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.
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
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
Patients meeting the eligibility criteria and are treated at the tertiary care centers LMU Munich and TUM Munich.
Cohort
Prospective
Not listed
Incidence of peripheral neuropathy ≥ CTCAE grade 2
Incidence of peripheral neuropathy ≥ grade 2 at baseline, week 18, week 36, week 52, and at End of Treatment (defined as the administration of the last dose of EV/P) assessed by the Patient Neurotoxicity Questionnaire (PNQ)
Change of degree of sensory, motor and/or autonomic peripheral neuropathy applying the EORTC-CIPN20 questionnaire
A higher EORTC-CIPN20 score indicates a worse degree of neuropathy.
Change of Quality of life (QoL) applying the FACT/GOG-NTX questionnaire
An higher FACT/GOG-NTX score indicates a better QoL.
Change of neuropathic pain applying the Neuropathic Pain Symptom Inventory (NPSI) questionnaire
A higher NPSI score indicates more neuropathic pain.
Change of depression based on the Allgemeine Depressionsskala (ADS)
A higher ADS value indicates higher degree of depression.
Click on the lead sponsor to view all of their trials.
Comprehensive Cancer Center Munich (CCCM)
Lead sponsor
Ludwig-Maximilians - University of Munich
Collaborator
Department of Urology, TUM Klinikum rechts der Isar, Munich, Germany
Collaborator
Department of Urology, Augsburg University Hospital, Augsburg, Germany
Collaborator
Wuerzburg University Hospital
Collaborator
