Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06211764
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-01-09
Brief Title:
A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer HR-NMIBC After Bacillus Calmette-Guérin BCG
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Phase 3 Randomized Open-label Multi-center Study Evaluating the Efficacy and Safety of TAR-200 Versus Investigators Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin BCG and Recurred With High-risk Non-muscle-invasive Bladder Cancer HR-NMIBC and Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy
Status:
RECRUITING
Status Verified Date:
2024-10
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:
SunRISe-5
Brief Summary:
The purpose of this study is to compare disease free survival DFS in participants with recurrence of papillary-only high-risk non-muscle-invasive bladder cancer HR-NMIBC within 1 year of last dose of Bacillus Calmette-Guérin BCG therapy and who refused or are unfit for Radical Cystectomy RC receiving TAR-200 versus investigators choice of single agent intravesical chemotherapy
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-507685-10-00 | REGISTRY | EUCT number | None |