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.
What is the Condition Being Studied?
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.
Age Group
Adults
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
Study Details
Full Title
(Neo)adjuvant IDE196 in patients with localized ocular melanoma [DAR-UM-
09]
Principal Investigator
Medical Oncologist
Protocol Number
IRB:
PRO00113524
NCT:
NCT05907954
Phase
Phase
II
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment