Trials / Active Not Recruiting
Active Not RecruitingNCT04895358
Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49)
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 (HR+/HER2-) Locally Recurrent Inoperable or Metastatic Breast Cancer (KEYNOTE-B49)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 340 (estimated)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The safety and efficacy of pembrolizumab plus the investigator's choice of chemotherapy will be assessed compared to placebo plus the investigator's choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) 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) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1. Prior to protocol amendment 7, participants who discontinued pembrolizumab/placebo with SD or better and subsequently experienced disease progression may have been eligible for up to 17 additional administrations of pembrolizumab if, upon unblinding, they were found to have received pembrolizumab, at the same dose and schedule used for the initial treatment period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | pembrolizumab | Intravenous (IV) infusion |
| DRUG | paclitaxel | IV infusion |
| DRUG | nab-paclitaxel | IV infusion |
| DRUG | liposomal doxorubicin | IV infusion |
| DRUG | capecitabine | oral administration |
| DRUG | normal saline | IV infusion |
| DRUG | dextrose | IV infusion |
Timeline
- Start date
- 2021-06-18
- Primary completion
- 2027-12-18
- Completion
- 2027-12-18
- First posted
- 2021-05-20
- Last updated
- 2026-03-11
Locations
256 sites across 31 countries: United States, Argentina, Australia, Austria, Brazil, Canada, Chile, China, Colombia, France, Germany, Greece, Guatemala, Hungary, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Philippines, Poland, Portugal, Romania, Russia, South Korea, Spain, Sweden, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04895358. Inclusion in this directory is not an endorsement.