NCT07870577 Peripheral Neuropathy in Patients Receiving Enfortumab Vedotin and Pembrolizumab as Perioperative Systemic Therapy for Urothelial Carcinoma
| NCT ID | NCT07870577 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Comprehensive Cancer Center Munich (CCCM) |
| Condition | Urothelial Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 79 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 79 participants in total. It began in 2026-06-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT07870577 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Urothelial Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07870577 currently recruiting?
Yes, NCT07870577 is actively recruiting participants. Visit ClinicalTrials.gov or contact Comprehensive Cancer Center Munich (CCCM) to inquire about joining.
Where is the NCT07870577 trial being conducted?
This trial is being conducted at Munich, Germany, Munich, Germany, Munich, Germany.
Who is sponsoring the NCT07870577 clinical trial?
NCT07870577 is sponsored by Comprehensive Cancer Center Munich (CCCM). The trial plans to enroll 79 participants.
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