HCCPhase 1/2NCT04251117
GNOS-PV02 Personalized Neoantigen Vaccine, INO-9012 and Pembrolizumab in Subjects With Advanced HCC
A Phase 1/2 study testing GNOS-PV02, INO-9012 and Pembrolizumab in people with HCC, run by Geneos Therapeutics at 3 sites in 2 countries.
Trial summary
This is a single-arm, open-label, multi-site Phase I/IIa study of a personalized neoantigen DNA vaccine (GNOS-PV02) and plasmid encoded IL-12 (INO-9012) in combination with pembrolizumab (MK-3475) in subjects with histologically or cytologically confirmed diagnosis of HCC based on pathology report. 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 and Pembrolizumab
- Type of treatment
- Vaccines, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Mar 2020to 29 Nov 2028
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Be willing and able to provide written informed consent for the study. The subject may also provide consent for Future Biomedical Research (FBR). However, the subject may participate in the main study without participating in FBR.
- 18 years of age on day of signing informed consent.
- Have histologically or cytologically confirmed diagnosis of HCC based on pathology report. Radiological diagnosis is valid to initiate screening pending confirmation by pathology.
- Have Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease not amenable to locoregional therapy, or refractory to locoregional therapy, and not amenable to a curative treatment approach.
- Have a Child-Pugh Class A liver score.
- Have a predicted life expectancy of greater than 6 months.
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- Have measurable disease based on RECIST 1.1.
- Have a performance status of 0 or 1 using the ECOG Performance Scale within 7 days of first dose of study drug.
- Receiving or eligible for first-line therapy with sorafenib or lenvatinib.
- Willing to submit a tissue sample for personalized DNA vaccine manufacturing.
- Patients with chronic or acute HBV infection [as characterized by positive hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibodies (anti-HBcAb) with detectable HBV DNA (≥10 IU/ml)] must be treated with effective antiviral therapy, as per institutional practices, prior to enrollment and for the duration of the study therapy. Patients who test positive for anti-hepatitis B core (HBc) with undetectable HBV DNA (<10 IU/ml) do not require anti-viral therapy prior to enrollment however these subjects will be tested at every cycle to monitor HBV DNA levels and initiate antiviral therapy if HBV DNA is detected (≥10 IU/ml). Subjects with chronic infection by hepatitis C virus (HCV), who are untreated, are allowed on study. In addition, subjects with successful HCV treatment (defined as sustained virologic response [SVR] 12 or SVR 24) are allowed, as long as 4 weeks have passed between completion of HCV therapy and start of study drug. Subjects receiving antiviral therapy during TKI may be enrolled.
- Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test for the patient to be eligible for trial enrolment.
- Be willing to use an adequate method of contraception for the course of the study through 150 days after the last dose of study drug (male and female subjects of childbearing potential).
- Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
- Demonstrate adequate organ function
Who cannot join
- Is currently participating 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 of the first dose of treatment. Subjects must also have recovered from associated therapy (i.e., to Grade ≤1 or baseline) and from AEs due to any prior therapy.
- Has received sorafenib or lenvatinib within 14 days of first dose of study drug.
- Has had esophageal or gastric variceal bleeding within the last 6 months. If suspected, subjects will be screened for esophageal varices. If varices are present, they should be treated according to institutional standards before starting study treatment.
- Has clinically apparent ascites on physical examination. Note: only ascites detectable on imaging studies is allowed.
- Evidence of portal vein invasion based on imaging is allowed pending subjects meet laboratory criteria for enrollment.
- Has had encephalopathy in the last 6 months. Subjects on rifaximin or lactulose to control their encephalopathy are not allowed.
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- Had a solid organ or hematologic transplant.
- Had prior systemic therapy for HCC other than sorafenib or lenvatinib.
- Has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., T4, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Has a 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. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.
- Has received locoregional therapy to liver (transarterial chemoembolization [TACE], transarterial embolization [TAE], radiation, radioembolization, or ablation) or major surgery to liver or other site within 3 weeks prior to the first dose of study drug. Minor surgery (e.g., simple excision, tooth extraction) must have occurred at least 7 days prior to the first dose of study drug (Cycle 1, Day 1). Subjects must have recovered adequately (i.e., Grade ≤1 or baseline) from the toxicity and/or complications from any intervention prior to starting therapy.
- Has a diagnosed additional malignancy within 5 years prior to first dose of study drug, with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curatively resected in situ cervical and/or breast cancers. Subjects with history of early-stage prostate cancer that has been curatively treated or appropriate for observation may be enrolled.
- Has radiographically detectable (even if asymptomatic and/or previously treated) central nervous system (CNS) metastases and/or carcinomatous meningitis, as assessed by local site investigator.
- Has a known history of, or any evidence of, interstitial lung disease or active non- infectious pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator, including dialysis.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 150 days after the last dose of study drug.
- Has received prior immunotherapy including anti-programmed death (PD) 1, anti-programmed death ligand (PD-L)-1, or anti-PD-L2 agents, or personalized therapies such as adoptive cell therapy or neoantigen-based vaccine.
- Has a known history of human immunodeficiency virus (HIV) (HIV I/II antibodies).
- Has untreated active hepatitis B virus (HBV), unless planned antiviral therapy during TKI.
- Note: Patients with HBV infection, characterized by positive HBsAg and/or HBcAb with detectable HBV DNA (≥10 IU/ml or above the limit of detection per local lab standard), must be treated with antiviral therapy as per institutional practice to ensure adequate viral suppression (HBV DNA ≤2000 IU/mL) prior to treatment with the study drug. Patients who test positive for HBcAg with undetectable HBV DNA (<10 IU/ml or under the limit of detection per local lab standard) do not require anti-viral therapy prior to enrollment.
- Has received a live vaccine within 30 days of planned start of study treatment (Cycle 1, Day 1).
- Note: The killed virus vaccines used for seasonal influenza vaccines for injection are allowed; however intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Non-live COVID-19 vaccines are allowed.
- Any contraindication for treatment with the CELLECTRA® 2000 Device:
- Less than two acceptable sites available for ID injection and EP considering the deltoid and anterolateral quadriceps muscles:
- Tattoos, keloids or hypertrophic scars located within 2 cm of intended administration site.
- Implantable-Cardioverter-defibrillator (ICD) or pacemaker (to prevent a life-threatening arrhythmia) that is located ipsilateral to the deltoid injection site (unless deemed acceptable by a cardiologist).
- Any metal implants or implantable medical device within the intended treatment site (i.e. electroporation area).
- Has no mutations detected after sequencing of the tumor
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: An Open-label, Multi-center, Phase I/IIa Study of a Personalized Neoantigen DNA Vaccine (GNOS-PV02) and Plasmid Encoded IL-12 (INO-9012) in Combination With Pembrolizumab (MK-3475) in Subjects With Advanced Hepatocellular Carcinoma
This is a single-arm, open-label, multi-site Phase I/IIa study of a personalized neoantigen DNA vaccine (GNOS-PV02) and plasmid encoded IL-12 (INO-9012) in combination with pembrolizumab (MK-3475) in subjects with histologically or cytologically confirmed diagnosis of HCC based on pathology report.
- Conditions
- HCC
- Being tested
- GNOS-PV02, INO-9012, Pembrolizumab, CELLECTRA®2000 EP Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GNOS-PV02Biological
GNOS-PV02 delivered by intradermal injection and electroporation
INO-9012Biological
INO-9012 delivered by intradermal injection and electroporation
PembrolizumabDrug
Pembrolizumab administered as an intravenous (IV) infusion
CELLECTRA®2000 EP DeviceDevice
CELLECTRA® 2000 Device is a system indicated for use to enhance the uptake and expression of plasmid-based biologics in order to enhance vaccine efficacy.
| Study group | Role | What they receive |
|---|---|---|
| GNOS-PV02 + INO-9012 + Pembrolizumab | Experimental | First line therapy with standard of care tyrosine kinase inhibitors (TKI) during which patient-specific GNOS-PV02 will be manufactured.
GNOS-PV02 + INO-9012 + Pembrolizumab will be administered upon disease progression or intolerance to TKI. Receives: Biological: GNOS-PV02; Biological: INO-9012; Drug: Pembrolizumab; Device: CELLECTRA®2000 EP Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Related Adverse Events
Incidence of treatment-related adverse events (TRAEs), defined as adverse events deemed possibly, probably, or definitely related to study treatment (PTCV, IL-12, electroporation and/or immune checkpoint inhibitor), with onset on or after the first dose and graded according to CTCAE version 5.0.
Measured: From first study drug administration to approximately 57 months
Neoantigen-Specific T-Cell Response
Neoantigen-specific T-cell immune response measured using interferon-gamma (IFNγ) ELISpot assays in peripheral blood mononuclear cells (PBMCs). Immune responses were assessed as the magnitude and presence of vaccine-induced T-cell responses to patient-specific neoantigens.
Measured: From baseline (pretreatment) through on-treatment assessments (approximately up to Week 12), with additional exploratory follow-up time points.
Immunogenicity of a Personalized Neoantigen DNA Vaccine as Measured by T-cell Activation and Cytolytic Cell Phenotype in PBMCs Using Flow Cytometry
Immunogenicity assessed by flow cytometry in peripheral blood mononuclear cells (PBMCs), including T-cell activation (CD69+CD107a+), proliferation (Ki67+) and cytolytic phenotype (GZMA+PRF1+) in CD4+ and CD8+ T-cell populations following stimulation with personalized neoantigen vaccine (PTCV) compared to unstimulated control.
Results are summarized as mean percentage of marker-positive T-cell populations among CD4+ or CD8+ T cells. Measurements were performed under unstimulated and antigen-stimulated conditions and data were averaged across the timepoints for the 4 subjects.
Measured: Assessments completed at Weeks 9 or Weeks 12 post-treatment for 4 subjects.
Secondary outcomes (7)
Objective Response Rate (ORR)
Objective response rate, defined as the proportion of patients achieving a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by investigator review.
Measured: From first dose to first documented disease progression or death, up to 60 months
Anti-tumor Activity as Measured by Objective Response Rate (ORR) by iRECIST
Objective response rate (ORR) defined as the proportion of patients achieving an immune complete response (iCR) or immune partial response (iPR) according to immune Response Evaluation Criteria in Solid Tumors (iRECIST), as assessed by investigator review.
Measured: From treatment initiation to first documented disease progression or death. Up to 60 months.
Anti-tumor Activity as Measured by Duration of Response (DOR)
Duration of response defined as the time from first documented confirmed response (complete or partial response) to disease progression or death from any cause, whichever occurred first, assessed according to RECIST version 1.1 using Kaplan-Meier estimation.
Measured: From first documented response until disease progression or death, assessed up to approximately 5 years.
Disease Control Rate (DCR)
Disease control rate defined as the proportion of participants achieving a complete response (CR), partial response (PR), or stable disease (SD) according to RECIST version 1.1, as assessed by investigator review.
Measured: From baseline through disease progression; dosing can occur for up to 5 years. Tumor assessments performed every 9 weeks through Week 54 and every 12 weeks thereafter until progression or study end (up to 5 years).
Progression-Free Survival (PFS)
Progression-free survival defined as the time from first dose of study treatment to the first documented radiographic disease progression according to RECIST version 1.1 or death from any cause, whichever occurred first.
Measured: From first dose of study treatment until disease progression or death, assessed up to approximately 5 years.
Anti-tumor Activity as Measured by Progression Free Survival (PFS) as Assessed by iRECIST
Progression-free survival (PFS) defined as the time from first dose of study treatment to confirmed progressive disease or death from any cause, whichever occurred first, assessed according to immune Response Evaluation Criteria in Solid Tumors (iRECIST) using Kaplan-Meier estimation.
Measured: From first dose of study treatment until confirmed disease progression or death, assessed up to approximately 5 years.
Overall Survival (OS)
Overall survival defined as the time from first dose of study treatment to death from any cause.
Measured: From first dose of study treatment until death from any cause, with follow up conducted for up to approximately 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start1 Mar 2020
- Primary completion29 Nov 2024
- Study completion29 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geneos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251117
- Sponsor's protocol ID
- GT-30
- Status last verified
- Apr 2026
- First submitted
- 27 Jan 2020
- Last updated
- 24 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Publications
Yarchoan M, Gane EJ, Marron TU, Perales-Linares R, Yan J, Cooch N, Shu DH, Fertig EJ, Kagohara LT, Bartha G, Northcott J, Lyle J, Rochestie S, Peters J, Connor JT, Jaffee EM, Csiki I, Weiner DB, Perales-Puchalt A, Sardesai NY. Personalized neoantigen vaccine and pembrolizumab in advanced hepatocellular carcinoma: a phase 1/2 trial. Nat Med. 2024 Apr;30(4):1044-1053. doi: 10.1038/s41591-024-02894-y. Epub 2024 Apr 7.
PubMed 38584166
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center, Phase I/IIa Study of a Personalized Neoantigen DNA Vaccine (GNOS-PV02) and Plasmid Encoded IL-12 (INO-9012) in Combination With Pembrolizumab (MK-3475) in Subjects With Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04251117
- Acronym / sponsor ID
- GT-30
- Conditions
- HCC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Geneos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 29 Nov 2024 (actual)
- Study completion
- 29 Nov 2028 (estimated)
- First posted
- 31 Jan 2020 (actual)
- Results
- Posted 24 Sep 2026
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 single-arm, open-label, multi-site Phase I/IIa study of a personalized neoantigen DNA vaccine (GNOS-PV02) and plasmid encoded IL-12 (INO-9012) in combination with pembrolizumab (MK-3475) in subjects with histologically or cytologically confirmed diagnosis of HCC based on pathology report.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GNOS-PV02 + INO-9012 + Pembrolizumab | Experimental | Biological: GNOS-PV02, Biological: INO-9012, Drug: Pembrolizumab, Device: CELLECTRA®2000 EP DeviceFirst line therapy with standard of care tyrosine kinase inhibitors (TKI) during which patient-specific GNOS-PV02 will be manufactured. GNOS-PV02 + INO-9012 + Pembrolizumab will be administered upon disease progression or intolerance to TKI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Be willing and able to provide written informed consent for the study. The subject may also provide consent for Future Biomedical Research (FBR). However, the subject may participate in the main study without participating in FBR.
- 18 years of age on day of signing informed consent.
- Have histologically or cytologically confirmed diagnosis of HCC based on pathology report. Radiological diagnosis is valid to initiate screening pending confirmation by pathology.
- Have Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease not amenable to locoregional therapy, or refractory to locoregional therapy, and not amenable to a curative treatment approach.
- Have a Child-Pugh Class A liver score.
Key exclusion criteria (30 listed)
- Is currently participating 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 of the first dose of treatment. Subjects must also have recovered from associated therapy (i.e., to Grade ≤1 or baseline) and from AEs due to any prior therapy.
- Has received sorafenib or lenvatinib within 14 days of first dose of study drug.
- Has had esophageal or gastric variceal bleeding within the last 6 months. If suspected, subjects will be screened for esophageal varices. If varices are present, they should be treated according to institutional standards before starting study treatment.
- Has clinically apparent ascites on physical examination. Note: only ascites detectable on imaging studies is allowed.
- Evidence of portal vein invasion based on imaging is allowed pending subjects meet laboratory criteria for enrollment.
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-PV02GNOS-PV02 delivered by intradermal injection and electroporation | Biological | GNOS-PV02 + INO-9012 + Pembrolizumab |
| INO-9012INO-9012 delivered by intradermal injection and electroporation | Biological | GNOS-PV02 + INO-9012 + Pembrolizumab |
| PembrolizumabPembrolizumab administered as an intravenous (IV) infusion | Drug | GNOS-PV02 + INO-9012 + Pembrolizumab |
| CELLECTRA®2000 EP DeviceCELLECTRA® 2000 Device is a system indicated for use to enhance the uptake and expression of plasmid-based biologics in order to enhance vaccine efficacy. | Device | GNOS-PV02 + INO-9012 + Pembrolizumab |
Primary outcome
Incidence of Treatment-Related Adverse Events
Time frame: From first study drug administration to approximately 57 months
Incidence of treatment-related adverse events (TRAEs), defined as adverse events deemed possibly, probably, or definitely related to study treatment (PTCV, IL-12, electroporation and/or immune checkpoint inhibitor), with onset on or after the first dose and graded according to CTCAE version 5.0.
Neoantigen-Specific T-Cell Response
Time frame: From baseline (pretreatment) through on-treatment assessments (approximately up to Week 12), with additional exploratory follow-up time points.
Neoantigen-specific T-cell immune response measured using interferon-gamma (IFNγ) ELISpot assays in peripheral blood mononuclear cells (PBMCs). Immune responses were assessed as the magnitude and presence of vaccine-induced T-cell responses to patient-specific neoantigens.
Immunogenicity of a Personalized Neoantigen DNA Vaccine as Measured by T-cell Activation and Cytolytic Cell Phenotype in PBMCs Using Flow Cytometry
Time frame: Assessments completed at Weeks 9 or Weeks 12 post-treatment for 4 subjects.
Immunogenicity assessed by flow cytometry in peripheral blood mononuclear cells (PBMCs), including T-cell activation (CD69+CD107a+), proliferation (Ki67+) and cytolytic phenotype (GZMA+PRF1+) in CD4+ and CD8+ T-cell populations following stimulation with personalized neoantigen vaccine (PTCV) compared to unstimulated control. Results are summarized as mean percentage of marker-positive T-cell populations among CD4+ or CD8+ T cells. Measurements were performed under unstimulated and antigen-stimulated conditions and data were averaged across the timepoints for the 4 subjects.
7 secondary outcomes
Objective Response Rate (ORR)
Time frame: From first dose to first documented disease progression or death, up to 60 months
Anti-tumor Activity as Measured by Objective Response Rate (ORR) by iRECIST
Time frame: From treatment initiation to first documented disease progression or death. Up to 60 months.
Anti-tumor Activity as Measured by Duration of Response (DOR)
Time frame: From first documented response until disease progression or death, assessed up to approximately 5 years.
Disease Control Rate (DCR)
Time frame: From baseline through disease progression; dosing can occur for up to 5 years. Tumor assessments performed every 9 weeks through Week 54 and every 12 weeks thereafter until progression or study end (up to 5 years).
Progression-Free Survival (PFS)
Time frame: From first dose of study treatment until disease progression or death, assessed up to approximately 5 years.
Anti-tumor Activity as Measured by Progression Free Survival (PFS) as Assessed by iRECIST
Time frame: From first dose of study treatment until confirmed disease progression or death, assessed up to approximately 5 years.
Overall Survival (OS)
Time frame: From first dose of study treatment until death from any cause, with follow up conducted for up to approximately 5 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38584166Yarchoan M, Gane EJ, Marron TU, Perales-Linares R, Yan J, Cooch N, Shu DH, Fertig EJ, Kagohara LT, Bartha G, Northcott J, Lyle J, Rochestie S, Peters J, Connor JT, Jaffee EM, Csiki I, Weiner DB, Perales-Puchalt A, Sardesai NY. Personalized neoantigen vaccine and pembrolizumab in advanced hepatocellular carcinoma: a phase 1/2 trial. Nat Med. 2024 Apr;30(4):1044-1053. doi: 10.1038/s41591-024-02894-y. Epub 2024 Apr 7.
- Nature MedicineLink provided by the sponsor.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GNOS-PV02, INO-9012 and Pembrolizumab in people with HCC, run by Geneos Therapeutics at 3 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 15 inclusion and 30 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: under way, not looking for participants, as of the sponsor's last update on 24 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 3 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 24 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Related Adverse Events (time frame: From first study drug administration to approximately 57 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04251117, which also lists 1 linked publication.
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 24 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.