Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06393374
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-04-26
Brief Title:
Sacituzumab Tirumotecan MK-2870 Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR MK-2870-012
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase 3 Randomized Open-label Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination With Pembrolizumab MK-3475 Versus Treatment of Physicians Choice TPC in Participants With Triple-Negative Breast Cancer TNBC Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response pCR at Surgery
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:
This is a randomized open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan sac-TMT MK-2870 in combination with pembrolizumab compared to treatment of physicians choice TPC in participants with triple-negative breast cancer TNBC who received neoadjuvant therapy and did not achieve a pathological complete response pCR at surgery The primary objective is to compare sac-TMT plus pembrolizumab to TPC pembrolizumab or pembrolizumab plus capecitabine with respect to invasive disease-free survival iDFS per investigator assessment It is hypothesized that sac-TMT plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment
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 |
|---|---|---|---|
| U1111-1289-8264 | OTHER | UTN | None |
| 2023-504962-52 | OTHER_GRANT | None | None |