Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapies; An Observational Prospective Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Isala
- 入组人数
- 679
- 试验地点
- 1
- 主要终点
- Incidence of infusion related reactions
研究概览
简要总结
This study is an interventional, explorative, prospective study to show whether shortening of infusion times for patients using nivolumab, pembrolizumab, ipilimumab, trastuzumab, bevacizumab, durvalumab or atezolizumab continues to be associated with an acceptable safety profile.
Infusion times will be gradually shortened if tolerability allowes.
详细描述
After two cycles with normal infusion times, infusion time will be shortened to 15 mintues en 10 minutes subsequently if no infusion reaction occurs.
Patient satisfaction will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Starting treatment with monoclonal antibodies: nivolumab, pembrolizumab ipilimumab, bevacizumab, trastuzumab, durvalumab or atezolizumab.
- •18 years and older.
- •No known history of increased susceptibility to immunological reactions.
- •Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
排除标准
- •Other research medication within 4 weeks of the start of the study.
- •Inclusion in medical research in which the administration of medication should follow its stated times and dosages of infusions
- •Dosage deviates from standard protocol
- •Patients whom receive drugs through a central venous catheter (and for example porth-a-cath).
研究组 & 干预措施
Nivolumab
If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
干预措施: Nivolumab (Drug)
Pembrolizumab
If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
干预措施: Pembrolizumab (Drug)
ipilimumab
If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
干预措施: Ipilimumab (Drug)
Durvalumab
If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
干预措施: Durvalumab (Drug)
Atezolizumab
If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
干预措施: Atezolizumab (Drug)
bevacizumab
If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
干预措施: Bevacizumab (Drug)
Trastuzumab
If no infusion reaction has occurred after 2 cyclues, infusion time will stepwise be shortened to 10 minutes in the following cycles.
干预措施: Trastuzumab (Drug)
结局指标
主要结局
Incidence of infusion related reactions
时间窗: During or within 30 minutes after the end of the infusion
次要结局
- Plasma levels of the administered mAb(Within 15 minutes before start of the infusion)