A Phase 1/2 Study Evaluating Brentuximab Vedotin in Combination With Nivolumab in Patients With Relapsed or Refractory Hodgkin Lymphoma After Failure of Frontline Therapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Seagen Inc.
- 入组人数
- 93
- 试验地点
- 13
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to assess the safety profile and antitumor activity of brentuximab vedotin administered in combination with nivolumab in patients with relapsed or refractory Hodgkin lymphoma (HL)
详细描述
This study will examine the safety profile and antitumor activity when brentuximab vedotin is combined with nivolumab. Patients will be treated for up to four 21-day cycles with brentuximab vedotin 1.8 mg/kg and nivolumab 3 mg/kg.
There will be 3 parts to this study. In Part 1, the safety of combination treatment will be evaluated by a Safety Monitoring Committee (SMC) prior to expansion of enrollment to evaluate treatment effect in Part 2. Part 2 of the study will further characterize the safety and antitumor activity of brentuximab vedotin combined with nivolumab by enrolling patients at the recommended dose schedule determined in Part 1. Part 3 of the study will evaluate the safety and antitumor activity of combination treatment administered at an alternate dosing schedule determined by cumulative safety and activity data from Parts 1 and 2.
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
- •Relapsed or refractory Hodgkin lymphoma following failure of standard frontline chemotherapy for the treatment of classical Hodgkin lymphoma
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
排除标准
- •Previously treated with brentuximab vedotin, immune-oncology agents, or received an allogeneic or autologous stem cell transplant
- •Documented history of a cerebral vascular event
- •History of another invasive malignancy that has not been in remission for at least 3 years
- •History of progressive multifocal leukoencephalopathy (PML)
研究组 & 干预措施
Brentuximab Vedotin + Nivolumab
Brentuximab vedotin plus nivolumab
干预措施: brentuximab vedotin (Drug)
Brentuximab Vedotin + Nivolumab
Brentuximab vedotin plus nivolumab
干预措施: nivolumab (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Up to 28.9 months
Treatment-emergent adverse events (TEAEs) are presented and defined as newly occurring (not present at baseline) or worsening after first dose of investigational product. The timeframe includes a 6.01 month safety reporting period and additional long-term follow up through 28.9 months.
Complete Remission Rate
时间窗: Up to 3.42 months
Number of patients with complete metabolic response (CMR) at end of treatment
次要结局
- Duration of Complete Response(Up to 69.3 months)
- Duration of Objective Response(Up to 69.3 months)
- Objective Response Rate(Up to 3.42 months)
- Progression-free Survival Post-autologous Stem Cell Transplant(Up to 67.3 months)