Investigating nerve damage in patients treated for advanced bladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Peripheral neuropathy during perioperative therapy with enfortumab vedotin and pembrolizumab in muscle-invasive urothelial cancer

  This study follows adults with muscle-invasive urothelial cancer to see how nerve-related side effects develop when people receive enfortumab vedotin and pembrolizumab around surgery as part of standard care.

  Recruiting at 3 sites Comprehensive Cancer Center Munich (CCCM) · Munich, Bavaria and 2 other locations · NCT07870577

• Enfortumab vedotin plus pembrolizumab versus chemoradiotherapy for muscle-invasive bladder cancer

  This trial tests whether combining enfortumab vedotin with pembrolizumab can help people with non-metastatic muscle-invasive bladder cancer keep their bladder and control the cancer better than standard concurrent chemoradiotherapy.

  Recruiting at 29 sites Phase 3 Astellas Pharma Inc · Little Rock, Arkansas and 28 other locations · NCT07566156

• Sacituzumab govitecan plus enfortumab vedotin for metastatic urothelial cancer

  This trial tests whether combining sacituzumab govitecan and enfortumab vedotin, with pembrolizumab in some patients, helps people with metastatic urothelial carcinoma who have progressed after platinum chemotherapy and PD‑1/PD‑L1 inhibitors.

  Recruiting Phase 1/2 Dana-Farber Cancer Institute · Boston, Massachusetts · NCT04724018

• Bladder cancer: test a biomarker-guided plan after neoadjuvant therapy

  This phase 2 study tests a biomarker- and response-guided plan to preserve the bladder in patients with muscle-invasive bladder cancer after neoadjuvant therapy.

  Recruiting Phase 2 Fox Chase Cancer Center · Philadelphia, Pennsylvania · NCT07908979

• Ivonescimab plus enfortumab vedotin vs pembrolizumab plus enfortumab vedotin in untreated locally advanced or metastatic urothelial cancer

  This trial tests if adding ivonescimab to enfortumab vedotin works better than pembrolizumab plus enfortumab vedotin for people with untreated locally advanced or metastatic urothelial cancer.

  Recruiting at 2 sites Phase 2/3 Summit Therapeutics · Phoenix, Arizona and 6 other locations · NCT07815665

• Enfortumab Vedotin, Pembrolizumab, and Quemliclustat for unresectable or metastatic urothelial cancer

  This trial tests a three-drug combination to see if it can safely treat unresectable or metastatic urothelial cancer in adults.

  Recruiting Phase 1/2 Fred Hutchinson Cancer Center · Seattle, Washington · NCT07667335

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.