1,174
Participants
Start Date
March 7, 2017
Primary Completion Date
October 14, 2025
Study Completion Date
October 14, 2025
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.
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.
Paclitaxel
On Days 1, 8 and 15 of Cycles 1-4 in the neoadjuvant phase of the study; IV infusion.
Doxorubicin
On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV injection.
Epirubicin
On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV injection.
Cyclophosphamide
On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV infusion.
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
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.
National Taiwan University Hospital ( Site 2301), Taipei
MacKay Memorial Hospital ( Site 2303), Taipei
Linkou Chang Gung Memorial Hospital ( Site 2300), Taoyuan District
National Cheng Kung University Hospital ( Site 2305), Tainan City
Royal North Shore Hospital ( Site 2000), Sydney
Westmead Hospital ( Site 2002), Sydney
Cabrini Health ( Site 2009), Malvern East
Frankston Hospital ( Site 2010), Franskton
Royal Brisbane and Women s Hospital ( Site 2003), Herston
Royal Adelaide Hospital ( Site 2008), Adelaide
St John of God Subiaco Hospital ( Site 2006), Perth
Nyack Hospital Infusion Center ( Site 0059), Nyack
Taipei Veterans General Hospital ( Site 2302), Taipei
Koo Foundation Sun Yat-Sen Cancer Center ( Site 2304), Taipei
HELIOS Klinikum Berlin-Buch ( Site 1005), Berlin
Broome Oncology, LLC ( Site 8002), Johnson City
Centre Francois Baclesse ( Site 0907), Caen
Hospital Universitario Reina Sofia ( Site 1304), Córdoba
Magee - Women's Hospital ( Site 0011), Pittsburgh
Complejo Hospitalario Universitario de Santiago ( Site 1308), Santiago de Compostela
Christiana Hospital ( Site 0029), Newark
Istituto Europeo di Oncologia ( Site 1106), Milan
Universitaetsklinikum Hamburg-Eppendorf ( Site 1007), Hamburg
Trakya University Medical Faculty Balkan Oncology Hospital ( Site 1901), Edirne
Virginia Cancer Specialists, PC ( Site 8009), Fairfax
University of Virginia ( Site 0022), Charlottesville
Bon Secours Cancer Institute Medical Oncology at St. Mary's ( Site 0033), Midlothian
Virginia Oncology Associates ( Site 8000), Norfolk
Peninsula Cancer Institute, LLC ( Site 0041), Newport News
CHU Jean Minjoz ( Site 0917), Besançon
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia ( Site 1103), Brescia
Hospital Universitario Ramon y Cajal ( Site 1300), Madrid
Hospital Quiron de Madrid ( Site 1303), Pozuelo de Alarcón
Institut Claudius Regaud IUCT Oncopole ( Site 0914), Toulouse
Polyclinique Bordeaux Nord Aquitaine ( Site 0911), Bordeaux
Univ of Miami-Sylvester Comprehensive Cancer Center- Kendall satellite ( Site 0079), Miami
İstanbul University Cerrahpaşa Medical Faculty ( Site 1904), Istanbul
Amerikan Hospital Medical ( Site 1902), Istanbul
Memorial Sisli Hastanesi ( Site 1913), Istanbul
Acibadem Altunizade Hastanesi ( Site 1900), Istanbul
Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 1905), Izmir
Izmir Medical Park Hospital Department of Medical Oncology ( Site 1907), Izmir
The West Clinic, P.C. ( Site 0078), Germantown
Hospital Universitario Virgen del Rocio ( Site 1314), Seville
Hopital prive du Confluent ( Site 0902), Nantes
Kliniken Essen Mitte ( Site 1012), Essen
TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0044), Cincinnati
Oncology Hematology Care, Inc. ( Site 8011), Cincinnati
Hospital Clinico Univ de Valencia ( Site 1313), Valencia
Goshen Center for Cancer Care ( Site 0010), Goshen
Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 1101), Meldola
Henry Ford Hospital ( Site 0003), Detroit
University of Iowa Hospital and Clinics ( Site 0038), Iowa City
Gynaekologisches Zentrum ( Site 1004), Bonn
Ospedale San Luca, AZIENDA USL2 TOSCANA NORD OVEST ( Site 1105), Lucca
Samsun Ondokuz Mayıs Universitesi Tıp Fakultesi Hastanesi ( Site 1910), Samsun
Minnesota Oncology Hematology, PA ( Site 8013), Minneapolis
Orchard Healthcare Research Inc. ( Site 0049), Skokie
North Shore University Health System ( Site 0081), Evanston
Ospedale Civile di Macerata ( Site 1104), Macerata
Centre Jean Perrin ( Site 0903), Clermont-Ferrand
Caritasklinik St. Theresia ( Site 1011), Saarbrücken
Clinique Victor Hugo ( Site 0901), Le Mans
Universitaets-Frauenklinik Tuebingen ( Site 1003), Tübingen
Institut Curie ( Site 0909), Paris
Hopital Saint Louis ( Site 0908), Paris
Hopital Diaconesses Croix Saint Simon ( Site 0905), Paris
Texas Oncology- Plano East ( Site 8010), Plano
Parkland Health and Hospital System ( Site 0093), Dallas
Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8006), Dallas
Texas Oncology-Tyler ( Site 8007), Tyler
Moncrief Cancer Institute ( Site 0092), Fort Worth
Texas Oncology-Memorial City ( Site 8003), Houston
Houston Methodist Cancer Center ( Site 0013), Houston
Texas Oncology-San Antonio Northeast ( Site 8012), San Antonio
Texas Oncology-Austin Central ( Site 8005), Austin
University of Colorado Cancer Center ( Site 0021), Aurora
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1102), Napoli
Klinikum der Universit. Muenchen ( Site 1002), München
Virginia G. Piper Cancer Center Pharmacy - Scottsdale Healthcare ( Site 0089), Scottsdale
Arizona Oncology Associates PC- HOPE ( Site 8001), Tucson
CHU de la Miletrie Poitiers ( Site 0913), Poitiers
Cedars Sinai Medical Center ( Site 0091), Los Angeles
ICRI ( Site 0072), Whittier
Universitaetsklinikum Erlangen ( Site 1001), Erlangen
Pacific Cancer Care ( Site 0069), Monterey
Providence Portland Medical Center ( Site 0052), Portland
Northwest Cancer Specialists, P.C. ( Site 8008), Portland
Seattle Cancer Care Alliance ( Site 0068), Seattle
YVMH dba Vrigina Mason Memorial/North Star Lodge Cancer Center ( Site 8004), Yakima
Medical Oncology Associates (Summit Cancer Centers) ( Site 0014), Spokane
Kadlec Clinic Hematology and Oncology ( Site 0087), Kennewick
Hospital Universitario San Ignacio ( Site 0401), Bogotá
Instituto Nacional de Cancerologia [Bogota-Colombia] ( Site 0403), Bogotá
Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 1801), Moscow
Arkhangelsk Clinical Oncological Dispensary ( Site 1810), Arkhangelsk
National Cancer Centre Singapore ( Site 2600), Singapore
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1803), Saint Petersburg
Oncomedica S.A. ( Site 0404), Montería
GBU RO Regional Clinical Oncological Dispensary ( Site 1808), Ryazan
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1806), Kazan'
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1804), Ufa
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1805), Chelyabinsk
Oncologos del Occidente S.A. ( Site 0405), Pereira
Hemato Oncologos S.A. ( Site 0400), Santiago de Cali
Rabin-Medical Center ( Site 1604), Petah Tikva
Sheba Medical Center ( Site 1602), Ramat Gan
Sourasky Medical Center ( Site 1603), Tel Aviv
Assaf Harofeh MC ( Site 1605), Beer Yaakov-Zerifin
Oncology institute ( Site 1601), Beersheba
Hadassah Ein Karem - Sharett Institute of Oncology ( Site 1600), Jerusalem
Yale University School of Medicine ( Site 0054), New Haven
Ozel Medicana International Ankara Hastanesi ( Site 1915), Ankara
The University of Chicago Medical Center ( Site 0047), Chicago
New England Cancer Specialists ( Site 0005), Scarborough
Rutgers Cancer Institute of New Jersey ( Site 0073), New Brunswick
Rhode Island Hospital ( Site 0060), Providence
Simmons Cancer Center ( Site 0094), Dallas
UT Southwestern Medical Center ( Site 0030), Dallas
Hospital Nossa Senhora da Conceicao ( Site 0203), Porto Alegre
UOPECCAN - Uniao Oeste Paranaense de Estudos e Combate ao Cancer ( Site 0206), Cascavel
Universidade de Caxias do Sul ( Site 0201), Caxias do Sul
Hospital Erasto Gaertner ( Site 0207), Curitiba
Instituto do Cancer do Ceara ( Site 0205), Fortaleza
Hospital Araujo Jorge ( Site 0204), Goiânia
Hospital Sao Lucas da PUCRS ( Site 0200), Porto Alegre
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0208), São José do Rio Preto
Instituto do Cancer de Sao Paulo - ICESP ( Site 0211), São Paulo
Tom Baker Cancer Centre ( Site 0105), Calgary
The Ottawa Hospital - Cancer Care ( Site 0100), Ottawa
Princess Margaret Cancer Centre ( Site 0103), Toronto
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0106), Montreal
Jewish General Hospital ( Site 0101), Montreal
CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0104), Québec
CIUSSS de l'Estrie-CHUS ( Site 0102), Sherbrooke
Instituto De Cancerologia S.A. ( Site 0406), Medellín
Universitaetsklinik und Poliklinik Halle/Saale ( Site 1008), Halle
Bon Secours Hospital ( Site 1551), Cork
St Vincents University Hospital ( Site 1550), Dublin
Aichi Cancer Center Hospital ( Site 2502), Nagoya
National Cancer Center Hospital East ( Site 2518), Kashiwa
National Hospital Organization Hokkaido Cancer Center ( Site 2512), Sapporo
Hyogo College of Medicine Hospital ( Site 2506), Nishinomiya
Tokai University Hospital ( Site 2517), Isehara
St. Marianna University School of Medicine Hospital ( Site 2516), Kawasaki
Kindai University Hospital ( Site 2507), Sayama
Saitama Medical University International Medical Center ( Site 2513), Hidaka
Saitama Cancer Center ( Site 2510), Kitaadachi-gun
Shizuoka Cancer Center Hospital and Research Institute ( Site 2514), Sunto-gun
Chiba Cancer Center ( Site 2519), Chiba
Hiroshima City Hiroshima Citizens Hospital ( Site 2501), Hiroshima
Social medical corporation Hakuaikai Sagara Hospital ( Site 2508), Kagoshima
Kumamoto University Hospital ( Site 2515), Kumamoto
National Hospital Organization Osaka National Hospital ( Site 2505), Osaka
National Cancer Center Hospital ( Site 2500), Tokyo
St.Luke's International Hospital ( Site 2511), Tokyo
Toranomon Hospital ( Site 2503), Tokyo
The Cancer Institute Hospital of JFCR ( Site 2509), Tokyo
Mazowiecki Szpital Onkologiczny ( Site 1713), Wieliszew
Centrum Onkologii Instytut im. Marii Skłodowskiej Curie ( Site 1717), Gliwice
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1708), Bydgoszcz
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1712), Bydgoszcz
Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1701), Gdynia
Centrum Onkologii Instytut im. Marii Sklodowskiej Curie ( Site 1719), Krakow
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 1700), Lublin
Dolnoslaskie Centrum Onkologii. ( Site 1702), Wroclaw
Fundacao Champalimaud ( Site 2444), Lisbon
Hospital de Santa Maria, E.P.E. ( Site 2445), Lisbon
Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 2446), Porto
Seoul National University Hospital ( Site 2101), Seoul
Severance Hospital Yonsei University Health System ( Site 2100), Seoul
Asan Medical Center ( Site 2102), Seoul
Samsung Medical Center ( Site 2103), Seoul
ICO L Hospitalet ( Site 1305), L'Hospitalet de Llobregat
Hospital del Mar ( Site 1306), Barcelona
Instituto Oncologico Baselga.Hospital Quiron. ( Site 1312), Barcelona
Hospital General Universitari Vall d Hebron ( Site 1301), Barcelona
Linkopings Universitetssjukhus ( Site 1402), Linköping
Karolinska Universitetssjukhuset Solna ( Site 1404), Solna
Norrlands Universitetssjukhus ( Site 1401), Umeå
Akademiska Sjukhuset ( Site 1403), Uppsala
Adana Acıbadem Hospital Department of Medical Oncology ( Site 1906), Adana
Baskent Unıversity Adana Kısla Hospital ( Site 1903), Adana
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1912), Ankara
Abdurrahman Yurtaslan Oncology Training and Research Hospital ( Site 1909), Ankara
Antalya Memorial Hospital Department of Medical Oncology ( Site 1908), Antalya
Colchester General Hospital ( Site 1508), Colchester
Barts Cancer Institute ( Site 1500), London
St George s Hospital ( Site 1516), London
Maidstone Hospital ( Site 1511), Maidstone
The James Cook University Hospital ( Site 1515), Middlesbrough
Nottingham University Hospitals NHS Trust ( Site 1505), Nottingham
Royal Cornwall Hospitals NHS Trust ( Site 1504), Truro
Merck Sharp & Dohme LLC
INDUSTRY