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| Name | Class |
|---|---|
| Ludwig-Maximilians - University of Munich | OTHER |
| Department of Urology, TUM Klinikum rechts der Isar, Munich, Germany | UNKNOWN |
| Department of Urology, Augsburg University Hospital, Augsburg, Germany | UNKNOWN |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | baseline, week 18, week 36, week 52, and End of Treatment (defined as the administration of the last dose of EV/P) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, week 18, week 36, week 52, and End of Treatment (defined as the administration of the last dose of EV/P) |
| Change of Quality of life (QoL) applying the FACT/GOG-NTX questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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Patients meeting the eligibility criteria and are treated at the tertiary care centers LMU Munich and TUM Munich.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, University Hosptial Augsburg | Recruiting | Augsburg | Bavaria | 86156 | Germany |
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| Wuerzburg University Hospital | OTHER |
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An higher FACT/GOG-NTX score indicates a better QoL. |
| Baseline, week 18, week 36, week 52, and End of Treatment (defined as the administration of the last dose of EV/P) |
| Change of neuropathic pain applying the Neuropathic Pain Symptom Inventory (NPSI) questionnaire | A higher NPSI score indicates more neuropathic pain. | Baseline, week 18, week 36, week 52, and End of Treatment (defined as the administration of the last dose of EV/P) |
| Change of depression based on the Allgemeine Depressionsskala (ADS) | A higher ADS value indicates higher degree of depression. | Baseline, week 18, week 36, week 52, and End of Treatment (defined as the administration of the last dose of EV/P) |
| Time to onset of peripheral neuropathy ≥ CTCAE grade 2 | From the administration of the first dose of EV/P to the end of treatment (defined as the administration of the final dose of EV/P), which is expected to occur after approximately one year. |
| Number of dose reductions, delays or treatment discontinuation due to peripheral neuropathy or other adverse events | From the administration of the first dose of EV/P to the end of treatment (defined as the administration of the final dose of EV/P), which is expected to occur after approximately one year. |
| Number of cycles of EV + P administered | From the administration of the first dose of EV/P to the end of treatment (defined as the administration of the final dose of EV/P), which is expected to occur after approximately one year. |
| Change in nerve conduction studies, as measured by neurography, in the right tibial (motor) nerve | A higher nerve conduction velocity indicates a faster transmission of electrical signal along the nerve. And vice versa. | Baseline, Week 18, End of Treatment (defined as the administration of the final dose of EV/P) |
| Change in nerve conduction studies, as measured by neurography, in the right sural (sensory) nerve | A higher nerve conduction velocity indicates a faster transmission of electrical signal along the nerve. And vice versa. | Baseline, Week 18, End of Treatment (defined as the administration of the final dose of EV/P) |
| Changes in hand force as measured with a Martin-Vigorimeter | Baseline, Week 18, End of Treatment (defined as the administration of the final dose of EV/P) |
| Changes in sensory perception using a monofilament test | Baseline, Week 18, End of Treatment (defined as the administration of the final dose of EV/P) |
| Overall survival | defined as the time from administration of the first dose to date of death due to any cause | From administration of first dose to date of death of any cause, assessed for up to 60 months |
| real world Progression free survival (rw-PFS) | rw-PFS, defined as the time from the administration of the first dose of EV/P to the first documented disease progression, as determined by the investigator, or to death from any cause, whichever occurs first, assessed up to 60 months. | From administration of the first dose of EV/P to the first documented disease progression, as determined by the investigator, or to death from any cause, whichever occurs first, assessed up to 60 months. |
| Department of Urology, LMU University Hospital, Ludwig-Maximilians-University Munich | Recruiting | Munich | Bavaria | 81377 | Germany |
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| Department of Urology, Klinikum rechts der Isar, Technical University Munich | Recruiting | Munich | Bavaria | 81675 | Germany |
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| Department of Urology, University Hospital of Würzburg | Recruiting | Würzburg | Bavaria | 97080 | Germany |
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| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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