REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis

NCT07410117 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: R7508-CAT-23922024-519298-21-00
• Study Type: interventional
• Target: 1,120
• Locations: 2 countries
• Sites: 12

Brief Summary

This study is researching an experimental drug called REGN7508 (called "study drug"). The study is focused on the prevention of Cancer-Associated Thrombosis (CAT) in participants. The aim of the study is to see how effective the study drug is in preventing blood clots in participants with solid tumors who are currently receiving anticancer treatment or planning to start anticancer treatment within a month of being assigned to a study treatment, or recovering from surgery, and how the study drug compares to placebo for CAT. 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 study drug less effective or could lead to side effects)

Conditions

Cancer-Associated Thrombosis (CAT)

Keywords

Venous Thromboembolism (VTE); Deep Vein Thrombosis (DVT); Pulmonary Embolism (PE); Arterial Thromboembolism (ATE); Solid tumors (cancers); Clinically Relevant Non-Major (CRNM) bleeding; International Society of Thrombosis and Hemostasis (ISTH)

Outcome Measures

Primary Outcomes (2)

• Time-to-first event of centrally adjudicated VTE (DVT, PE) or ATE, or thromboembolism- or ATE-related death

  Through 6 months

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

  Through 6 months

Secondary Outcomes (16)

• Time-to-first event of the centrally adjudicated symptomatic or incidental VTE (DVT, PE) or ATE and thromboembolism- or ATE-related death

  Through 6 months

• Time-to-first event of symptomatic VTE

  Through 6 months

• Time-to-first event of symptomatic DVT

  Through 6 months

• Time-to-first event of symptomatic non-fatal PE

  Through 6 months

• Time-to-first event of thromboembolism-related death

  Through 6 months

Study Arms (2)

REGN7508

EXPERIMENTAL

Drug: REGN7508

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

REGN7508 DRUG

Administered per the protocol

Also known as: cenvacibart

REGN7508

Placebo DRUG

Administered per the protocol

Placebo

Eligibility Criteria

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

You may qualify if:

• Has a histologically confirmed diagnosis of malignant solid tumors which are locally advanced or metastatic as described in the protocol
• Has a Khorana thromboembolic risk score ≥2 during screening period or harbors a somatic documented tumor genetic variant known to be associated with a similar increased risk of VTE as described in the protocol
• Has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2 at the time of screening and day 1 prior to the first dose of study intervention

You may not qualify if:

• Has 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)
• Has a cancer diagnosis consisting solely of basal cell or squamous cell skin carcinoma
• Has a primary brain tumor or brain metastases as described in the protocol
• Has proximal lower extremity DVT locally detected by Compression Ultrasound (CUS) during screening period
• Has any condition that, as judged by the investigator, may confound the results of the study or would place the participant at increased risk of harm if he/she participated in the study

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (12)

Bioresearch Partner- Hialeah Hospital

Hialeah, Florida, 33013, United States

RECRUITING

Helios Clinical Research

North Miami Beach, Florida, 33169, United States

RECRUITING

El Paso Medical Research Institute (Medresearch Inc)

El Paso, Texas, 79902, United States

RECRUITING

LTD High Technology Hospital Medcenter

Batumi, Adjara, 6000, Georgia

RECRUITING

Krystyna Kiel Oncology Center

Kutaisi, Imereti, 4600, Georgia

RECRUITING

American Hospital Tbilisi

Tbilisi, 0102, Georgia

RECRUITING

Llc Todua Clinic

Tbilisi, 0112, Georgia

RECRUITING

Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic

Tbilisi, 0144, Georgia

RECRUITING

Institute of Clinical Oncology

Tbilisi, 0159, Georgia

RECRUITING

JSC Evex Hospitals - Caraps Medline

Tbilisi, 0179, Georgia

RECRUITING

LTD Cancer Research Centre

Tbilisi, 0179, Georgia

RECRUITING

Caucasus Medical Centre

Tbilisi, 0186, Georgia

RECRUITING

MeSH Terms

Conditions

Venous Thromboembolism; Venous Thrombosis; Pulmonary Embolism; Neoplasms; Hemorrhage

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Lung Diseases; Respiratory Tract Diseases; Embolism; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 13, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): January 23, 2030
• Study Completion (Estimated): May 6, 2030
• Last Updated: May 27, 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

GE (9); US (3)