IDE196-002 (Metastatic Uveal Melanoma)

IDE196-002 (Metastatic Uveal Melanoma)

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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)
For more information, contact the study team at emily.bolch@duke.edu.

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
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.

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