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RecruitingNCT07410117ROXI-CAT-IUpdated Nov 5, 2026

REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis

A Phase 3 interventional study of REGN7508 and Placebo in Cancer-Associated Thrombosis (CAT), sponsored by Regeneron Pharmaceuticals. Recruiting at 28 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

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

From the registry’s dates

  • Started Mar 2026; still recruiting 8 months later.
Updated Nov 5, 2026Site recruiting status changed10 sites added+1 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
1,120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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)
02

Conditions studied

  • 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)
03

In context

Venous Thromboembolism

712 studies on the registry are indexed under Venous Thromboembolism; 146 are open to participants now.

This study's planned enrollment of 1,120 is above the median of 240 across 401 interventional studies indexed under Venous Thromboembolism.

Browse Venous Thromboembolism studies →

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 411 studies on the registry; 90 are open to participants now.

Of its 125 completed or terminated interventional studies of FDA-regulated products, 79 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Eligibility criteria

Key Inclusion Criteria:

  1. Has a confirmed diagnosis of malignant solid tumors which are locally advanced or as described in the protocol
  2. 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
  3. Has an (ECOG) Performance Status 0 to 2 at the time of screening and day 1 prior to the first dose of study intervention

Key Exclusion Criteria:

  1. 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)
  2. Has a cancer diagnosis consisting solely of basal cell or squamous cell skin carcinoma
  3. Has a primary brain tumor or as described in the protocol
  4. Has proximal lower extremity DVT locally detected by Compression Ultrasound (CUS) during screening period
  5. 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

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,120 participants (estimated)

Study arms

  • Experimental
    REGN7508

    Drug: REGN7508

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • Administered per the protocol

    Also known as: cenvacibart

  • DrugPlacebo

    Administered per the protocol

06

What researchers measure

Primary outcomes

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

    Time frame: Through 6 months

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

    Time frame: Through 6 months

Secondary outcomes

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

    Time frame: Through 6 months

  2. Time-to-first event of symptomatic VTE

    Time frame: Through 6 months

  3. Time-to-first event of symptomatic DVT

    Time frame: Through 6 months

  4. Time-to-first event of symptomatic non-fatal PE

    Time frame: Through 6 months

  5. Time-to-first event of thromboembolism-related death

    Time frame: Through 6 months

  6. Time-to-first event of incidental VTE

    Time frame: Through 6 months

  7. Time-to-first event of incidental upper extremity or incidental proximal lower extremity DVT

    Time frame: Through 6 months

  8. Time-to-first event of incidental non-fatal PE (in a segmental or larger pulmonary artery)

    Time frame: Through 6 months

  9. Time-to-first event of asymptomatic VTE (Asymptomatic DVT detected by lower extremities ultrasound)

    Time frame: Through 6 months

  10. Time-to-first event of ATE

    Time frame: Through 6 months

  11. Time-to-first event of ATE-related death

    Time frame: Through 6 months

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

    Time frame: Through 6 months

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

    Time frame: Up to day 245

  14. Severity of TEAEs

    Time frame: Up to day 245

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

    Time frame: Up to day 245

  16. Magnitude of ADA to REGN7508

    Time frame: Up to day 245

07

Study locations

27 of 28 sites recruiting
08

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, Statistical analysis plan, Informed consent form, Clinical study report, 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

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

09

Updates

3 registry updates since Sep 25, 2026
Sites
10 sites added, 2 sites removed. El Paso Medical Research Institute (Medresearch Inc) is now Withdrawn
Show 10 added (8 Japan, 1 United States, 1 Georgia)
  • Hyogo Cancer Center · Akashi, Japan
  • Saitama Cancer Center · Ina-machi, Japan
  • Ehime University Hospital · Tōon, Japan
  • University Hospital Kyoto Prefectural University of Medicine · Kyoto, Japan
  • Tokyo Medical University Hospital · Shinjuku, Japan
  • Beth Israel Deaconess Medical Center · Boston, United States
  • Israel Georgia Medical Research Clinic Helsicore · Tbilisi, Georgia
  • Gunma Prefectural Cancer Center · Ōta, Japan
  • Tohoku University Hospital · Sendai, Japan
  • National Cancer Center Hospital - Tsukiji Campus · Chuo Ku, Japan
Show 2 removed
  • Hyogo Cancer Center - Gastroenterology Department · Akashi, Japan
  • Saitama Cancer Center · Kitaadachigun, Japan
across 3 updates, Sep 29, 2026 – Nov 5, 2026
Show all 3 updates
  1. Nov 5, 2026
    5 sites added. El Paso Medical Research Institute (Medresearch Inc) is now Withdrawn
    Show 5 added (3 Japan, 1 United States, 1 Georgia)
    • Beth Israel Deaconess Medical Center · Boston, United States
    • Israel Georgia Medical Research Clinic Helsicore · Tbilisi, Georgia
    • Gunma Prefectural Cancer Center · Ōta, Japan
    • Tohoku University Hospital · Sendai, Japan
    • National Cancer Center Hospital - Tsukiji Campus · Chuo Ku, Japan
    + 1 other change: verification date
  2. Oct 13, 2026
    3 sites added
    Show 3 added (3 Japan)
    • Ehime University Hospital · Tōon, Japan
    • University Hospital Kyoto Prefectural University of Medicine · Kyoto, Japan
    • Tokyo Medical University Hospital · Shinjuku, Japan
    + 1 other change: verification date
  3. Sep 29, 2026
    2 sites added, 2 sites removed
    Show 2 added (2 Japan)
    • Hyogo Cancer Center · Akashi, Japan
    • Saitama Cancer Center · Ina-machi, Japan
    Show 2 removed
    • Hyogo Cancer Center - Gastroenterology Department · Akashi, Japan
    • Saitama Cancer Center · Kitaadachigun, Japan

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07410117
Responsible party
Sponsor
First posted
Feb 13, 2026
Start date
Mar 9, 2026
Primary completion
Jan 23, 2030 (estimated)
Completion
May 6, 2030 (estimated)
Last update
Nov 5, 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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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Cenvacibart

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