Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06657157
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-19
Brief Title:
Peripheral Neuropathy in Patients Receiving Enfortumab Vedotin and Pembrolizumab As First Line Treatment for Metastatic or Locally Advanced Urothelial Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
P-EVOLUTION
Brief Summary:
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None