NCT06657157Recruiting
Peripheral Neuropathy in Patients Receiving Enfortumab Vedotin and Pembrolizumab as First Line Treatment for Metastatic or Locally Advanced Urothelial Carcinoma
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.
Source: ClinicalTrials.gov · Last updated 24 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 80 (estimated)
- First submitted
- 19 Oct 2024
- Start date
- 22 Jan 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Comprehensive Cancer Center Munich (CCCM)
- Diseases
- Bladder cancer
- NCT number
- NCT06657157
What you commit to
- Study type: Observational
- Planned participants: 80
- From 22 Jan 2025 to the primary completion date, Dec 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- Patients with contraindications for enfortumab vedotin and/or pembrolizumab
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Urology, University Hosptial Augsburg Coordinator of this site? Confirm its status | Augsburg | Germany | Recruiting |
| Department of Urology, Klinikum rechts der Isar, Technical University Munich Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Department of Urology, LMU University Hospital, Ludwig-Maximilians-University Munich Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Department of Urology, University Hospital of Würzburg Coordinator of this site? Confirm its status | Würzburg | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.