A Single Arm, Open-Label Phase 2 Study of Nivolumab (BMS-936558) in Subjects With Relapsed or Refractory Follicular Lymphoma (FL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 21
- 主要终点
- Overall Response Rate (ORR) as Determined by IRRC
研究概览
简要总结
The purpose of this study is to assess the clinical benefit of Nivolumab, as measured by independent radiologic review committee (IRRC)-assessed objective response rate (ORR) in subjects with FL lymphoma who have failed therapy with both CD20 antibody and an alkylating agent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Grade 1, 2, or 3a FL without pathologic evidence of transformation
- •Male and female, ages 18 and above, with relapsed or refractory FL lymphoma after > or =2 prior treatment lines; each of the 2 prior treatment lines must include at least CD20 antibody and/or an alkylating agent
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
排除标准
- •Known central nervous system lymphoma
- •History of interstitial lung disease
- •Subjects with active, known or suspected autoimmune disease
- •Prior allogeneic stem cell transplant
- •Prior autologous stem cell transplant ≤12 weeks prior to first dose of study drug
研究组 & 干预措施
Arm 1: Nivolumab
Nivolumab 3 mg/kg injection by Intravenous for every 2 weeks until disease progression or discontinuation due to toxicity
干预措施: Nivolumab (Drug)
结局指标
主要结局
Overall Response Rate (ORR) as Determined by IRRC
时间窗: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
ORR is determined by an independent radiologic review committee (IRRC) according to the revised International Working Group Criteria for non-Hodgkin Lymphoma. ORR is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) and expressed as a percentage of all treated participants. CR=Disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement. PR=Regression of measurable disease and no new sites; no increase in size of liver or spleen. \>=50% decrease in SPD of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions)
次要结局
- Progression Free Survival (PFS) Based on IRRC Assessment(From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months))
- Complete Remission Rate (CRR) Based on IRRC Assessment(From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months))
- Partial Remission (PR) Rate Based on IRRC Assessment(From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months))
- Duration of Response (DOR) Based on IRRC Assessments(From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months))
- Overall Response Rate (ORR) Based on Investigator Assessments(From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months))