Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Personalized Neoantigen Vaccine Plus IL-12 (INO-9012) Versus Active Surveillance in Subjects With High-Risk HCC (IMPACT31)

3. september 2026 oppdatert av: Geneos Therapeutics

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

90

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70112
        • Rekruttering
        • Louisiana State University Health Sciences Center
        • Ta kontakt med:
    • Maryland
      • Baltimore, Maryland, Forente stater, 21287
        • Rekruttering
        • Johns Hopkins University
        • Ta kontakt med:
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • Har ikke rekruttert ennå
        • University of Michigan
        • Ta kontakt med:
    • New York
      • New York, New York, Forente stater, 10029
        • Rekruttering
        • Icahn School of Medicine at Mount Sinai
        • Ta kontakt med:
    • Texas
      • Houston, Texas, Forente stater, 77030
        • Har ikke rekruttert ennå
        • MD Anderson Cancer Center
        • Ta kontakt med:
    • Washington
      • Seattle, Washington, Forente stater, 98109
        • Har ikke rekruttert ennå
        • Fred Hutchinson Cancer Center
        • Ta kontakt med:
  • New Zealand
      • Auckland, New Zealand, 1023
        • Rekruttering
        • Auckland City Hospital (Te Toka Tumai)
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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 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
  2. Evidence of residual, recurrent, or metastatic disease at randomization
  3. Active or history of autoimmune disease or immune deficiency
  4. 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
  5. 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.
  6. Active infection requiring systemic therapy
  7. Is pregnant, breastfeeding or expecting to conceive or father children within the study's projected duration
  8. History of human immunodeficiency virus (HIV) (HIV I/II antibodies).
  9. Co-infection with HBV and hepatitis D viral infection
  10. Co-infection with HBV and HCV
  11. Has received a live vaccine within 30 days of planned start of study

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Personalized Immunotherapy for Cancer:
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
Biologisk: GNOS-PV02 + INO-9012 delivered by intradermal injection, followed by electroporation
delivered by intradermal injection and electroporation
Enhet: Electroporation Device
GNOS-PV02 + INO-9012 ID followed by electroporation
Biologisk: INO-9012
cytokine interleukin-12 (IL-12), a vaccine adjuvant
Ingen inngripen: Standard of Care
Active Surveillance for 5 years or until recurrence, plus 3 years follow-up survival.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Recurrence-free survival
Tidsramme: 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.
Up to 5 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to extra-hepatic spread or macro-vascular invasion
Tidsramme: Up to 5 years
Time to extra-hepatic spread or macro-vascular invasion (TTEHS/MVI)
Up to 5 years
Overall survival
Tidsramme: Up to 5 years on study + 3 years follow up
OS is defined as time from randomization to death of any cause
Up to 5 years on study + 3 years follow up
Incidence of treatment emergent adverse events (safety and tolerability)
Tidsramme: Up to 5 years
Summary adverse events according to CTCAE 6.0
Up to 5 years
RFS rate at 12, 18 and 24 months as assessed by the investigator
Tidsramme: Randomization up to 12 months, 18 and 24 months
The proportion of patients who remain free from disease recurrence after treatment over a specified period
Randomization up to 12 months, 18 and 24 months
RFS rate at 12, 18 and 24 months as assessed by the BIRC
Tidsramme: Randomization up to 12 months, 18 months and 24 months
The proportion of patients who remain free from disease recurrence after treatment over a specified period
Randomization up to 12 months, 18 months and 24 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Geneos Therapeutics

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. september 2029

Studiet fullført (Antatt)

1. juni 2032

Datoer for studieregistrering

Først innsendt

20. juli 2026

Først innsendt som oppfylte QC-kriteriene

20. juli 2026

Først lagt ut (Faktiske)

23. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • GT-31

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere