NCT03138499终止3 期
Randomized, Open-label, Phase 3 Trial of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Participants With Relapsed Refractory or Ineligible for Autologous Stem Cell Transplant (ASCT) Advanced Stage Classical Hodgkin Lymphoma (CheckMate 812: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 812)
Bristol-Myers Squibb22 个研究点 分布在 3 个国家目标入组 23 人开始时间: 2017年6月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 22
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to determine whether an investigational immuno-therapy combination, nivolumab with Brentuximab vedotin compared to Brentuximab vedotin alone is safe and effective in the treatment of relapsed and refractory Classical Hodgkin Lymphoma. The participants of this trial will comprise of patients who have relapsed or did not respond to treatment and are not eligible for stem cell transplant
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
- None
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
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or
- •Participants must have a pathologic diagnosis of classical Hodgkin lymphoma (cHL) who are relapsed or refractory with one of the following:.
- •i) Autologous stem cell transplant (ASCT) ineligible patients.
- •ii) Patients after failure of ASCT.
- •Must have at least one lesion that is > 15 mm (1.5 cm) in the longest diameter and avid by Fluoro Deoxy Glucose (FDG) Positron Emission Tomography (PET) scan.
排除标准
- •Known central nervous system lymphoma.
- •Participants with nodular lymphocyte-predominant Hodgkin lymphoma (HL).
- •Participants with known history of pancreatitis or progressive multifocal leukoencephalopathy (PML).
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Module B
Experimental
Brentuximab alone
干预措施: Brentuximab vedotin (Biological)
Module A
Experimental
Nivolumab combined with Brentuximab
干预措施: Brentuximab vedotin (Biological)
Module A
Experimental
Nivolumab combined with Brentuximab
干预措施: Nivolumab (Biological)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: From randomization to date of death, or disease progression (up to approximately 45 months)
Progression Free Survival (PFS) is defined as time from date of randomization to death, or disease progression per investigator assessment estimated using the Kaplan-Meier (KM) product-limit method.
次要结局
- Objective Response Rate (ORR)(From randomization up to approximately 45 months)
- Overall Survival (OS)(From randomization to the date of death (up to approximately 3 years 7 months))
- Complete Response Rate (CRR):(From randomization up to approximately 45 months)
- Duration of Response (DOR)(From randomization to date of documented progression or death (up to approximately 45 months))
- Duration of Complete Response (DOCR)(From randomization to date of documented progression or death (up to approximately 45 months))
研究者
研究点 (22)
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