Darovasertib: Oral, potent, selective inhibitor of Protein Kinase C
Study summary
Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Primary localized uveal melanoma requiring either enucleation or plaque brachytherapy
* Cohort 3 (patients with small UM tumors) - clinically diagnosed uveal (not iris) melanoma that is \< 4 mm in thickness requiring treatment
* Able to dose orally
* ECOG Performance status of 0-1
* No other significant underlying ocular disease
* Adequate organ function
* Not pregnant/nursing or planning to become pregnant. Willing to use birth control
Exclusion Criteria:
* Previous treatment with a Protein Kinase C (PKC) inhibitor
* Concurrent malignant disease
* Active HIV infection or Hep B/C
* Malabsorption disorder
* Unable to discontinue prohibited medication
* Impaired cardiac function or clinically significant cardiac disease
* Any other condition which may interfere with study interpretation or results
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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