Ignite Creation Date:
2024-05-06 @ 1:50 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04149574
Status:
TERMINATED
Last Update Posted:
2024-04-19
First Post:
2019-10-31
Brief Title:
A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin BCG Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer HR NMIBC
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
A Phase 3 Randomized Double-blind Trial of Nivolumab in Combination With Intravesical BCG Versus Standard of Care BCG Alone in Participants With High-risk Non-muscle Invasive Bladder Cancer That Is Persistent or Recurrent After Treatment With BCG
Status:
TERMINATED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient enrollment inability to meet protocol objectives and slow accrual
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03126643
Has Expanded Access, NCT# Status:
APPROVED_FOR_MARKETING
Acronym:
CheckMate 7G8
Brief Summary:
A study comparing nivolumab and bacterial drugs given to help the bodys immune system in the bladder versus bacterial drugs alone in high risk bladder cancer participants
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None