Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-522/KEYNOTE-522)

Summary

The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs placebo as adjuvant therapy in participants who have triple negative breast cancer (TNBC).

After a screening phase of approximately 28 days, each participant will receive neoadjuvant study treatment (Pembrolizumab + Chemotherapy OR Placebo + Chemotherapy) based on the randomization schedule for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment. After definitive surgery, each participant will receive adjuvant study treatment (Pembrolizumab OR Placebo) for approximately 27 weeks (9 cycles). Following adjuvant study treatment, each participant will be monitored for safety, survival and disease recurrence.

The primary study hypothesis is that pembrolizumab is superior to placebo, in combination with chemotherapy, as measured by the rate of Pathological Complete Response (pCR) and/or Event-free Survival (EFS), in participants with locally advanced TNBC.

Conditions

• Triple Negative Breast Neoplasms

Interventions

BIOLOGICAL

Pembrolizumab

On Day 1 of each cycle in the neoadjuvant and adjuvant phases of the study for a total of 17 cycles; intravenous (IV) infusion.

DRUG

Carboplatin

On Day 1 of Cycles 1-4 of the neoadjuvant phase of the study OR on Days 1, 8, 15 of Cycles 1-4 of the neoadjuvant phase of the study; IV infusion.

DRUG

Paclitaxel

On Days 1, 8 and 15 of Cycles 1-4 in the neoadjuvant phase of the study; IV infusion.

DRUG

Doxorubicin

On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV injection.

DRUG

Epirubicin

On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV injection.

DRUG

Cyclophosphamide

On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV infusion.

DRUG

Placebo

normal saline solution or dextrose: On Day 1 of each cycle in the neoadjuvant and adjuvant phases of the study for a total of 17 cycles; IV infusion

BIOLOGICAL

Granulocyte colony stimulating factor: Filgrastim or Pegfilgastrim

For prevention of neutropenia, filgrastim 5 μg/kg/day via subcutaneous (SC) injection administered per standard of care after chemotherapy OR pegfilgastrim 100 µg/kg (individualized) or 6 mg (general approach) via SC injection administered per standard of care.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC

  lead INDUSTRY

Principal Investigators

• Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-03-07

Primary Completion

2025-10-14

Completion

2025-10-14

FDA Drug

Yes

Countries

• United States
• Australia
• Brazil
• Canada
• Colombia
• France
• Germany
• Ireland
• Israel
• Italy
• Japan
• Poland
• Portugal
• Russia
• Singapore
• South Korea
• Spain
• Sweden
• Taiwan
• Turkey (Türkiye)
• United Kingdom

Study Locations