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Peripheral Neuropathy in Patients Receiving Enfortumab Vedotin and Pembrolizumab as Perioperative Systemic Therapy for Urothelial Carcinoma

Recruitingn/aAges 18 Years - anyAllComprehensive Cancer Center Munich (CCCM)
NCT07870577 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

P-EVOLVE is a prospective, multicenter, non-interventional observational study in adults with muscle-invasive urothelial carcinoma who receive perioperative treatment with enfortumab vedotin and pembrolizumab as part of routine clinical care. The study is designed to describe how peripheral neuropathy develops and changes during treatment and whether symptoms persist at the end of treatment. Peripheral neuropathy will be assessed using patient-reported questionnaires, standardized neurological examinations, and nerve conduction studies. The study will also assess neuropathic pain, neurotoxicity-related quality of life, depressive symptoms, and changes in taste and smell. Objective gustatory function will be evaluated using standardized Taste Strip testing. Study assessments will be performed before treatment, during the neoadjuvant and adjuvant treatment phases, around radical cystecto

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adult patients ≥18 years of age at the time of signing the informed consent form (ICF) * Patients with histologically confirmed muscle-invasive urothelial carcinoma * Patients who have not received any prior systemic treatment for muscle-invasive bladder cancer * Patients who are eligible to receive enfortumab ve-dotin and pembrolizumab according to the respec-tive medicinal product information Exclusion Criteria: * Patients with contraindications to enfortumab ve-dotin and/or pembrolizumab * Patients who have received prior systemic therapy for muscle-invasive bladder cancer (e.g. platinum-based chemotherapy, immune checkpoint inhibitors) * Patients who have previously been treated with en-fortumab vedotin, other MMAE-based antibody-drug conjugates, or PD-(L)1 inhibitors
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What it tests

  • Not listed
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Where

3 sites
Department of Urology, Krankenhaus Barmherzige Brüder
Munich, Germany
Department of Urology, LMU University Hospital, Ludwig-Maximilians-University Munich
Munich, Germany
Department of Urology, Klinikum rechts der Isar, Technical University Munich
Munich, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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