ClinicalTrials.gg
RecruitingNCT07493304ROXI-CAT-IIUpdated Nov 5, 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 14 sites in 5 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 Aug 2026; still recruiting 2 months later.
Updated Nov 5, 2026First sites in Bulgaria, Japan and RomaniaSite recruiting status changed+5 moreGo to Updates ↓

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

Where this study stands

Counted across the records on this site · 2026-11-14

Among 30 studies in Venous Thromboembolism with a site in Korea, Republic of — 2 open to participants now, 2 under way, 1 of them phase 3. Venous Thromboembolism · Korea, Republic of.

Planned enrollment
8th of 19
1,600 · median 1,197
Started
2026
with 1 other
Phase 3
15 of 30
1 open now
Registered
29th of 30
by date

Among the 30 studies in Venous Thromboembolism with a site in Korea, Republic of, this one is the 8th largest by planned enrollment of the 19 interventional ones that give a count, is one of 2 that started in 2026, is one of 15 in phase 3, and was the 29th registered.

Venous Thromboembolism

713 studies on the registry are indexed under Venous Thromboembolism; 147 are open to participants now.

Browse Venous Thromboembolism studies →

Open to participants now

2 of the 30 studies in Venous Thromboembolism with a site in Korea, Republic of are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 113 Venous Thromboembolism studies recruiting now, 90 (80%) set no upper age limit and 13 (12%) stop at 75 or younger; 9 take children under 18; 10 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 30 studies in Venous Thromboembolism with a site in Korea, Republic of, or all of them as a file.
02

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)
03

Conditions studied

  • Venous Thromboembolism (VTE)

Keywords

  • Cancer-Associated Thrombosis (CAT)
  • Deep Vein Thrombosis (DVT)
  • Pulmonary Embolism (PE)
  • Cancer
04

Who can participate

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

Eligibility criteria

Key Inclusion Criteria:

  1. Has an (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: 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. to anticoagulation in the opinion of the investigator
  4. 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 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

Terms in these criteria, in plain language(5)

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.

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.

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.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

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
None (open label)
Enrollment
1,600 participants (estimated)

Study arms

  • Experimental
    REGN7508

    Drug: REGN7508

  • Active comparator
    Apixaban

    Drug: Apixaban

Interventions

  • Administered per the protocol

    Also known as: cenvacibart

  • Administered per the protocol

06

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

07

Study locations

12 of 14 sites recruiting
  • Bioresearch Partner- Hialeah Hospital
    Hialeah, Florida 33013, United States
    Withdrawn

    Not enrolling at this site.

  • 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

    Not enrolling at this site.

  • Arensia Exploratory Medicine, Multiprofile Hospital for Active Treatment Sveta Sofia
    Sofia, 1618, Bulgaria
    Recruiting
  • Tokai University Hospital
    Isehara-Shi, Kanagawa 259-1193, Japan
    Recruiting
  • Tokyo Medical University Hospital
    Shinjuku, Tokyo 160-0023, 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
  • Seoul National University Hospital
    Seoul, 3080, South Korea
    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

Timeline

3 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Jul 2031, 58 months after the start.

Of 47 phase 3 interventional studies under Venous Thromboembolism, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 60. This study's planned 58 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 5, 2026
First posted
Mar 25, 2026
StartActual
Aug 26, 2026
Primary completionEst.
Jul 18, 2031
CompletionEst.
Jul 18, 2031
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
11 sites added, 3 sites removed — first sites in Bulgaria, Japan and Romania. 2 sites changed recruiting status (2 now withdrawn)
Show 2 sites
  • Bioresearch Partner- Hialeah Hospital · Hialeah, United StatesRecruiting→Withdrawn
  • El Paso Medical Research Institute (Medresearch Inc) · El Paso, United StatesRecruiting→Withdrawn
Show 11 added (5 South Korea, 3 Japan, 2 Romania, 1 Bulgaria)
  • Arensia Exploratory Medicine, Multiprofile Hospital for Active Treatment Sveta Sofia · Sofia, Bulgaria
  • Tokai University Hospital · Isehara-Shi, Japan
  • Yamaguchi University Hospital · Ube, Japan
  • Institute of Oncology Bucharest · Bucharest, Romania
  • Arensia Exploratory Medicine, The Oncology Institute "Prof. Dr. Ion Chiricuta" · Cluj-Napoca, Romania
  • Yonsei University Health System, Yongin Severance Hospital · Yongin-si, South Korea
  • Inje University, Haeundae Paik Hospital · Busan, South Korea
  • Yonsei University Health System, Severance Hospital · Seoul, South Korea
  • Samsung Medical Center · Seoul, South Korea
  • Seoul National University Hospital · Seoul, South Korea
  • Tokyo Medical University Hospital · Shinjuku, Japan
Show 3 removed
  • Yongin Severance Hospital · Yongin-si, South Korea
  • Haeundae Paik Hospital · Pusan, South Korea
  • Severance Hospital · Seoul, South Korea
across 3 updates, Sep 28, 2026 – Nov 5, 2026
Start date
Aug 31, 2026→Aug 26, 2026 (actual)
Sep 28, 2026
Primary completion
Jul 8, 2031→Jul 18, 2031
Sep 28, 2026
Study completion
Jul 8, 2031→Jul 18, 2031
Sep 28, 2026
Show all 3 updates
  1. Nov 5, 2026
    1 site added
    Show site
    • Tokyo Medical University Hospital · Shinjuku, Japan
    + 1 other change: verification date
  2. Oct 21, 2026
    1 site added
    Show site
    • Seoul National University Hospital · Seoul, South Korea
    + 1 other change: verification date
  3. Sep 28, 2026
    9 sites added, 3 sites removed — first sites in Bulgaria, Japan and Romania. 2 sites changed recruiting status (2 now withdrawn)
    Show 2 sites
    • Bioresearch Partner- Hialeah Hospital · Hialeah, United StatesRecruiting→Withdrawn
    • El Paso Medical Research Institute (Medresearch Inc) · El Paso, United StatesRecruiting→Withdrawn
    Show 9 added (4 South Korea, 2 Japan, 2 Romania, 1 Bulgaria)
    • Arensia Exploratory Medicine, Multiprofile Hospital for Active Treatment Sveta Sofia · Sofia, Bulgaria
    • Tokai University Hospital · Isehara-Shi, Japan
    • Yamaguchi University Hospital · Ube, Japan
    • Institute of Oncology Bucharest · Bucharest, Romania
    • Arensia Exploratory Medicine, The Oncology Institute "Prof. Dr. Ion Chiricuta" · Cluj-Napoca, Romania
    • Yonsei University Health System, Yongin Severance Hospital · Yongin-si, South Korea
    • Inje University, Haeundae Paik Hospital · Busan, South Korea
    • Yonsei University Health System, Severance Hospital · Seoul, South Korea
    • Samsung Medical Center · Seoul, South Korea
    Show 3 removed
    • Yongin Severance Hospital · Yongin-si, South Korea
    • Haeundae Paik Hospital · Pusan, South Korea
    • Severance Hospital · Seoul, South Korea
    Start date Aug 31, 2026→Aug 26, 2026 (now actual)
    Primary completion Jul 8, 2031→Jul 18, 2031
    Study completion Jul 8, 2031→Jul 18, 2031
    + 1 other change: verification date

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
NCT07493304
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
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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Studies of the drug tested here: Cenvacibart

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