Peripheral Neuropathy in Patients Receiving Enfortumab Vedotin and Pembrolizumab as First Line Treatment for Metastatic or Locally Advanced Urothelial Carcinoma

NCT06657157 · tracked via the Priya Life Science Germany tracker

Sponsor

Comprehensive Cancer Center Munich (CCCM)

Phase

Observational

Started

2025-01-22

Last updated

2026-02-24

Condition(s) studied

Urothelial Cancer

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Incidence of peripheral neuropathy ≥ CTCAE grade 2 — baseline, week 18, week 36, week 52, and End of Treatment (defined as the administration of the last dose of EV/P)
Incidence of peripheral neuropathy ≥ grade 2 at baseline, week 18, week 36, week 52, and at End of Treatment (defined as the administration of the last dose of EV/P) assessed by the Patient Neurotoxicity Questionnaire (PNQ)

Trial sites (4)

Facility	City	Region	Status
Department of Urology, University Hosptial Augsburg	Augsburg	Bavaria	Recruiting
Department of Urology, LMU University Hospital, Ludwig-Maximilians-University Munich	Munich	Bavaria	Recruiting
Department of Urology, Klinikum rechts der Isar, Technical University Munich	Munich	Bavaria	Recruiting
Department of Urology, University Hospital of Würzburg	Würzburg	Bavaria	Recruiting

Other trials for the same condition

Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy Recruiting

A Study Evaluating Different Immunotherapies (LAG-3 and PD-1 With or Without TIGIT, Compared to PD-L1 Alone) in Participants With Untreated Locally Advanced Metastatic Urothelial Cancer Active, not recruiting

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer Active, not recruiting

An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer Active, not recruiting

Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06657157 on ClinicalTrials.gov ↗ ← All trials in Germany