Personalized Neoantigen Vaccine Plus IL-12 (INO-9012) Versus Active Surveillance in Subjects With High-Risk HCC (NCT07722741)
IMPACT31: 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 HCC
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Emory University — Atlanta, Georgia
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (8 Sites)
- Emory University — Atlanta, Georgia
- Louisiana State University Health Sciences Center — New Orleans, Louisiana
- Johns Hopkins University — Baltimore, Maryland
- University of Michigan — Ann Arbor, Michigan
- Icahn School of Medicine at Mount Sinai — New York, New York
- MD Anderson Cancer Center — Houston, Texas
- Fred Hutchinson Cancer Center — Seattle, Washington
- Auckland City Hospital (Te Toka Tumai) — Auckland,
📞 Contact the Study Coordinator
Phone: (434) 825-2551
Email: peters@geneostx.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in HCC
- GNOS-PV02 Personalized Neoantigen Vaccine, INO-9012 and Pembrolizumab in Subjects With Advanced HCC — Baltimore, Maryland
- Optimizing Y90 Therapy for Radiation Lobectomy — Jacksonville, Florida
- Y-90 Treatment Response Using Transarterial Radioembolization — Philadelphia, Pennsylvania
- Effect of the HCC Liver-Link Intervention — Indianapolis, Indiana
- CEUS vs. AMRI for HCC Detection in Patients With Indeterminate Liver Nodules — Ann Arbor, Michigan
Explore by condition: All HCC clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.