This mechanism is being evaluated in clinical trials for patients with uveal melanoma.
Darovasertib is being developed by IDEAYA Biosciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker IDYA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in uveal melanoma.
Darovasertib is in Phase 3 clinical development for uveal melanoma. It is an investigational drug, not yet approved by the FDA. A Phase 3 trial (NCT07015190) is currently recruiting patients to evaluate neoadjuvant darovasertib in primary uveal melanoma.
Darovasertib is being studied in two active clinical trials. NCT07015190 is a Phase 3 trial of neoadjuvant darovasertib in primary uveal melanoma, with 520 participants. NCT05907954 is a Phase 2 trial of (neo)adjuvant IDE196 (darovasertib) in localized ocular melanoma, with 160 participants. Both are enrolling or active.
Yes, Darovasertib is also known as IDE196. In clinical trials, it is sometimes referred to by this alternative name. For example, the Phase 2 trial NCT05907954 uses the name IDE196 in its title, while the Phase 3 trial uses Darovasertib.