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NCT Number: NCT07493304

Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers

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)

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Key information

Conditions

Venous Thromboembolism (VTE) Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Neoplasms Pulmonary Embolism Respiratory Tract Diseases Thromboembolism Thrombosis Vascular Diseases Venous Thromboembolism Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bioresearch Partner- Hialeah Hospital, Hialeah, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

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

Key Exclusion Criteria:

  • Is at high risk of intracranial bleeding in the opinion of the investigator
  • 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)
  • Contraindication to anticoagulation in the opinion of the investigator
  • Life expectancy of < 6 months
  • Part 1 participants with cancer and Part 2 additional exclusion criteria:
  • Has acute leukemia or myelodysplastic syndrome
  • Has primary brain tumor
  • Has brain metastases as described in the protocol
  • Part 1 additional exclusion criteria:
  • Has a symptomatic PE
  • Has an asymptomatic (incidentally-diagnosed) PE in a segmental or larger pulmonary artery
  • Part 2 additional exclusion criteria: PE leading to hemodynamic instability as described in the protocol

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Treatment and study plan

REGN7508

Drug

Administered per the protocol

Other names: cenvacibart

Apixaban

Drug

Administered per the protocol

Primary outcomes

  1. Occurrence of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Approximately 6 months

    Part 1

  2. Severity of TEAEs

    Time frame: Approximately 6 months

    Part 1

  3. 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)]

    Time frame: Up to approximately 3.5 years

    Part 2

  4. Time-to-first event of centrally adjudicated International Society of Thrombosis and Hemostasis (ISTH)-defined major bleeding or Clinically Relevant Non-Major (CRNM) bleeding

    Time frame: Up to approximately 3.5 years

    Part 2

Secondary outcomes

  1. Percent inhibition of Factor XI functional Coagulant activity (FXI:C)

    Time frame: Approximately 3 months

    Part 1

  2. Fold change from baseline in activated Partial Thromboplastin Time (aPTT)

    Time frame: Approximately 3 months

    Part 1

  3. Functional REGN7508 concentration

    Time frame: Approximately 3 months

    Part 1

  4. Factor XI (FXI) concentration

    Time frame: Approximately 3 months

    Part 1

  5. Occurrence of Anti-Drug Antibody (ADA) to REGN7508

    Time frame: Up to approximately 3.5 years

    Part 1 and Part 2

  6. Magnitude of ADA to REGN7508

    Time frame: Up to approximately 3.5 years

    Part 1 and Part 2

  7. Time-to-first centrally adjudicated event of DVT (symptomatic or asymptomatic [proximal])

    Time frame: Up to approximately 3.5 years

    Part 2

  8. Time-to-first centrally adjudicated event of Non-fatal PE (symptomatic or asymptomatic [in a segmental or larger pulmonary artery])

    Time frame: Up to approximately 3.5 years

    Part 2

  9. Time-to-first centrally adjudicated event of VTE-related death

    Time frame: Up to approximately 3.5 years

    Part 2

  10. Time-to-first event of centrally adjudicated venous thromboembolic events other than DVT and PE

    Time frame: Up to approximately 3.5 years

    Part 2

  11. Time-to-first event of centrally adjudicated Arterial Thromboembolism (ATE)

    Time frame: Up to approximately 3.5 years

    Part 2

  12. 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)]

    Time frame: Up to approximately 3.5 years

    Part 2

  13. Occurrence of TEAEs

    Time frame: Up to approximately 3.5 years

    Part 2

  14. Severity of TEAEs

    Time frame: Up to 3.5 approximately years

    Part 2

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A 2-Part, Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study to Assess Efficacy and Safety of REGN7508, a Monoclonal Antibody Against Factor XI, for the Treatment and Secondary Prevention of Venous Thromboembolism in Participants With Solid and Hematologic Cancers (ROXI-CAT-II)

Acronym: ROXI-CAT-II

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Mar 25, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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