Ignite Creation Date:
2024-07-17 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06483334
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-21
Brief Title:
A Study of Efficacy and Safety of Sacituzumab Tirumotecan MK-2870 Plus Enfortumab Vedotin EV With and Without Pembrolizumab in Advanced Urothelial Carcinoma MK-3475-04CKEYMAKER-U04
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase 12 Randomized Umbrella Study to Evaluate the Efficacy and Safety of MK-2870 Plus Enfortumab Vedotin EV With and Without Pembrolizumab as Treatment for Participants With Advanced Urothelial Carcinoma KEYMAKER-U04 Substudy 04C
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a substudy being conducted under one pembrolizumab umbrella master study KEYMAKER-U04 The substudy will consist of 2 parts Part 1 will evaluate the safety and preliminary efficacy of sacituzumab tirumotecan plus enfortumab vedotin EV Part 2 will be based on Part 1 results and will evaluate the efficacy pharmacokinetics and safety of sacituzumab tirumotecan plus EV in combination with pembrolizumab in participants with advanced urothelial carcinoma
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-3475-04C | OTHER | None | None |
| U1111-1293-7631 | OTHER | None | None |