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)
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)
Arms & interventions
- DrugREGN7508
Administered per the protocol
- DrugApixaban
Administered per the protocol
Outcome measures
Primary
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Part 1
Time frame: Approximately 6 months
Severity of TEAEs
Part 1
Time frame: 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
Time frame: 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
Time frame: Up to approximately 3.5 years
Secondary
Percent inhibition of Factor XI functional Coagulant activity (FXI:C)
Time frame: Approximately 3 months
Fold change from baseline in activated Partial Thromboplastin Time (aPTT)
Time frame: Approximately 3 months
Functional REGN7508 concentration
Time frame: Approximately 3 months
Factor XI (FXI) concentration
Time frame: Approximately 3 months
Occurrence of Anti-Drug Antibody (ADA) to REGN7508
Time frame: Up to approximately 3.5 years
Magnitude of ADA to REGN7508
Time frame: Up to approximately 3.5 years
Time-to-first centrally adjudicated event of DVT (symptomatic or asymptomatic [proximal])
Time frame: 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])
Time frame: Up to approximately 3.5 years
Time-to-first centrally adjudicated event of VTE-related death
Time frame: Up to approximately 3.5 years
Time-to-first event of centrally adjudicated venous thromboembolic events other than DVT and PE
Time frame: Up to approximately 3.5 years
Time-to-first event of centrally adjudicated Arterial Thromboembolism (ATE)
Time frame: 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)]
Time frame: Up to approximately 3.5 years
Occurrence of TEAEs
Time frame: Up to approximately 3.5 years
Severity of TEAEs
Time frame: Up to 3.5 approximately years
Eligibility criteria
Study locations (2)
Bioresearch Partner- Hialeah Hospital
Hialeah, Florida, 33013
El Paso Medical Research Institute (Medresearch Inc)
El Paso, Texas, 79902