Melanoma Clinical Trial
(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
Summary
Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma
Full Description
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
Inclusion Criteria:
Primary localized uveal melanoma requiring either enucleation or plaque brachytherapy
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
How clear is this clinincal trial information?