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RecruitingNCT06657157

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

Peripheral Neuropathy in Patients Receiving Pembrolizumab and Enfortumab Vedotin as First Line Treatment for Metastatic or Locally Advanced Urothelial Carcinoma. An Investigator-Initiated, Prospective, Multicenter, Non-Interventional Trial.

Sponsor

Comprehensive Cancer Center Munich (CCCM)

Enrollment

80 participants

Start Date

Jan 22, 2025

Study Type

OBSERVATIONAL

Conditions

Urothelial Cancer

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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

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Locations(4)

Department of Urology, University Hosptial Augsburg

Augsburg, Bavaria, Germany

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

Munich, Bavaria, Germany

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

Munich, Bavaria, Germany

Department of Urology, University Hospital of Würzburg

Würzburg, Bavaria, Germany

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NCT06657157

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