IDEAYA: (Melanoma with GNAQ/11 Mutations or PRKC Fusions)
What is the Purpose of this Study?
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.
- 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.
What is the Condition Being Studied?
Uveal Melanoma & Other Cancers with Gene Mutations
Who Can Participate in this 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
Participating Institutions
What is Involved?
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.
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
Protocol Number
IRB:
PRO00109482
NCT:
NCT03947385
ClinicalTrials.gov
View on ClinicalTrials.gov