Study of Peripheral Neuropathy in Patients With Advanced Urothelial Cancer Treated With Enfortumab Vedotin and Pembrolizumab With Supportive Neuridase (ENDEAVOR) (ENDEAVOR)
ENDEAVOR Study: A Prospective Exploratory Study Describing the Course of Peripheral Neuropathy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Treated With Enfortumab Vedotin in Combination With Pembrolizumab and Supportive Neuridase
his prospective exploratory study aims to describe the course of peripheral neuropathy in patients with locally advanced or metastatic urothelial carcinoma treated with enfortumab vedotin in combination with pembrolizumab and receiving supportive Neuridase.
Peripheral neuropathy is a common adverse event associated with enfortumab vedotin and may negatively affect treatment tolerability, quality of life, and treatment continuation. Neuridase is a non-pharmacological supportive product intended to support peripheral nervous system function; however, its role in this clinical setting has not yet been established.
Participants enrolled in this single-arm study will receive standard-of-care treatment with enfortumab vedotin plus pembrolizumab, together with supportive Neuridase according to clinical practice. The study will prospectively assess neuropathy symptoms and severity using clinical evaluations and patient-reported outcome measures, including quality-of-life questionnaires, over the course of treatment.
The objective of the study is to explore neuropathy patterns and treatment tolerability in this patient population.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Lorenzo Antonuzzo, MD Phd, MD
- 电话号码：055-5465353
- 邮箱：lorenzo.antonuzzo@unifi.it
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
IInclusion Criteria:
- Age ≥18 years
- Histologically confirmed locally advanced or metastatic urothelial carcinoma
- Candidate for treatment with enfortumab vedotin in combination with pembrolizumab according to clinical practice
- Ability to provide written informed consent
- Adequate clinical conditions to participate in the study according to investigator judgment
Exclusion Criteria:
- Pre-existing severe peripheral neuropathy that may interfere with study assessments
- Contraindications to enfortumab vedotin or pembrolizumab according to clinical practice
- Known hypersensitivity to components of Neuridase
- Pregnancy or breastfeeding
- Any medical, psychiatric, or social condition that, in the investigator's judgment, may interfere with study participation or interpretation of results
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：arm label
Neuridase: Participants with locally advanced or metastatic urothelial carcinoma will receive standard-of-care enfortumab vedotin in combination with pembrolizumab together with supportive Neuridase according to the study protocol. Peripheral neuropathy symptoms, treatment tolerability, and patient-reported outcomes will be prospectively assessed during treatment. |
Standard-of-care enfortumab vedotin administered according to approved clinical practice.
Standard-of-care pembrolizumab administered in combination with enfortumab vedotin according to approved clinical practice.
Supportive non-pharmacological product administered during treatment with enfortumab vedotin and pembrolizumab to prospectively explore peripheral neuropathy trajectory, tolerability, and patient-reported outcomes.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence and Severity of Peripheral Neuropathy
大体时间：From baseline to 6 months after treatment initiation
|
Incidence and severity of peripheral neuropathy will be prospectively assessed according to clinical evaluation and CTCAE criteria in patients receiving enfortumab vedotin plus pembrolizumab with supportive Neuridase.
|
From baseline to 6 months after treatment initiation
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- ENDEAVOR
- CE 30693_spe (注册表标识符：CE Careggi)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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