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Immunocore Uveal-202 (Advanced Uveal Melanoma) - Clinical Trial

What is the Purpose of this Study?

This research study is testing a drug called IMCgp100 and comparing it to standard therapies in patients with uveal melanoma (melanoma starts in the eye) that has spread

We want to compare IMCgp100 safety with the other therapies. We also want to find out if IMCgp100 can make patients with uveal melanoma live longer and feel better, and if IMCgp100 can make uveal melanoma tumors stop growing (or shrink).

What is the Condition Being Studied?

Advanced uveal melanoma

Who Can Participate in the Study?

Adults with advanced uveal melanoma (melanoma that starts in the eye) that has spread to other parts of the body. Must have the HLA-A*0201 protein in the blood.

Age Group
Adults

What is Involved?

This study has a pre-screening period where your blood will be tested to see if you have a certain protein. If you do, then you can join the study.

After pre-screening, you will have a screening exam that includes a physical exam, blood tests and CT scans.

You will be randomized (put into one of two groups by chance like a flip of a coin) and get either:

Group 1: IMCgp100
Group 2: Standard therapy (ipilimumab every 3 weeks for 4 cycles, pembrolizumab every 3 weeks or dacarbazine every 3 weeks)

If you are assigned to group 1:
-- You will receive IMCgp100 every week up to 5 years or until your cancer grows or you have severe side effects.
--You will need to stay overnight in the hospital for the first three weeks.
-- You will have CT scans every three months and several blood tests while you are getting the therapy.
-- Your condition will be followed for 2 years after you stop therapy.

Study Details

Full Title
A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared With Investigator Choice in HLA-A*0201 Positive Patients With Previously Untreated Advanced Uveal Melanoma
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00082289
NCT:NCT03070392
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698