(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
← catalyst calendarNCT05907954 · readout in 254 d
Sponsored by IDEAYA Biosciences (industry) · IDYA — their whole pipeline →.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
160estimated
Sites
18
Countries
Australia, Canada, France +4
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-07-03 | actual | When the study began enrolling |
| Primary completion | 2027-04-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-04-30 | estimated | The whole study's end, after follow-up |
| First posted | 2023-06-18 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-16 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Uveal Melanoma
Intervention
- Drug: Darovasertib — also filed as IDE196, LXS196
Primary outcomes
what the primary-completion date above is the date OFIncidence of Adverse Events (AEs) and significant laboratory abnormalities
measured from first dose to 28 days after last dose of therapy, approximately 18 months
Cohort 1 (enucleation): Number of patients converted from requiring enucleation to radiation
measured from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months
Cohort 2 (plaque brachytherapy): Estimated change in modeled radiation dose
measured from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months
Cohort 3 (patients with small UM tumors): Number of patients with clinical benefit per protocol-defined UM response criteria
measured from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months
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