Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06312176
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-03-07
Brief Title:
A Study of Sacituzumab Tirumotecan MK-2870 as a Single Agent and in Combination With Pembrolizumab MK-3475 Versus Treatment of Physicians Choice in Participants With HRHER2- Unresectable Locally Advanced or Metastatic Breast Cancer MK-2870-010
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
An Open-label Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination With Pembrolizumab Versus Treatment of Physicians Choice in Participants With HRHER2- Unresectable Locally Advanced or Metastatic Breast Cancer
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:
The purpose of this study is to compare sacituzumab tirumotecan as a single agent and in combination with pembrolizumab versus Treatment of Physicians Choice TPC in participants with hormone receptor positivehuman epidermal growth factor receptor-2 negative HRHER2- unresectable locally advanced or metastatic breast cancer
The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival PFS per Response Evaluation Criteria in Solid Tumors version 11 RECIST 11 by blinded independent central review BICR in all participants
The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival PFS per Response Evaluation Criteria in Solid Tumors version 11 RECIST 11 by blinded independent central review BICR in all participants
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 |
|---|---|---|---|
| U1111-1289-8119 | OTHER | UTN | None |
| MK-2870-010 | OTHER | None | None |
| 2023-504918-29 | REGISTRY | None | None |