AzTrials
AzTrials

Venous Thromboembolism (VTE)Phase 3ROXI-CAT-IINCT07493304

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

A Phase 3 study testing REGN7508 and Apixaban in people with Venous Thromboembolism (VTE), run by Regeneron Pharmaceuticals at 13 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Thromboembolism (VTE)
What is being tested?
REGN7508 and Apixaban
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,600 participants
Where
13 sitesin 5 countries
Study dates
26 Aug 2026to 18 Jul 2031
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
  • Part 1 participants with cancer and Part 2 additional exclusion criteria:
  • Has acute leukemia or myelodysplastic syndrome
Show all 13Show fewer
  • Has primary brain tumor
  • Has brain metastases as described in the protocol
  • Part 1 additional exclusion criteria:
  • Has a symptomatic PE
  • Has an asymptomatic (incidentally-diagnosed) PE in a segmental or larger pulmonary artery
  • Part 2 additional exclusion criteria: PE leading to hemodynamic instability as described in the protocol
  • Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Trial locations and contacts

13 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Clinical Trials Administrator contact

844-734-6643

clinicaltrials@regeneron.com

13 sites in 5 countries

South Korea5 sites, 5 recruiting

  • Inje University, Haeundae Paik Hospital

    Busan, 48108

    Recruiting

  • Yonsei University Health System, Severance Hospital

    Seoul, 03722

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

  • Seoul National University Hospital

    Seoul, 3080

    Recruiting

  • Yonsei University Health System, Yongin Severance Hospital

    Yongin-si, Gyeonggi-do, 16995

    Recruiting

Other trials in South Korea

United States3 sites, 1 recruiting

  • El Paso Medical Research Institute (Medresearch Inc)

    El Paso, Texas, 79902

    Withdrawn

  • Bioresearch Partner- Hialeah Hospital

    Hialeah, Florida, 33013

    Withdrawn

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

    Recruiting

Other trials in United States

Japan2 sites, 2 recruiting

  • Tokai University Hospital

    Isehara-Shi, Kanagawa, 259-1193

    Recruiting

  • Yamaguchi University Hospital

    Ube, Yamaguchi, 755-8505

    Recruiting

Other trials in Japan

Romania2 sites, 2 recruiting

  • Institute of Oncology Bucharest

    Bucharest, Bucharest, 022328

    Recruiting

  • Arensia Exploratory Medicine, The Oncology Institute "Prof. Dr. Ion Chiricuta"

    Cluj-Napoca, Cluj, 400015

    Recruiting

Other trials in Romania

Bulgaria1 site, 1 recruiting

  • Arensia Exploratory Medicine, Multiprofile Hospital for Active Treatment Sveta Sofia

    Sofia, 1618

    Recruiting

Other trials in Bulgaria

About this study

Official title: A 2-Part, Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study to Assess Efficacy and Safety of REGN7508, a Monoclonal Antibody Against Factor XI, for the Treatment and Secondary Prevention of Venous Thromboembolism in Participants With Solid and Hematologic Cancers (ROXI-CAT-II)

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).

Read more

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)
Being tested
REGN7508, Apixaban
Keywords
Cancer-Associated Thrombosis (CAT), Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Cancer
Medical subject headings
Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REGN7508Drug

    Also called cenvacibart

    Administered per the protocol

  • ApixabanDrug

    Administered per the protocol

Study groups in NCT07493304
Study groupRoleWhat they receive
REGN7508ExperimentalNot described
Receives: Drug: REGN7508
ApixabanActive comparatorNot described
Receives: Drug: Apixaban

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Part 1

    Measured: Approximately 6 months

  2. Severity of TEAEs

    Part 1

    Measured: 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

    Measured: 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

    Measured: Up to approximately 3.5 years

Secondary outcomes (14)

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

    Part 1

    Measured: Approximately 3 months

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

    Part 1

    Measured: Approximately 3 months

  3. Functional REGN7508 concentration

    Part 1

    Measured: Approximately 3 months

  4. Factor XI (FXI) concentration

    Part 1

    Measured: Approximately 3 months

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

    Part 1 and Part 2

    Measured: Up to approximately 3.5 years

  6. Magnitude of ADA to REGN7508

    Part 1 and Part 2

    Measured: Up to approximately 3.5 years

  7. Time-to-first centrally adjudicated event of DVT (symptomatic or asymptomatic [proximal])

    Part 2

    Measured: 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

    Measured: Up to approximately 3.5 years

  9. Time-to-first centrally adjudicated event of VTE-related death

    Part 2

    Measured: Up to approximately 3.5 years

  10. Time-to-first event of centrally adjudicated venous thromboembolic events other than DVT and PE

    Part 2

    Measured: Up to approximately 3.5 years

  11. Time-to-first event of centrally adjudicated Arterial Thromboembolism (ATE)

    Part 2

    Measured: 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

    Measured: Up to approximately 3.5 years

  13. Occurrence of TEAEs

    Part 2

    Measured: Up to approximately 3.5 years

  14. Severity of TEAEs

    Part 2

    Measured: Up to 3.5 approximately years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2026
  2. Study start26 Aug 2026
  3. Primary completion18 Jul 2031 (estimated)
  4. Study completion18 Jul 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07493304
Sponsor's protocol ID
R7508-CAT-2396
Other IDs
2024-519299-16-00
Acronym
ROXI-CAT-II
Status last verified
Oct 2026
First submitted
5 Mar 2026
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in