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:<ul>
<li>Have an initial diagnosis of localized uveal melanoma [Note: Patients with local relapse after prior primary therapies are excluded]</li>
<li>Are clinically diagnosed with uveal (not iris) melanoma in which enucleation (surgical removal of the eye) is recommended</li>
<li>Are clinically diagnosed with uveal (not iris) melanoma in which plaque brachytherapy is recommended</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: chandler.warren@duke.edu">chandler.warren@duke.edu.</a>
<li>Have an initial diagnosis of localized uveal melanoma [Note: Patients with local relapse after prior primary therapies are excluded]</li>
<li>Are clinically diagnosed with uveal (not iris) melanoma in which enucleation (surgical removal of the eye) is recommended</li>
<li>Are clinically diagnosed with uveal (not iris) melanoma in which plaque brachytherapy is recommended</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: chandler.warren@duke.edu">chandler.warren@duke.edu.</a>
What is Involved?
If you agree to the study you will undergo a screening period where you will receive the following:<ul>
<li>Eye Exam</li>
<li>Blood Samples</li>
<li>CT and MRI</li>
<li>Other standard of care procedures</li></ul>
During the study dosing period you will:<ul>
<li>Take the study drug IDE196 (darovasertib) orally (by mouth) for up to 6 months before your enucleation surgery or radiation therapy</li>
<li>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</li>
<li>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</li></ul>
<li>Eye Exam</li>
<li>Blood Samples</li>
<li>CT and MRI</li>
<li>Other standard of care procedures</li></ul>
During the study dosing period you will:<ul>
<li>Take the study drug IDE196 (darovasertib) orally (by mouth) for up to 6 months before your enucleation surgery or radiation therapy</li>
<li>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</li>
<li>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</li></ul>
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