NCT06829199

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	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.
DRUG	Paclitaxel	80 mg/m\^2 by IV infusion every week for up to 12 weeks.
DRUG	Carboplatin	AUC 1.5 mg/mL/min by IV infusion every week for up to 12 weeks.
DRUG	Doxorubicin (hydrochloride)	60 mg/m\^2 by IV infusion Q3W for up to 12 weeks.
BIOLOGICAL	Boserolimab	30 mg by IV infusion every 6 weeks (Q6W) for up to 12 Weeks.
DRUG	Epirubicin Hydrochloride	90 mg/m\^2 by IV infusion every 3 weeks (Q3W) for up to 12 weeks.
DRUG	Cyclophosphamide	600 mg/m\^2 by IV infusion every 3 weeks (Q3W) for up to 12 weeks.
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.
DRUG	Olaparib (if approved/available locally)	300 mg by oral administration twice a day for up to approximately 52 weeks.

Timeline

• Start date: 2025-03-26
• Primary completion: 2029-01-18
• Completion: 2031-03-18
• First posted: 2025-02-17
• Last updated: 2026-02-19

Locations

2 sites across 2 countries: United States, Taiwan

Regulatory

• FDA-regulated drug study