NCT07870577Recruiting
Peripheral Neuropathy in Patients Receiving Enfortumab Vedotin and Pembrolizumab as Perioperative Systemic Therapy for Urothelial Carcinoma
Peripheral Neuropathy in Patients Receiving Enfortumab Vedotin and Pembrolizumab as Perioperative Systemic Therapy for Urothelial Carcinoma. An Investigator-Initiated, Prospective, Multicenter, Non-Interventional Trial.
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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 cystectomy, and at the end of treatment. Participation in the study does not determine whether treatment is started or how treatment is given. All anticancer treatment decisions remain part of routine clinical care. The study aims to improve understanding of the onset, severity, longitudinal course, and persistence of peripheral neuropathy associated with perioperative enfortumab vedotin and pembrolizumab and to compare patient-reported symptoms with objective neurological and neurophysiological findings.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 79 (estimated)
- First submitted
- 1 Oct 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Comprehensive Cancer Center Munich (CCCM)
- Diseases
- Bladder cancer
- NCT number
- NCT07870577
What you commit to
- Study type: Observational
- Planned participants: 79
- From 1 Jun 2026 to the primary completion date, 31 Dec 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- Patients with contraindications to enfortumab ve-dotin and/or pembrolizumab
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Urology, Klinikum rechts der Isar, Technical University Munich Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Department of Urology, Krankenhaus Barmherzige Brüder Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Department of Urology, LMU University Hospital, Ludwig-Maximilians-University Munich Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.