IMCgp100-201 Melanoma - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if the study drug IMCgp100 is safe when it is given alone or when IMCgp100 is given with durvalumab and tremelimumab. We want to learn if the therapies can make melanoma tumors stop growing (or shrink) and if patients with melanoma can live longer and feel better.
Stage 3 or Stage 4 Melanoma
Who Can Participate in the Study?
- Have stage 3 or stage 4 melanoma
- Test positive for the protein HLA-A*0201 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 have this protein, then you may join the study.
If you choose to join this study, you will:
- Have a screening exam that includes a physical exam, blood tests and CT scans after you finish your pre-screening visit.
- Be assigned to one of the 4 groups to test different therapy combinations:
Group 1: IMCgp100 plus durvalumab
Group 2: IMCgp100plus tremelimumab
Group 3: IMCgp100 plus durvalumab and tremelimumab
Group 4: IMCgp100 alone
- Get the therapy every week for the first year on this study and will need to stay overnight in the hospital for the first three weeks
- Get therapy every 4 weeks for the second year on the study
-- While your are getting the therapy, you will have CT scans every three months and several blood tests.
- Be followed for 2 years after you stop therapy to watch your condition