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Peripheral Neuropathy in Patients Receiving Enfortumab Vedotin and Pembrolizumab as First Line Treatment for Metastatic or Locally Advanced Urothelial Carcinoma
Sponsor: Comprehensive Cancer Center Munich (CCCM)
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.
Official title: Peripheral Neuropathy in Patients Receiving Pembrolizumab and Enfortumab Vedotin as First Line Treatment for Metastatic or Locally Advanced Urothelial Carcinoma. An Investigator-Initiated, Prospective, Multicenter, Non-Interventional Trial.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
80
Start Date
2025-01-22
Completion Date
2027-02
Last Updated
2026-02-24
Healthy Volunteers
No
Conditions
Locations (4)
Department of Urology, University Hosptial Augsburg
Augsburg, Bavaria, Germany
Department of Urology, LMU University Hospital, Ludwig-Maximilians-University Munich
Munich, Bavaria, Germany
Department of Urology, Klinikum rechts der Isar, Technical University Munich
Munich, Bavaria, Germany
Department of Urology, University Hospital of Würzburg
Würzburg, Bavaria, Germany