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

NCT ID: NCT06829199

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-26
• Study Completion Date: 2031-03-18

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.

Detailed 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.

Conditions

Early Triple Negative Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pembrolizumab+ Paclitaxel+ Carboplatin

Participants 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.

Group Type: ACTIVE_COMPARATOR

Pembrolizumab

Intervention Type: BIOLOGICAL

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.

Paclitaxel

Intervention Type: DRUG

80 mg/m\^2 by IV infusion every week for up to 12 weeks.

Carboplatin

Intervention Type: DRUG

AUC 1.5 mg/mL/min by IV infusion every week for up to 12 weeks.

Doxorubicin (hydrochloride)

Intervention Type: DRUG

60 mg/m\^2 by IV infusion Q3W for up to 12 weeks.

Epirubicin Hydrochloride

Intervention Type: DRUG

90 mg/m\^2 by IV infusion every 3 weeks (Q3W) for up to 12 weeks.

Cyclophosphamide

Intervention Type: DRUG

600 mg/m\^2 by IV infusion every 3 weeks (Q3W) for up to 12 weeks.

Capecitabine

Intervention Type: DRUG

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.

Olaparib (if approved/available locally)

Intervention Type: DRUG

300 mg by oral administration twice a day for up to approximately 52 weeks.

Pembrolizumab+Boserolimab+Paclitaxel+ Carboplatin

Participants 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.

Group Type: EXPERIMENTAL

Pembrolizumab

Intervention Type: BIOLOGICAL

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.

Paclitaxel

Intervention Type: DRUG

80 mg/m\^2 by IV infusion every week for up to 12 weeks.

Carboplatin

Intervention Type: DRUG

AUC 1.5 mg/mL/min by IV infusion every week for up to 12 weeks.

Doxorubicin (hydrochloride)

Intervention Type: DRUG

60 mg/m\^2 by IV infusion Q3W for up to 12 weeks.

Boserolimab

Intervention Type: BIOLOGICAL

30 mg by IV infusion every 6 weeks (Q6W) for up to 12 Weeks.

Epirubicin Hydrochloride

Intervention Type: DRUG

90 mg/m\^2 by IV infusion every 3 weeks (Q3W) for up to 12 weeks.

Cyclophosphamide

Intervention Type: DRUG

600 mg/m\^2 by IV infusion every 3 weeks (Q3W) for up to 12 weeks.

Capecitabine

Intervention Type: DRUG

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.

Olaparib (if approved/available locally)

Intervention Type: DRUG

300 mg by oral administration twice a day for up to approximately 52 weeks.

Interventions

Pembrolizumab

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.

Intervention Type: BIOLOGICAL

Paclitaxel

80 mg/m\^2 by IV infusion every week for up to 12 weeks.

Intervention Type: DRUG

Carboplatin

AUC 1.5 mg/mL/min by IV infusion every week for up to 12 weeks.

Intervention Type: DRUG

Doxorubicin (hydrochloride)

60 mg/m\^2 by IV infusion Q3W for up to 12 weeks.

Intervention Type: DRUG

Boserolimab

30 mg by IV infusion every 6 weeks (Q6W) for up to 12 Weeks.

Intervention Type: BIOLOGICAL

Epirubicin Hydrochloride

90 mg/m\^2 by IV infusion every 3 weeks (Q3W) for up to 12 weeks.

Intervention Type: DRUG

Cyclophosphamide

600 mg/m\^2 by IV infusion every 3 weeks (Q3W) for up to 12 weeks.

Intervention Type: DRUG

Capecitabine

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.

Intervention Type: DRUG

Olaparib (if approved/available locally)

300 mg by oral administration twice a day for up to approximately 52 weeks.

Intervention Type: DRUG

Other Intervention Names

MK-3475; Keytruda®; SCH 900475; MK-5890

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Optum Care Cancer Center ( Site 0004)

Las Vegas, Nevada, United States

National Cheng Kung University Hospital ( Site 0901)

Tainan City, , Taiwan

Countries

United States; Taiwan

Related Links

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

MK-5890-003

Identifier Type: OTHER

Identifier Source: secondary_id

2024-517505-87-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1312-3982

Identifier Type: REGISTRY

Identifier Source: secondary_id

5890-003

Identifier Type: -

Identifier Source: org_study_id