Clinical trial · Observational
A Study of Neuropathy Caused by Enfortumab Vedotin in People With Urothelial Carcinoma
Interrogating Enfortumab Vedotin-associated Neuropathy in Patients With Metastatic or Muscle-Invasive Urothelial Carcinoma Receiving Enfortumab Vedotin
NCT07390617CI-TRIAL-00112952recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to see how results of nerve tests change in people with urothelial cancer who receive treatment with enfortumab vedotin (EV)
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Urothelial Carcinoma | Urothelial Carcinoma | CURATED_BROADER | 0.78 |
| Neuropathy | — | UNRESOLVED | — |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-therapeutic assessment of patient-reported neuropathy | Other | — | UNRESOLVED |
| Non-therapeutic Nerve Conduction Studies | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Participants With Urothelial Carcinoma
- description
- Participants will have histological or cytologically confirmed urothelial carcinoma
- interventionNames
- Other: Non-therapeutic Nerve Conduction Studies
- Other: Non-therapeutic assessment of patient-reported neuropathy
Primary outcomes (1)
- measure
- Change in Nerve Conduction Studies and patient reported neuropathy from baseline to 9 -15 weeks
- timeFrame
- up to 15 weeks
- description
- Describe change in Nerve Conduction Studies 9-15 weeks. An NCS measures the flow of electrical current through motor and sensory nerves. The primary outcome will be analyzed as a binary endpoint. Nerve conduction studies measure 9 domains, and if one domain changes from normal to abnormal between baseline and the second timepoint, the patient will be counted as experiencing a worsening neuropathy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent by and HIPAA authorization for release of personal health information obtained from the research participant. * Able to speak and read English to a sufficient level of fluency to provide informed consent and complete the study questionnaires. * Age ≥ 18 years at the time of consent. * ECOG Performance Status of ≤ 3 within 28 days prior to consent. * Histological or cytologically confirmed urothelial carcinoma. * Patients must be planned to start systemic therapy with enfortumab vedotin * At time of enrollment, patients must be planned to start enfortumab with or without pembrolizumab Exclusion Criteria: Subjects meeting any of the criteria below may not participate in the study: * Inability of the subject to understand and comply with study procedures. * Having previously received enfortumab vedotin * Students/employees of the study institution, pregnant women, prisoners, and institutionalized individuals (to prevent enrollment of vulnerable subjects).
References
Publications (0)
Data not yet available
No reference posted for this study.