A Phase II, Open Label, Single Arm, Single Center Study to Evaluate Pyrexia Management (with or Without Any Other Cytokine Release Symptoms) Using Tocilizumab, an Humanized Monoclonal Antibody Against the Interleukin - 6 Receptor in BRAF+ Melanoma Patients Treated with Dabrafenib/ Trametinib +/- Immunotherapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pyrexia management
研究概览
简要总结
The study examines the development of fever after administration of Actemra (tocilizumab) in patients who have fever and other cytokine release symptoms (headache, nausea, palpitations, low blood pressure) due to cancer therapy (Tafinlar (dabrafenib) / Mekinist (trametinib) +/- immunotherapy) . The goal of the study is to better understand the side effects and to find an effective therapy against them.
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
- •Informed Consent as documented by signature
- •Subjects (males and females) age ≥ 18 years
- •Subjects with pyrexia grade 1*- 4 and elevated CRP with persistent fever after one day of antipyretic therapy with or without at least one other additional symptom of cytokine release syndrome such as nausea, headache, tachycardia, hypotension, maculopapular rash, shortness of breath, transaminitis, renal failure, dehydration
- •Elevated CRP serum levels further than normal baseline levels (> 3.0 mg/L)
- •Subjects with resected, non-resectable, adjuvant or metastatic BRAF+ melanoma treated with :
- •BRAF inhibitor (dabrafenib) in combination with MEK inhibitor (trametinib)
- •BRAF inhibitor (dabrafenib) in combination with MEK inhibitor (trametinib) preceded by therapy with anti-PD-1/PD-L1 and/or anti CTLA-4 inhibitor
- •BRAF inhibitor (dabrafenib) in combination with MEK inhibitor (trametinib) plus anti-PD- 1/PD-L1 inhibitor
排除标准
- 未提供
研究组 & 干预措施
Treatment arm
The patients will be administered Tocilizmab (Actemra) at the following dosage :
- First dose: 8mg/kg, max. 800mg iv. during 60min
- If necessary second dose: 8mg/kg, max. 800mg iv. during 60min after 20-36 hours from first dose
干预措施: Actemra (Drug)
结局指标
主要结局
Pyrexia management
时间窗: 1 hour to up to 72 hours.
The primary outcome represents the proportion of patients that reduce to at least \<38°C after tocilizumab infusion in BRAF+ melanoma patients under treatment with dabrafenib/trametinib +/- immunotherapy - pyrexia status will be assessed at screening visit and on every other defined visit until remission, by assessing body temperature.
次要结局
未报告次要终点