Study of Peripheral Neuropathy in Patients With Advanced Urothelial Cancer Treated With Enfortumab Vedotin and Pembrolizumab With Supportive Neuridase (ENDEAVOR)

Официальное название

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

Обзор

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.

Вмешательства

• Препарат enfortumab vedotin (EV)
  Standard-of-care enfortumab vedotin administered according to approved clinical practice.
• Препарат PEMBROLIZUMAB (alone or when added to a regimen above)
  Standard-of-care pembrolizumab administered in combination with enfortumab vedotin according to approved clinical practice.
• Другое Neuridase
  Supportive non-pharmacological product administered during treatment with enfortumab vedotin and pembrolizumab to prospectively explore peripheral neuropathy trajectory, tolerability, and patient-reported outcomes.

Первичные конечные точки

• Incidence and Severity of Peripheral Neuropathy [Срок оценки: From baseline to 6 months after treatment initiation]

Критерии участия

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07629700 · ENDEAVOR · CE 30693_spe

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗