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)

Cancer Associated Thrombosis

Part 1: Occurrence of Treatment-Emergent Adverse Events (TEAEs), Part 1: Severity of TEAEs, Part 2: 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-to-first event of centrally adjudicated International Society of Thrombosis and Hemostasis (ISTH)-defined major bleeding or Clinically Relevant Non-Major (CRNM) bleeding

Part 1: Percent inhibition of Factor XI functional Coagulant activity (FXI:C), Part 1: Fold change from baseline in activated Partial Thromboplastin Time (aPTT), Part 1: Functional REGN7508 concentration, Part 1: Factor XI (FXI) concentration, Part 1 and 2: Occurrence of Anti-Drug Antibody (ADA) to REGN7508, Part 1 and 2: Magnitude of ADA to REGN7508, Part 2: Time-to-first centrally adjudicated event of DVT (symptomatic or asymptomatic [proximal]), Part 2: Time-to-first centrally adjudicated event of Non-fatal PE (symptomatic or asymptomatic [in a segmental or larger pulmonary artery]), Part 2: Time-to-first centrally adjudicated event of VTE-related death, Part 2: Time-to-first event of centrally adjudicated venous thromboembolic events other than DVT and PE, Part 2: Time-to-first event of centrally adjudicated Arterial Thromboembolism (ATE), Part 2: 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)], Part 2: Occurrence of TEAEs, Part 2: Severity of TEAEs

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