IDE196-009 - Clinical Trial
What is the Purpose of this Study?
The purpose of this study is to understand the safety of IDE196 when given before and after treatment.
A certain cancer in the eye, called uveal melanoma.
Who Can Participate in the Study?
Adults ages 18+ who:
- Have an initial diagnosis of localized uveal melanoma [Note: Patients with local relapse after prior primary therapies are excluded]
- Are clinically diagnosed with uveal (not iris) melanoma in which enucleation (surgical removal of the eye) is recommended
- Are clinically diagnosed with uveal (not iris) melanoma in which plaque brachytherapy is recommended
For more information about who can join this study, please contact the study team at chandler.warren@duke.edu.
What is Involved?
If you agree to the study you will undergo a screening period where you will receive the following:
- Eye Exam
- Blood Samples
- CT and MRI
- Other standard of care procedures
During the study dosing period you will:
- Take the study drug IDE196 (darovasertib) orally (by mouth) for up to 6 months before your enucleation surgery or radiation therapy
- Restart the study drug approximately 4-6 weeks after surgery or radiation and last for up to an additional 6 months if the study drug is thought to be helping your condition
- Be followed for approximately three years for continued evaluation of your vision and any evidence of tumor outside of the eye, as well as your general health status