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

NCT06829199 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2026-02-19

No results posted yet for this 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.

Conditions

  • Early Triple Negative Breast Cancer

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-26
Primary Completion
2029-01-18
Completion
2031-03-18
FDA Drug
Yes

Countries

  • United States
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06829199 on ClinicalTrials.gov