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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 164
- 试验地点
- 6
- 主要终点
- Part 1: Occurrence of Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
Part 1: To evaluate the safety and tolerability of REGN7508 in participants with DVT
Part 2: To evaluate the effect of REGN7508 compared to standard-of-care anticoagulation (apixaban) in the prevention of recurrent symptomatic or asymptomatic VTE and VTE-related death in participants with cancer associated VTE
Part 2: To evaluate the effect of REGN7508 compared to apixaban on clinically important bleeding events
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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
- •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
- •Part 1 additional criteria: a. 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) b. 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
- •Part 2 additional criteria: a. Newly diagnosed VTE within 5 days (120 hours) of randomization (with imaging confirmation) as described in the protocol b. Anticoagulation therapy with a therapeutic dose of a DOAC for at least 6 months is indicated for newly diagnosed VTE
- •Note: Other Protocol Defined Inclusion Criteria Apply
排除标准
- •Is at high risk of intracranial bleeding in the opinion of the investigator
- •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)
- •Contraindication to anticoagulation in the opinion of the investigator
- •Life expectancy of < 6 months
- •Part 1 participants with cancer and Part 2 additional exclusion criteria: a. Has acute leukemia or myelodysplastic syndrome b. Has primary brain tumor c. Has brain metastases as described in the protocol
- •Part 1 additional exclusion criteria: a. Has a symptomatic PE b. Has an asymptomatic (incidentally-diagnosed) PE in a segmental or larger pulmonary artery
- •Part 2 additional exclusion criteria: PE leading to hemodynamic instability as described in the protocol
- •Note: Other Protocol Defined Exclusion Criteria Apply
研究组 & 干预措施
Eliquis 2.5 mg film-coated tablets, Eliquis 5 mg film-coated tablets
干预措施: Eliquis 2.5 mg film-coated tablets (Drug)
Eliquis 2.5 mg film-coated tablets, Eliquis 5 mg film-coated tablets
干预措施: Eliquis 5 mg film-coated tablets (Drug)
REGN7508
干预措施: REGN7508 (Drug)
结局指标
主要结局
Part 1: Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Part 1: Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Part 1: Severity of 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 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 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
次要结局
- 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
研究者
Medical Affairs
Scientific
Regeneron Pharmaceuticals Inc.