A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess Efficacy and Safety of REGN7508, a Monoclonal Antibody Against FXI, for Primary Prophylaxis of Cancer-Associated Thrombosis for Participants With Solid Tumors Undergoing Cancer Treatment (ROXI-CAT-I)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,120
- 试验地点
- 20
- 主要终点
- Time-to-first event of centrally adjudicated VTE [Deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE) or Arterial thromboembolism (ATE), or thromboembolism- or ATE-related death]
研究概览
简要总结
This study is researching an experimental drug called REGN7508 (called "study drug"). The study is focused on the prevention of Cancer-Associated Thrombosis (CAT) in participants.
The aim of the study is to see how effective the study drug is in preventing blood clots in participants with solid tumors who are currently receiving anticancer treatment or planning to start anticancer treatment within a month of being assigned to a study treatment, or recovering from surgery, and how the study drug compares to placebo for CAT.
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 study drug less effective or could lead to side effects)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a histologically confirmed diagnosis of malignant solid tumors which are locally advanced or metastatic as described in the protocol
- •Has a Khorana thromboembolic risk score ≥2 during screening period or harbors a somatic documented tumor genetic variant known to be associated with a similar increased risk of VTE as described in the protocol
- •Has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2 at the time of screening and day 1 prior to the first dose of study intervention
排除标准
- •Has 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)
- •Has a cancer diagnosis consisting solely of basal cell or squamous cell skin carcinoma
- •Has a primary brain tumor or brain metastases as described in the protocol
- •Has proximal lower extremity DVT locally detected by Compression Ultrasound (CUS) during screening period
- •Has any condition that, as judged by the investigator, may confound the results of the study or would place the participant at increased risk of harm if he/she participated in the study
- •Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
研究组 & 干预措施
REGN7508
干预措施: REGN7508 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time-to-first event of centrally adjudicated VTE [Deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE) or Arterial thromboembolism (ATE), or thromboembolism- or ATE-related death]
时间窗: Through 6 months
Time-to-first event of centrally adjudicated International Society of Thrombosis and Hemostasis (ISTH) major bleeding or Clinically Relevant Non-Major (CRNM) bleeding
时间窗: Through 6 months
次要结局
- Time-to-first event of DVT (symptomatic or asymptomatic [proximal])(Through 6 months)
- Time-to-first event of non-fatal PE (symptomatic or asymptomatic)(Through 6 months)
- Time-to-first event of any ATE(Through 6 months)
- Time-to-first event of thromboembolism- or ATE-related death(Through 6 months)
- Occurrence of Treatment-Emergent Adverse Events (TEAEs)(Up to day 245)
- Severity of TEAEs(Up to day 245)
- Incidence of Anti-Drug Antibody (ADA) to REGN7508(Up to day 245)
- Magnitude of ADA to REGN7508(Up to day 245)