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

Официальное название

Peripheral Neuropathy in Patients Receiving Pembrolizumab and Enfortumab Vedotin as First Line Treatment for Metastatic or Locally Advanced Urothelial Carcinoma. An Investigator-Initiated, Prospective, Multicenter, Non-Interventional Trial.

Обзор

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.

Первичные конечные точки

• Incidence of peripheral neuropathy ≥ CTCAE grade 2 [Срок оценки: baseline, week 18, week 36, week 52, and End of Treatment (defined as the administration of the last dose of EV/P)]

Вторичные конечные точки (12)

• Change of degree of sensory, motor and/or autonomic peripheral neuropathy applying the EORTC-CIPN20 questionnaire [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline, Week 18, End of Treatment (defined as the administration of the final dose of EV/P)]
• Overall survival [Срок оценки: From administration of first dose to date of death of any cause, assessed for up to 60 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 4 центра

• Department of Urology, University Hosptial Augsburg — Augsburg
• Department of Urology, LMU University Hospital, Ludwig-Maximilians-University Munich — Munich
• Department of Urology, Klinikum rechts der Isar, Technical University Munich — Munich
• Department of Urology, University Hospital of Würzburg — Würzburg

Идентификаторы

NCT: NCT06657157 · P-EVOLUTION

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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