Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04700124
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-26
First Post:
2021-01-05
Brief Title:
Perioperative Enfortumab Vedotin EV Plus Pembrolizumab MK-3475 Versus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle Invasive Bladder Cancer MIBC MK-3475-B15 KEYNOTE-B15 EV-304
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase 3 Randomized Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab MK-3475 Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer KEYNOTE-B15 EV-304
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
KEYNOTE-B15
Brief Summary:
The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin EV plus pembrolizumab and radical cystectomy RC pelvic lymph node dissection PLND compared with the current standard of care neoadjuvant chemotherapy gemcitabine plus cisplatin and RC PLND for participants with MIBC who are cisplatin-eligible The primary hypothesis is perioperative EV and pembrolizumab and RC PLND Arm A will achieve superior event free survival EFS compared with neoadjuvant gemcitabine cisplatin and RC PLND Arm B
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 |
|---|---|---|---|
| 2020-003106-31 | EUDRACT_NUMBER | Philippine Health Research Registry PHRR | None |
| MK-3475-B15 | OTHER | None | None |
| KEYNOTE-B15 | OTHER | None | None |
| EV-304 | OTHER | None | None |
| jRCT2041210011 | REGISTRY | None | None |
| PHRR221021-005086 | REGISTRY | None | None |