Boserolimab + Pembrolizumab + Chemotherapy for Breast Cancer

No longer recruiting at 2 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Merck Sharp & Dohme LLC

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Cardiovascular disease, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding a new treatment, boserolimab, to the standard care of pembrolizumab and chemotherapy can improve outcomes for people with triple-negative breast cancer (TNBC). Researchers aim to determine if this combination, administered before surgery, helps eliminate all signs of cancer in the tissues and lymph nodes. They also assess patient tolerance and the safety of the new treatment. This trial suits individuals with early-stage, non-metastatic triple-negative breast cancer who have not yet received any treatment. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or steroids, you may need to stop them at least 7 days before starting the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining boserolimab and pembrolizumab with chemotherapy is generally safe, based on previous studies. Patients tolerated the treatment well, and the side effects were manageable. This combination has also shown early signs of shrinking tumors, which is encouraging. Adding pembrolizumab to chemotherapy has been shown to extend patient survival compared to chemotherapy alone. These findings suggest that the treatment is generally safe and could be effective, but potential risks and side effects must be considered. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for breast cancer because they explore new combinations of immunotherapy and chemotherapy. Unlike traditional treatments that typically focus on chemotherapy alone, these investigational treatments include pembrolizumab and boserolimab, which are immunotherapy drugs that help the body's immune system target cancer cells more effectively. The addition of boserolimab, in particular, is a unique feature, as it may enhance the immune response and improve outcomes when used alongside chemotherapy agents like paclitaxel and carboplatin. By combining these therapies, the hope is to achieve better results in fighting cancer before and after surgery.

What evidence suggests that this trial's treatments could be effective for triple negative breast cancer?

Research has shown that combining boserolimab with pembrolizumab and chemotherapy may help treat triple negative breast cancer (TNBC). In this trial, one group of participants will receive boserolimab and pembrolizumab alongside chemotherapy. Specifically, one study found that nearly half of the patients who received boserolimab and pembrolizumab experienced a noticeable reduction in their cancer. Another group in this trial will receive pembrolizumab with chemotherapy alone, which has also proven effective, helping patients live longer without their cancer worsening. Specifically, another study found that about 86.6% of patients who received pembrolizumab and chemotherapy were still alive after five years. These findings suggest that adding boserolimab could further improve treatment outcomes for those with TNBC. ^{1 2 3 5 6}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for individuals with early-stage, high-risk triple-negative breast cancer that hasn't spread. Participants must have a recent tissue diagnosis and controlled HIV or hepatitis if present. They should be relatively active and able to carry out daily activities (ECOG status 0-1).

Inclusion Criteria

I have a new diagnosis of high-risk, early-stage TNBC that hasn't spread.

I provided a tissue sample for my current breast cancer diagnosis less than 29 days ago.

I have HIV and it is well controlled with medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Participants receive pembrolizumab, boserolimab, paclitaxel, and carboplatin followed by pembrolizumab, doxorubicin hydrochloride or epirubicin hydrochloride, and cyclophosphamide prior to surgery

Up to approximately 9 months

Surgery

Definitive surgery to assess pathological complete response (pCR)

Adjuvant Treatment

Participants receive pembrolizumab with optional additional adjuvant treatment of physician's choice, capecitabine, or olaparib

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 72 months

What Are the Treatments Tested in This Trial?

Interventions

• Boserolimab
• Epirubicin Hydrochloride, Paclitaxel, Carboplatin, Doxorubicin (hydrochloride), Cyclophosphamide, Capecitabine, Olaparib
• Pembrolizumab

Trial Overview The study tests Boserolimab combined with Pembrolizumab and chemotherapy before surgery in treating triple-negative breast cancer. It aims to assess the safety of this combination therapy, how well patients tolerate it, and its effectiveness in eliminating cancer signs.

How Is the Trial Designed?

Group I: Pembrolizumab+Boserolimab+Paclitaxel+ Carboplatin Experimental Treatment 9 Interventions

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 II: Pembrolizumab+ Paclitaxel+ Carboplatin Active Control 8 Interventions

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.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Published Research Related to This Trial

Pembrolizumab, a monoclonal antibody that blocks PD-1, effectively enhances antitumor immune responses and has been approved for treating advanced melanoma, renal cell cancer, and non-small cell lung cancer.

In vivo studies using PET imaging showed that pembrolizumab is stable in circulation and primarily accumulates in the liver and spleen, providing valuable insights into its pharmacokinetics and potential for optimizing dosing strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical Pharmacokinetics and Biodistribution Studies of 89Zr-Labeled Pembrolizumab. England, CG., Ehlerding, EB., Hernandez, R., et al.[2020]

In a phase II trial involving 50 patients with early triple-negative breast cancer, 66% achieved a pathological complete response (pCR) after treatment with nab-paclitaxel and pembrolizumab, indicating a promising efficacy of this combination therapy.

The treatment was associated with manageable side effects, with fatigue, peripheral sensory neuropathy, and neutropenia being the most common adverse events, suggesting that this regimen could be a viable alternative to platinum-based chemotherapy for patients who cannot tolerate it.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab in combination with nab-paclitaxel for the treatment of patients with early-stage triple-negative breast cancer - A single-arm phase II trial (NeoImmunoboost, AGO-B-041). Fasching, PA., Hein, A., Kolberg, HC., et al.[2023]

In a case series of 19 patients with previously treated HER2-positive metastatic breast cancer, the combination of pertuzumab, trastuzumab, and taxane therapy resulted in a median progression-free survival of 4.1 months.

The treatment was associated with minimal adverse effects, showing only a slight decrease in left ventricular ejection fraction (-1%) and no occurrences of neutropenic fever, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination pertuzumab, trastuzumab, and taxane for metastatic breast cancer after first progression: a single institution's experience. Dao, BD., Ho, H., Quintal, LN.[2016]

In a phase 3 trial involving 1177 participants with completely resected stage IB-IIIA non-small-cell lung cancer (NSCLC), pembrolizumab significantly improved median disease-free survival to 53.6 months compared to 42.0 months for placebo, indicating its efficacy as an adjuvant therapy.

The safety profile of pembrolizumab was consistent with previous studies, showing no new safety signals, although serious adverse events were more common in the pembrolizumab group (24%) compared to placebo (15%), highlighting the need for careful monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab versus placebo as adjuvant therapy for completely resected stage IB-IIIA non-small-cell lung cancer (PEARLS/KEYNOTE-091): an interim analysis of a randomised, triple-blind, phase 3 trial. O'Brien, M., Paz-Ares, L., Marreaud, S., et al.[2022]

In a multicenter retrospective analysis of early triple-negative breast cancer (eTNBC) patients treated with pembrolizumab and chemotherapy, the incidence of immune-related adverse events (irAEs) was found to be 63.9%, with 20% of patients experiencing severe (grade 3 or higher) irAEs.

The study reported a pathological complete response (pCR) rate of 57.1%, with a significant correlation between the occurrence of irAEs and higher pCR rates (72.2% vs. 30.8%), indicating that while irAEs are common, they may be associated with better treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emergence of immune-related adverse events correlates with pathological complete response in patients receiving pembrolizumab for early triple-negative breast cancer. Marhold, M., Udovica, S., Halstead, A., et al.[2023]

In the KEYNOTE-522 study involving 1174 patients, the addition of pembrolizumab to neoadjuvant chemotherapy significantly improved pathologic complete response (pCR) rates, with 58.7% achieving pCR compared to 40.0% in the placebo group, regardless of PD-L1 status.

Event-free survival (EFS) was also enhanced, with a 36-month EFS rate of 91.2% for the pembrolizumab group versus 77.2% for the placebo group, indicating that this treatment combination could be a new standard of care for early triple-negative breast cancer in Asian populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab Plus Chemotherapy Followed by Pembrolizumab in Patients With Early Triple-Negative Breast Cancer: A Secondary Analysis of a Randomized Clinical Trial. Takahashi, M., Cortés, J., Dent, R., et al.[2023]

In a phase Ib trial involving women with triple-negative breast cancer, both pembrolizumab combined with weekly paclitaxel and with capecitabine were found to be safe, meeting the safety endpoint with 87% and 100% of patients respectively not experiencing severe toxicities.

The efficacy results showed an objective response rate of 29% for the pembrolizumab/paclitaxel combination and 43% for the pembrolizumab/capecitabine combination, indicating that both regimens are clinically active, particularly in patients with specific biomarkers like PD-L1 scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase Ib trial of pembrolizumab plus paclitaxel or flat-dose capecitabine in 1st/2nd line metastatic triple-negative breast cancer. Page, DB., Pucilowska, J., Chun, B., et al.[2023]

Pembrolizumab is an effective cancer treatment that works by reactivating T cells, but it can lead to various immune-related adverse events, including rare cases of synovitis.

Healthcare providers should be vigilant about the potential for pembrolizumab-induced synovitis and act quickly to treat it to prevent lasting joint damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Could knee inflammatory synovitis be induced by pembrolizumab? Mahmoud, F., Wilkinson, JT., Gizinski, A., et al.[2018]

Pembrolizumab, when combined with carboplatin and pemetrexed, significantly improves overall and progression-free survival rates in patients with non-small cell lung cancer (NSCLC), demonstrating its efficacy as a treatment option.

This case report highlights a unique instance of immune-mediated sarcoidosis developing in a patient with NSCLC after receiving pembrolizumab, indicating potential immune-related side effects of this therapy that require further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary Sarcoidosis Activation following Neoadjuvant Pembrolizumab plus Chemotherapy Combination Therapy in a Patient with Non-Small Cell Lung Cancer: A Case Report. Fakhri, G., Akel, R., Salem, Z., et al.[2022]

The PELICAN-IPC trial is investigating the safety and efficacy of pembrolizumab, an anti-PD-1 antibody, combined with chemotherapy in patients with HER2-negative inflammatory breast cancer (IBC), which is known for its aggressive nature and poor treatment outcomes.

The primary goal of the trial is to assess the rate of pathologic complete response (pCR) after treatment, while also monitoring safety and tolerability, with additional objectives focusing on long-term survival outcomes and translational research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PELICAN-IPC 2015-016/Oncodistinct-003: A Prospective, Multicenter, Open-Label, Randomized, Non-Comparative, Phase II Study of Pembrolizumab in Combination With Neo Adjuvant EC-Paclitaxel Regimen in HER2-Negative Inflammatory Breast Cancer. Bertucci, A., Bertucci, F., Zemmour, C., et al.[2022]

Citations

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Phase 1 evaluation of triple therapy with boserolimab (anti ... 9.8% of pts (4/41) discontinued ≥1 study treatment due to treatment-related AEs. Confirmed ORR was 46.3% (95% CI, 30.7%-62.6%), with 2 CRs and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06829199

NCT06829199 | A Clinical Study of Boserolimab (MK-5890 ... Researchers want to learn if giving boserolimab (MK-5890) with standard treatment (pembrolizumab and chemotherapy) before surgery can help treat triple ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39282906/

Overall Survival with Pembrolizumab in Early-Stage Triple ... The estimated overall survival at 60 months was 86.6% (95% confidence interval [CI], 84.0 to 88.8) in the pembrolizumab-chemotherapy group, as ...

4. withpower.com withpower.com/trial/phase-2-breast-neoplasms-2-2025-fff33

Boserolimab + Pembrolizumab + Chemotherapy for Breast Cancer The efficacy results showed an objective response rate of 29% for the pembrolizumab/paclitaxel combination and 43% for the pembrolizumab/capecitabine ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2202809

Pembrolizumab plus Chemotherapy in Advanced Triple ... Data from a prespecified interim analysis showed that pembrolizumab plus chemotherapy resulted in significantly longer progression-free survival ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03396445

Study of Boserolimab (MK-5890) as Monotherapy and in ... The purpose of this study is to assess the safety and pharmacokinetics of boserolimab (MK-5890) when administered alone and in combination with pembrolizumab ( ...