Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04895358
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-04
First Post:
2021-05-17
Brief Title:
Study of Pembrolizumab MK-3475 Plus Chemotherapy Versus Placebo Plus Chemotherapy for HRHER2- Locally Recurrent Inoperable or Metastatic Breast Cancer MK-3475-B49KEYNOTE-B49
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive Human Epidermal Growth Factor Receptor 2-Negative HRHER2- Locally Recurrent Inoperable or Metastatic Breast Cancer KEYNOTE-B49
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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 safety and efficacy of pembrolizumab plus the investigators choice of chemotherapy will be assessed compared to placebo plus the investigators choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive human epidermal growth factor receptor 2-negative HRHER2- locally recurrent inoperable or metastatic breast cancer
The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival PFS or overall survival OS in participants with programmed cell death-ligand 1 PD-L1 combined positive score CPS 1 and 10
The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival PFS or overall survival OS in participants with programmed cell death-ligand 1 PD-L1 combined positive score CPS 1 and 10
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-B49 | OTHER | None | None |
| KEYNOTE-B49 | OTHER | None | None |
| jRCT2051210049 | REGISTRY | None | None |
| PHRR210721-003751 | REGISTRY | None | None |
| 2020-005407-38 | EUDRACT_NUMBER | Philippine Health Research Registry PHRR | None |