A Randomized Study Investigating the Pharmacokinetics of Standard Interval Dosing Compared to Extended Interval Dosing of Nivolumab or Pembrolizumab in Locally Advanced or Metastatic Cancers
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 264
- 试验地点
- 2
- 主要终点
- Noninferiority margin of extended interval dosing compared to standard dosing
研究概览
简要总结
A randomized research study of drugs nivolumab and pembrolizumab in patients with locally advanced or metastatic cancers. Based on data from earlier studies it appears that the drugs can be given less often then the currently approved schedule. This trial will compare drug levels from the blood from standard interval dosing levels versus taking the drugs less often.
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
- 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
- •Patients with locally advandced or metastatic cancer whose physician has determined they are candidates for treatment with nivolumab or pembrolizumab
- •18 years old or older
- •Measurable disease per RECIST criteria
排除标准
- •Patients who have previously received immune checkpoint inhibitors or investigational monoclonal antibody therapy.
- •Patients whose treatment plan is to receive ipilimumab or other anti-CTLA4 monoclonal antibody in combination with either nivolumab or pembrolizumab.
- •Ipilimumab and nivolumab combination are not eligible for this trial.
- •(Note: Patients whose planned treatment is the combination of anti-PD-1 and tyrosine kinase inhibitor such as pembrolizumab-axitinib or the combination of traditional cytotoxic chemotherapy and anti-PD-1 are eligible)
研究组 & 干预措施
standard interval dosing
干预措施: Nivolumab Standard (Drug)
standard interval dosing
干预措施: Pembrolizumab Standard (Drug)
extended interval dosing
干预措施: Nivolumab Extended (Drug)
extended interval dosing
干预措施: Pembrolizumab Extended (Drug)
结局指标
主要结局
Noninferiority margin of extended interval dosing compared to standard dosing
时间窗: 2 years
To assess the noninferiority of pharmacokinetic success, defined as drug trough levels above the target concentration of 1.5 µg/mL. Evaluable patients will be categorized as success or failure for this primary objective.
次要结局
- Compare the efficacy of extended interval and standard interval dosing(2 years)