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

No results posted yet for this study

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

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

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04251117 on ClinicalTrials.gov