A Phase Ib/II Randomized Double-blind Placebo Controlled Trial Evaluating the Effect of Nivolumab for Patients With In-transit Melanoma Metastases Treated With Isolated Limb Perfusion - the NivoILP Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 74
- 试验地点
- 3
- 主要终点
- Complete response rate (CR)
研究概览
简要总结
To evaluate safety and the effect of isolated limb perfusion together with nivolumab as a way to increase efficacy and give further insights in early immunological mechanisms.
In the first phase Ib part, 20 patients will be enrolled and followed for a minimum of 3 months. An independent data safety monitoring board (DSMB) will continuously review safety and judge the seriousness of the events and also recommend the study to stop if necessary. If the DSMB do not find safety issues, the trial will continue as a phase II trial.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ILP + Nivolumab
The day before planned ILP, the patient will receive one infusion of nivolumab 480mg
干预措施: Nivolumab (Drug)
ILP + Nivolumab
The day before planned ILP, the patient will receive one infusion of nivolumab 480mg
干预措施: Isolated limb perfusion (ILP) (Procedure)
ILP + Placebo
The day before planned ILP, the patient will receive one infusion of placebo
干预措施: Isolated limb perfusion (ILP) (Procedure)
结局指标
主要结局
Complete response rate (CR)
时间窗: 3 months
To evaluate if melphalan based isolated limb perfusion (ILP) synergizes with nivolumab in inducing complete responses (CR) at 3 months after treatment in melanoma patients with in-transit metastasis.
次要结局
- Progression-free survival (PFS)(36 months)
- Melanoma specific survival (MSS)(36 months)
- Quality of life measured by FACT-M(36 months)
- Time to local progression (TTLP)(36 months)
- Distant metastases-free survival (DMFS)(36 months)
- Overall survival (OS)(36 months)
- Quality of life measured by EQ-5D(36 months)
研究者
Roger Olofsson Bagge
Associate professor
Sahlgrenska University Hospital, Sweden