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NCT04895358 · ClinicalTrials.gov registry record · Phase 3
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 Phase 3 study of Breast Neoplasms, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 340
- Enrollment target
- 20
- Study locations
NCT04895358: Active Phase 3 study of Breast Neoplasms, sponsored by Merck Sharp & Dohme.
NCT04895358 is a Phase 3 study of Breast Neoplasms that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 340 participants, below the 565-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (40% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04895358, a Phase 3 study of Breast Neoplasms, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 340 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
PFS is defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD
Conditions Studied
Interventions
- BIOLOGICAL pembrolizumab
- DRUG nab-paclitaxel
- DRUG paclitaxel
- DRUG liposomal doxorubicin
- DRUG capecitabine
Study Locations (20)
Illinois
- University of Illinois at Chicago ( Site 0061) - Chicago
- Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0067) - Elmhurst
- Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0066) - Naperville
- Edward-Elmhurst Healthcare, Edward Hospital - Plainfield-Edward Cancer Center - Plainfield ( Site 00 - Plainfield
- Orchard Healthcare Research Inc. ( Site 0037) - Skokie
Florida
- Baptist MD Anderson Cancer Center ( Site 0013) - Jacksonville
- Miami Cancer Institute at Baptist Health, Inc. ( Site 0070) - Miami
- Miami Cancer Institute - Plantation ( Site 0076) - Plantation
California
- Pacific Cancer Care ( Site 0023) - Monterey
- UCSF Medical Center at Mission Bay ( Site 0043) - San Francisco
District of Columbia
- Georgetown University Medical Center-Department of Medicine and Oncology ( Site 0026) - Washington D.C.
- MedStar Washington Hospital Center ( Site 0063) - Washington D.C.
Georgia
- University Cancer & Blood Center, LLC ( Site 0032) - Athens
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0028) - Marietta
Louisiana
- Louisiana State University Health Sciences Shreveport ( Site 0072) - Shreveport
- CHRISTUS Highland-Oncology Research ( Site 0073) - Shreveport
Alabama
- University of Alabama at Birmingham-Medicine ( Site 0065) - Birmingham
Arizona
- Arizona Oncology Associates-Arizona Oncology ( Site 0049) - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 340 participants |
| Start Date | 2021-06-18 |
| Est. Completion | 2027-12-18 |
| Phase | Phase 3 |
What the registry record for NCT04895358 still lists
NCT04895358 is an interventional study that assigns participants to a tested intervention. The registered 340 participants enrollment target is mid-sized for trials with a published cap, below the 565-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Breast Neoplasms appearing as the primary indexed condition, and to 5 interventions - of which pembrolizumab is the first listed.
NCT04895358 names 20 study sites across 10 states, led by Illinois, Florida, California.
Frequently Asked Questions
What is clinical trial NCT04895358 about?
NCT04895358 is a clinical study titled "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)". 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+/HER...
What is the current status of trial NCT04895358?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 340 participants. The study started on 2021-06-18. Estimated completion is 2027-12-18.
What conditions does trial NCT04895358 study?
This clinical trial studies the following conditions: Breast Neoplasms.
What interventions are being tested in trial NCT04895358?
The interventions under investigation include: pembrolizumab (BIOLOGICAL), nab-paclitaxel (DRUG), paclitaxel (DRUG), liposomal doxorubicin (DRUG), capecitabine (DRUG).
Who is sponsoring clinical trial NCT04895358?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04895358 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04895358's enrollment target sits among peer trials
340 30th of 97 higher than 68 of 97 other Breast Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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