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

NCT07493304
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,600
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Lead sponsor
Regeneron Pharmaceuticals
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Start date
2026-08-31
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Number of sites
6
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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)
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Acronym
ROXI-CAT-II
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Short title
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
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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)
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2031-07-08
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First posted
2026-03-25
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Registry last updated
2026-08-19
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Primary completion date
2031-07-08
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Start date
2026-08-31
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Participants
1,600
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Participant count basis
Estimated
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Planned participants
1,600
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Protocol amendments
1
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Number of sites
6
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Regeneron Pharmaceuticals
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07493304
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ClinicalTrials.gov ID
NCT07493304
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

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

    Timeframe: Approximately 6 months

    Part 1

  2. Severity of TEAEs

    Timeframe: Approximately 6 months

    Part 1

  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)]

    Timeframe: Up to approximately 3.5 years

    Part 2

  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

    Timeframe: Up to approximately 3.5 years

    Part 2

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

    Timeframe: Approximately 3 months

    Part 1

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

    Timeframe: Approximately 3 months

    Part 1

  3. Functional REGN7508 concentration

    Timeframe: Approximately 3 months

    Part 1

  4. Factor XI (FXI) concentration

    Timeframe: Approximately 3 months

    Part 1

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

    Timeframe: Up to approximately 3.5 years

    Part 1 and Part 2

  6. Magnitude of ADA to REGN7508

    Timeframe: Up to approximately 3.5 years

    Part 1 and Part 2

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

    Timeframe: Up to approximately 3.5 years

    Part 2

  8. Time-to-first centrally adjudicated event of Non-fatal PE (symptomatic or asymptomatic [in a segmental or larger pulmonary artery])

    Timeframe: Up to approximately 3.5 years

    Part 2

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

    Timeframe: Up to approximately 3.5 years

    Part 2

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

    Timeframe: Up to approximately 3.5 years

    Part 2

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

    Timeframe: Up to approximately 3.5 years

    Part 2

  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)]

    Timeframe: Up to approximately 3.5 years

    Part 2

  13. Occurrence of TEAEs

    Timeframe: Up to approximately 3.5 years

    Part 2

  14. Severity of TEAEs

    Timeframe: Up to 3.5 approximately years

    Part 2

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

Key Inclusion Criteria:

  1. 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

  2. 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

  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. Contraindication to anticoagulation in the opinion of the investigator

  4. Life expectancy 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 brain metastases 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

Sources for eligibility
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  • Bioresearch Partner- Hialeah HospitalHialeah, United StatesRecruiting
  • Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting
  • El Paso Medical Research Institute (Medresearch Inc)El Paso, United StatesRecruiting
  • Yongin Severance HospitalYongin-si, South KoreaRecruiting
  • Haeundae Paik HospitalPusan, South KoreaRecruiting
  • Severance HospitalSeoul, South KoreaRecruiting
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2024-519299-16-00
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (3)

Targets (3)