[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643694":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":31,"locations":22,"responsibleParty":37,"collaborators":41,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":22,"enrollmentInfo":55,"targetDuration":22,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":22,"overallStatus":65,"whyStopped":22,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":22},{"fullName":5,"class":6},"University of Florence","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"arm label","EXPERIMENTAL","Neuridase:\n\nParticipants 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.",[13,14,15],"Drug: enfortumab vedotin (EV)","Drug: PEMBROLIZUMAB (alone or when added to a regimen above)","Other: Neuridase",[17,23,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","enfortumab vedotin (EV)","Standard-of-care enfortumab vedotin administered according to approved clinical practice.",[9],null,{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"PEMBROLIZUMAB (alone or when added to a regimen above)","Standard-of-care pembrolizumab administered in combination with enfortumab vedotin according to approved clinical practice.",[9],{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":22},"Neuridase","Supportive non-pharmacological product administered during treatment with enfortumab vedotin and pembrolizumab to prospectively explore peripheral neuropathy trajectory, tolerability, and patient-reported outcomes.",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":22,"email":36},"Lorenzo Antonuzzo, MD Phd, MD","CONTACT","055-5465353","lorenzo.antonuzzo@unifi.it",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Giandomenico Roviello","Professor",[42],{"name":43,"class":44},"Enfarma S.p.A.","UNKNOWN","100643694","study-of-peripheral-neuropathy-in-patients-with-advanced-urothelial-cancer-treated-with-enfortumab-vedotin-and-pembrolizumab-with-supportive-neuridase-endeavor-100643694",false,"NCT07629700","Study of Peripheral Neuropathy in Patients With Advanced Urothelial Cancer Treated With Enfortumab Vedotin and Pembrolizumab With Supportive Neuridase (ENDEAVOR)","ENDEAVOR Study: A Prospective Exploratory Study Describing the Course of Peripheral Neuropathy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Treated With Enfortumab Vedotin in Combination With Pembrolizumab and Supportive Neuridase","ENDEAVOR","IInclusion Criteria:\n\n* Age ≥18 years\n* Histologically confirmed locally advanced or metastatic urothelial carcinoma\n* Candidate for treatment with enfortumab vedotin in combination with pembrolizumab according to clinical practice\n* Ability to provide written informed consent\n* Adequate clinical conditions to participate in the study according to investigator judgment\n\nExclusion Criteria:\n\n* Pre-existing severe peripheral neuropathy that may interfere with study assessments\n* Contraindications to enfortumab vedotin or pembrolizumab according to clinical practice\n* Known hypersensitivity to components of Neuridase\n* Pregnancy or breastfeeding\n* Any medical, psychiatric, or social condition that, in the investigator's judgment, may interfere with study participation or interpretation of results","ALL","18 Years",{"count":56,"type":57},40,"ESTIMATED","INTERVENTIONAL",[60],"NA","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.\n\nPeripheral 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.\n\nParticipants 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.\n\nThe objective of the study is to explore neuropathy patterns and treatment tolerability in this patient population.",[63,64],"Urothelial Carcinoma (UC)","Peripheral Nerve Disease","NOT_YET_RECRUITING","2026-06-04",{"date":68,"type":69},"2026-06-08","ACTUAL",{"date":71,"type":57},"2026-09-01",{"date":73,"type":57},"2028-09-01",{"name":5,"class":6}]