REGN7508 / Venous Thromboembolism (VTE) / Apixaban · Phase 3 Trial

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

ClinicalTrials.gov · August 19, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 3 trial registration comparing REGN7508 to apixaban for treatment and secondary prevention of VTE in cancer patients. No results are available in this registry record; the study is actively recruiting and outcomes will not accrue for approximately 3.5 years.

What was studied

Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Venous Thromboembolism (VTE); age from 18 Years. Intervention: REGN7508. Compared with: Apixaban — Active Comparator. n = 1,600. 6 sites: United States, South Korea.

Key findings

Safety

No efficacy or safety results reported; study is actively recruiting and ongoing.

Who this may help

When results become available, this trial may inform treatment choice for VTE in cancer populations. Until results are published, clinicians should follow established guidelines and await outcome data.

Plain-language summary

This is an ongoing Phase 3 trial registration with no results reported; it describes a planned interventional study in a clinically important area but carries no efficacy or safety data yet.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Occurrence of Treatment-Emergent Adverse Events (TEAEs) (assessed at Approximately 6 months); Severity of TEAEs (assessed at 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 pulm… (assessed at 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 (assessed at Up to app…

DesignPhase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose

PopulationVenous Thromboembolism (VTE); age from 18 Years

Sample size1,600

InterventionREGN7508

ComparatorApixaban — Active Comparator

Setting6 sites: United States, South Korea

Reported figures

Quoted from the source exactly as published.

Estimated enrollment1600

Primary outcome: Safety assessment durationApproximately 6 months

Primary outcome: Recurrent VTE and bleeding follow-up durationUp to approximately 3.5 years

Clinical bottom line

Caveats

No efficacy or safety results reported; study is actively recruiting and ongoing.
Registry record does not specify whether the comparison is randomized, blinded, or describe allocation methods.
No data on primary or secondary outcomes; follow-up duration is planned, not completed.
REGN7508 is experimental; clinical relevance depends on results not yet available.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 3 randomized comparison planned; design details sparse in registry record.

Directness

strong

Addresses treatment and secondary prevention of VTE in cancer patients directly.

Consistency

insufficient

No results reported; consistency with other evidence cannot be assessed.

Risk of bias

insufficient

Registry record does not describe blinding, allocation concealment, or analysis plan.

Sample adequacy

moderate

Estimated enrollment 1600 participants; adequate for Phase 3 but not yet achieved.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07493304). This is a study registration, not published results. Lead sponsor: Regeneron Pharmaceuticals. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 1600 participants (ESTIMATED). Conditions: Venous Thromboembolism (VTE). Interventions: DRUG: REGN7508; DRUG: Apixaban. Primary outcome measures: Occurrence of Treatment-Emergent Adverse Events (TEAEs) , Approximately 6 months; Severity of TEAEs , 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)] , 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 , Up to approximately 3.5 years. 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)

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

REGN7508Venous Thromboembolism (VTE)ApixabanNCT07493304Regeneron Pharmaceuticals