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Behandling og sekundær forebygging av venøs tromboembolisme (VTE) hos voksne deltakere med solide og hematologiske kreftformer (ROXI-CAT-II)

20. oktober 2026 oppdatert av: Regeneron Pharmaceuticals

En 2-delt, fase 3, multicenter, randomisert, åpen merket, aktivkontrollert studie for å vurdere effekt og sikkerhet av REGN7508, en monoklonal antistoff mot faktor XI, for behandling og sekundær forebygging av venøs tromboembolisme hos deltakere med solide og hematologiske kreftformer (ROXI-CAT-II)

This study is researching an experimental drug called REGN7508 (called "study drug") and will consist of 2 parts: Part 1 and Part 2. The study is focused on participants with or without cancer who develop blood clots in certain veins (called Deep Vein Thrombosis [DVT]) that block blood flow (Part 1) or focused on participants with cancer who develop blood clots in certain veins (DVT) or the lungs (also called Pulmonary Embolism [PE]) (Part 2).

The aim of the study is to see how safe and effective the study drug is at treating and preventing further blood clots in participants with or without cancer (Part 1) or in participants with cancer (Part 2) compared with another treatment (apixaban).

The study is looking at several other research questions, including:

  • What side effects may happen from taking the study drug
  • How much study drug is in the blood at different times
  • Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

1600

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

  • Bulgaria
      • Sofia, Bulgaria, 1618
        • Rekruttering
        • Arensia Exploratory Medicine, Multiprofile Hospital for Active Treatment Sveta Sofia
  • Forente stater
    • Florida
      • Hialeah, Florida, Forente stater, 33013
        • Tilbaketrukket
        • Bioresearch Partner- Hialeah Hospital
    • New York
      • New York, New York, Forente stater, 10021
        • Rekruttering
        • Memorial Sloan Kettering Cancer Center
    • Texas
      • El Paso, Texas, Forente stater, 79902
        • Tilbaketrukket
        • El Paso Medical Research Institute (Medresearch Inc)
  • Japan
    • Kanagawa
      • Isehara-Shi, Kanagawa, Japan, 259-1193
        • Rekruttering
        • Tokai University Hospital
    • Yamaguchi
      • Ube, Yamaguchi, Japan, 755-8505
        • Rekruttering
        • Yamaguchi University Hospital
  • Romania
    • Bucharest
      • Bucharest, Bucharest, Romania, 022328
        • Rekruttering
        • Institute of Oncology Bucharest
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Rekruttering
        • Arensia Exploratory Medicine, The Oncology Institute "Prof. Dr. Ion Chiricuta"
  • Sør -Korea
      • Busan, Sør -Korea, 48108
        • Rekruttering
        • Inje University, Haeundae Paik Hospital
      • Seoul, Sør -Korea, 06351
        • Rekruttering
        • Samsung Medical Center
      • Seoul, Sør -Korea, 3080
        • Rekruttering
        • Seoul National University Hospital
      • Seoul, Sør -Korea, 03722
        • Rekruttering
        • Yonsei University Health System, Severance Hospital
    • Gyeonggi-do
      • Yongin-si, Gyeonggi-do, Sør -Korea, 16995
        • Rekruttering
        • Yonsei University Health System, Yongin Severance Hospital

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Key Inclusion Criteria:

  1. Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 at the time of screening and day 1 prior to first dose of study intervention

  2. In Part 1 participants with cancer and Part 2 participants: Histologically confirmed diagnosis of malignant solid or select hematologic tumor (other than basal-cell or squamous-cell carcinoma of the skin alone) as described in the protocol

  3. Part 1 additional criteria:

    1. Has newly diagnosed symptomatic lower extremity DVT or incidentally-detected proximal lower extremity DVT (eg, popliteal or femoral) within 5 days (120 hours) of randomization (with imaging confirmation)
    2. Anticoagulation therapy with a therapeutic dose of a Direct Oral Anticoagulant (DOAC) for at least 3 months is indicated for the newly diagnosed proximal lower extremity DVT

  4. Part 2 additional criteria:

    1. Newly diagnosed VTE within 5 days (120 hours) of randomization (with imaging confirmation) as described in the protocol
    2. Anticoagulation therapy with a therapeutic dose of a DOAC for at least 6 months is indicated for newly diagnosed VTE

Key Exclusion Criteria:

  1. Is at high risk of intracranial bleeding in the opinion of the investigator

  2. Known bleeding conditions (eg, Hemophilia A or B, von Willebrand's disease), hemorrhagic tumor sites, or other conditions with a high risk for bleeding (eg, hepatic disease associated with coagulopathy)

  3. Contraindication to anticoagulation in the opinion of the investigator

  4. Life expectancy of < 6 months

  5. Part 1 participants with cancer and Part 2 additional exclusion criteria:

    1. Has acute leukemia or myelodysplastic syndrome
    2. Has primary brain tumor
    3. Has brain metastases as described in the protocol

  6. Part 1 additional exclusion criteria:

    1. Has a symptomatic PE
    2. Has an asymptomatic (incidentally-diagnosed) PE in a segmental or larger pulmonary artery

  7. Part 2 additional exclusion criteria: PE leading to hemodynamic instability as described in the protocol

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

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
Aktiv komparator: Apixaban
Legemiddel: Apixaban

Administered per the protocol
Eksperimentell: REGN7508
Legemiddel: REGN7508

Administered per the protocol

Andre navn:
  • cenvacibart

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Tidsramme: Approximately 6 months

Part 1
Approximately 6 months
Severity of TEAEs
Tidsramme: Approximately 6 months

Part 1
Approximately 6 months
Time-to-first event of centrally adjudicated recurrent VTE [DVT (symptomatic or asymptomatic [proximal] or Non-fatal PE (symptomatic or asymptomatic [in a segmental or larger pulmonary artery] )or VTE-related death)]
Tidsramme: Up to approximately 3.5 years

Part 2
Up to approximately 3.5 years
Time-to-first event of centrally adjudicated International Society of Thrombosis and Hemostasis (ISTH)-defined major bleeding or Clinically Relevant Non-Major (CRNM) bleeding
Tidsramme: Up to approximately 3.5 years

Part 2
Up to approximately 3.5 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percent inhibition of Factor XI functional Coagulant activity (FXI:C)
Tidsramme: Approximately 3 months

Part 1
Approximately 3 months
Fold change from baseline in activated Partial Thromboplastin Time (aPTT)
Tidsramme: Approximately 3 months

Part 1
Approximately 3 months
Functional REGN7508 concentration
Tidsramme: Approximately 3 months

Part 1
Approximately 3 months
Factor XI (FXI) concentration
Tidsramme: Approximately 3 months

Part 1
Approximately 3 months
Occurrence of Anti-Drug Antibody (ADA) to REGN7508
Tidsramme: Up to approximately 3.5 years

Part 1 and Part 2
Up to approximately 3.5 years
Magnitude of ADA to REGN7508
Tidsramme: Up to approximately 3.5 years

Part 1 and Part 2
Up to approximately 3.5 years
Time-to-first centrally adjudicated event of DVT (symptomatic or asymptomatic [proximal])
Tidsramme: Up to approximately 3.5 years

Part 2
Up to approximately 3.5 years
Time-to-first centrally adjudicated event of Non-fatal PE (symptomatic or asymptomatic [in a segmental or larger pulmonary artery])
Tidsramme: Up to approximately 3.5 years

Part 2
Up to approximately 3.5 years
Time-to-first centrally adjudicated event of VTE-related death
Tidsramme: Up to approximately 3.5 years

Part 2
Up to approximately 3.5 years
Time-to-first event of centrally adjudicated venous thromboembolic events other than DVT and PE
Tidsramme: Up to approximately 3.5 years

Part 2
Up to approximately 3.5 years
Time-to-first event of centrally adjudicated Arterial Thromboembolism (ATE)
Tidsramme: Up to approximately 3.5 years

Part 2
Up to approximately 3.5 years
Time-to-first event of centrally adjudicated recurrent VTE and bleeding events [DVT (symptomatic or asymptomatic [proximal] or Non-fatal PE (symptomatic or asymptomatic) or VTE-related death) or bleeding (ISTH-defined major bleeding or CRNM bleeding)]
Tidsramme: Up to approximately 3.5 years

Part 2
Up to approximately 3.5 years
Occurrence of TEAEs
Tidsramme: Up to approximately 3.5 years

Part 2
Up to approximately 3.5 years
Severity of TEAEs
Tidsramme: Up to 3.5 approximately years

Part 2
Up to 3.5 approximately years

Samarbeidspartnere og etterforskere

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

Sponsor

Regeneron Pharmaceuticals

Etterforskere

  • Studieleder: Clinical Trial Management, Regeneron Pharmaceuticals

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 (Faktiske)

26. august 2026

Primær fullføring (Antatt)

18. juli 2031

Studiet fullført (Antatt)

18. juli 2031

Datoer for studieregistrering

Først innsendt

5. mars 2026

Først innsendt som oppfylte QC-kriteriene

19. mars 2026

Først lagt ut (Faktiske)

25. mars 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • R7508-CAT-2396
  • 2024-519299-16-00 (Ctis)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

IPD-delingstidsramme

When Regeneron has:

  • received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
  • made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
  • the legal authority to share the data, and
  • ensured the ability to protect participant privacy

Tilgangskriterier for IPD-deling

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • ANALYTIC_CODE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

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. .

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