[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100660015":3},{"organization":4,"outcomesModule":7,"designInfo":73,"detailedDescription":72,"studyPopulation":76,"armGroups":72,"interventions":72,"overallOfficials":72,"centralContacts":72,"locations":77,"responsibleParty":120,"collaborators":124,"id":132,"slug":133,"hasResults":134,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":134,"sex":140,"minAge":141,"maxAge":72,"enrollmentInfo":142,"targetDuration":72,"studyType":145,"phases":72,"briefSummary":146,"conditions":147,"keywords":150,"overallStatus":80,"whyStopped":72,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},{"fullName":5,"class":6},"Comprehensive Cancer Center Munich (CCCM)","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":72},[9],{"measure":10,"description":11,"timeFrame":12},"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.","Baseline, within 14 days before initiation of neoadjuvant therapy, to end of treatment (EOT) ±14 days",[14,18,21,24,27,30,33,36,40,44,47,50,53,57,60,63,66,69],{"measure":15,"description":16,"timeFrame":17},"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.","Baseline; within 14 days before radical cystectomy; start of adjuvant therapy ±14 days; weeks 12, 21, and 30 of adjuvant therapy ±14 days; and EOT ±14 days",{"measure":19,"description":20,"timeFrame":17},"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.",{"measure":22,"description":23,"timeFrame":17},"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.",{"measure":25,"description":26,"timeFrame":17},"Change From Baseline in Neuropathy-Related Quality of Life Assessed by the FACT\u002FGOG-NTX","Change and longitudinal course of neuropathy-related patient-reported outcomes assessed using the Functional Assessment of Cancer Therapy\u002FGynecologic Oncology Group-Neurotoxicity (FACT\u002FGOG-NTX) questionnaire. The FACT\u002FGOG-NTX total score will be assessed during treatment, with change from baseline to EOT included as a prespecified endpoint.",{"measure":28,"description":29,"timeFrame":17},"Change From Baseline in Depressive Symptoms Assessed by the Allgemeine Depressionsskala","Change and longitudinal course of depressive symptoms assessed using the Allgemeine Depressionsskala (ADS). The ADS total score will be assessed during treatment, with change from baseline to EOT included as a prespecified endpoint.",{"measure":31,"description":32,"timeFrame":17},"Change Over Time in Patient-Reported Taste Alteration Assessed by the Patient-Generated Subjective Global Assessment","Change in patient-reported taste alteration assessed using the Patient-Generated Subjective Global Assessment (PG-SGA). Taste alteration is captured as a patient-reported symptom within the PG-SGA and will be evaluated longitudinally over the treatment period.",{"measure":34,"description":35,"timeFrame":17},"Change Over Time in Patient-Reported Taste and Smell Disturbances Assessed by the CCC MünchenLMU Taste and Smell Questionnaire","Change and longitudinal course of patient-reported taste and smell disturbances assessed using the Fragebogen zu Geschmack und Geruch developed by the Comprehensive Cancer Center MünchenLMU. The questionnaire assesses the presence and onset of taste and smell disturbances, persistence of abnormal taste, changes in sweet, sour, salty, and bitter taste perception, changes in smell, severity of abnormal sensations, and their perceived impact on quality of life.",{"measure":37,"description":38,"timeFrame":39},"Change From Baseline Over Time in Objective Gustatory Function Assessed by the Taste Strip Test","Longitudinal change in objective gustatory function assessed using a standardized Taste Strip test covering the four basic taste qualities of sweet, sour, salty, and bitter. Recorded parameters include the total taste score, defined as the number of correctly identified taste strips; taste-specific scores for sweet, sour, salty, and bitter; and classification of gustatory function as normogeusia, hypogeusia, or ageusia according to established reference values. Lower total or taste-specific scores indicate greater impairment of gustatory function.","Baseline; within 14 days before radical cystectomy; start of adjuvant therapy ±14 days; week 21 of adjuvant therapy ±14 days; and EOT ±14 days",{"measure":41,"description":42,"timeFrame":43},"Change From Baseline in Modified Medical Research Council (MRC) Sum Score","Change from baseline in muscle strength as assessed using the modified Medical Research Council (MRC) sum score. The MRC assessment evaluates muscle strength, with greater muscle strength reflected by higher individual muscle strength ratings.","Baseline, within 14 days before radical cystectomy, start of adjuvant therapy (±14 days), Week 21 of adjuvant therapy (±14 days), and EOT (±14 days)",{"measure":45,"description":46,"timeFrame":43},"Change From Baseline in Hand Grip Strength Assessed by Martin Vigorimeter","Change from baseline in hand grip strength as assessed using a Martin Vigorimeter. Grip strength measurements will be compared with the baseline measurement to evaluate changes in muscle strength over the course of treatment.",{"measure":48,"description":49,"timeFrame":43},"Change From Baseline in Modified Toronto Clinical Neuropathy Score (TCNS)","Change from baseline in peripheral neuropathy severity as assessed using the modified Toronto Clinical Neuropathy Score (TCNS). The modified TCNS evaluates clinical signs and symptoms of peripheral neuropathy, with changes from baseline used to assess development or progression of neuropathy.",{"measure":51,"description":52,"timeFrame":43},"Change From Baseline in Cutaneous Sensory Function Assessed by Semmes-Weinstein Monofilament Test","Change from baseline in cutaneous sensory function as assessed using the Semmes-Weinstein monofilament test. The test assesses the ability to perceive standardized monofilament stimulation and is used to evaluate changes in peripheral sensory function.",{"measure":54,"description":55,"timeFrame":56},"Change From Baseline in Right Sural Nerve Sensory Response Amplitude","Change from baseline in sensory response amplitude of the right sural nerve as assessed by nerve conduction studies. Sensory response amplitude is used as an electrophysiological measure of peripheral sensory nerve function.","Baseline, within 14 days before radical cystectomy, and EOT (±14 days)",{"measure":58,"description":59,"timeFrame":56},"Change From Baseline in Right Sural Nerve Distal Latency","Change from baseline in distal latency of the right sural nerve as assessed by nerve conduction studies. Distal latency reflects the time required for an electrical impulse to produce a measurable sensory nerve response.",{"measure":61,"description":62,"timeFrame":56},"Change From Baseline in Right Sural Nerve Conduction Velocity","Change from baseline in nerve conduction velocity of the right sural nerve as assessed by nerve conduction studies. Nerve conduction velocity reflects the speed of electrical impulse transmission along the sensory nerve.",{"measure":64,"description":65,"timeFrame":56},"Change From Baseline in Right Tibial Nerve Motor Response Amplitude","Change from baseline in motor response amplitude of the right tibial nerve as assessed by nerve conduction studies. Motor response amplitude is used as an electrophysiological measure of peripheral motor nerve function.",{"measure":67,"description":68,"timeFrame":56},"Change From Baseline in Right Tibial Nerve Distal Latency","Change from baseline in distal latency of the right tibial nerve as assessed by nerve conduction studies. Distal latency reflects the time required for an electrical impulse to produce a measurable motor nerve response.",{"measure":70,"description":71,"timeFrame":56},"Change From Baseline in Right Tibial Nerve Conduction Velocity","Change from baseline in nerve conduction velocity of the right tibial nerve as assessed by nerve conduction studies. Nerve conduction velocity reflects the speed of electrical impulse transmission along the motor nerve.",null,{"allocation":72,"interventionModel":72,"interventionModelDescription":72,"primaryPurpose":72,"observationalModel":74,"timePerspective":75,"maskingInfo":72},"COHORT","PROSPECTIVE","Patients meeting the eligibility criteria and are treated at the tertiary care centers LMU Munich, TUM Munich, and Krankenhaus Barmherzige Bürde Munich.",[78,98,109],{"facility":79,"status":80,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"Department of Urology, Krankenhaus Barmherzige Brüder","RECRUITING","Munich","Bavaria","80639","Germany","DE",{"type":87,"coordinates":88},"Point",[89,90],11.57549,48.13743,{"lat":90,"lon":89},[93],{"name":94,"role":95,"phone":96,"phoneExt":72,"email":97},"Tobias Hauser, MD","CONTACT","0049 89 17970","Tobias.Hauser@barmherzige-muenchen.de",{"facility":99,"status":80,"city":81,"state":82,"zip":100,"country":84,"countryCode":85,"cosmosGeoPoint":101,"geoPoint":103,"contacts":104},"Department of Urology, LMU University Hospital, Ludwig-Maximilians-University Munich","81377",{"type":87,"coordinates":102},[89,90],{"lat":90,"lon":89},[105],{"name":106,"role":95,"phone":107,"phoneExt":72,"email":108},"Jozefina Casuscelli","+49 89 4400 0","jozefina.casuscelli@med.uni-muenchen.de",{"facility":110,"status":80,"city":81,"state":82,"zip":111,"country":84,"countryCode":85,"cosmosGeoPoint":112,"geoPoint":114,"contacts":115},"Department of Urology, Klinikum rechts der Isar, Technical University Munich","81675",{"type":87,"coordinates":113},[89,90],{"lat":90,"lon":89},[116],{"name":117,"role":95,"phone":118,"phoneExt":72,"email":119},"Kira Schüller, MD","+49 89 4140 0","kira.shueller@tum.de",{"type":121,"investigatorFullName":122,"investigatorTitle":123,"investigatorAffiliation":5,"oldNameTitle":72,"oldOrganization":72},"PRINCIPAL_INVESTIGATOR","Can Aydogdu, MD","Principal Investigator",[125,128,130],{"name":126,"class":127},"Department of Urology, TUM Klinikum rechts der Isar, Munich, Germany","UNKNOWN",{"name":129,"class":127},"Department of Urology, Krankenhaus Barmherzige Brüder, Munich, Germany",{"name":131,"class":127},"Department of Urology, LMU University Hospital, Munich, Germany","100660015","peripheral-neuropathy-in-patients-receiving-enfortumab-vedotin-and-pembrolizumab-as-perioperative-systemic-therapy-for-urothelial-carcinoma-100660015",false,"NCT07870577","Peripheral Neuropathy in Patients Receiving Enfortumab Vedotin and Pembrolizumab as Perioperative Systemic Therapy for Urothelial Carcinoma","Peripheral Neuropathy in Patients Receiving Enfortumab Vedotin and Pembrolizumab as Perioperative Systemic Therapy for Urothelial Carcinoma. An Investigator-Initiated, Prospective, Multicenter, Non-Interventional Trial.","P-EVOLVE","Inclusion Criteria:\n\n* Adult patients ≥18 years of age at the time of signing the informed consent form (ICF)\n* Patients with histologically confirmed muscle-invasive urothelial carcinoma\n* Patients who have not received any prior systemic treatment for muscle-invasive bladder cancer\n* Patients who are eligible to receive enfortumab ve-dotin and pembrolizumab according to the respec-tive medicinal product information\n\nExclusion Criteria:\n\n* Patients with contraindications to enfortumab ve-dotin and\u002For pembrolizumab\n* Patients who have received prior systemic therapy for muscle-invasive bladder cancer (e.g. platinum-based chemotherapy, immune checkpoint inhibitors)\n* Patients who have previously been treated with en-fortumab vedotin, other MMAE-based antibody-drug conjugates, or PD-(L)1 inhibitors","ALL","18 Years",{"count":143,"type":144},79,"ESTIMATED","OBSERVATIONAL","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.\n\nThe 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.\n\nStudy 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.\n\nThe 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.",[148,149],"Urothelial Cancer","MIBC",[151,152,153,154],"enfortumab vedotin","Pembrolizumab","peripheral neuropathy","muscle-invsive bladder cancer","2026-10-06",{"date":157,"type":158},"2026-10-13","ACTUAL",{"date":160,"type":158},"2026-06-01",{"date":162,"type":144},"2028-12",{"name":5,"class":6},3]