Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2025-12-27 @ 9:27 PM
Study NCT ID:
NCT04066595
Status:
TERMINATED
Last Update Posted:
2021-08-30
First Post:
2019-08-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cabozantinib in Patients With Locally Advanced or Metastatic Urothelial Cell Carcinoma.
Sponsor:
Johannes Gutenberg University Mainz
Organization:
Study Overview
Official Title:
Cabozantinib in Patients With Locally Advanced or Metastatic Urothelial Cell Carcinoma Who Have Progressed After Cisplatin-based Chemotherapy and Anti-PD-1/PD-L1 Therapy or After Anti-PD-1/PD-L1 Therapy Only.
Status:
TERMINATED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment problems
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CabUC
Brief Summary:
In this Phase II study we investigate the benefit of cabozantinib treatment for patients with locally advanced or metastasized urothelial cell carcinoma who have been pre-treated with checkpoint inhibitors only (cohort 1) or who have been pre-treated with cisplatin-based chemotherapy and checkpoint inhibitors (cohort 2). We are lacking adequate response and outcome data in patients after immunotherapy and consider that this study will improve future treatment modalities for this important patient cohort.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: