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)

Completed · Phase 3 · Has a placebo group

Conditions studied: Triple Negative Breast Neoplasms

In brief

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.

Key facts

Study ID: NCT03036488
Run by: Merck Sharp & Dohme LLC
People needed: 1174
Starts: 2017-03-07
Expected to finish: 2025-10-14
Last updated by the study team: 2025-10-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Has newly diagnosed, locally advanced, centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
Has previously untreated locally advanced non-metastatic (M0) TNBC defined as the following combined primary tumor (T) and regional lymph node (N) staging per current American Joint Committee of Cancer (AJCC) staging criteria for breast cancer as assessed by the investigator based on radiological and/or clinical assessment:
T1c, N1-N2
T2, N0-N2
T3, N0-N2
T4a-d, N0-N2
Provides a core needle biopsy consisting of at least 2 separate tumor cores from the primary tumor at screening to the central laboratory.
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days of treatment initiation.
Demonstrates adequate organ function.
Males and female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 12 months after the last dose of study treatment for participants who have received cyclophosphamide, and 6 months after the last dose of study treatment for participants who did not.

You may not qualify if…

Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months.
Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death - ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated antigen-4 [CTLA-4], OX-40, CD137 [tumor necrosis factor receptor superfamily member 9 (TNFRSF9)]) or has previously participated in a pembrolizumab (MK-3475) clinical study.
Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 4 weeks of the first dose of treatment in this current study.
Has received a live vaccine within 30 days of the first dose of study treatment.
Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (i.e., dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
Has a known history of Human Immunodeficiency Virus (HIV).
Has known active Hepatitis B or Hepatitis C.
Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
Has an active infection requiring systemic therapy.
Has significant cardiovascular disease, such as: history of myocardial infarction, acute coronary syndrome or coronary angioplasty/stenting/bypass grafting within the last 6 months OR congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA Class III or IV.
Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the screening visit through 12 months after the last dose of study treatment for participants who have received cyclophosphamide, and for 6 months after the last dose of study treatment for participants who have not.
Has a known hypersensitivity to the components of the study treatment or its analogs.
Has a known history of active tuberculosis (TB, Bacillus Tuberculosis).

Where it is running

Arizona Oncology Associates PC- HOPE ( Site 8001) — Tucson, Arizona, United States
Cedars Sinai Medical Center ( Site 0091) — Los Angeles, California, United States
Pacific Cancer Care ( Site 0069) — Monterey, California, United States
ICRI ( Site 0072) — Whittier, California, United States
University of Colorado Cancer Center ( Site 0021) — Aurora, Colorado, United States
Yale University School of Medicine ( Site 0054) — New Haven, Connecticut, United States
Christiana Hospital ( Site 0029) — Newark, Delaware, United States
Univ of Miami-Sylvester Comprehensive Cancer Center- Kendall satellite ( Site 0079) — Miami, Florida, United States
The University of Chicago Medical Center ( Site 0047) — Chicago, Illinois, United States
North Shore University Health System ( Site 0081) — Evanston, Illinois, United States
Orchard Healthcare Research Inc. ( Site 0049) — Skokie, Illinois, United States
Goshen Center for Cancer Care ( Site 0010) — Goshen, Indiana, United States
University of Iowa Hospital and Clinics ( Site 0038) — Iowa City, Iowa, United States
New England Cancer Specialists ( Site 0005) — Scarborough, Maine, United States
Henry Ford Hospital ( Site 0003) — Detroit, Michigan, United States
Minnesota Oncology Hematology, PA ( Site 8013) — Minneapolis, Minnesota, United States
Rutgers Cancer Institute of New Jersey ( Site 0073) — New Brunswick, New Jersey, United States
Broome Oncology, LLC ( Site 8002) — Johnson City, New York, United States
Nyack Hospital Infusion Center ( Site 0059) — Nyack, New York, United States
TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0044) — Cincinnati, Ohio, United States
Oncology Hematology Care, Inc. ( Site 8011) — Cincinnati, Ohio, United States
Providence Portland Medical Center ( Site 0052) — Portland, Oregon, United States
Northwest Cancer Specialists, P.C. ( Site 8008) — Portland, Oregon, United States
Magee - Women's Hospital ( Site 0011) — Pittsburgh, Pennsylvania, United States
Virginia G. Piper Cancer Center Pharmacy - Scottsdale Healthcare ( Site 0089) — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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