EUCTR2018-001030-17-GR进行中（未招募）1 期
Multiple Phase 1/2 Cohorts of Nivolumab Monotherapy or Nivolumab Combination Regimens Across Relapsed/Refractory Hematologic Malignancies
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
- •-Have received at least 3 prior lines of therapy, including a proteasome
- •inhibitor [PI] and an immunomodulatory agent [IMiD] OR have disease
- •that is double refractory to a PI and IMiD
- •- More than 12 weeks post-transplant of your own blood forming stem
- •cells (autologous transplant)
- •- Have detectable disease measured by a specific protein in your blood
- •and/or urine
- •- Must consent to bone marrow aspirate or biopsy.
- •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 46
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 34
排除标准
- •- Solitary bone or extramedullary plasmacytoma as the only evidence of
- •plasma cell dyscrasia, or monoclonal gammopathy of undetermined
- •significance (MGUS), smoldering multiple myeloma (SMM), primary
- •amyloidosis, Waldenstrom’s macroglobulinemia, POEMS syndrome or
- •active plasma cell leukemia
- •- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti
- •CTLA 4, or anti-CD38 antibody, or allogeneic stem cell transplantation
- •- Seropositive for human immunodeficiency virus (HIV), Hepatitis B
- •surface antigen or Hepatitis C antibody positive (except if HCV-RNA
- •negative), or history of active chronic hepatitis B or C
- •- History of central nervous system involvement or symptoms
- •suggestive of central nervous system involvement by multiple myeloma
研究者
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