Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers (NCT07493304)
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)
🩺 Plain-English Summary (8th-Grade Level)
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)
Who can join: Review the eligibility criteria below.
Location: Bioresearch Partner- Hialeah Hospital — Hialeah, Florida
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (6 Sites)
- Bioresearch Partner- Hialeah Hospital — Hialeah, Florida
- Memorial Sloan Kettering Cancer Center — New York, New York
- El Paso Medical Research Institute (Medresearch Inc) — El Paso, Texas
- Yongin Severance Hospital — Yongin-si, Gyeonggi-do
- Haeundae Paik Hospital — Pusan, Gyeongsangnam-do
- Severance Hospital — Seoul,
📞 Contact the Study Coordinator
Phone: (844) 734-6643
Email: clinicaltrials@regeneron.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Venous Thromboembolism (VTE)
- Decision Aid for Anticoagulation Duration After Unprovoked Venous Thromboembolism — Calgary, Alberta
- Collaborative Risk-stratified Investigation in Thrombosis-prone Inpatients With Critical Illness: Anticoagulation With LMWH in Teens for ThromboProphylaxis (CRITICAL-Teens-TP). — St. Petersburg, Florida
- Extended Prophylactic Anticoagulation Following Spinal Surgery for Metastatic Disease — Pittburgh, Pennsylvania
- REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults — Sheffield, Alabama
Explore by condition: All Venous Thromboembolism (VTE) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.