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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 opdateret af: 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)

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

600

Fase

  • Fase 3

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Australien
      • Auchenflower, Australien, 4066
        • Research Site
      • Blacktown, Australien, 2148
        • Research Site
      • Clayton, Australien, 3168
        • Research Site
      • Liverpool, Australien, 2170
        • Research Site
  • Brasilien
      • Porto Alegre, Brasilien, 90035903
        • Research Site
      • São Caetano do Sul, Brasilien, 09541-270
        • Research Site
      • São José do Rio Preto, Brasilien, 15090-000
        • Research Site
      • São José dos Campos, Brasilien, 12210-030
        • Research Site
      • São Paulo, Brasilien, 01327-001
        • Research Site
      • Teresina, Brasilien, 64049-200
        • Research Site
      • Vitória, Brasilien, 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
  • Forenede Stater
    • Alaska
      • Anchorage, Alaska, Forenede Stater, 99508
        • Research Site
    • Maryland
      • Columbia, Maryland, Forenede Stater, 21044
        • Research Site
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48201
        • Research Site
    • New York
      • Albany, New York, Forenede Stater, 12206
        • Research Site
      • Bay Shore, New York, Forenede Stater, 11706
        • Research Site
      • Greenlawn, New York, Forenede Stater, 11740
        • Research Site
      • New Hyde Park, New York, Forenede Stater, 11042
        • Research Site
      • New York, New York, Forenede Stater, 10029
        • Research Site
      • Rego Park, New York, Forenede Stater, 11374
        • Research Site
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Research Site
      • Cleveland, Ohio, Forenede Stater, 44111
        • Research Site
      • Columbus, Ohio, Forenede Stater, 43210
        • Research Site
      • Mayfield Heights, Ohio, Forenede Stater, 44124
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Research Site
      • Willow Grove, Pennsylvania, Forenede Stater, 19090
        • Research Site
    • West Virginia
      • Morgantown, West Virginia, Forenede Stater, 26506
        • Research Site
  • Indien
      • Ahmedabad, Indien, 380060
        • Research Site
      • Bangalore, Indien, 560004
        • Research Site
      • Gurgaon, Indien, 122002
        • Research Site
      • Kottayam, Indien, 686008
        • Research Site
      • Madurai, Indien, 625107
        • Research Site
      • Nashik, Indien, 422002
        • Research Site
      • Nashik, Indien, 422 009
        • Research Site
      • New Delhi, Indien, 11029
        • Research Site
      • Vadodara, Indien, 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
  • Sydkorea
      • Goyang-si, Sydkorea, 10408
        • Research Site
      • Seoul, Sydkorea, 03080
        • Research Site
      • Seoul, Sydkorea, 03722
        • Research Site
      • Seoul, Sydkorea, 135-710
        • Research Site
      • Seoul, Sydkorea, 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

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Torvutatug samrotecan monotherapy or in combination with bevacizumab
Torvutatug samrotecan monotherapy intravenous (IV) or Torvutatug samrotecan IV with bevacizumab IV.
Medicin: Torvutatug samrotecan
FRa targeting antibody drug conjugate Topoisomerase I inhibitor
Andre navne:
  • AZD5335
Medicin: Bevacizumab
Monoclonal antibody inhibitor of Vascular Endothelial Growth Factor
Aktiv komparator: Observation or bevacizumab
Observation or bevacizumab IV.
Medicin: Bevacizumab
Monoclonal antibody inhibitor of Vascular Endothelial Growth Factor

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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

Sponsor

AstraZeneca

Samarbejdspartnere

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

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 (Anslået)

29. september 2026

Primær færdiggørelse (Anslået)

26. september 2028

Studieafslutning (Anslået)

27. oktober 2031

Datoer for studieregistrering

Først indsendt

7. september 2026

Først indsendt, der opfyldte QC-kriterier

7. september 2026

Først opslået (Faktiske)

14. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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.

IPD-delingsadgangskriterier

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 Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner