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Not yet recruiting NCT07722741

Personalized Neoantigen Vaccine Plus IL-12 (INO-9012) Versus Active Surveillance in Subjects With High-Risk HCC

Phase II Interventional HCC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GNOS-PV02 + INO-9012 delivered by intradermal injection, followed by electroporation, Electroporation Device, INO-9012.
Who it may be relevant to
Registry conditions: HCC. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, New Zealand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

IMPACT31: A Randomized Open-label, Multi-center, Phase II Adjuvant Study of a Personalized Neoantigen DNA Vaccine (GNOS-PV02) and Plasmid Encoded IL-12 (INO-9012) Versus Active Surveillance in Subjects With High-Risk HCC

Overview

This is a randomized, open-label, multi-site Phase II study of a personalized neoantigen DNA vaccine (GNOS-PV02) and plasmid encoded IL-12 (INO-9012) in subjects with histologically or cytologically confirmed diagnosis of HCC based on pathology report, who were eligible to undergo definitive resection, have demonstrated laboratory, radiographic and/or pathologic high-risk criteria for recurrence (described under eligibility), have no evidence of disease (NED) as per MRI approximately 28 days post resection, and are able to provide a tissue sample for personalized neoantigen DNA vaccine development.

Interventions

  • Biological GNOS-PV02 + INO-9012 delivered by intradermal injection, followed by electroporation
    delivered by intradermal injection and electroporation
  • Device Electroporation Device
    GNOS-PV02 + INO-9012 ID followed by electroporation
  • Biological INO-9012
    cytokine interleukin-12 (IL-12), a vaccine adjuvant

Primary outcome measures

  • Recurrence-free survival [Time frame: Up to 5 years]
Secondary outcome measures (3)
  • Incidence of treatment emergent adverse events (safety and tolerability) [Time frame: Up to 5 years]
  • Time to extra-hepatic spread or macro-vascular invasion [Time frame: Up to 5 years]
  • Overall survival [Time frame: Up to 5 years on study + 3 years follow up]

Eligibility criteria

Inclusion criteria

  • Written informed consent
  • ≥18 years of age
  • Histologically or cytologically confirmed diagnosis of HCC (not accepted: fibrolamellar, sarcomatoid, mixed cholangiocarcinoma)
  • Child-Pugh Class A liver score
  • Documented virology status of hepatitis
  • Availability of a representative post-resection tumor tissue sample
  • ECOG performance status of 0 or 1
  • Adequate organ function
  • Women of childbearing potential (WOCBP) and men must be willing to use an adequate method of contraception

Exclusion criteria

  • Is currently participating in and receiving study drug or has participated in a study of an investigational agent and received study drug or used an investigation device, within 4 weeks to baseline
  • Evidence of residual, recurrent, or metastatic disease at randomization
  • Active or history of autoimmune disease or immune deficiency
  • Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
  • Diagnosed additional malignancy within 5 years prior to baseline, except for: (a) non-invasive carcinomas subject to successful curative treatment in the opinion of the investigator which require no further therapy and (b) other malignancies for which subjects have undergone potentially curative therapy and have been considered disease free for at least 3 years prior to screening.
  • Active infection requiring systemic therapy
  • Is pregnant, breastfeeding or expecting to conceive or father children within the study's projected duration
  • History of human immunodeficiency virus (HIV) (HIV I/II antibodies).
  • Co-infection with HBV and hepatitis D viral infection
  • Co-infection with HBV and HCV
  • Has received a live vaccine within 30 days of planned start of study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Johns Hopkins University — Baltimore
  • MD Anderson Cancer Center — Houston
New Zealand · 1 center
  • Auckland City Hospital (Te Toka Tumai) — Auckland

Identifiers

NCT: NCT07722741 · GT-31

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗