EICHORCondition: Urothelial Cancer · Sponsor: Comprehensive Cancer Center Munich (CCCM)
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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.
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
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Inclusion Criteria: * 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 Criteria: * 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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Department of Urology, University Hosptial Augsburg | Augsburg, Bavaria, Germany | Recruiting |
| Department of Urology, LMU University Hospital, Ludwig-Maximilians-University Munich | Munich, Bavaria, Germany | Recruiting |
| Department of Urology, Klinikum rechts der Isar, Technical University Munich | Munich, Bavaria, Germany | Recruiting |
| Department of Urology, University Hospital of Würzburg | Würzburg, Bavaria, Germany | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06657157