Peripheral Neuropathy in Patients Receiving Enfortumab Vedotin and Pembrolizumab as First Line Treatment for Metastatic or Locally Advanced Urothelial Carcinoma
NCT06657157 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80
Last updated 2026-02-24
Summary
The P-EVOLUTION trial is a prospective, multicenter, non-interventional observational study aimed at investigating peripheral neuropathy in patients receiving first-line treatment for metastatic or locally advanced urothelial carcinoma with enfortumab vedotin (EV) and pembrolizumab (P). Conducted at two German university hospitals, the study will track the incidence and severity of peripheral neuropathy, its impact on quality of life, and treatment regimen adjustments due to side effects. Approximately 80 patients are expected to be enrolled over one year.
Conditions
Sponsors & Collaborators
-
Department of Urology, LMU University Hospital Munich, Munich, Germany
collaborator UNKNOWN -
Department of Urology, TUM Klinikum rechts der Isar, Munich, Germany
collaborator UNKNOWN -
Department of Urology, Augsburg University Hospital, Augsburg, Germany
collaborator UNKNOWN -
Department of Urology, University Hospital of Würzburg, Würzburg, Germany
collaborator UNKNOWN -
Comprehensive Cancer Center Munich (CCCM)
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-22
- Primary Completion
- 2026-12-31
- Completion
- 2027-02-28
Countries
- Germany
Study Locations
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