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NCT Number: NCT07697599

Venous Thromboembolism (VTE) Prophylaxis With REGN7508 and REGN9933 in Adult and Adolescent Participants With a Peripherally Inserted Central Catheter (PICC)

This study is researching 2 different experimental drugs called REGN7508 and REGN9933 (called "study drugs"). The study is focused on people who have a tube placed in a vein to receive treatment (called Peripherally Inserted Central Catheter [PICC]). Patients with PICCs have a higher risk of getting blood clots which can block the veins (this is called Venous Thromboembolism [VTE]) and lead to serious health problems or be life threatening.

The aim of the study is to see how well REGN7508 and REGN9933 prevent blood clots compared to placebo after PICC placement and to see if these medications cause certain types of bleeding.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drugs * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects) * If the study drugs affect the ability of the blood to clot normally

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Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Is undergoing PICC placement for Intravenous (IV) administration of clinically indicated medications, including chemotherapy, antibiotics, TPN, and/or other indications as described in the protocol
  • Has Eastern Cooperative Oncology Group Performance (ECOG) Status ≤3 or equivalent functional status as described in the protocol
  • Has International Normalization Ratio (INR) and aPTT values no more than 25% above the upper limit as described in the protocol
  • Weighs at least 40 kg during the screening period

Key Exclusion Criteria:

  • Has a history of prior venous thrombosis in the arm and/or ipsilateral thoracic central veins in which the PICC is to be placed
  • Has acute leukemia, myelodysplastic syndrome, or primary and secondary myelofibrosis
  • Has unresected luminal gastrointestinal (GI) (including esophageal) or unresected genitourinary (GU) malignancy
  • Has current or history of known brain tumors or brain metastases
  • Has any major cardiovascular event within approximately the past 30 days prior to study administration
  • Pre-existing central venous catheter or indwelling spinal or epidural catheter during the screening period

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Treatment and study plan

REGN7508

Drug

Administered per the protocol

Other names: cenvacibart

REGN9933

Drug

Administered per the protocol

Other names: amrecibart

Placebo

Drug

Administered per the protocol

Primary outcomes

  1. Time-to-first event of centrally adjudicated VTE [symptomatic VTE or incidental VTE or asymptomatic VTE]

    Time frame: Approximately 6 months

  2. Time-to-first event of centrally adjudicated International Society on Thrombosis and Haemostasis (ISTH)-defined major bleeding or Clinically Relevant Non-Major (CRNM) bleeding

    Time frame: Approximately 6 months

Secondary outcomes

  1. Time-to-first event of centrally adjudicated symptomatic VTE [symptomatic Deep Vein Thrombosis (DVT) or symptomatic non-fatal Pulmonary Embolism (PE) or VTE-related death]

    Time frame: Approximately 6 months

  2. Time-to-first event of symptomatic DVT

    Time frame: Approximately 6 months

  3. Time-to-first event of symptomatic non-fatal PE

    Time frame: Approximately 6 months

  4. Time-to-first event of VTE-related death

    Time frame: Approximately 6 months

  5. Time-to-first event of incidental VTE

    Time frame: Approximately 6 months

  6. Time-to-first event of incidental upper extremity or incidental proximal lower extremity DVT

    Time frame: Approximately 6 months

  7. Time-to-first event of incidental PE (in a segmental or larger pulmonary artery)

    Time frame: Approximately 6 months

  8. Time-to-first event of asymptomatic VTE (Asymptomatic DVT detected by upper extremity ultrasound)

    Time frame: Approximately 6 months

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

    Time frame: Up to approximately 9 months

  10. Severity of TEAEs

    Time frame: Up to approximately 9 months

  11. Concentrations of REGN7508

    Time frame: Up to approximately 9 months

  12. Concentrations of REGN9933

    Time frame: Up to approximately 9 months

  13. Change from baseline in activated Partial Thromboplastin Time (aPTT)

    Time frame: Up to approximately 9 months

  14. Change from baseline in Prothrombin Time (PT)

    Time frame: Up to approximately 9 months

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

    Time frame: Up to approximately 9 months

  16. Magnitude of ADA to REGN7508

    Time frame: Up to approximately 9 months

  17. Occurrence of ADA to REGN9933

    Time frame: Up to approximately 9 months

  18. Magnitude of ADA to REGN9933

    Time frame: Up to approximately 9 months

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Master Protocol for a Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, for Prophylaxis of Venous Thromboembolism in Participants With a Peripherally Inserted Central Catheter (PICC) (ROXI-PEAK)

Acronym: ROXI-PEAK

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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