Actively Recruiting
Peripheral Neuropathy in Patients Receiving Enfortumab Vedotin and Pembrolizumab as First Line Treatment for Metastatic or Locally Advanced Urothelial Carcinoma
Led by Comprehensive Cancer Center Munich (CCCM) · Updated on 2026-02-24
80
Participants Needed
4
Research Sites
105 weeks
Total Duration
On this page
Sponsors
C
Comprehensive Cancer Center Munich (CCCM)
Lead Sponsor
L
Ludwig-Maximilians - University of Munich
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Peripheral Neuropathy in Patients Receiving Enfortumab Vedotin and Pembrolizumab as First Line Treatment for Metastatic or Locally Advanced Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients 18 years of age or older at the time of signing informed consent
- Histologically confirmed metastatic or locally advanced, unresectable urothelial carcinoma
- No prior systemic treatment for locally advanced or metastatic urothelial carcinoma
- Able to receive enfortumab vedotin and pembrolizumab according to medicinal product information
You will not qualify if you...
- Contraindications to enfortumab vedotin and/or pembrolizumab
- Previous systemic therapy for locally advanced or metastatic urothelial carcinoma (e.g., platinum-based chemotherapy, checkpoint inhibitors)
- Prior treatment with enfortumab vedotin, other MMAE-based antibody-drug conjugates, or PD-(L)1 checkpoint inhibitors
- Receipt of neoadjuvant or adjuvant platinum-based chemotherapy within the last 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Department of Urology, University Hosptial Augsburg
Augsburg, Bavaria, Germany, 86156
Actively Recruiting
2
Department of Urology, LMU University Hospital, Ludwig-Maximilians-University Munich
Munich, Bavaria, Germany, 81377
Actively Recruiting
3
Department of Urology, Klinikum rechts der Isar, Technical University Munich
Munich, Bavaria, Germany, 81675
Actively Recruiting
4
Department of Urology, University Hospital of Würzburg
Würzburg, Bavaria, Germany, 97080
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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