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RecruitingNCT07493304ROXI-CAT-IIUpdated Sep 28, 2026

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

A Phase 3 interventional study of REGN7508 and Apixaban in Venous Thromboembolism (VTE), sponsored by Regeneron Pharmaceuticals. Recruiting at 12 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Regeneron Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,600
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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)
02

Conditions studied

  • Venous Thromboembolism (VTE)

Keywords

  • Cancer-Associated Thrombosis (CAT)
  • Deep Vein Thrombosis (DVT)
  • Pulmonary Embolism (PE)
  • Cancer
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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

04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,600 participants (estimated)

Study arms

  • Experimental
    REGN7508

    Drug: REGN7508

  • Active comparator
    Apixaban

    Drug: Apixaban

Interventions

  • DrugREGN7508

    Administered per the protocol

    Also known as: cenvacibart

  • DrugApixaban

    Administered per the protocol

05

What researchers measure

Primary outcomes

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

    Part 1

    Time frame: Approximately 6 months

  2. Severity of TEAEs

    Part 1

    Time frame: Approximately 6 months

  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)]

    Part 2

    Time frame: Up to approximately 3.5 years

  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

    Part 2

    Time frame: Up to approximately 3.5 years

Secondary outcomes

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

    Part 1

    Time frame: Approximately 3 months

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

    Part 1

    Time frame: Approximately 3 months

  3. Functional REGN7508 concentration

    Part 1

    Time frame: Approximately 3 months

  4. Factor XI (FXI) concentration

    Part 1

    Time frame: Approximately 3 months

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

    Part 1 and Part 2

    Time frame: Up to approximately 3.5 years

  6. Magnitude of ADA to REGN7508

    Part 1 and Part 2

    Time frame: Up to approximately 3.5 years

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

    Part 2

    Time frame: Up to approximately 3.5 years

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

    Part 2

    Time frame: Up to approximately 3.5 years

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

    Part 2

    Time frame: Up to approximately 3.5 years

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

    Part 2

    Time frame: Up to approximately 3.5 years

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

    Part 2

    Time frame: Up to approximately 3.5 years

  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)]

    Part 2

    Time frame: Up to approximately 3.5 years

  13. Occurrence of TEAEs

    Part 2

    Time frame: Up to approximately 3.5 years

  14. Severity of TEAEs

    Part 2

    Time frame: Up to 3.5 approximately years

06

Study locations

10 of 12 sites recruiting
  • Bioresearch Partner- Hialeah Hospital
    Hialeah, Florida 33013, United States
    Withdrawn
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10021, United States
    Recruiting
  • El Paso Medical Research Institute (Medresearch Inc)
    El Paso, Texas 79902, United States
    Withdrawn
  • Arensia Exploratory Medicine, Multiprofile Hospital for Active Treatment Sveta Sofia
    Sofia, 1618, Bulgaria
    Recruiting
  • Tokai University Hospital
    Isehara-Shi, Kanagawa 259-1193, Japan
    Recruiting
  • Yamaguchi University Hospital
    Ube, Yamaguchi 755-8505, Japan
    Recruiting
  • Institute of Oncology Bucharest
    Bucharest, Bucharest 022328, Romania
    Recruiting
  • Arensia Exploratory Medicine, The Oncology Institute "Prof. Dr. Ion Chiricuta"
    Cluj-Napoca, Cluj 400015, Romania
    Recruiting
  • Yonsei University Health System, Yongin Severance Hospital
    Yongin-si, Gyeonggi-do 16995, South Korea
    Recruiting
  • Inje University, Haeundae Paik Hospital
    Busan, 48108, South Korea
    Recruiting
  • Yonsei University Health System, Severance Hospital
    Seoul, 03722, South Korea
    Recruiting
  • Samsung Medical Center
    Seoul, 06351, South Korea
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07493304
Lead sponsor
Regeneron Pharmaceuticals
Responsible party
Sponsor
First posted
Mar 25, 2026
Start date
Aug 26, 2026
Primary completion
Jul 18, 2031 (estimated)
Completion
Jul 18, 2031 (estimated)
Last update
Sep 28, 2026

Study contacts

Clinical Trials Administrator
Contact
clinicaltrials@regeneron.com
844-734-6643
Clinical Trial Management
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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