IDE196-002 (Metastatic Uveal Melanoma) - Clinical Trial
What is the 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.
melanoma uveal
Who Can Participate in the Study?
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)
For more information, contact the study team at emily.bolch@duke.edu.
What is Involved?
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. Durante este período, usted:
- Hacer un examen físico
- Responder encuestas
- Hacer extracciones de sangre y dar muestras de orina
- Hacerse un escáner del corazón (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
If you are eligible for the study, you will get a random assignment (by chance) to 1 of 2 groups. You will either:
- 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
You have a 2-in-3 chance of being assigned to the study drug group and a 1-in-3 chance of being assigned to the doctor's choice group. You will have tumor measurements every 12 weeks. You will continue with your assigned regimen until the study doctor believes that your are no longer receiving a positive benefit.
Study Details
