Health Trials

Personalized Neoantigen Vaccine Plus IL-12 (INO-9012) Versus Active Surveillance in Subjects With High-Risk HCC

ConditionHCC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeneos Therapeutics

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • GNOS-PV02 + INO-9012 delivered by intradermal injection, followed by electroporation

    Biological/Vaccine

    delivered by intradermal injection and electroporation

  • Electroporation Device

    Device

    GNOS-PV02 + INO-9012 ID followed by electroporation

  • INO-9012

    Biological/Vaccine

    cytokine interleukin-12 (IL-12), a vaccine adjuvant

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Personalized Immunotherapy for Cancer:Experimental treatment 3 interventions
Group B: Standard of CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 5 years

Secondary outcomes

1

Incidence of treatment emergent adverse events (safety and tolerability)

Summary adverse events according to CTCAE 6.0

Time frame
Up to 5 years
2

Time to extra-hepatic spread or macro-vascular invasion

Time to extra-hepatic spread or macro-vascular invasion (TTEHS/MVI)

Time frame
Up to 5 years
3

Overall survival

OS is defined as time from randomization to death of any cause

Time frame
Up to 5 years on study + 3 years follow up
4

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

Time frame
Randomization up to 12 months, 18 and 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Geneos Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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