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

Launched by LMU KLINIKUM · Oct 22, 2024

Keywords

ClinConnect Summary

The P-EVOLUTION trial is a study looking at the side effects of a specific treatment for patients with advanced urothelial cancer, which is a type of cancer that typically affects the bladder. In this trial, researchers are focusing on a condition called peripheral neuropathy, which involves nerve damage that can cause symptoms like pain, tingling, or weakness in the hands and feet. The study will enroll about 80 adults who are starting a first-line treatment involving two medications: enfortumab vedotin and pembrolizumab. The goal is to see how often these side effects occur, how severe they are, and how they affect patients' quality of life.

To participate in this trial, patients need to be at least 18 years old and have a confirmed diagnosis of advanced urothelial carcinoma that hasn’t been treated with other systemic therapies before. They should also be eligible to receive the two medications being studied. Throughout the year-long study, participants will be monitored for any side effects and their overall experience with the treatment. This information will help doctors understand how to better manage side effects and improve the quality of care for future patients.

Gender

ALL

Eligibility 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