IDEAYA: (Melanoma with GNAQ/11 Mutations or PRKC Fusions) - 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) is a safe and effective treatment for uveal melanoma (melanoma in the eye) that has spread to another part of the body or other types of cancer with a tumor mutation in genes called GNAQ, GNA11, or PRKC.

What is the Condition Being Studied?

Uveal Melanoma & Other Cancers with Gene Mutations

Who Can Participate in the Study?

Adults ages 18+ who:
- Are diagnosed with uveal melanoma that has spread to other parts of their body (metastasis); OR
- Are diagnosed with another form of cancer that has a tumor mutation associated with the genes GNAQ, GNA11, or PRKC

For more information about who can be in this study, please contact the study team at joshua.thomas@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join the study, you will come in for a screening visit to see if you are eligible. During this visit, you will:
- Have a physical exam
- Have blood draws and give urine samples
- Have an eye exam
- Get a chest X-ray
- Have lung function tests
- If applicable, have a tumor biopsy to test for mutations in its genes

If you are eligible, you will continue on to the dosing period. During this period, you will:
- Take the study drug along with another drug called crizotinib by mouth every day for drug cycles that last 4 weeks each
- Have images (CT or MRI) taken of your tumors every 2 months for up to a year

The number of drug cycles you do will depend on how your body and cancer respond to the study drug and crizotinib.

Study Details

Full Title
A Phase 1/2 Study of IDE196 In Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00109482
NCT: NCT03947385
Phase
Phase I/II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698