Peripheral Neuropathy in Patients Receiving Enfortumab Vedotin and Pembrolizumab as Perioperative Systemic Therapy for Urothelial Carcinoma
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
P-EVOLVE is a prospective, multicenter, non-interventional observational study in adults with muscle-invasive urothelial carcinoma who receive perioperative treatment with enfortumab vedotin and pembrolizumab as part of routine clinical care. The study is designed to describe how peripheral neuropathy develops and changes during treatment and whether symptoms persist at the end of treatment. Peripheral neuropathy will be assessed using patient-reported questionnaires, standardized neurological examinations, and nerve conduction studies. The study will also assess neuropathic pain, neurotoxicity-related quality of life, depressive symptoms, and changes in taste and smell. Objective gustatory function will be evaluated using standardized Taste Strip testing. Study assessments will be performed before treatment, during the neoadjuvant and adjuvant treatment phases, around radical cystectomy, and at the end of treatment. Participation in the study does not determine whether treatment is started or how treatment is given. All anticancer treatment decisions remain part of routine clinical care. The study aims to improve understanding of the onset, severity, longitudinal course, and persistence of peripheral neuropathy associated with perioperative enfortumab vedotin and pembrolizumab and to compare patient-reported symptoms with objective neurological and neurophysiological findings.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Potwierdzony diagnozą rak pęcherza moczowego (zaawansowany, wnikający w mięśnie)
- •Brak wcześniejszego leczenia systemowego (podawanego do całego organizmu) z powodu tego nowotworu
- •Kwalifikacja do leczenia obiema lekami stosowanymi w badaniu zgodnie z zaleceniami producenta
✗ Disqualifies
- •Przeciwwskazania do stosowania któregoś z leków badawczych
- •Wcześniejsze leczenie systemowe raka pęcherza (np. chemioterapia, immunoterapia)
- •Wcześniejsza terapia podobnymi lekami lub inhibitorami PD-1/PD-L1
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- October 13, 2026
- Sex
- No restrictions
Locations (3)
Department of Urology, Krankenhaus Barmherzige Brüder
Munich, Germany
Department of Urology, LMU University Hospital, Ludwig-Maximilians-University Munich
Munich, Germany
Department of Urology, Klinikum rechts der Isar, Technical University Munich
Munich, Germany
Trial contact
Tobias Hauser, MD
Jozefina Casuscelli
Kira Schüller, MD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/14/2026.
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