Peripheral neuropathy during perioperative therapy with enfortumab vedotin and pembrolizumab in muscle-invasive urothelial cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

P-EVOLVE is a multicenter, prospective observational study of adults with muscle-invasive urothelial carcinoma who are treated with perioperative enfortumab vedotin and pembrolizumab as part of routine care. The study documents the onset and progression of peripheral neuropathy using patient questionnaires, neurological exams, and nerve conduction tests, and also tracks neuropathic pain, quality of life related to neurotoxicity, depressive symptoms, and changes in taste and smell withTaste Strip testing. Assessments occur before treatment, during neoadjuvant and adjuvant therapy, around radical cystectomy, and at the end of treatment to describe the trajectory of neuropathy and related factors. Participation does not influence treatment decisions or access.

Why it matters

Who can join: the full rules

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

Where it's running

• Department of Urology, Krankenhaus Barmherzige Brüder
  Munich, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.