What is the Purpose of this Study?
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).
Who Can Participate in this 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.
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.