Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT03557918
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2018-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Trial of Tremelimumab in Patients With Previously Treated Metastatic Urothelial Cancer
Sponsor:
Matthew Galsky
Organization:
Study Overview
Official Title:
Phase 2 Trial of Tremelimumab in Patients With Metastatic Urothelial Cancer Previously Treated With PD-1/PD-L1 Blockade
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase II trial designed to estimate the activity of single agent tremelimumab in subjects with metastatic urothelial cancer with disease progression despite prior treatment with PD-1/PD-L1 blockade. The primary endpoint is objective response rate and the study will employ a Simon's 2-stage design.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?: