Investigating nerve damage in patients treated for advanced bladder cancer
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.
This study is testing how the treatments enfortumab vedotin and pembrolizumab affect nerve damage and quality of life in people with advanced bladder cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Comprehensive Cancer Center Munich (CCCM) Academic / other |
| Drugs / interventions | enfortumab, pembrolizumab, chemotherapy |
| Locations | 4 sites (Augsburg, Bavaria and 3 other locations) |
| Trial ID | NCT06657157 on ClinicalTrials.gov |
What this trial studies
This observational study, known as the P-EVOLUTION trial, aims to assess the incidence and severity of peripheral neuropathy in patients receiving first-line treatment for metastatic or locally advanced urothelial carcinoma with enfortumab vedotin and pembrolizumab. Conducted at two university hospitals in Germany, the study will monitor how these treatments affect patients' quality of life and whether treatment regimens need to be adjusted due to side effects. Approximately 80 treatment-naïve patients will be enrolled over the course of one year to gather comprehensive data on this side effect.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed metastatic or locally advanced unresectable urothelial carcinoma who have not received prior systemic treatment.
Not a fit: Patients who have contraindications for enfortumab vedotin or pembrolizumab, or those who have previously received systemic therapy for their condition, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into managing peripheral neuropathy in patients undergoing treatment for advanced bladder cancer.
How similar studies have performed: While this study focuses on a specific combination of treatments, similar observational studies have shown success in understanding treatment-related side effects in cancer therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Augsburg, Bavaria and 3 other locations
- Department of Urology, University Hosptial Augsburg — Augsburg, Bavaria, Germany (Recruiting)
- Department of Urology, LMU University Hospital, Ludwig-Maximilians-University Munich — Munich, Bavaria, Germany (Recruiting)
- Department of Urology, Klinikum rechts der Isar, Technical University Munich — Munich, Bavaria, Germany (Recruiting)
- Department of Urology, University Hospital of Würzburg — Würzburg, Bavaria, Germany (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.