HCCPhase 2IMPACT31NCT07722741
Personalized Neoantigen Vaccine Plus IL-12 (INO-9012) Versus Active Surveillance in Subjects With High-Risk HCC
A Phase 2 study testing GNOS-PV02 + INO-9012 delivered by intradermal injection, followed by electroporation, Electroporation Device and INO-9012 in people with HCC, run by Geneos Therapeutics at 9 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC
- What is being tested?
- GNOS-PV02 + INO-9012 delivered by intradermal injection, followed by electroporation, Electroporation Device and INO-9012
- Type of treatment
- Vaccines, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Sep 2026to Jun 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 2 countries
United States8 sites, 8 recruiting
- Not yet recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Principal Investigator, MD, 734-936-8643, ndparikh@med.umich.edu
- Not yet recruiting
Emory University
Atlanta, Georgia, 30322
Principal Investigator, MD, 404-251-1278, kathleen.marie.coleman@emory.edu
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
Principal Investigator, MD, 410-955-8893, GIClinicalTrials@jh.edu
- Not yet recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Principal Investigator, MD, 713-792-2828, GIClinicalTrials@mdanderson.org
- Recruiting
Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70112
Principal Investigator, MD, 504-568-4750, omoave@lsuhsc.edu
- Not yet recruiting
New York Presbyterian Hospital-Columbia University Irving Medical Center
New York, New York, 10027
Principal Investigator, MD, 212-342-5162, Cancerclinicaltrials@cumc.columbia.edu
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Principal Investigator, MD, 212-241-7840, denise.rodriguez3@mssm.edu
- Not yet recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Principal Investigator, MD, 206-667-1392, giresearch@fredhutch.org
New Zealand1 site, 1 recruiting
- Recruiting
Auckland City Hospital (Te Toka Tumai)
Auckland, 1023
Principal Investigator, MD, 64 0800 488 434 ext. 22932, LiverResearchUnit@adhb.govt.nz
About this study
Official title: 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
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.
- Conditions
- HCC
- Being tested
- GNOS-PV02 + INO-9012 delivered by intradermal injection, followed by electroporation, Electroporation Device, INO-9012
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GNOS-PV02 + INO-9012 delivered by intradermal injection, followed by electroporationBiological
delivered by intradermal injection and electroporation
Electroporation DeviceDevice
GNOS-PV02 + INO-9012 ID followed by electroporation
INO-9012Biological
cytokine interleukin-12 (IL-12), a vaccine adjuvant
| Study group | Role | What they receive |
|---|---|---|
| Personalized Immunotherapy for Cancer: | Experimental | 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 Receives: Biological: GNOS-PV02 + INO-9012 delivered by intradermal injection, followed by electroporation; Device: Electroporation Device; Biological: INO-9012 |
| Standard of Care | No intervention | Active Surveillance for 5 years or until recurrence, plus 3 years follow-up survival. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival
RFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary HCC, as assessed by the investigator, or death due to any cause, whichever occurs first.
Measured: Up to 5 years
Secondary outcomes (5)
Incidence of treatment emergent adverse events (safety and tolerability)
Summary adverse events according to CTCAE 6.0
Measured: Up to 5 years
Time to extra-hepatic spread or macro-vascular invasion
Time to extra-hepatic spread or macro-vascular invasion (TTEHS/MVI)
Measured: Up to 5 years
Overall survival
OS is defined as time from randomization to death of any cause
Measured: Up to 5 years on study + 3 years follow up
RFS rate at 12, 18 and 24 months as assessed by the investigator
The proportion of patients who remain free from disease recurrence after treatment over a specified period
Measured: Randomization up to 12 months, 18 and 24 months
RFS rate at 12, 18 and 24 months as assessed by the BIRC
The proportion of patients who remain free from disease recurrence after treatment over a specified period
Measured: Randomization up to 12 months, 18 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionJun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Adjuvant Therapy, Active Surveillance
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geneos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722741
- Sponsor's protocol ID
- GT-31
- Acronym
- IMPACT31
- Status last verified
- Sep 2026
- First submitted
- 20 Jul 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: At the time of registration, the sponsor has not yet determined whether de-identified individual participant data collected during the study will be shared. A decision regarding data sharing will be made following study completion and in accordance with sponsor policies, applicable regulations, and ethical considerations.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07722741
- Acronym / sponsor ID
- IMPACT31 / GT-31
- Conditions
- HCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Geneos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Jun 2032 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Adjuvant Therapy, Active Surveillance
| Arm | Type | Receives |
|---|---|---|
| Personalized Immunotherapy for Cancer: | Experimental | Biological: GNOS-PV02 + INO-9012 delivered by intradermal injection, followed by electroporation, Device: Electroporation Device, Biological: INO-9012GNOS-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 |
| Standard of Care | No intervention | –Active Surveillance for 5 years or until recurrence, plus 3 years follow-up survival. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GNOS-PV02 + INO-9012 delivered by intradermal injection, followed by electroporationdelivered by intradermal injection and electroporation | Biological | Personalized Immunotherapy for Cancer: |
| Electroporation DeviceGNOS-PV02 + INO-9012 ID followed by electroporation | Device | Personalized Immunotherapy for Cancer: |
| INO-9012cytokine interleukin-12 (IL-12), a vaccine adjuvant | Biological | Personalized Immunotherapy for Cancer: |
Primary outcome
Recurrence-free survival
Time frame: Up to 5 years
RFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary HCC, as assessed by the investigator, or death due to any cause, whichever occurs first.
5 secondary outcomes
Incidence of treatment emergent adverse events (safety and tolerability)
Time frame: Up to 5 years
Time to extra-hepatic spread or macro-vascular invasion
Time frame: Up to 5 years
Overall survival
Time frame: Up to 5 years on study + 3 years follow up
RFS rate at 12, 18 and 24 months as assessed by the investigator
Time frame: Randomization up to 12 months, 18 and 24 months
RFS rate at 12, 18 and 24 months as assessed by the BIRC
Time frame: Randomization up to 12 months, 18 months and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Geneos Therapeutics Website - Platform and company informationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. At the time of registration, the sponsor has not yet determined whether de-identified individual participant data collected during the study will be shared. A decision regarding data sharing will be made following study completion and in accordance with sponsor policies, applicable regulations, and ethical considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GNOS-PV02 + INO-9012 delivered by intradermal injection, followed by electroporation, Electroporation Device and INO-9012 in people with HCC, run by Geneos Therapeutics at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joann Peters, MHA (434-825-2551, peters@geneostx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.