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

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