IMPACT 31: 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 Hepatocellular Carcinoma
Geneos Therapeutics
Summary
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 dru…
Interventions
- BiologicalGNOS-PV02 + INO-9012 delivered by intradermal injection, followed by electroporation
delivered by intradermal injection and electroporation
- DeviceElectroporation Device
GNOS-PV02 + INO-9012 ID followed by electroporation
Location
- Johns Hopkins UniversityBaltimore, Maryland