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

NCT07870577 · tracked via the Priya Life Science Germany tracker

Sponsor

Comprehensive Cancer Center Munich (CCCM)

Phase

Observational

Started

2026-06-01

Last updated

2026-10-13

Condition(s) studied

Urothelial CancerMIBC

Study 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

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 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

Primary outcome measure(s)

Change From Baseline to End of Treatment in Sensory Peripheral Neuropathy Symptoms Assessed by the EORTC QLQ-CIPN20 Sensory Subscale — Baseline, within 14 days before initiation of neoadjuvant therapy, to end of treatment (EOT) ±14 days
Change from baseline to end of treatment (EOT) in the sensory subscale score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20 (EORTC QLQ-CIPN20). The sensory subscale is scored according to the EORTC scoring manual and linearly transformed to a 0 to 100 scale, with higher scores indicating greater peripheral neuropathy symptom burden. The individual change score is calculated as the EOT score minus the baseline score.

Trial sites (3)

Facility	City	Region	Status
Department of Urology, Krankenhaus Barmherzige Brüder	Munich	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

More Comprehensive Cancer Center Munich (CCCM) trials in Germany

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

Other trials for the same condition

Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma 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

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

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

Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy 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 NCT07870577 on ClinicalTrials.gov ↗ ← All trials in Germany