A Clinical Study of Boserolimab (MK-5890) With Pembrolizumab and Chemotherapy in People With Early Triple-Negative Breast Cancer (MK-5890-003)

Last updated: February 17, 2026
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Trial Not Available

Phase

2

Condition

N/A

Treatment

Olaparib (if approved/available locally)

Carboplatin

Capecitabine

Clinical Study ID

NCT06829199
5890-003
U1111-1312-3982
2024-517505-87
MK-5890-003
2024-517505-87-00
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • 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 stageN0-2

  • Has provided a core needle biopsy for tissue diagnosis of the current breast cancerless than 29 days prior to the date of informed consent

  • Has centrally confirmed diagnosis of BC that is triple-negative based on theAmerican 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 ormultigated acquisition scan performed at screening

  • Has a history of exposure to anthracycline; participants can be eligible aftercompletion of a Sponsor consultation form, if cumulative lifetime doses are asfollows: Doxorubicin <100 mg/m2, Epirubicin <180 mg/m2, Mitoxantrone <40 mg/m2,Idarubicin <22.5 mg/m2. Note: If another anthracycline or more than oneanthracycline has been used, the cumulative dose must not exceed the equivalent of 100 mg/m2 of doxorubicin

Exclusion

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • 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 anagent directed to another stimulatory or coinhibitory T-cell receptor (e.g.,cytotoxic T-lymphocyte-associated protein-4 [CTLA-4], OX-40 [cluster ofdifferentiation (CD) 134], or CD137)

  • Has received any prior treatment, including radiation, systemic therapy, and/ordefinitive surgery for currently diagnosed breast cancer

  • Has received prior systemic anticancer therapy

  • Has undergone excisional biopsy of the primary tumor and/or axillary lymph nodedissection prior to study treatment

  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapyor any other form of immunosuppressive therapy within 7 days prior to the first doseof study intervention

  • Has a known additional malignancy that is progressing or has required activetreatment within the past 5 years

  • Has active autoimmune disease that has required systemic treatment in the past 2years with need for disease modifying agents such as corticosteroids orimmunosuppressive drugs

  • Has history of (noninfectious) pneumonitis/interstitial lung disease that requiredsteroids 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 MulticentricCastleman's Disease

  • Has severe hypersensitivity (Grade ≥3) to pembrolizumab, any investigational agentor study intervention, any of its excipients, and/or to another biologic therapy

  • Has a history of allogeneic tissue/solid organ transplant

Study Design

Treatment Group(s): 9
Primary Treatment: Olaparib (if approved/available locally)
Phase: 2
Study Start date:
March 26, 2025
Estimated Completion Date:
March 18, 2031

Study Description

The umbrella design of this study provides the framework to evaluate the safety, tolerability and clinical activity of different investigational agents in participants with newly diagnosed, high-risk, early-stage TNBC who might benefit from adding these investigational agents to pembrolizumab plus chemotherapy.

Connect with a study center

  • National Cheng Kung University Hospital ( Site 0901)

    Tainan, 704
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital ( Site 0901)

    Tainan 1668355, 704
    Taiwan

    Site Not Available

  • Optum Care Cancer Center ( Site 0004)

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • Optum Care Cancer Center ( Site 0004)

    Las Vegas 5506956, Nevada 5509151 89102
    United States

    Site Not Available

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