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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: enfortumab vedotin (EV) (Drug)
研究者
Giandomenico Roviello
Professor
University of Florence