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Clinical Trial NCT07493304 (ROXI-CAT-II) for Venous Thromboembolism (VTE) is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
Regeneron PharmaceuticalsTreatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers (ROXI-CAT-II) Phase 3 1,600 Prevention
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)
- ROXI-CAT-II
- R7508-CAT-2396
- 2024-519299-16-00 (EU Study (CTIS) Number)
Deep Vein Thrombosis (DVT)
Pulmonary Embolism (PE)
Cancer
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalREGN7508 | REGN7508 Administered per the protocol |
Active ComparatorApixaban | Apixaban Administered per the protocol |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Occurrence of Treatment-Emergent Adverse Events (TEAEs) | Part 1 | Approximately 6 months |
Severity of TEAEs | Part 1 | 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)] | Part 2 | 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 | Part 2 | Up to approximately 3.5 years |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Percent inhibition of Factor XI functional Coagulant activity (FXI:C) | Part 1 | Approximately 3 months |
Fold change from baseline in activated Partial Thromboplastin Time (aPTT) | Part 1 | Approximately 3 months |
Functional REGN7508 concentration | Part 1 | Approximately 3 months |
Factor XI (FXI) concentration | Part 1 | Approximately 3 months |
Occurrence of Anti-Drug Antibody (ADA) to REGN7508 | Part 1 and Part 2 | Up to approximately 3.5 years |
Magnitude of ADA to REGN7508 | Part 1 and Part 2 | Up to approximately 3.5 years |
Time-to-first centrally adjudicated event of DVT (symptomatic or asymptomatic [proximal]) | Part 2 | Up to approximately 3.5 years |
Time-to-first centrally adjudicated event of Non-fatal PE (symptomatic or asymptomatic [in a segmental or larger pulmonary artery]) | Part 2 | Up to approximately 3.5 years |
Time-to-first centrally adjudicated event of VTE-related death | Part 2 | Up to approximately 3.5 years |
Time-to-first event of centrally adjudicated venous thromboembolic events other than DVT and PE | Part 2 | Up to approximately 3.5 years |
Time-to-first event of centrally adjudicated Arterial Thromboembolism (ATE) | Part 2 | Up to approximately 3.5 years |
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 | Up to approximately 3.5 years |
Occurrence of TEAEs | Part 2 | Up to approximately 3.5 years |
Severity of TEAEs | Part 2 | Up to 3.5 approximately years |
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
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
- 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
Regeneron Pharmaceuticals214 active studies to explore