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

Comprehensive Cancer Center Munich (CCCM)

Status: Enrolling

Conditions: Urothelial Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06657157

P-EVOLUTION

Details and patient eligibility

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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