Peripheral Neuropathy in Patients Receiving Enfortumab Vedotin and Pembrolizumab as First Line Treatment for Metastatic or Locally Advanced Urothelial Carcinoma
Recruiting now
Conditions studied: Urothelial Cancer
In brief
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.
Key facts
- Study ID
- NCT06657157
- Run by
- Comprehensive Cancer Center Munich (CCCM)
- People needed
- 80
- Starts
- 2025-01-22
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2026-02-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Patients with contraindications for enfortumab vedotin and/or pembrolizumab
- 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
Where it is running
- Department of Urology, University Hosptial Augsburg — Augsburg, Bavaria, Germany (enrolling)
- Department of Urology, LMU University Hospital, Ludwig-Maximilians-University Munich — Munich, Bavaria, Germany (enrolling)
- Department of Urology, Klinikum rechts der Isar, Technical University Munich — Munich, Bavaria, Germany (enrolling)
- Department of Urology, University Hospital of Würzburg — Würzburg, Bavaria, Germany (enrolling)
Full record on ClinicalTrials.gov
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