Combining boserolimab with pembrolizumab and chemotherapy for early triple-negative breast cancer
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
This study is testing if adding boserolimab to standard treatments like pembrolizumab and chemotherapy can help people with early triple-negative breast cancer respond better before surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Drugs / interventions | pembrolizumab, radiation, Doxorubicin, boserolimab, chemotherapy |
| Locations | 2 sites (Las Vegas, Nevada and 1 other locations) |
| Trial ID | NCT06829199 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to evaluate the safety and tolerability of boserolimab (MK-5890) when combined with standard treatments, pembrolizumab and chemotherapy, in patients with early-stage triple-negative breast cancer (TNBC). The study will assess how well patients respond to this combination before surgery, focusing on the absence of cancer in tissue and lymph nodes post-treatment. It utilizes an umbrella design to explore the clinical activity of investigational agents in high-risk, newly diagnosed TNBC patients.
Who should consider this trial
Good fit: Ideal candidates are individuals with untreated high-risk, early-stage, non-metastatic triple-negative breast cancer.
Not a fit: Patients with metastatic breast cancer or those who have previously received treatment for their breast cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could improve outcomes for patients with early triple-negative breast cancer by enhancing the effectiveness of standard therapies.
How similar studies have performed: Other studies have shown promise in combining immunotherapy with chemotherapy for breast cancer, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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: 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 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
Where this trial is running
Las Vegas, Nevada and 1 other locations
- Optum Care Cancer Center ( Site 0004) — Las Vegas, Nevada, United States (Recruiting)
- National Cheng Kung University Hospital ( Site 0901) — Tainan, Taiwan (Recruiting)
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@merck.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.