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

Conditions

• Early Triple Negative Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pembrolizumab — 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 — DRUG
  80 mg/m\^2 by IV infusion every week for up to 12 weeks.
• Carboplatin — DRUG
  AUC 1.5 mg/mL/min by IV infusion every week for up to 12 weeks.
• Doxorubicin (hydrochloride) — DRUG
  60 mg/m\^2 by IV infusion Q3W for up to 12 weeks.
• Boserolimab — BIOLOGICAL
  30 mg by IV infusion every 6 weeks (Q6W) for up to 12 Weeks.
• Epirubicin Hydrochloride — DRUG
  90 mg/m\^2 by IV infusion every 3 weeks (Q3W) for up to 12 weeks.
• Cyclophosphamide — DRUG
  600 mg/m\^2 by IV infusion every 3 weeks (Q3W) for up to 12 weeks.
• Capecitabine — 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) — DRUG
  300 mg by oral administration twice a day for up to approximately 52 weeks.

Study Details

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.

Key Dates

Start date

Mar 26, 2025

Status verified

Feb 2026

Primary completion

Jan 18, 2029

Completion

Mar 18, 2031

Study Design

Enrollment

0 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: 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.
• Experimental: 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.

Primary Outcome Measure

Number of participants with one or more adverse events (AEs) [ Time Frame: Up to approximately 34 months ]

Locations (1)

Find similar trials in Las Vegas, NV