P-EVOLVE is a prospective, multicenter, non-interventional observational study in adults with muscle-invasive urothelial carcinoma who receive perioperative treatment with enfortumab vedotin and pembrolizumab as part of routine clinical care.
The study is designed to describe how peripheral neuropathy develops and changes during treatment and whether symptoms persist at the end of treatment. Peripheral neuropathy will be assessed using patient-reported questionnaires, standardized neurological examinations, and nerve conduction studies. The study will also assess neuropathic pain, neurotoxicity-related quality of life, depressive symptoms, and changes in taste and smell. Objective gustatory function will be evaluated using standardized Taste Strip testing.
Study assessments will be performed before treatment, during the neoadjuvant and adjuvant treatment phases, around radical cystectomy, and at the end of treatment. Participation in the study does not determine whether treatment is started or how treatment is given. All anticancer treatment decisions remain part of routine clinical care.
The study aims to improve understanding of the onset, severity, longitudinal course, and persistence of peripheral neuropathy associated with perioperative enfortumab vedotin and pembrolizumab and to compare patient-reported symptoms with objective neurological and neurophysiological findings.
Adult patients ≥18 years of age at the time of signing the informed consent form (ICF)
Patients with histologically confirmed muscle-invasive urothelial carcinoma
Patients who have not received any prior systemic treatment for muscle-invasive bladder cancer
Patients who are eligible to receive enfortumab ve-dotin and pembrolizumab according to the respec-tive medicinal product information
Patients with contraindications to enfortumab ve-dotin and/or pembrolizumab
Patients who have received prior systemic therapy for muscle-invasive bladder cancer (e.g. platinum-based chemotherapy, immune checkpoint inhibitors)
Patients who have previously been treated with en-fortumab vedotin, other MMAE-based antibody-drug conjugates, or PD-(L)1 inhibitors
Patients meeting the eligibility criteria and are treated at the tertiary care centers LMU Munich, TUM Munich, and Krankenhaus Barmherzige Bürde Munich.
Cohort
Prospective
Not listed
Change From Baseline to End of Treatment in Sensory Peripheral Neuropathy Symptoms Assessed by the EORTC QLQ-CIPN20 Sensory Subscale
Change from baseline to end of treatment (EOT) in the sensory subscale score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20 (EORTC QLQ-CIPN20). The sensory subscale is scored according to the EORTC scoring manual and linearly transformed to a 0 to 100 scale, with higher scores indicating greater peripheral neuropathy symptom burden. The individual change score is calculated as the EOT score minus the baseline score.
Change From Baseline Over Time in Peripheral Neuropathy Symptoms Assessed by the EORTC QLQ-CIPN20
Longitudinal change in peripheral neuropathy symptoms assessed using the sensory, motor, and autonomic subscales of the EORTC QLQ-CIPN20. Subscale scores are calculated according to the EORTC scoring manual and transformed to a 0 to 100 scale, with higher scores indicating greater peripheral neuropathy symptom burden. Change from baseline will be evaluated at each post-baseline assessment.
Change Over Time in Peripheral Neuropathy Assessed by the Patient Neurotoxicity Questionnaire
Change and longitudinal course of patient-reported peripheral neuropathy assessed using the Patient Neurotoxicity Questionnaire (PNQ). The PNQ evaluates sensory and motor neurotoxicity using five ordered response categories from A to E. Increasing response categories indicate greater symptom severity and functional impairment.
Change From Baseline Over Time in Neuropathic Pain Assessed by the Neuropathic Pain Symptom Inventory
Change and longitudinal course of neuropathic pain assessed using the Neuropathic Pain Symptom Inventory (NPSI). The NPSI total score will be assessed at each scheduled time point, and change from baseline will be evaluated at post-baseline assessments and at EOT. The NPSI consists of 12 items assessing different characteristics of neuropathic pain, with symptom intensity items rated on an 11-point scale from 0 to 10.
Change From Baseline in Neuropathy-Related Quality of Life Assessed by the FACT/GOG-NTX
Change and longitudinal course of neuropathy-related patient-reported outcomes assessed using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) questionnaire. The FACT/GOG-NTX total score will be assessed during treatment, with change from baseline to EOT included as a prespecified endpoint.
Click on the lead sponsor to view all of their trials.
Comprehensive Cancer Center Munich (CCCM)
Lead sponsor
Department of Urology, TUM Klinikum rechts der Isar, Munich, Germany
Collaborator
Department of Urology, Krankenhaus Barmherzige Brüder, Munich, Germany
Collaborator
Department of Urology, LMU University Hospital, Munich, Germany
Collaborator
