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

ConditionHCC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeneos Therapeutics

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • GNOS-PV02 + INO-9012 delivered by intradermal injection, followed by electroporation
  • Electroporation Device
  • INO-9012

Treatment groups

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators