Purpose of this Study
The purpose of this study is to understand the safety of IDE196 when given before and after treatment.
Who Can Participate?
Eligibility
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
What is Involved?
Description
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
- 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
Study Details
Full Title
(Neo)adjuvant IDE196 in patients with localized ocular melanoma [DAR-UM-
09]
09]
Principal Investigator
April
Salama
Protocol Number
PRO00113524
NCT ID
NCT05907954
Phase
II
Enrollment Status
Open to Enrollment