Purpose of this Study
We are doing this study to find out if an experimental drug called IDE196 (the study drug) in combination with crizotinib is a safe and effective treatment for uveal melanoma (melanoma in the eye) that has spread to another part of the body.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with uveal melanoma
- Are HLA-A*02:01 negative (a blood test will confirm your HLA-A*02:01 status)
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
The study will consist of 3 periods: screening, dosing, and follow-up. If you choose to join this study, we will find out if you are eligible during the screening period. During this period, you will:
- Have a physical exam
- Answer questionnaires
- Have blood draws and give urine samples
- Have a heart scan (ECG)
- Have several images taken of your tumor(s) and organs (photographs and CT/MRI scans)
- Have a small biopsy done of your tumor, unless you have already had one recently
- Take a combination of the study drug with crizotinib (both are oral drugs); OR
- Take the study doctor's choice of either pembrolizumab alone or ipilimumab and nivolumab every 3 weeks
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
IDE196 (darovasertib) in combination with crizotinib versus investigator?s choice of treatment as first-line therapy in HLA-A2 negative metastatic uveal melanoma
Principal Investigator
April
Salama
Protocol Number
PRO00113647
NCT ID
NCT05987332
Phase
II/III
Enrollment Status
Open to Enrollment