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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.

What is the Condition Being Studied?

Stage 3 or Stage 4 Melanoma

Who Can Participate in the Study?

Adults who:
- Have stage 3 or stage 4 melanoma
- Test positive for the protein HLA-A*0201 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 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

Study Details

Full Title
A Phase Ib/II Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 in Combination with Durvalumab (MEDI4736) or Tremelimumab or the Combination of Durvalumab and Tremelimumab Compared to IMCgp100 Alone in Patients with Advanced Melanoma
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00067271
NCT:NCT02535078
Phase
Phase I/II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698