Ignite Creation Date:
2024-05-06 @ 12:14 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03711032
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2018-10-15
Brief Title:
Efficacy and Safety of Pembrolizumab MK-3475 in Combination With Bacillus Calmette-Guerin BCG in High-Risk Non-Muscle Invasive Bladder Cancer HR NMIBC MK-3475-676KEYNOTE-676
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase 3 Randomized Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab MK-3475 in Combination With Bacillus Calmette-Guerin BCG in Participants With High-risk Non-muscle Invasive Bladder Cancer HR NMIBC That is Either Persistent or Recurrent Following BCG Induction or That is Naïve to BCG Treatment KEYNOTE-676
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:
None
Brief Summary:
Researchers are looking for new ways to treat high-risk non muscle invasive bladder cancer HR NMIBC NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or outside of the bladder High-risk means NMIBC may have a high chance of getting worse or coming back after treatment
The goals of this study are to learn 1 If more people who receive pembrolizumab with Bacillus Calmette-Guerin BCG have no signs of cancer in their body and live longer without the cancer growing spreading or coming back compared to people who receive BCG alone 2 About the safety and how well people tolerate BCG alone or in combination with pembrolizumab
The goals of this study are to learn 1 If more people who receive pembrolizumab with Bacillus Calmette-Guerin BCG have no signs of cancer in their body and live longer without the cancer growing spreading or coming back compared to people who receive BCG alone 2 About the safety and how well people tolerate BCG alone or in combination with pembrolizumab
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 |
|---|---|---|---|
| 2018-001967-22 | EUDRACT_NUMBER | JAPIC-CTI | None |
| MK-3475-676 | OTHER | None | None |
| 194713 | OTHER | None | None |