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Torvutatug Samrotecan With or Without Bevacizumab as Maintenance Treatment of Platinum-sensitive Relapsed Epithelial Ovarian Cancer (TREVI-OC-03)

7. september 2026 oppdatert av: AstraZeneca

A Randomised, Open-label, Phase III Study of Torvutatug Samrotecan With or Without Bevacizumab Versus Standard of Care as Second- or Third-Line Maintenance Treatment in Participants With Platinum-sensitive Relapsed Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (TREVI-OC-03)

The purpose of this study is to measure the efficacy and safety of torvutatug samrotecan (torvu-sam) with or without bevacizumab compared to standard of care (SoC) as maintenance treatment in participants with platinum-sensitive relapsed ovarian cancer (PSR OC)

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

600

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiekontakt

Studiesteder

  • Australia
      • Auchenflower, Australia, 4066
        • Research Site
      • Blacktown, Australia, 2148
        • Research Site
      • Clayton, Australia, 3168
        • Research Site
      • Liverpool, Australia, 2170
        • Research Site
  • Brasil
      • Porto Alegre, Brasil, 90035903
        • Research Site
      • São Caetano do Sul, Brasil, 09541-270
        • Research Site
      • São José do Rio Preto, Brasil, 15090-000
        • Research Site
      • São José dos Campos, Brasil, 12210-030
        • Research Site
      • São Paulo, Brasil, 01327-001
        • Research Site
      • Teresina, Brasil, 64049-200
        • Research Site
      • Vitória, Brasil, 29043-260
        • Research Site
  • Canada
    • British Columbia
      • Abbotsford British Columbia, British Columbia, Canada, V2S0C2
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • Research Site
      • Montreal, Quebec, Canada, H2X 0A9
        • Research Site
  • Forente stater
    • Alaska
      • Anchorage, Alaska, Forente stater, 99508
        • Research Site
    • Maryland
      • Columbia, Maryland, Forente stater, 21044
        • Research Site
    • Michigan
      • Detroit, Michigan, Forente stater, 48201
        • Research Site
    • New York
      • Albany, New York, Forente stater, 12206
        • Research Site
      • Bay Shore, New York, Forente stater, 11706
        • Research Site
      • Greenlawn, New York, Forente stater, 11740
        • Research Site
      • New Hyde Park, New York, Forente stater, 11042
        • Research Site
      • New York, New York, Forente stater, 10029
        • Research Site
      • Rego Park, New York, Forente stater, 11374
        • Research Site
    • Ohio
      • Cleveland, Ohio, Forente stater, 44195
        • Research Site
      • Cleveland, Ohio, Forente stater, 44111
        • Research Site
      • Columbus, Ohio, Forente stater, 43210
        • Research Site
      • Mayfield Heights, Ohio, Forente stater, 44124
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Research Site
      • Willow Grove, Pennsylvania, Forente stater, 19090
        • Research Site
    • West Virginia
      • Morgantown, West Virginia, Forente stater, 26506
        • Research Site
  • India
      • Ahmedabad, India, 380060
        • Research Site
      • Bangalore, India, 560004
        • Research Site
      • Gurgaon, India, 122002
        • Research Site
      • Kottayam, India, 686008
        • Research Site
      • Madurai, India, 625107
        • Research Site
      • Nashik, India, 422002
        • Research Site
      • Nashik, India, 422 009
        • Research Site
      • New Delhi, India, 11029
        • Research Site
      • Vadodara, India, 391760
        • Research Site
  • Japan
      • Fukuoka, Japan, 812-8582
        • Research Site
      • Fukushima, Japan, 960-1295
        • Research Site
      • Kobe, Japan, 650-0047
        • Research Site
      • Kyoto, Japan, 612-8555
        • Research Site
      • Kōtoku, Japan, 135-8550
        • Research Site
      • Minatoku, Japan, 105-8471
        • Research Site
      • Natori-shi, Japan, 981-1293
        • Research Site
      • Sagamihara-shi, Japan, 252-0375
        • Research Site
      • Shinjuku-ku, Japan, 160-0023
        • Research Site
      • Suita-shi, Japan, 565-0871
        • Research Site
      • Toyoake-shi, Japan, 470-1192
        • Research Site
      • Yokohama, Japan, 236-0004
        • Research Site
  • Kina
      • Beijing, Kina, 100210
        • Research Site
      • Guangdong Province, Kina, 510060
        • Research Site
      • Guangzhou, Kina, 510060
        • Research Site
      • Wuhan, Kina, 430030
        • Research Site
  • Sør -Korea
      • Goyang-si, Sør -Korea, 10408
        • Research Site
      • Seoul, Sør -Korea, 03080
        • Research Site
      • Seoul, Sør -Korea, 03722
        • Research Site
      • Seoul, Sør -Korea, 135-710
        • Research Site
      • Seoul, Sør -Korea, 5505
        • Research Site
  • Taiwan
      • Kaohsiung City, Taiwan, 81362
        • Research Site
      • Taichung, Taiwan, 40705
        • Research Site
      • Taichung, Taiwan, 40447
        • Research Site
      • Tainan, Taiwan, 70403
        • Research Site
      • Taipei, Taiwan, 10449
        • Research Site
  • Thailand
      • Bangkok, Thailand, 10210
        • Research Site
      • Bangkok, Thailand, 10330
        • Research Site
      • Bangkok, Thailand, 10700
        • Research Site
      • Hat Yai, Thailand, 90110
        • Research Site
      • Muang, Thailand, 50200
        • Research Site
  • Tyskland
      • Bad Homburg, Tyskland, 61352
        • Research Site
      • Bonn, Tyskland, 53127
        • Research Site
      • Brandenburg, Tyskland, 14770
        • Research Site
      • Gütersloh, Tyskland, 33332
        • Research Site
      • Homburg, Tyskland, 66421
        • Research Site
      • Kassel, Tyskland, 34125
        • Research Site
      • Mainz, Tyskland, 55131
        • Research Site
      • Mannheim, Tyskland, 68167
        • Research Site
      • Wiesbaden, Tyskland, 65189
        • Research Site

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:

  • Participants with confirmed histology of high-grade epithelial serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer.
  • Provision of an archival FFPE tumour sample
  • Participants who received at least one, and no more than 2 lines of prior systemic anticancer therapy.
  • Participants with radiologically confirmed disease relapse ≥ 6 months after their last platinum chemotherapy infusion in the previous line of treatment
  • Participants who received at least 6 cycles of PBC during the induction phase of their current line of treatment.
  • Participants assigned to bevacizumab must have received a minimum of 3 cycles of bevacizumab with 3 cycles of PBC prior to randomisation.
  • Participants with non-progressive disease upon completion of PBC in their current line of treatment.
  • Participants with documented BRCA mutation 1/2 must have received prior PARP inhibitor (unless ineligible due to contraindications, precautions, or intolerance).

Exclusion Criteria:

  • Participants with tumours of non-epithelial origin, borderline tumours, clear cell OC, mucinous OC, carcinosarcoma, or low-grade epithelial tumours.
  • Participants with history of (non-infectious) ILD/pneumonitis that required steroids, or supplemental oxygen, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening
  • Participants with non-healing wound, active ulcer, or bone fracture (not applicable if not receiving bevacizumab)
  • Participants with evidence of active or ongoing bowel obstruction (not applicable if not receiving bevacizumab)
  • Participants with prior exposure to any FRα-targeted therapy, including MIRV, or any TOP1i Antibody-drug Conjugate (ADC)

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: Torvutatug samrotecan monotherapy or in combination with bevacizumab
Torvutatug samrotecan monotherapy intravenous (IV) or Torvutatug samrotecan IV with bevacizumab IV.
Legemiddel: Torvutatug samrotecan
FRa targeting antibody drug conjugate Topoisomerase I inhibitor
Andre navn:
  • AZD5335
Legemiddel: Bevacizumab
Monoclonal antibody inhibitor of Vascular Endothelial Growth Factor
Aktiv komparator: Observation or bevacizumab
Observation or bevacizumab IV.
Legemiddel: Bevacizumab
Monoclonal antibody inhibitor of Vascular Endothelial Growth Factor

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression-Free Survival (PFS)
Tidsramme: Up to approximately 5 years
PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by Blinded Independent Central Review, or death due to any cause.
Up to approximately 5 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: Up to approximately 5 years
OS is defined as time from randomisation until the date of death due to any cause.
Up to approximately 5 years
Second Progression-Free Survival (PFS2)
Tidsramme: Up to approximately 5 years
PFS2 is defined as time from randomisation to the earliest of the progression event (following the initial investigator-assessed progression) after first subsequent therapy, or death.
Up to approximately 5 years
Time to First Subsequent Therapy (TFST)
Tidsramme: Up to approximately 5 years
TFST is defined as time from randomisation until the start date of the first subsequent anti-cancer therapy after discontinuation of randomised treatment, or death due to any cause.
Up to approximately 5 years
Time to Second Subsequent Therapy (TSST)
Tidsramme: Up to approximately 5 years
TSST is defined as time from randomisation until the start date of the second subsequent anti-cancer therapy after discontinuation of randomised treatment, or death due to any cause.
Up to approximately 5 years
Health-related Quality of Life (HrQoL)
Tidsramme: Up to approximately 5 years
Change from baseline and time to deterioration in global health status/quality of life (GHS/QoL), physical functioning (PF), and ovarian cancer symptoms (EORTC IL433).
Up to approximately 5 years
Number and percentage of participants with adverse events as graded by CTCAE v6 criteria
Tidsramme: Up to approximately 5 years
Adverse Event Incidence
Up to approximately 5 years

Samarbeidspartnere og etterforskere

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

Sponsor

AstraZeneca

Samarbeidspartnere

GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Ventana Medical Systems, Inc

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)

29. september 2026

Primær fullføring (Antatt)

26. september 2028

Studiet fullført (Antatt)

27. oktober 2031

Datoer for studieregistrering

Først innsendt

7. september 2026

Først innsendt som oppfylte QC-kriteriene

7. september 2026

Først lagt ut (Faktiske)

14. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • D8992C00001
  • 2026-526776-23-00 (Ctis)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD-delingstidsramme

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Tilgangskriterier for IPD-deling

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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