NCT04251117

GNOS-PV02 Personalized Neoantigen Vaccine, INO-9012 and Pembrolizumab in Subjects With Advanced HCC

An Open-label, Multi-center, 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 Advanced Hepatocellular Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Geneos Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• HCC

Interventions

Type	Name	Description
BIOLOGICAL	GNOS-PV02	GNOS-PV02 delivered by intradermal injection and electroporation
BIOLOGICAL	INO-9012	INO-9012 delivered by intradermal injection and electroporation
DRUG	Pembrolizumab	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.

Timeline

• Start date: 2020-03-01
• Primary completion: 2024-11-29
• Completion: 2028-11-29
• First posted: 2020-01-31
• Last updated: 2025-01-31

Locations

3 sites across 2 countries: United States, New Zealand

Regulatory

• FDA-regulated drug study
• FDA-regulated device study