Nerve Side Effects in Bladder Cancer Patients Receiving Enfortumab Vedotin and Pembrolizumab
Observes nerve damage in adults with urothelial cancer receiving enfortumab vedotin and pembrolizumab.
Plain-language title generated from the registry record
Registry title: Peripheral Neuropathy in Patients Receiving Enfortumab Vedotin and Pembrolizumab as First Line Treatment for Metastatic or Locally Advanced Urothelial Carcinoma
Key facts
- Where
- Augsburg, Munich, and Würzburg, GermanySee the 4 sites
Where in Germany
- Department of Urology, University Hosptial AugsburgAugsburg, GermanyTaking people
- Department of Urology, Klinikum rechts der Isar, Technical University MunichMunich, GermanyTaking people
- Department of Urology, LMU University Hospital, Ludwig-Maximilians-University MunichMunich, GermanyTaking people
- Department of Urology, University Hospital of WürzburgWürzburg, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Comprehensive Cancer Center Munich (CCCM)
- Trial code
- NCT06657157
- Record updated
- 24 February 2026
- Original description
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.Read full original descriptionShow less
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.
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.
Inclusion: Adult patients, ≥18 years of age at the time of signing the informed consent form (ICF); Patients with histologically confirmed metastatic or locally advanced, unresectable urothelial carcinoma; Patients who did not receive any systemic treatment for their laUC or mUC (treatment-naïve); Patients who are able to receive enfortumab vedotin and pembrolizumab according to the respective medicinal product information.
Exclusion: Patients who have received a systemic therapy for their laUC or mUC (e.g. platinum-based chemotherapy, checkpoint-inhibitors); Patients who have previously been treated with enfortumab vedotin, other MMAE-based antibody-drug-conjugates or PD-(L)1-checkpoint inhibitors; Patients who received neoadjuvant or adjuvant platinum-based chemotherapy <12 months ago; Patients with contraindications for enfortumab vedotin and/or pembrolizumab.