A Phase 1/2, Open-Label Study of the Pressure-Enabled Hepatic Artery Infusion of SD-101, a TLR9 Agonist, Alone or in Combination with Intravenous Checkpoint Blockade in Adults with Metastatic Uveal Melanoma
Contact:
NCT Number:
Protocol:
AAAT6585
Study Status:
Active/Enrolling
Population:
Adult
Phase:
I
The purpose of this study is to determine the best level of dose of SD-101 given by hepatic artery infusion (HAI, a method of putting medication directly into your liver) with using Pressure-Enabled Drug Delivery™ (PEDD™) alone or in combination with nivolumab and/or ipilimumab. Also to find out what effects (both good and bad) SD-101 given by HAI with PEDD has on you and your cancer when given alone or with nivolumab and/or ipilimumab.
Are you Eligible? (Inclusion Criteria)
- Must be 18 years or older at time of consent
- Confirmed diagnosis of metastatic uveal melanoma with liver only or liver- dominant disease
- Has not previously received SD-101
Specialty Area(s)
Ocular Melanoma, Immunotherapy
Principal Investigator
Trial Location(s)
CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032