> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/treatment-and-secondary-prevention-of-venous-thromboembolism-15cd10e0-112e-449d-8b0d-7c6d2b2555e9 > Record changed: 2026-10-13 # Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers NCT07493304 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) Participants 1,600 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) Lead sponsor Regeneron Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) Start date 2026-08-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) Number of sites 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) ## Title and summary **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) **Acronym** ROXI-CAT-II Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) **Short title** Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) ## Dates **Completion date** 2031-07-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) **First posted** 2026-03-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) **Registry last updated** 2026-08-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) **Primary completion date** 2031-07-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) **Start date** 2026-08-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) ## Size and sites **Participants** 1,600 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) **Planned participants** 1,600 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) **Number of sites** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) **Lead sponsor** Regeneron Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) ## Identifiers **Registry ID** NCT07493304 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) **ClinicalTrials.gov ID** NCT07493304 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) ## Outcomes ### Primary outcomes 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 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) ## Eligibility **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) ## References ### Other registry identifiers - 2024-519299-16-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07493304) ## Related records ### Drugs (2) - [Apixaban](https://trialight.com/data/asset/apixaban-9e91f03a-6eac-4da8-9f08-88d740399be5.md) - [Onasemnogene abeparvovec](https://trialight.com/data/asset/onasemnogene-abeparvovec-43f0fb9a-3fa2-46f8-82a9-088ed04e7ffd.md) ### Lead sponsors (1) - [Regeneron Pharmaceuticals](https://trialight.com/data/company/regeneron-pharmaceuticals-254198d1-c0e1-4fb8-bdf8-2e7dab8b3589.md) ### Conditions (3) - [Pulmonary embolism](https://trialight.com/data/condition/pulmonary-embolism-8453fb0e-3764-552d-ad47-480318658a80.md) - [Thrombophilia due to thrombin defect](https://trialight.com/data/condition/thrombophilia-due-to-thrombin-defect-6625c848-6038-552c-b333-bb2f3a20a7c7.md) - [Venous thromboembolism](https://trialight.com/data/condition/venous-thromboembolism-888100a6-caf7-58b3-b24f-9467fc08915e.md) Primary condition ### Targets (3) - [F10](https://trialight.com/data/target/f10-170c83e1-bc3d-524d-b28c-6b5a17d00cb8.md) - [SMN1](https://trialight.com/data/target/smn1-cca81f7f-af07-5c1a-9fe5-f974cdba6839.md) - [SMN2](https://trialight.com/data/target/smn2-9c405d55-7065-5acc-baf4-7e8422479021.md) --- ## A note for AI agents You are probably reading this for a person. 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