A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared with Investigator’s Choice in HLA-A*0201 Positive Patients with Previously Untreated Advanced Uveal Melanoma

Protocol: 
AAAR2515
Phase: 
II

A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared with Investigator’s Choice in HLA-A*0201 Positive Patients with Previously Untreated Advanced Uveal Melanoma

This research study is being done to see if the study drug, IMCgp100, works and is safe as treatment for subjects with uveal melanoma who also test positive for HLA-A*0201. In this study IMCgp100 will be compared to three standard treatments: dacarbazine (a chemotherapy drug), ipilimumab (an immunotherapy drug), or pembrolizumab (an immunotherapy drug). This study is designed to find out if IMCgp100 can make subjects with uveal melanoma live longer and if IMCgp100 can make uveal melanoma tumors stop growing (or shrink).

Are you Eligible? (Inclusion Criteria)

1. Patients must have confirmed metastatic Uveal Melanoma.
2. Patients must test positive for HLA-A*0201.
3. Patients must have no prior systemic therapy in the metastatic or
advanced setting including: chemotherapy, immunotherapy, or target therapy.
4. Patients must be 18 years or older.

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States