Study Stopped
Since patients were not recruited yet, we would mark this as a Withdrawn status per the NIH definition of that status. Study halted prematurely, prior to enrollment of first participant.
A Clinical Study of Boserolimab (MK-5890) With Pembrolizumab and Chemotherapy in People With Early Triple-Negative Breast Cancer (MK-5890-003)
A Phase 2, Umbrella Study to Evaluate the Safety, Tolerability, and Clinical Activity of Investigational Agents for Newly Diagnosed, High-Risk, Early-Stage Triple-Negative Breast Cancer
4 other identifiers
interventional
N/A
2 countries
2
Brief Summary
Researchers want to learn if giving boserolimab (MK-5890) with standard treatment (pembrolizumab and chemotherapy) before surgery can help treat triple negative breast cancer (TNBC). The goals of this study are to learn about the safety of boserolimab given with standard treatment before surgery and to learn if people tolerate it and how many people have no signs of cancer in the tissues and lymph nodes removed during surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2025
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2025
CompletedFirst Posted
Study publicly available on registry
February 17, 2025
CompletedStudy Start
First participant enrolled
March 26, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 18, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 18, 2031
February 19, 2026
February 1, 2026
3.8 years
February 11, 2025
February 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of participants with one or more adverse events (AEs)
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Up to approximately 34 months
Number of participants who discontinue study intervention due to an AE
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Up to approximately 27 months
Pathological complete response (pCR) rate at the time of definitive surgery
pCR (ypT0/Tis ypN0) is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes after completion of neoadjuvant systemic therapy per current American Joint Committee on Cancer (AJCC) staging criteria assessed by the local pathologist at the time of definitive surgery.
Up to approximately 9 months
Secondary Outcomes (3)
pCR-no ductal carcinoma in situ (DCIS) rate at the time of definitive surgery
Up to approximately 9 months
Event-Free Survival (EFS)
Up to approximately 72 months
Overall Survival (OS)
Up to approximately 72 months
Study Arms (2)
Pembrolizumab+ Paclitaxel+ Carboplatin
ACTIVE COMPARATORParticipants will receive pembrolizumab PLUS paclitaxel PLUS carboplatin followed by pembrolizumab PLUS doxorubicin hydrochloride or epirubicin hydrochloride and cyclophosphamide as neoadjuvant therapy prior to surgery. In adjuvant therapy participants will receive pembrolizumab PLUS optional additional adjuvant treatment of physician's choice (TPC), capecitabine or olaparib.
Pembrolizumab+Boserolimab+Paclitaxel+ Carboplatin
EXPERIMENTALParticipants will receive pembrolizumab PLUS boserolimab PLUS paclitaxel PLUS carboplatin followed by pembrolizumab PLUS doxorubicin hydrochloride or epirubicin hydrochloride and cyclophosphamide PLUS boserolimab as neoadjuvant therapy prior to surgery. In adjuvant therapy participants will receive pembrolizumab PLUS optional additional adjuvant treatment of physician's choice (TPC), capecitabine or olaparib.
Interventions
AUC 1.5 mg/mL/min by IV infusion every week for up to 12 weeks.
300 mg by oral administration twice a day for up to approximately 52 weeks.
60 mg/m\^2 by IV infusion Q3W for up to 12 weeks.
30 mg by IV infusion every 6 weeks (Q6W) for up to 12 Weeks.
90 mg/m\^2 by IV infusion every 3 weeks (Q3W) for up to 12 weeks.
600 mg/m\^2 by IV infusion every 3 weeks (Q3W) for up to 12 weeks.
1000 mg/m\^2 to 1250 mg/m\^2 by oral administration twice a day (2 weeks on and 1 week off) for up to approximately 24 weeks.
Neoadjuvant therapy - 200 mg intravenous (IV) infusion every 3 weeks (Q3W) for up to approximately 24 weeks Adjuvant therapy - 200 mg IV infusion Q3W or 400 mg IV infusion every 6 weeks (Q6W) for up to approximately 30 weeks.
80 mg/m\^2 by IV infusion every week for up to 12 weeks.
Eligibility Criteria
You may qualify if:
- Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as tumor stage T1c, nodal stage N1-2, or tumor stage T2-4, nodal stage N0-2
- Has provided a core needle biopsy for tissue diagnosis of the current breast cancer less than 29 days prior to the date of informed consent
- Has centrally confirmed diagnosis of BC that is triple-negative based on the American Society of Clinical Oncology/College of American Pathologists guidelines
- Has Eastern Cooperative Oncology Group performance status of 0 or 1 performed within 28 days before treatment randomization
- Has left ventricle ejection fraction of ≥50% as assessed by echocardiogram or multigated acquisition scan performed at screening
- Has a history of exposure to anthracycline; participants can be eligible after completion of a Sponsor consultation form, if cumulative lifetime doses are as follows: Doxorubicin \<100 mg/m2, Epirubicin \<180 mg/m2, Mitoxantrone \<40 mg/m2, Idarubicin \<22.5 mg/m2. Note: If another anthracycline or more than one anthracycline has been used, the cumulative dose must not exceed the equivalent of 100 mg/m2 of doxorubicin
You may not qualify if:
- Has documented Grade ≥2 peripheral neuropathy
- Has uncontrolled or significant cardiovascular disease
- Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein-4 \[CTLA-4\], OX-40 \[cluster of differentiation (CD) 134\], or CD137)
- Has received any prior treatment, including radiation, systemic therapy, and/or definitive surgery for currently diagnosed breast cancer
- Has received prior systemic anticancer therapy
- Has undergone excisional biopsy of the primary tumor and/or axillary lymph node dissection prior to study treatment
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
- Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
- Has active autoimmune disease that has required systemic treatment in the past 2 years with need for disease modifying agents such as corticosteroids or immunosuppressive drugs
- Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has an active infection requiring systemic therapy
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has severe hypersensitivity (Grade ≥3) to pembrolizumab, any investigational agent or study intervention, any of its excipients, and/or to another biologic therapy
- Has a history of allogeneic tissue/solid organ transplant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Optum Care Cancer Center ( Site 0004)
Las Vegas, Nevada, 89102, United States
National Cheng Kung University Hospital ( Site 0901)
Tainan, 704, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2025
First Posted
February 17, 2025
Study Start
March 26, 2025
Primary Completion (Estimated)
January 18, 2029
Study Completion (Estimated)
March 18, 2031
Last Updated
February 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf