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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-22

Study Completion Date

2027-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Urothelial Cancer

Keywords

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enfortumab vedotin Pembrolizumab peripheral neuropathy metastatic urothelial carcinoma advanced urothelial carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Can Aydogdu, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Munich, Bavaria, Germany

Site Status RECRUITING

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

Munich, Bavaria, Germany

Site Status NOT_YET_RECRUITING

Countries

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Germany

Facility Contacts

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Jozefina Casuscelli

Role: primary

Kira Schüller