GNOS-PV02 Personalized Neoantigen Vaccine, INO-9012 and Pembrolizumab in Subjects With Advanced HCC
NCT04251117 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2026-04-22
Summary
This is a single-arm, open-label, multi-site Phase I/IIa study of a personalized neoantigen DNA vaccine (GNOS-PV02) and plasmid encoded IL-12 (INO-9012) in combination with pembrolizumab (MK-3475) in subjects with histologically or cytologically confirmed diagnosis of HCC based on pathology report.
Conditions
Interventions
- BIOLOGICAL
-
GNOS-PV02
GNOS-PV02 delivered by intradermal injection and electroporation
- BIOLOGICAL
-
INO-9012
INO-9012 delivered by intradermal injection and electroporation
- DRUG
-
Pembrolizumab administered as an intravenous (IV) infusion
- DEVICE
-
CELLECTRA®2000 EP Device
CELLECTRA® 2000 Device is a system indicated for use to enhance the uptake and expression of plasmid-based biologics in order to enhance vaccine efficacy.
Sponsors & Collaborators
-
Geneos Therapeutics
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-03-01
- Primary Completion
- 2024-11-29
- Completion
- 2028-11-29
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
- New Zealand
Study Locations
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