NCT05907954Phase 2Active not recruiting

(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2027-04-30Estimated

Enrollment · participants160Estimated

Source updated2026-03-16Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-03-16 · 1 field changed

Recruitment status changed

− Before

~~Recruiting~~

+ After

Active not recruiting

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Posted 2025-10-22 · 3 fields changed

Main study measure wording changed

Text changed; whether the study measures changed has not been verified. Saved text may be shortened.

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− Before

+ After

Measure: Incidence of Adverse Events (AEs) and significant laboratory abnormalities Measure: Cohort 1 (enucleation): Number of patients converted from requiring enucleation to radiation Measure: Cohort 2 (plaque brachytherapy): Estimated change in modeled radiation dose Measure: Cohort 3 (patients with small UM tumors): Number of patients with clinical benefit per protocol-defined UM response criteria

Planned enrollment increased by 78 participants

− Before

~~82 participants (planned)~~

+ After

160 participants (planned)

Primary completion date changed

− Before

~~31 Jan 2026~~

+ After

30 Apr 2027

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Study details

Conditions studied

Uveal Melanoma

Treatments or interventions studied

DarovasertibDrugAlso known as IDE196, LXS196

Primary outcomes · main study measures

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measure: Incidence of Adverse Events (AEs) and significant laboratory abnormalities; description: 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.; timeFrame: from first dose to 28 days after last dose of therapy, approximately 18 months; measure: Cohort 1 (enucleation): Number of patients converted from requiring enucleation to radiation; description: Rate of eye salvage as determined by the ocular oncologist based on tumor response to neoadjuvant therapy; timeFrame: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months; measure: Cohort 2 (plaque brachytherapy): Estimated change in modeled radiation dose; description: Change in modeled radiation dose at critical eye structures before and after neoadjuvant therapy; timeFrame: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months; measure: Cohort 3 (patients with small UM tumors): Number of patients with clinical benefit per protocol-defined UM response criteria; description: 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; timeFrame: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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