Personalized Neoantigen Vaccine Plus IL-12 in High-Risk Hepatocellular Carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, open-label Phase II trial across multiple sites evaluating GNOS-PV02, a personalized neoantigen DNA vaccine, with plasmid-encoded IL-12 (INO-9012) delivered by intradermal injection followed by electroporation. Eligible participants are adults with hepatocellular carcinoma who have undergone resection and meet high-risk criteria for recurrence, with no detectable disease on MRI about 28 days post-surgery. The study compares the vaccine regimen to active surveillance and requires a post-resection tumor tissue sample for personalized vaccine development. Primary endpoints likely include safety and recurrence metrics, with ongoing monitoring for immune response and tolerability.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Written informed consent
2. ≥18 years of age
3. Histologically or cytologically confirmed diagnosis of HCC (not accepted: fibrolamellar, sarcomatoid, mixed cholangiocarcinoma)
4. Child-Pugh Class A liver score
5. Documented virology status of hepatitis
6. Availability of a representative post-resection tumor tissue sample
7. ECOG performance status of 0 or 1
8. Adequate organ function
9. Women of childbearing potential (WOCBP) and men must be willing to use an adequate method of contraception

Exclusion Criteria:

1. 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
2. Evidence of residual, recurrent, or metastatic disease at randomization
3. Active or history of autoimmune disease or immune deficiency
4. 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
5. 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.
6. Active infection requiring systemic therapy
7. Is pregnant, breastfeeding or expecting to conceive or father children within the study's projected duration
8. History of human immunodeficiency virus (HIV) (HIV I/II antibodies).
9. Co-infection with HBV and hepatitis D viral infection
10. Co-infection with HBV and HCV
11. Has received a live vaccine within 30 days of planned start of study

Where it's running

• Louisiana State University Health Sciences Center
  New Orleans, Louisiana, United States Recruiting
• Johns Hopkins University
  Baltimore, Maryland, United States Recruiting
• Icahn School of Medicine at Mount Sinai
  New York, New York, United States Recruiting
• Auckland City Hospital (Te Toka Tumai)
  Auckland, New Zealand Recruiting
• Emory University
  Atlanta, Georgia, United States Not yet recruiting
• University of Michigan
  Ann Arbor, Michigan, United States Not yet recruiting

Study contacts

• Study coordinator: Joann Peters, MHA
• Email: peters@geneostx.com
• Phone: 434-825-2551

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.