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(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma.
Study details:
Phase 2 multi-center open-label IDE196 study in patients with primary uveal melanoma requiring either enucleation or plaque brachytherapy. Patients will be treated in neoadjuvant setting up to 6 months (or maximum benefit) followed by primary local therapy. An additional 6 months of adjuvant treatment to follow with long term follow-up (up to 3 years) to assess visual outcome, disease recurrence, and development of metastatic disease.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-07-03
Primary completion: 2026-01-31
Study completion finish: 2029-01-31
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT05907954
Intervention or treatment
DRUG: Darovasertib
Conditions
- • Uveal Melanoma
Find a site
Closest Location:
Alfred Health
Research sites nearby
Select from list below to view details:
Alfred Health
Melbourne, Victoria, Australia
St. Vincent's Health Sydney
Sydney, New South Wales, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: darovasertib
| DRUG: Darovasertib
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) and significant laboratory abnormalities | 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. | from first dose to last dose of adjuvant therapy, approximately 12 months |
| Cohort 1 (enucleation): Number of patients converted from requiring enucleation to radiation | Rate of eye salvage as determined by the ocular oncologist based on tumor response to neoadjuvant therapy | from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months |
| Cohort 2 (plaque brachytherapy): Estimated change in modeled radiation dose | Change in modeled radiation dose at critical eye structures before and after neoadjuvant therapy | from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Evaluate tumor response to neoadjuvant IDE196 | Measurement of tumor diameter and thickness before and after neoadjuvant therapy with IDE196, specifically as measured by ocular ultrasound, evaluating largest basal diameter and apical thickness of the uveal melanoma (measured in millimeters) | from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months |
| Assessment of visual acuity loss | Best corrected visual acuity loss over time | from time of primary local therapy to one year after surgery, approximately 12 months |
| Rate of local disease recurrence | Evaluate uveal melanoma progression or recurrence | from date of primary local therapy to end of follow-up, approximately 36 months |
| Rate of metastatic disease | Evaluate occurrence of metastatic uveal melanoma | from date of primary local therapy to end of follow-up, approximately 36 months |
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