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GL-ONC1 onkolytisk immunterapi hos patienter med tilbagevendende eller refraktær ovariecancer

18. maj 2026 opdateret af: Genelux Corporation

Fase 1b og 2 undersøgelse med GL-ONC1 onkolytisk immunterapi hos patienter med recidiverende eller refraktær ovariecancer (VIRO-15)

Formålet med denne undersøgelse er at bestemme, om GL-ONC1 onkolytisk immunterapi er veltolereret med antitumoraktivitet hos patienter diagnosticeret med recidiverende eller refraktær ovariecancer og peritoneal carcinomatose.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Ovariecancer (OC) er fortsat den mest dødelige gynækologiske malignitet på grund af sen påvisning, iboende og erhvervet kemo-resistens og bemærkelsesværdig heterogenitet. Der er et udækket medicinsk behov for at udvikle nye terapiformer. I prækliniske undersøgelser har GL-ONC1 vist evnen til fortrinsvis at lokalisere, kolonisere og ødelægge tumorceller i mere end 30 forskellige humane tumorer, herunder ovariecancer. GL-ONC1 er blevet undersøgt i tidlige kliniske forsøg i USA og Europa via systemisk levering som monoterapi og i kombination med andre terapier og via regional levering som monoterapi. GL-ONC1-behandling blev godt tolereret på tværs af forskellige maligniteter, administrationsveje og monoterapi samt kombinationsbehandlingsprotokoller. GL-ONC1's evne til at inficere tumorvæv og dræbe tumorceller blev demonstreret. Derudover er virus-induceret immunaktivering og gunstigt antitumorimmunrespons blevet observeret. Beviser for antitumoreffektivitet og kliniske fordele er også blevet dokumenteret.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

46

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Newport Beach, California, Forenede Stater, 92663
        • Gynecologic Oncology Associates
    • Florida
      • Orlando, Florida, Forenede Stater, 32804
        • AdventHealth Cancer Institute

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Underskrevet, skriftligt informeret samtykke.
  • Højgradig serøs (herunder Malign Mixed Mullerian Tumor (MMMT) med metastaser, der indeholder højgradigt epitelcarcinom), endometrioid eller klarcellet ovariecancer, som omfatter: (1) platin-resistent (tilbagevendende eller progression i < 6 måneder) eller (2) platin-refraktær (progression under platin-baseret terapi); patienten skal have fejlet enten mindst 2 på hinanden følgende behandlinger eller ikke være berettiget til yderligere cytotoksiske behandlinger (undtagelse er fase 2, der modtager kemoterapi med/uden bevacizumab).
  • Mellemliggende platinfølsomme patienter (tilbagefald af sygdom 6 til 12 måneder efter sidste platinforbindelsesbehandling): Tilbagevendende ovariekarcinom med mindst fire tidligere individuelle behandlingsregimer inklusive mindst to separate platinbaserede behandlinger med tilbagefald fra det sidste platinbaserede regime mindre over 12 måneder, som ikke vil eller er i stand til at gennemgå yderligere platinbaseret cytotoksisk behandling (denne underpopulation er ikke relevant for fase 2, der modtager kemoterapi med/uden bevacizumab).
  • Ydeevnestatus ECOG er på 0 eller 1, og forventet levetid på 6 måneder
  • Har enten målbar sygdom i bughulen som defineret af RECIST 1.1 (Fase 1b & 2) eller har ikke-målbar sygdom i bughulen (Fase 1b) og kan bekræftes ved laparoskopi og/eller forhøjet CA-125. Patienter, som har ikke-målbar sygdom, der ikke kan identificeres ved PET/PET-CT-scanning, men som har forhøjet CA-125 og/eller ascites med synlig sygdom bekræftet ved laparoskopi, er også kvalificerede.
  • I stand til at gennemgå IP-injektion.
  • Tilstrækkelige nyre-, lever-, knoglemarvs- og immunfunktioner.
  • Baseline tumorbiopsi er påkrævet.
  • Dokumenteret progressiv sygdomsstatus ved baseline (fase 2).

Ekskluderingskriterier:

  • Tumorer af mucinøse undertyper eller ikke-epiteliale ovariecancer (f.eks. Brenner-tumorer, Sex-cord-tumorer).
  • Uløst tarmobstruktion.
  • Kendt metastaser i centralnervesystemet (CNS).
  • Kendt seropositivitet for HIV eller aktiv hepatitisinfektion.
  • Anamnese med tromboembolisk hændelse inden for de sidste 3 måneder.
  • Gravide eller ammende kvinder.
  • Koppevaccination inden for 1 år efter studiebehandling.
  • Klinisk signifikant hjertesygdom.
  • Modtaget forudgående genterapi eller terapi med cytolytisk virus af enhver type.
  • Modtager samtidig antiviralt middel, der er aktivt mod vacciniavirus.
  • Har kendt allergi over for ovalbumin eller andre ægprodukter.
  • Har klinisk signifikante dermatologiske lidelser (f.eks. eksem, psoriasis eller uhelede hudsår eller sår) som vurderet af investigator.
  • Symptomatisk ondartet ascites og ikke-håndterbar pleural effusion.
  • Kendt overfølsomhed over for bevacizumab, ukontrolleret hypertension, anamnese med slagtilfælde eller kliniske fund, der tyder på overdreven risiko for GL-perforation (ukontrolleret mavesår, delvis tyndtarmsobstruktion osv.), som ville gøre risikoen for bevacizumab uacceptabel efter investigator.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Phase 1b - Cohort 1
Participants treated in Cohort 1 received 2 IP infusions at 3 x 10e9 pfu.
Biologisk: Olvi-Vec
Olvi-Vec is a genetically-engineered oncolytic vaccinia virus, which is administered via intraperitoneal infusion as multiple doses.
Andre navne:
  • Olvimulogene nanivacirepvec
Eksperimentel: Phase 1b - Cohort 2
Participants treated in Cohort 2 received 2 IP infusions at 1 x 10e10 pfu.
Biologisk: Olvi-Vec
Olvi-Vec is a genetically-engineered oncolytic vaccinia virus, which is administered via intraperitoneal infusion as multiple doses.
Andre navne:
  • Olvimulogene nanivacirepvec
Eksperimentel: Phase 1b - Cohort 3
Participants treated in Cohort 3 received 2 IP infusions at 2.5 x 10e10 pfu.
Biologisk: Olvi-Vec
Olvi-Vec is a genetically-engineered oncolytic vaccinia virus, which is administered via intraperitoneal infusion as multiple doses.
Andre navne:
  • Olvimulogene nanivacirepvec
Eksperimentel: Phase 2
Participants treated in the Phase 2 portion received 2 IP infusions of Olvi-Vec at 3 x 10e9 pfu followed by platinum-doublet chemotherapy with or without bevacizumab.
Biologisk: Olvi-Vec
Olvi-Vec is a genetically-engineered oncolytic vaccinia virus, which is administered via intraperitoneal infusion as multiple doses.
Andre navne:
  • Olvimulogene nanivacirepvec
Medicin: Platinum-doublet with or without bevacizumab
Carboplatin + choice of non-platinum chemotherapy drug: taxane, paclitaxel, nab-paclitaxel, gemcitabine or doxorubicin pegylated liposomal with or without bevacizumab.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Related Treatment-emergent Adverse Event [Safety and Tolerability] (Phase 1b)
Tidsramme: Change from baseline during Treatment and for 30 days following last dose over average of 2 years.
Determine safety and tolerability of administering 2 consecutive doses of Olvi-Vec via intraperitoneal catheter by the evaluation of the number of participants with related treatment-emergent adverse events (type, frequency, and severity) as assessed by CTCAE 4.03.
Change from baseline during Treatment and for 30 days following last dose over average of 2 years.
Progression-free Survival Following Treatment in Participants Enrolled in the Phase 2 Portion of Study With Platinum-resistant or Platinum-refractory Ovarian Cancer.
Tidsramme: For participants enrolled in the Phase 2 portion, outcome is from the date of starting chemotherapy until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed up to 24 months.
Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
For participants enrolled in the Phase 2 portion, outcome is from the date of starting chemotherapy until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed up to 24 months.
Overall Response Rate (ORR) by Tumor Marker Cancer Antigen-125 (CA-125) for Participants Enrolled in the Phase 2 Portion of Study With Platinum-resistant or Platinum-refractory Ovarian Cancer
Tidsramme: Assessed pre-treatment, during treatment at 2- to 3-week intervals and post-treatment assessed up to 24 months.
To assess anti-tumor response by Overall Response Rate by Tumor Marker Cancer Antigen-125 (CA-125) for participants who were enrolled in the Phase 2 portion of this study with platinum-resistant or platinum-refractory ovarian cancer.
Assessed pre-treatment, during treatment at 2- to 3-week intervals and post-treatment assessed up to 24 months.
Overall Response Rate (ORR) by RECIST 1.1 for Participants Enrolled in the Phase 2 Portion of the Study With Platinum-resistant or Platinum-refractory Ovarian Cancer
Tidsramme: For evaluable participants enrolled in the Phase 2 portion of this study with platinum-resistant or platinum-refractory ovarian cancer who were assessed at pre-treatment, during treatment at 6- to 12-week intervals and post-treatment up to 24 months.
To assess anti-tumor response by Overall Response Rate (ORR) defined as disease control rate (DCR = CR + PR + SD≥15 weeks) by RECIST 1.1 criteria: Complete Response (CR) is a disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions; stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to quality for progressive disease; Progressive Disease (PD) is at least a 20% increase in sum of longest diameter of target lesions, with an absolute increase of at least 5 mm, or the appearance of new lesions.
For evaluable participants enrolled in the Phase 2 portion of this study with platinum-resistant or platinum-refractory ovarian cancer who were assessed at pre-treatment, during treatment at 6- to 12-week intervals and post-treatment up to 24 months.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluation of Tumor Response to Treatment for Participants Enrolled in the Phase 1b Portion of This Study
Tidsramme: Assessed post-treatment at 6 to 12 week intervals or until disease progression or death from any cause, whichever comes first, assessed up to 24 months.
Participants enrolled in the Phase 1b study were assessed for best overall response to treatment with therapeutic intent by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. criteria: Complete Response (CR) is a disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions; stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to quality for progressive disease; Progressive Disease (PD) is at least a 20% increase in sum of longest diameter of target lesions, with an absolute increase of at least 5 mm, or the appearance of new lesions.
Assessed post-treatment at 6 to 12 week intervals or until disease progression or death from any cause, whichever comes first, assessed up to 24 months.
CA-125 Response in Participants Enrolled in the Phase 1b Portion of This Study
Tidsramme: Assessed pre-treatment, during treatment and post-treatment at 6 to 12 week intervals, assessed up to 24 months.
CA-125 according to the Gynecologic Cancer Intergroup (GCIG) is measured by at least a 50% reduction in CA-125 levels from pre-treatment sample which is confirmed and maintained for at least 28 days. Pre-treatment CA-125 sample must be at least twice the upper limit of normal and obtained within 2 weeks prior to starting treatment.
Assessed pre-treatment, during treatment and post-treatment at 6 to 12 week intervals, assessed up to 24 months.
Determine Progression-free Survival Following Treatment (Phase 1b)
Tidsramme: From the date of starting chemotherapy until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed up to 24 months.
To assess the number of months of progression-free survival (PFS) by RECIST 1.1.
From the date of starting chemotherapy until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed up to 24 months.
Overall Survival
Tidsramme: By medical chart review until death or 3 years from the date of last treatment whichever comes first.
To determine overall survival (OS) in the participant population.
By medical chart review until death or 3 years from the date of last treatment whichever comes first.
Clinical Benefit Rate
Tidsramme: Approximately 24 months
Defined as the percentage of patients who have achieved CR + PR + SD by RECIST 1.1.
Approximately 24 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluation of Immune-related Tumor Response
Tidsramme: Assessed post-treatment at 6 to 12 week intervals or until disease progression or death from any cause, whichever comes first, assessed up to 24 months.
This exploratory outcome measure evaluates participants' best overall response to treatment with oncolytic immunotherapy assessed by Immune-related Response Criteria (immune-related complete response, immune-related partial response, immune-related stable disease, or immune-related progressive disease).
Assessed post-treatment at 6 to 12 week intervals or until disease progression or death from any cause, whichever comes first, assessed up to 24 months.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Genelux Corporation

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2016

Primær færdiggørelse (Faktiske)

31. december 2021

Studieafslutning (Faktiske)

31. december 2022

Datoer for studieregistrering

Først indsendt

25. april 2016

Først indsendt, der opfyldte QC-kriterier

29. april 2016

Først opslået (Anslået)

3. maj 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GL-ONC1-015

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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