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RECRUITING
NCT06657157

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)

View on ClinicalTrials.gov

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

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