Safety and Modulation of Adaptive Immunity by Iscador® Qu Viscum Album Extract in Patients With Advanced, Recurrent or Metastatic Cancers Treated With Immune Checkpoint Inhibitors - a Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Percentage of patients with a relative increase in T cell richness or diversity of 20% or more
研究概览
简要总结
The main objective of this study is to test if adding the mistletoe extract Iscador® Qu to regular cancer treatment with immune checkpoint inhibitors affects:
- The immune system's ability to fight cancer
- Safety of the treatment
- How well the treatment performs against cancer
- How the patient feels during treatment
Researchers will compare patients treated with immune checkpoint inhibitors plus Iscador® Qu with patients treated with imune checkpoint inhibitors only.
详细描述
The impact of mistletoe preparations - that are claimed to have immunostimulatory properties - on cancer treatment with immune checkpoint inhibitors remains unclear. To address this knowledge gap, the current study aims to investigate the modulation of adaptive immunity through the combination of Iscador (a specific mistletoe preparation) and immune checkpoint inhibitors. Additionally, researchers will evaluate the safety profile of this combination therapy in patients with locally advanced non-operable or metastatic cancers except for skin cancers. By examining the modulation of adaptive immunity and safety of this treatment approach, researchers aim to provide valuable insights for clinicians and patients in the context of advanced cancer care.
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
- •Locally advanced non-operable or metastatic solid tumor, except for skin cancer
- •Eligible for routine (standard) treatment with immune checkpoint inhibitor (+/- chemo/targeted therapy) as per the discretion of the local investigator
- •Subjects must be eligible for treatment with mistletoe preparations (controlled brain metastases, prednisolone equivalent below 10mg, no known hypersensitivity)
- •ECOG (Eastern Cooperative Oncology Group) performance status score of 0-2
- •Males and Females at least 18 years of age; no subjects under tutelage
- •No previous mistletoe treatment
排除标准
- •Contraindications to Iscador® Qu or immune checkpoint inhibitors, e.g. hypersensitivity, active autoimmune disorder
- •Patients with skin cancer
- •Participation in another study with investigational drug within 30 days prior to enrolment (participation in observational studies or diagnostic studies without a particular drug intervention are allowed)
- •Enrolment of the investigator, his/her family members, employees and other dependent
研究组 & 干预措施
Arm A: Immune checkpoint inhibitors plus Iscador® Qu
Patients randomized to Arm A will be treated with Immune checkpoint inhibitors plus Iscador® Qu.
干预措施: Immune checkpoint inhibitors plus Iscador® Qu. (Drug)
Arm B: Immune checkpoint inhibitors
Patients randomized to Arm B will be treated with Immune checkpoint inhibitors only.
干预措施: Immune Checkpoint Inhibitors (Drug)
结局指标
主要结局
Percentage of patients with a relative increase in T cell richness or diversity of 20% or more
时间窗: baseline and 12 weeks (+/- 2 weeks)
Percentage of patients with a relative increase in T cell richness or diversity of 20% or more as measured by peripheral blood T cell receptor Next-generation sequencing.
Percentage of patients with a relative decrease in T cell clonality of 20% or more
时间窗: baseline and 12 weeks (+/- 2 weeks)
Percentage of patients with a relative decrease in T cell clonality of 20% or more as measured by peripheral blood T cell receptor Next-generation sequencing.
Level of T cell richness
时间窗: baseline and 12 weeks (+/- 2 weeks)
Level of T cell richness as measured by peripheral blood T cell receptor Next-generation sequencing.
Level of T cell diversity
时间窗: baseline and 12 weeks (+/- 2 weeks)
Level of T cell diversity as measured by peripheral blood T cell receptor Next-generation sequencing.
Level of T cell clonality
时间窗: baseline and 12 weeks (+/- 2 weeks)
Level of T cell clonality as measured by peripheral blood T cell receptor Next-generation sequencing.
次要结局
- Safety and tolerability according to the NCI CTC AE v5(up to 18 weeks)
- Rate of early immune checkpoint inhibitor-based treatment termination(up to 24 months)
- Best tumor response(up to 24 months)
- Progression-free survival(up to 24 months)
- Overall survival(up to 24 months)
- EORTC QLQ C30(up to 24 months)