Treatment and prevention of blood clots in adults with cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 interventional trial compares REGN7508 to apixaban for treating and preventing venous thromboembolism in adults with solid or hematologic cancers, as well as in those without cancer. Part 1 focuses on newly diagnosed lower-extremity DVT, while Part 2 expands to cancer patients with DVT or PE. The study will assess safety, effectiveness, drug levels over time, and antibody formation against REGN7508. Participants will be monitored for adverse events and recurrence of clots, with imaging confirmation of DVT/PE as applicable. Primary outcomes include prevention of recurrent VTE and safety in both cancer and non-cancer populations.

Why it matters

Who can join: the full rules

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

Where it's running

• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting
• Arensia Exploratory Medicine, Multiprofile Hospital for Active Treatment Sveta Sofia
  Sofia, Bulgaria Recruiting
• Tokai University Hospital
  Isehara-Shi, Kanagawa, Japan Recruiting
• Tokyo Medical University Hospital
  Shinjuku, Tokyo, Japan Recruiting
• Yamaguchi University Hospital
  Ube, Yamaguchi, Japan Recruiting
• Institute of Oncology Bucharest
  Bucharest, Bucharest, Romania Recruiting

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.