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| ID | Type | Description | Link |
|---|---|---|---|
| CE 30693_spe | Registry Identifier | CE Careggi |
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| Name | Class |
|---|---|
| Enfarma S.p.A. | UNKNOWN |
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his prospective exploratory study aims to describe the course of peripheral neuropathy in patients with locally advanced or metastatic urothelial carcinoma treated with enfortumab vedotin in combination with pembrolizumab and receiving supportive Neuridase.
Peripheral neuropathy is a common adverse event associated with enfortumab vedotin and may negatively affect treatment tolerability, quality of life, and treatment continuation. Neuridase is a non-pharmacological supportive product intended to support peripheral nervous system function; however, its role in this clinical setting has not yet been established.
Participants enrolled in this single-arm study will receive standard-of-care treatment with enfortumab vedotin plus pembrolizumab, together with supportive Neuridase according to clinical practice. The study will prospectively assess neuropathy symptoms and severity using clinical evaluations and patient-reported outcome measures, including quality-of-life questionnaires, over the course of treatment.
The objective of the study is to explore neuropathy patterns and treatment tolerability in this patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| arm label | Experimental | Neuridase: Participants with locally advanced or metastatic urothelial carcinoma will receive standard-of-care enfortumab vedotin in combination with pembrolizumab together with supportive Neuridase according to the study protocol. Peripheral neuropathy symptoms, treatment tolerability, and patient-reported outcomes will be prospectively assessed during treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enfortumab vedotin (EV) | Drug | Standard-of-care enfortumab vedotin administered according to approved clinical practice. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Peripheral Neuropathy | Incidence and severity of peripheral neuropathy will be prospectively assessed according to clinical evaluation and CTCAE criteria in patients receiving enfortumab vedotin plus pembrolizumab with supportive Neuridase. | From baseline to 6 months after treatment initiation |
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IInclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lorenzo Antonuzzo, MD Phd, MD | Contact | 055-5465353 | lorenzo.antonuzzo@unifi.it |
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De-identified individual participant data collected during the study will not be made publicly available. Data sharing may be considered on reasonable request to the study investigators and in accordance with institutional policies, ethical approvals, and applicable data protection regulations.
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| PEMBROLIZUMAB (alone or when added to a regimen above) | Drug | Standard-of-care pembrolizumab administered in combination with enfortumab vedotin according to approved clinical practice. |
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| Neuridase | Other | Supportive non-pharmacological product administered during treatment with enfortumab vedotin and pembrolizumab to prospectively explore peripheral neuropathy trajectory, tolerability, and patient-reported outcomes. |
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| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000632577 | enfortumab vedotin |
| C582435 | pembrolizumab |
| D012847 | Single Person |
| ID | Term |
|---|---|
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D012959 | Socioeconomic Factors |
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