Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-02-25 @ 8:17 PM
Study NCT ID:
NCT06657157
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2024-10-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peripheral Neuropathy in Patients Receiving Enfortumab Vedotin and Pembrolizumab as First Line Treatment for Metastatic or Locally Advanced Urothelial Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}], 'ancestors': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2024-10-19', 'studyFirstSubmitQcDate': '2024-10-22', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of peripheral neuropathy ≥ CTCAE grade 2', 'timeFrame': 'baseline, week 18, week 36, week 52, and End of Treatment (defined as the administration of the last dose of EV/P)', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'Change of degree of sensory, motor and/or autonomic peripheral neuropathy applying the EORTC-CIPN20 questionnaire', 'timeFrame': 'Baseline, week 18, week 36, week 52, and End of Treatment (defined as the administration of the last dose of EV/P)', 'description': 'A higher EORTC-CIPN20 score indicates a worse degree of neuropathy.'}, {'measure': 'Change of Quality of life (QoL) applying the FACT/GOG-NTX questionnaire', 'timeFrame': 'Baseline, week 18, week 36, week 52, and End of Treatment (defined as the administration of the last dose of EV/P)', 'description': 'An higher FACT/GOG-NTX score indicates a better QoL.'}, {'measure': 'Change of neuropathic pain applying the Neuropathic Pain Symptom Inventory (NPSI) questionnaire', 'timeFrame': 'Baseline, week 18, week 36, week 52, and End of Treatment (defined as the administration of the last dose of EV/P)', 'description': 'A higher NPSI score indicates more neuropathic pain.'}, {'measure': 'Change of depression based on the Allgemeine Depressionsskala (ADS)', 'timeFrame': 'Baseline, week 18, week 36, week 52, and End of Treatment (defined as the administration of the last dose of EV/P)', 'description': 'A higher ADS value indicates higher degree of depression.'}, {'measure': 'Time to onset of peripheral neuropathy ≥ CTCAE grade 2', 'timeFrame': '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.'}, {'measure': 'Number of dose reductions, delays or treatment discontinuation due to peripheral neuropathy or other adverse events', 'timeFrame': '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.'}, {'measure': 'Number of cycles of EV + P administered', 'timeFrame': '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.'}, {'measure': 'Change in nerve conduction studies, as measured by neurography, in the right tibial (motor) nerve', 'timeFrame': 'Baseline, Week 18, End of Treatment (defined as the administration of the final dose of EV/P)', 'description': 'A higher nerve conduction velocity indicates a faster transmission of electrical signal along the nerve. And vice versa.'}, {'measure': 'Change in nerve conduction studies, as measured by neurography, in the right sural (sensory) nerve', 'timeFrame': 'Baseline, Week 18, End of Treatment (defined as the administration of the final dose of EV/P)', 'description': 'A higher nerve conduction velocity indicates a faster transmission of electrical signal along the nerve. And vice versa.'}, {'measure': 'Changes in hand force as measured with a Martin-Vigorimeter', 'timeFrame': 'Baseline, Week 18, End of Treatment (defined as the administration of the final dose of EV/P)'}, {'measure': 'Changes in sensory perception using a monofilament test', 'timeFrame': 'Baseline, Week 18, End of Treatment (defined as the administration of the final dose of EV/P)'}, {'measure': 'Overall survival', 'timeFrame': 'From administration of first dose to date of death of any cause, assessed for up to 60 months', 'description': 'defined as the time from administration of the first dose to date of death due to any cause'}, {'measure': 'real world Progression free survival (rw-PFS)', 'timeFrame': '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.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['enfortumab vedotin', 'Pembrolizumab', 'peripheral neuropathy', 'metastatic urothelial carcinoma', 'advanced urothelial carcinoma'], 'conditions': ['Urothelial Cancer']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients meeting the eligibility criteria and are treated at the tertiary care centers LMU Munich and TUM Munich.', 'healthyVolunteers': False, 'eligibilityCriteria': '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 metastatic or locally advanced, unresectable urothelial carcinoma\n* Patients who did not receive any systemic treatment for their laUC or mUC (treatment-naïve)\n* Patients who are able to receive enfortumab vedotin and pembrolizumab according to the respective medicinal product information\n\nExclusion Criteria:\n\n* Patients with contraindications for enfortumab vedotin and/or pembrolizumab\n* Patients who have received a systemic therapy for their laUC or mUC (e.g. platinum-based chemotherapy, checkpoint-inhibitors)\n* Patients who have previously been treated with enfortumab vedotin, other MMAE-based antibody-drug-conjugates or PD-(L)1-checkpoint inhibitors\n* Patients who received neoadjuvant or adjuvant platinum-based chemotherapy \\<12 months ago'}, 'identificationModule': {'nctId': 'NCT06657157', 'acronym': 'P-EVOLUTION', 'briefTitle': 'Peripheral Neuropathy in Patients Receiving Enfortumab Vedotin and Pembrolizumab as First Line Treatment for Metastatic or Locally Advanced Urothelial Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Comprehensive Cancer Center Munich (CCCM)'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'P-EVOLUTION'}}, 'contactsLocationsModule': {'locations': [{'zip': '81377', 'city': 'Munich', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jozefina Casuscelli', 'role': 'CONTACT', 'email': 'jozefina.casuscelli@med.uni-muenchen.de', 'phone': '+49 89 4400 0'}], 'facility': 'Department of Urology, LMU University Hospital, Ludwig-Maximilians-University Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '81675', 'city': 'Munich', 'state': 'Bavaria', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Kira Schüller', 'role': 'CONTACT', 'email': 'kira.shueller@tum.de', 'phone': '+49 89 4140 0'}], 'facility': 'Department of Urology, Klinikum rechts der Isar, Technical University Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Comprehensive Cancer Center Munich (CCCM)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Department of Urology, LMU University Hospital Munich, Munich, Germany', 'class': 'UNKNOWN'}, {'name': 'Department of Urology, TUM Klinikum rechts der Isar, Munich, Germany', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Can Aydogdu, MD', 'investigatorAffiliation': 'Comprehensive Cancer Center Munich (CCCM)'}}}}