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

No results posted yet for this study

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06657157 on ClinicalTrials.gov