Ignite Creation Date:
2024-05-06 @ 1:04 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03924895
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2019-04-22
Brief Title:
Perioperative Pembrolizumab MK-3475 Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer MK-3475-905KEYNOTE-905EV-303
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Randomized Phase 3 Study Evaluating Cystectomy With Perioperative Pembrolizumab and Cystectomy With Perioperative Enfortumab Vedotin and Pembrolizumab Versus Cystectomy Alone in Participants Who Are Cisplatin-Ineligible or Decline Cisplatin With Muscle-Invasive Bladder Cancer KEYNOTE-905EV-303
Status:
ACTIVE_NOT_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:
This is a study of perioperative pembrolizumab or enfortumab vedotin in combination with pembrolizumab in participants who are cisplatin-ineligible or decline cisplatin with muscle-invasive bladder cancer MIBC
The primary hypothesis is that perioperative pembrolizumab plus radical cystectomy RC plus pelvic lymph node dissection PLND and perioperative enfortumab vedotin in combination with pembrolizumab plus RCPLND will achieve superior event-free survival EFS compared with RCPLND alone
With Amendment 5 outcome measures for programmed cell death ligand 1 PD-L1 combined positive score CPS were removed
With Amendment 8 the primary outcome measure of pathologic complete response pCR rates was changed to a secondary outcome measure
The primary hypothesis is that perioperative pembrolizumab plus radical cystectomy RC plus pelvic lymph node dissection PLND and perioperative enfortumab vedotin in combination with pembrolizumab plus RCPLND will achieve superior event-free survival EFS compared with RCPLND alone
With Amendment 5 outcome measures for programmed cell death ligand 1 PD-L1 combined positive score CPS were removed
With Amendment 8 the primary outcome measure of pathologic complete response pCR rates was changed to a secondary outcome measure
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 |
|---|---|---|---|
| MK-3475-905 | OTHER | None | None |
| KEYNOTE-905 | OTHER | None | None |
| EV-303 | OTHER | None | None |
| PHRR210911-003890 | OTHER | None | None |
| jRCT2031220686 | REGISTRY | None | None |
| 2018-003809-26 | EUDRACT_NUMBER | Japan Registry of Clinical Trials jRCT | None |