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

Condition(s) studied

Investigational drug(s) / intervention(s)

Darovasertib: Oral, potent, selective inhibitor of Protein Kinase C

Study summary

Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma

Eligibility

Primary outcome measure(s)

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

Trial sites (18)

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