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

NCT07493304 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: R7508-CAT-23962024-519299-16-00
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 2

Brief 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)

Conditions

Venous Thromboembolism (VTE)

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Occurrence of Treatment-Emergent Adverse Events (TEAEs)

  Part 1

  Approximately 6 months

• Severity of TEAEs

  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)]

  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

  Part 2

  Up to approximately 3.5 years

Secondary Outcomes (14)

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

  Approximately 3 months

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

  Approximately 3 months

• Functional REGN7508 concentration

  Approximately 3 months

• Factor XI (FXI) concentration

  Approximately 3 months

• Occurrence of Anti-Drug Antibody (ADA) to REGN7508

  Up to approximately 3.5 years

Study Arms (2)

REGN7508

EXPERIMENTAL

Drug: REGN7508

Apixaban

ACTIVE COMPARATOR

Drug: Apixaban

Interventions

REGN7508 DRUG

Administered per the protocol

Also known as: cenvacibart

REGN7508

Apixaban DRUG

Administered per the protocol

Apixaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Has acute leukemia or myelodysplastic syndrome
• Has primary brain tumor
• Has brain metastases as described in the protocol
• Has a symptomatic PE
• Has an asymptomatic (incidentally-diagnosed) PE in a segmental or larger pulmonary artery

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (2)

Bioresearch Partner- Hialeah Hospital

Hialeah, Florida, 33013, United States

RECRUITING

El Paso Medical Research Institute (Medresearch Inc)

El Paso, Texas, 79902, United States

RECRUITING

MeSH Terms

Conditions

Venous Thromboembolism; Venous Thrombosis; Pulmonary Embolism; Neoplasms

Interventions

apixaban

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Lung Diseases; Respiratory Tract Diseases; Embolism

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 25, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): July 8, 2031
• Study Completion (Estimated): July 8, 2031
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 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
• Access Criteria: 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

Locations

US (2)