Nivolumab Dose Optimization in Patients With a Complete, Partial or Stable Response
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Difference between the nivolumab mean trough level after 3 reduced doses (240 mg every 4 weeks) and after the first dose of 6 mg/kg or 480 mg.
研究概览
简要总结
Patients with advanced melanoma are, amongst others, currently treated with nivolumab monotherapy or with nivolumab and ipilimumab followed by nivolumab. Even though registration studies administered nivolumab in a 3 mg/kg 2 weekly scheme, currently, nivolumab monotherapy is either administered in a 240 mg 2-weekly scheme or in a 6 mg/kg or 480 mg 4-weekly scheme. With the current dosing regimen, steady-state is achieved after approximately 5 to 6 months, whereas a tumour response is usually observed earlier in patients with metastatic melanoma. Moreover, PD-1 receptor occupancy is almost saturated above doses of 0.3 mg/kg, or at nivolumab serum levels of 10 mg/L, which is a concentration that is achieved after one treatment cycle. In melanoma patients, the additional probability on response in patients treated with 3 mg/kg compared to 1 mg/kg seems limited. PFS and OS for 3 mg/kg were not superior to 1 mg/kg. Therefore, in this study, our aim is to investigate nivolumab trough levels and pharmacokinetic parameters after 3 reduced nivolumab doses.
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
- •Age ≥ 18 years
- •Advanced or metastatic melanoma
- •Current treatment with nivolumab for advanced or metastatic melanoma, in a 6 mg/kg or 480 mg, 4 weekly scheme
- •Documented confirmed and ongoing CR, PR or SD according to RECIST v1.1
- •On treatment for at least 6 months
排除标准
- •Unable to draw blood for study purposes
- •Patients willing to participate or already included in the SAFE-STOP trial
研究组 & 干预措施
Nivolumab
Patients in the experimental arm receive three reduced nivolumab doses of 240 mg Q4W
干预措施: Nivolumab (Drug)
结局指标
主要结局
Difference between the nivolumab mean trough level after 3 reduced doses (240 mg every 4 weeks) and after the first dose of 6 mg/kg or 480 mg.
时间窗: Through study completion, an average of four months
Difference between the nivolumab mean trough level after 3 reduced doses (240 mg every 4 weeks) and after the first dose of 6 mg/kg or 480 mg.
次要结局
- - PD-1 receptor occupancy in PBMCs, measured 4 weeks after 3 reduced nivolumab doses(Through study completion, an average of four months)
- Grade ≥3 adverse events (CTCAE) during reduced doses(Through study completion, an average of four months)
- Number of patients with new PD during 3 reduced doses(Through study completion, an average of four months)
研究者
S. L. W. (Stijn) Koolen
Principal Investigator
Erasmus Medical Center