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.
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
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
Comprehensive Cancer Center Munich (CCCM)
Lead sponsor
Ludwig-Maximilians - University of Munich
Collaborator
Department of Urology, TUM Klinikum rechts der Isar, Munich, Germany
Collaborator
Department of Urology, Augsburg University Hospital, Augsburg, Germany
Collaborator
Wuerzburg University Hospital
Collaborator