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NCT03036488

PHASE3

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)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Official title: A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1174

Start Date

2017-03-07

Completion Date

2025-10-14

Last Updated

2026-10-22

Healthy Volunteers

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 Pegfilgrastim

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

Inclusion Criteria: * 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. Exclusion Criteria: * 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).

Locations (193)

Virginia G. Piper Cancer Center Pharmacy - Scottsdale Healthcare ( Site 0089)

Scottsdale, Arizona, United States

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

Rhode Island Hospital ( Site 0060)

Providence, Rhode Island, United States

The West Clinic, P.C. ( Site 0078)

Germantown, Tennessee, United States

Texas Oncology-Austin Central ( Site 8005)

Austin, Texas, United States

Parkland Health and Hospital System ( Site 0093)

Dallas, Texas, United States

Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8006)

Dallas, Texas, United States

Simmons Cancer Center ( Site 0094)

Dallas, Texas, United States

UT Southwestern Medical Center ( Site 0030)

Dallas, Texas, United States

Moncrief Cancer Institute ( Site 0092)

Fort Worth, Texas, United States

Texas Oncology-Memorial City ( Site 8003)

Houston, Texas, United States

Houston Methodist Cancer Center ( Site 0013)

Houston, Texas, United States

Texas Oncology- Plano East ( Site 8010)

Plano, Texas, United States

Texas Oncology-San Antonio Northeast ( Site 8012)

San Antonio, Texas, United States

Texas Oncology-Tyler ( Site 8007)

Tyler, Texas, United States

University of Virginia ( Site 0022)

Charlottesville, Virginia, United States

Virginia Cancer Specialists, PC ( Site 8009)

Fairfax, Virginia, United States

Bon Secours Cancer Institute Medical Oncology at St. Mary's ( Site 0033)

Midlothian, Virginia, United States

Peninsula Cancer Institute, LLC ( Site 0041)

Newport News, Virginia, United States

Virginia Oncology Associates ( Site 8000)

Norfolk, Virginia, United States

Kadlec Clinic Hematology and Oncology ( Site 0087)

Kennewick, Washington, United States

Seattle Cancer Care Alliance ( Site 0068)

Seattle, Washington, United States

Medical Oncology Associates (Summit Cancer Centers) ( Site 0014)

Spokane, Washington, United States

YVMH dba Vrigina Mason Memorial/North Star Lodge Cancer Center ( Site 8004)

Yakima, Washington, United States

Royal North Shore Hospital ( Site 2000)

Sydney, New South Wales, Australia

Westmead Hospital ( Site 2002)

Sydney, New South Wales, Australia

Royal Adelaide Hospital ( Site 2008)

Adelaide, South Australia, Australia

Cabrini Health ( Site 2009)

Malvern East, Victoria, Australia

Frankston Hospital ( Site 2010)

Franskton, Australia

Royal Brisbane and Women s Hospital ( Site 2003)

Herston, Australia

St John of God Subiaco Hospital ( Site 2006)

Perth, Australia

Hospital Nossa Senhora da Conceicao ( Site 0203)

Porto Alegre, Rio Grande do Sul, Brazil

UOPECCAN - Uniao Oeste Paranaense de Estudos e Combate ao Cancer ( Site 0206)

Cascavel, Brazil

Universidade de Caxias do Sul ( Site 0201)

Caxias do Sul, Brazil

Hospital Erasto Gaertner ( Site 0207)

Curitiba, Brazil

Instituto do Cancer do Ceara ( Site 0205)

Fortaleza, Brazil

Hospital Araujo Jorge ( Site 0204)

Goiânia, Brazil

Hospital Sao Lucas da PUCRS ( Site 0200)

Porto Alegre, Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0208)

São José do Rio Preto, Brazil

Instituto do Cancer de Sao Paulo - ICESP ( Site 0211)

São Paulo, Brazil

Tom Baker Cancer Centre ( Site 0105)

Calgary, Alberta, Canada

The Ottawa Hospital - Cancer Care ( Site 0100)

Ottawa, Ontario, Canada

Princess Margaret Cancer Centre ( Site 0103)

Toronto, Ontario, Canada

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0106)

Montreal, Quebec, Canada

Jewish General Hospital ( Site 0101)

Montreal, Quebec, Canada

CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0104)

Québec, Quebec, Canada

CIUSSS de l'Estrie-CHUS ( Site 0102)

Sherbrooke, Quebec, Canada

Oncomedica S.A. ( Site 0404)

Montería, Departamento de Córdoba, Colombia

Oncologos del Occidente S.A. ( Site 0405)

Pereira, Risaralda Department, Colombia

Hospital Universitario San Ignacio ( Site 0401)

Bogotá, Colombia

Instituto Nacional de Cancerologia [Bogota-Colombia] ( Site 0403)

Bogotá, Colombia

Hemato Oncologos S.A. ( Site 0400)

Cali, Colombia

Instituto De Cancerologia S.A. ( Site 0406)

Medellín, Colombia

CHU Jean Minjoz ( Site 0917)

Besançon, France

Polyclinique Bordeaux Nord Aquitaine ( Site 0911)

Bordeaux, France

Centre Francois Baclesse ( Site 0907)

Caen, France

Centre Jean Perrin ( Site 0903)

Clermont-Ferrand, France

Clinique Victor Hugo ( Site 0901)

Le Mans, France

Hopital prive du Confluent ( Site 0902)

Nantes, France

Institut Curie ( Site 0909)

Paris, France

Hopital Saint Louis ( Site 0908)

Paris, France

Hopital Diaconesses Croix Saint Simon ( Site 0905)

Paris, France

CHU de la Miletrie Poitiers ( Site 0913)

Poitiers, France

Institut Claudius Regaud IUCT Oncopole ( Site 0914)

Toulouse, France

HELIOS Klinikum Berlin-Buch ( Site 1005)

Berlin, Germany

Gynaekologisches Zentrum ( Site 1004)

Bonn, Germany

Universitaetsklinikum Erlangen ( Site 1001)

Erlangen, Germany

Kliniken Essen Mitte ( Site 1012)

Essen, Germany

Universitaetsklinik und Poliklinik Halle/Saale ( Site 1008)

Halle, Germany

Universitaetsklinikum Hamburg-Eppendorf ( Site 1007)

Hamburg, Germany

Klinikum der Universit. Muenchen ( Site 1002)

München, Germany

Caritasklinik St. Theresia ( Site 1011)

Saarbrücken, Germany

Universitaets-Frauenklinik Tuebingen ( Site 1003)

Tübingen, Germany

Bon Secours Hospital ( Site 1551)

Cork, Ireland

St Vincents University Hospital ( Site 1550)

Dublin, Ireland

Assaf Harofeh MC ( Site 1605)

Beer Yaakov-Zerifin, Israel

Oncology institute ( Site 1601)

Beersheba, Israel

And 93 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (193)