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.
Inclusion Criteria:
Exclusion Criteria:
peters@geneostx.com434-825-2551
GNOS-PV02 + INO-9012 ID followed by electroporation every 3 weeks for 4 doses, then every 9 weeks (Q9W) until week 104, then every 12 weeks (Q12W) until week 260 followed by 3 years follow-up survival
Active Surveillance for 5 years or until recurrence, plus 3 years follow-up survival.
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