EUCTR2015-005053-12-FR进行中（未招募）1 期
A Phase III, Randomized, Open-label, Clinical Trial to Compare Pembrolizumab with Brentuximab Vedotin in Subjects with Relapsed or Refractory Classical Hodgkin Lymphoma - Phase III trial of pembrolizumab or brentuximab vedotin in Hodgkin lymphoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •– =18 years of age
- •– Relapsed or refractory classical Hodgkin lymphoma
- •– Measurable disease on spiral computed tomography (CT)
- •– Evaluable core or excisional lymph node biopsy
- •– Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •– Adequate organ function (laboratory studies)
- •– Negative pregnancy/lactation
- •– Adequate contraception (males and females)
- •Refer to the protocol for more detail on each inclusion criterion.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 210
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •– Previous brentuximab vedotin
- •– Current study of an investigational agent
- •– Immunosuppressed
- •– Monoclonal antibody (mAB) within 4 weeks prior to first dose
- •– Allogeneic hematopoietic stem cell transplantation =5 years
- •– Known additional malignancy
- •– Active autoimmune disease, non-infectious pneumonitis, or central nervous system (CNS) metastases
- •– Known psychiatric or substance abuse disorders
- •– Prior therapy with antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- •– anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD30, anti-CD137, or CTLA?4 antibody
- •– HIV, hepatitis B (HBV), or hepatitis C (HCV)
- •– live vaccine within 30 days prior to first dose
- •Refer to the protocol for more detail on each exclusion criterion.
研究者
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