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

NCT06657157 | Recruiting

• 1 other identifier: P-EVOLUTION
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Urothelial Cancer

Keywords

enfortumab vedotin; Pembrolizumab; peripheral neuropathy; metastatic urothelial carcinoma; advanced urothelial carcinoma

Outcome Measures

Primary Outcomes (1)

• Incidence of peripheral neuropathy ≥ CTCAE grade 2

  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)

  baseline, week 18, week 36, week 52, and End of Treatment (defined as the administration of the last dose of EV/P)

Secondary Outcomes (13)

• Change of degree of sensory, motor and/or autonomic peripheral neuropathy applying the EORTC-CIPN20 questionnaire

  Baseline, week 18, week 36, week 52, and End of Treatment (defined as the administration of the last dose of EV/P)

• Change of Quality of life (QoL) applying the FACT/GOG-NTX questionnaire

  Baseline, week 18, week 36, week 52, and End of Treatment (defined as the administration of the last dose of EV/P)

• Change of neuropathic pain applying the Neuropathic Pain Symptom Inventory (NPSI) questionnaire

  Baseline, week 18, week 36, week 52, and End of Treatment (defined as the administration of the last dose of EV/P)

• Change of depression based on the Allgemeine Depressionsskala (ADS)

  Baseline, week 18, week 36, week 52, and End of Treatment (defined as the administration of the last dose of EV/P)

• Time to onset of peripheral neuropathy ≥ CTCAE grade 2

  From the administration of the first dose of EV/P to the end of treatment (defined as the administration of the final dose of EV/P), which is expected to occur after approximately one year.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients meeting the eligibility criteria and are treated at the tertiary care centers LMU Munich and TUM Munich.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Comprehensive Cancer Center Munich (CCCM): lead
• Department of Urology, LMU University Hospital Munich, Munich, Germany: collaborator
• Department of Urology, Augsburg University Hospital, Augsburg, Germany: collaborator
• Department of Urology, TUM Klinikum rechts der Isar, Munich, Germany: collaborator
• Department of Urology, University Hospital of Würzburg, Würzburg, Germany: collaborator

Study Sites (4)

Department of Urology, University Hosptial Augsburg

Augsburg, Bavaria, 86156, Germany

RECRUITING

Department of Urology, LMU University Hospital, Ludwig-Maximilians-University Munich

Munich, Bavaria, 81377, Germany

RECRUITING

Department of Urology, Klinikum rechts der Isar, Technical University Munich

Munich, Bavaria, 81675, Germany

RECRUITING

Department of Urology, University Hospital of Würzburg

Würzburg, Bavaria, 97080, Germany

RECRUITING

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 19, 2024
• First Posted: October 24, 2024
• Study Start: January 22, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

DE (4)