Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49)
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Locally Recurrent Inoperable or Metastatic Breast Cancer (KEYNOTE-B49)
8 other identifiers
interventional
340
30 countries
251
Brief Summary
The safety and efficacy of pembrolizumab plus the investigator's choice of chemotherapy will be assessed compared to placebo plus the investigator's choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer. The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1. Prior to protocol amendment 7, participants who discontinued pembrolizumab/placebo with SD or better and subsequently experienced disease progression may have been eligible for up to 17 additional administrations of pembrolizumab if, upon unblinding, they were found to have received pembrolizumab, at the same dose and schedule used for the initial treatment period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2021
Longer than P75 for phase_3
251 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2021
CompletedFirst Posted
Study publicly available on registry
May 20, 2021
CompletedStudy Start
First participant enrolled
June 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 18, 2027
March 11, 2026
March 1, 2026
6.5 years
May 17, 2021
March 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥1
PFS is defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The PFS in participants with a CPS of ≥1, as assessed by BICR, will be presented.
Up to approximately 50 months
Secondary Outcomes (33)
Overall Survival (OS) in Participants With Combined Positive Score (CPS) ≥1
Up to approximately 76 months
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥10
Up to approximately 76 months
OS in Participants With CPS ≥10
Up to approximately 76 months
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator in Participants With Combined Positive Score (CPS) ≥10
Up to approximately 76 months
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator in Participants With Combined Positive Score (CPS) ≥1
Up to approximately 76 months
- +28 more secondary outcomes
Study Arms (2)
Pembrolizumab + Chemotherapy
EXPERIMENTALParticipants receive pembrolizumab 200 mg administered by intravenous infusion (IV) on Day 1 of each 21-day cycle (Q3W) PLUS one of four chemotherapy regimens: 1) paclitaxel 90 mg/m\^2 IV on Days 1, 8, and 15 of each 28-day cycle (Q4W), 2) nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 Q4W, 3) liposomal doxorubicin 50 mg/m\^2 IV on Day 1 Q4W, OR 4) capecitabine 1000 mg/m\^2 by oral administration (PO) twice a day (BID) on Days 1-14 Q3W for up to 35 administrations.
Placebo + Chemotherapy
ACTIVE COMPARATORParticipants receive placebo (normal saline or dextrose) IV on Day 1 Q3W PLUS one of four chemotherapy regimens: 1) paclitaxel 90 mg/m\^2 IV on Days 1, 8, and 15 Q4W, 2) nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8, and 15 Q4W, 3) liposomal doxorubicin 50 mg/m\^2 IV on Day 1 Q4W, OR 4) capecitabine 1000 mg/m\^2 PO BID on Days 1-14 Q3W for up to 35 administrations.
Interventions
Intravenous (IV) infusion
IV infusion
IV infusion
oral administration
Eligibility Criteria
You may not qualify if:
- Has locally recurrent inoperable or metastatic HR+/HER2- breast cancer, which has not been previously treated with cytotoxic chemotherapy in the noncurative setting
- Has progressed on prior endocrine therapy and is now a chemotherapy candidate, meeting the characteristics in regard to previous treatments of one of the following 4 groups:
- Group 1: Has progressed on 2 or more lines of endocrine therapy for advanced/metastatic HR+/HER2-disease, with at least given in combination with a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. Prior treatment with mTOR and/or PI3-K inhibitors is allowed. OR
- GROUP 2a: Has progressed on 1 line of previous endocrine therapy for advanced/metastatic disease AND had a disease recurrence within 24 months of definitive surgery for the primary tumor and while on adjuvant endocrine therapy. Prior use of CDK4/6 inhibitors is required, either in the adjuvant and/or metastatic setting. Prior treatment with mTOR and/or PI3-K inhibitors is allowed. OR
- GROUP 2b: Has progressed within 12 months of starting 1 line of endocrine therapy with a CDK4/6 inhibitor for advanced/metastatic HR+/HER2- disease. OR
- GROUP 3: If no prior treatment with a CDK4/6 inhibitor, for advanced/metastatic disease and/or early stage disease (adjuvant), participants must have progressed within 6 months of starting 1 line of endocrine therapy with or without an mTOR or PI3-K inhibitor for metastatic disease AND had a relapse within 24 months of definitive surgery for primary tumor and while receiving adjuvant endocrine therapy.
- Has presented a documented radiographic disease progression (as assessed by the investigator and/or histology \[biopsy or cytology\] for participants presenting with new metastatic lesions) during or after the last administered endocrine therapy prior to entering the study.
- Is a chemotherapy candidate that meets the criteria specified in the protocol
- Provides a new or the last obtained core biopsy, preferably consisting of multiple cores, taken from a locally recurrent or a distant (metastatic) lesion not previously irradiated
- Has centrally confirmed PD-L1 CPS ≥1 and HR+ (estrogen receptor \[ER\] and/or progesterone receptor \[PgR\]) /HER2- breast cancer as defined by the most recent American Society of Clinical Oncology (ASCO)/(College of American Pathologists) CAP guidelines on most recent tumor biopsy
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to the first dose of study treatment
- Has adequate organ function within 10 days prior to the start of study
- Male participants must agree to the following during the treatment period and for at least 6 months after the last dose of chemotherapy: refrain from donating sperm PLUS either be abstinent from heterosexual intercourse as their preferred and usual lifestyle or use contraception and agree to use a male condom plus partner use of an additional contraceptive
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP) OR is a WOCBP and using a highly-effective contraceptive method during the treatment period and for at least 120 days after the last dose of pembrolizumab and 180 days after the last dose of chemotherapy (whichever occurs last), AND agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period
- A WOCBP must have a negative highly sensitive pregnancy test (urine or serum) within 24 hours for urine or within 72 hours for serum before the first dose of study intervention
- +30 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (256)
University of Alabama at Birmingham-Medicine ( Site 0065)
Birmingham, Alabama, 35294-3300, United States
Arizona Oncology Associates-Arizona Oncology ( Site 0049)
Tucson, Arizona, 85711, United States
Pacific Cancer Care ( Site 0023)
Monterey, California, 93940, United States
UCSF Medical Center at Mission Bay ( Site 0043)
San Francisco, California, 94158, United States
Georgetown University Medical Center-Department of Medicine and Oncology ( Site 0026)
Washington D.C., District of Columbia, 20007, United States
MedStar Washington Hospital Center ( Site 0063)
Washington D.C., District of Columbia, 20010, United States
Baptist MD Anderson Cancer Center ( Site 0013)
Jacksonville, Florida, 32207, United States
Miami Cancer Institute at Baptist Health, Inc. ( Site 0070)
Miami, Florida, 33176, United States
Miami Cancer Institute - Plantation ( Site 0076)
Plantation, Florida, 33324, United States
University Cancer & Blood Center, LLC ( Site 0032)
Athens, Georgia, 30607, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0028)
Marietta, Georgia, 30060, United States
University of Illinois at Chicago ( Site 0061)
Chicago, Illinois, 60612, United States
Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0067)
Elmhurst, Illinois, 60126, United States
Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0066)
Naperville, Illinois, 60540, United States
Edward-Elmhurst Healthcare, Edward Hospital - Plainfield-Edward Cancer Center - Plainfield ( Site 00
Plainfield, Illinois, 60585, United States
Orchard Healthcare Research Inc. ( Site 0037)
Skokie, Illinois, 60077, United States
Parkview Research Center at Parkview Regional Medical Center ( Site 0071)
Fort Wayne, Indiana, 46845, United States
McFarland Clinic, PC ( Site 0041)
Ames, Iowa, 50010-3014, United States
Louisiana State University Health Sciences Shreveport ( Site 0072)
Shreveport, Louisiana, 71103, United States
CHRISTUS Highland-Oncology Research ( Site 0073)
Shreveport, Louisiana, 71105, United States
New England Cancer Specialists ( Site 0007)
Scarborough, Maine, 04074, United States
Greater Baltimore Medical Center-Medical Oncology/Hematology ( Site 0062)
Baltimore, Maryland, 21204, United States
MFSMC-HJWCI ( Site 0064)
Baltimore, Maryland, 21237, United States
MedStar Good Samaritan Hospital-Oncology Research ( Site 0069)
Baltimore, Maryland, 21239, United States
University of Massachusetts Medical School-Division of Hematology/Oncology ( Site 0052)
Worcester, Massachusetts, 01655, United States
Henry Ford Hospital ( Site 0003)
Detroit, Michigan, 48202, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0009)
Omaha, Nebraska, 68130, United States
Broome Oncology ( Site 0018)
Johnson City, New York, 13790, United States
Hematology Oncology Associates of Rockland ( Site 0044)
Nyack, New York, 10960, United States
Waverly Hematology Oncology ( Site 0015)
Cary, North Carolina, 27518, United States
Sanford Fargo Medical Center ( Site 0040)
Fargo, North Dakota, 58102, United States
Providence Portland Medical Center ( Site 0038)
Portland, Oregon, 97213, United States
Oregon Health and Science University ( Site 0031)
Portland, Oregon, 97239-3011, United States
St Francis Cancer Center ( Site 0058)
Greenville, South Carolina, 29607, United States
Sanford Cancer Center ( Site 0021)
Sioux Falls, South Dakota, 57104, United States
University of Tennessee Medical Center ( Site 0039)
Knoxville, Tennessee, 37920, United States
Bon Secours St. Francis Medical Center-Oncology Research ( Site 0020)
Midlothian, Virginia, 23114, United States
Kadlec Clinic Hematology and Oncology ( Site 0055)
Kennewick, Washington, 99336, United States
Medical Oncology Associates, PS ( Site 0010)
Spokane, Washington, 99208, United States
Northwest Medical Specialties, PLLC ( Site 0008)
Tacoma, Washington, 98405, United States
North Star Lodge ( Site 0035)
Yakima, Washington, 98902, United States
Centro de Oncología e Investigación de Buenos Aires ( Site 0400)
Berazategui, Buenos Aires, 1884, Argentina
Hospital Británico de Buenos Aires-Oncology ( Site 0404)
Ciudad Autónoma de Buenos Aires, Buenos Aires, 1280, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0412)
Mar del Plata, Buenos Aires, B7600FZO, Argentina
Hospital Aleman-Oncology ( Site 0402)
Buenos Aires, Buenos Aires F.D., C1118AAT, Argentina
Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0403)
Buenos Aires, Buenos Aires F.D., C1431FWO, Argentina
Sanatorio de La Mujer ( Site 0405)
Rosario, Santa Fe Province, 2000, Argentina
Sanatorio Parque ( Site 0407)
Rosario, Santa Fe Province, S2000DSV, Argentina
Instituto de Oncología de Rosario ( Site 0401)
Rosario, Santa Fe Province, S2000KZE, Argentina
Hospital Italiano de Córdoba ( Site 0409)
Córdoba, 5000, Argentina
Fundación CEMAIC ( Site 0410)
Córdoba, X5008HHW, Argentina
Instituto San Marcos ( Site 0408)
San Juan, J5400EBB, Argentina
Macquarie University-MQ Health Clinical Trials Unit ( Site 2102)
Macquarie Park, New South Wales, 2109, Australia
Westmead Hospital-Department of Medical Oncology ( Site 2101)
Westmead, New South Wales, 2145, Australia
Frankston Hospital-Oncology and Haematology ( Site 2103)
Frankston, Victoria, 3199, Australia
Breast Cancer Research Centre-WA ( Site 2104)
Nedlands, Western Australia, 6009, Australia
Landesklinikum Wiener Neustadt-Innere Medizin, Hämatologie und internistische Onkologie ( Site 1604)
Wiener Neustadt, Lower Austria, 2700, Austria
Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 1609)
Graz, Styria, 8036, Austria
Medizinische Universitaet Innsbruck ( Site 1602)
Innsbruck, Tyrol, 6020, Austria
Medizinische Universität Wien ( Site 1601)
Vienna, Vienna, 1090, Austria
Uniklinikum Salzburg-Universitätsklinik für Innere Medizin III der PMU mit Hämatologie, internistis
Salzburg, 5020, Austria
Hospital de Câncer de Recife ( Site 0211)
Recife, Pernambuco, 50040-000, Brazil
Instituto de Oncologia Saint Gallen ( Site 0206)
Santa Cruz do Sul, Rio Grande do Sul, 96830-180, Brazil
Clínica de Oncologia Reichow ( Site 0210)
Blumenau, Santa Catarina, 89010-340, Brazil
YNOVA Pesquisa Clínica ( Site 0203)
Florianópolis, Santa Catarina, 88020210, Brazil
Instituto Nacional de Câncer - INCA-Pesquisa Clinica HC3 ( Site 0208)
Rio de Janeiro, 20560121, Brazil
Instituto de Educação, Pesquisa e Gestão em Saúde ( Site 0202)
Rio de Janeiro, 20775-001, Brazil
Tom Baker Cancer Center ( Site 0107)
Calgary, Alberta, T2N 4N2, Canada
North York General Hospital ( Site 0108)
Toronto, Ontario, M2K 1E1, Canada
Princess Margaret Cancer Centre ( Site 0101)
Toronto, Ontario, M5G 2M9, Canada
Centre Hospitalier de l'Université de Montréal ( Site 0105)
Montreal, Quebec, H2X 3E4, Canada
Jewish General Hospital ( Site 0110)
Montreal, Quebec, H3T 1E2, Canada
Hopital Du Saint-Sacrement ( Site 0109)
Québec, Quebec, G1S 4L8, Canada
Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec (
Trois-Rivières, Quebec, G8Z 3R9, Canada
FALP ( Site 0501)
Santiago, Region M. de Santiago, 7500921, Chile
Oncovida ( Site 0514)
Santiago, Region M. de Santiago, 7510032, Chile
Clínica RedSalud Vitacura ( Site 0515)
Santiago, Region M. de Santiago, 7650018, Chile
Instituto Nacional del Cancer-CR Investigación ( Site 0511)
Santiago, Region M. de Santiago, 8380455, Chile
Bradfordhill ( Site 0500)
Santiago, Region M. de Santiago, 8420383, Chile
Centro Investigación del Cáncer James Lind ( Site 0513)
Temuco, Región de la Araucanía, 4800827, Chile
Anhui Cancer Hospital-medical oncology ( Site 2632)
Hefei, Anhui, 230031, China
Cancer Hospital Chinese Academy of Medical Science ( Site 2635)
Beijing, Beijing Municipality, 100021, China
Beijing Cancer hospital-Department of Breast Cancer ( Site 2605)
Beijing, Beijing Municipality, 100142, China
Beijing Peking Union Medical College Hospital-Medical Oncology ( Site 2610)
Beijing, Beijing Municipality, 100730, China
The First Affiliated hospital of Xiamen University-Breast Surgery ( Site 2613)
Xiamen, Fujian, 361003, China
The First People's Hospital of Foshan-Oncology Department of Breast Cancer ( Site 2620)
Foshan, Guangdong, 528041, China
SUN YAT-SEN UNIVERSITY CANCER CENTRE-oncology breast ( Site 2616)
Guangzhou, Guangdong, 510060, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Breast Oncology Center ( Site 2641)
Guangzhou, Guangdong, 510289, China
Peking University Shenzhen Hospital-Oncology Department ( Site 2601)
Shenzhen, Guangdong, 518036, China
Guangxi Medical University Affiliated Tumor Hospital-Oncology Dept. of Breast and Bone Soft Tissue (
Nanning, Guangxi, 530021, China
Henan Cancer Hospital-Galactophore Department ( Site 2615)
Zhengzhou, Henan, 450003, China
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2629)
Wuhan, Hubei, 430022, China
Xiangya Hospital Central South University-Breast department ( Site 2621)
Changsha, Hunan, 410008, China
Hunan Cancer Hospital ( Site 2608)
Changsha, Hunan, 410013, China
Jiangsu provincial people's hospital-Oncology Department ( Site 2607)
Nanjing, Jiangsu, 210036, China
The Third Hospital of Nanchang-Oncology Dept ( Site 2628)
Nanchang, Jiangxi, 330009, China
Jilin Cancer Hospital-oncology department ( Site 2619)
Changchun, Jilin, 130012, China
The First Affiliated Hospital of Xian Jiaotong University wa-Oncology ( Site 2604)
Xi'an, Shaanxi, 710061, China
Shandong Cancer Hospital-Breast surgery ( Site 2623)
Jinan, Shandong, 250117, China
Fudan University Shanghai Cancer Center-Oncology ( Site 2600)
Shanghai, Shanghai Municipality, 200032, China
Renji Hospital Shanghai Jiao Tong University School of Medicine-Breast surgery ( Site 2626)
Shanghai, Shanghai Municipality, 200120, China
West China Hospital Sichuan University-Head and Neck Oncology ( Site 2630)
Chengdu, Sichuan, 610041, China
Tianjin Medical University Cancer Institute and Hospital-Department of Breast Cancer ( Site 2612)
Tianjin, Tianjin Municipality, 300060, China
Xinjiang Medical University Cancer Hospital - Urumqi-galactophore department ( Site 2624)
Ürümqi, Xinjiang, 830000, China
Zhejiang Cancer Hospital-Breast Oncology ( Site 2622)
Hangzhou, Zhejiang, 310022, China
Taizhou Hospital of Zhejiang Province ( Site 2636)
Linhai, Zhejiang, 317000, China
The First Affiliated Hospital of Wenzhou Medical University-Thyroid and breast surgery ( Site 2625)
Wenzhou, Zhejiang, 325000, China
Fundación Colombiana de Cancerología Clínica Vida ( Site 0605)
Medellín, Antioquia, 050021435, Colombia
Instituto de Cancerología-Oncology ( Site 0606)
Medellín, Antioquia, 050024, Colombia
Clinica de la Costa S.A.S. ( Site 0601)
Barranquilla, Atlántico, 080020, Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0607)
Bogotá, Bogota D.C., 111321, Colombia
Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 0603)
Valledupar, Cesar Department, 200001, Colombia
Oncomedica S.A.-Oncomedica S.A ( Site 0604)
Montería, Departamento de Córdoba, 230002, Colombia
CENTRE LEON BERARD ( Site 0919)
Lyon, Auvergne-Rhône-Alpes, 69008, France
Institut Paoli-Calmettes ( Site 0913)
Marseille, Bouches-du-Rhone, 13009, France
Centre François Baclesse ( Site 0920)
Caen, Calvados, 14076, France
CHU Besançon ( Site 0918)
Besançon, Franche-Comte, 25000, France
Institut Claudius Regaud ( Site 0902)
Toulouse, Haute-Garonne, 31059, France
Centre de Cancérologie du Grand Montpellier ( Site 0912)
Montpellier, Languedoc-Roussillon, 34070, France
Institut de Cancérologie de l'Ouest ( Site 0907)
Saint-Herblain, Loire-Atlantique, 44805, France
Institut de Cancérologie de l'Ouest ( Site 0915)
Angers, Maine-et-Loire, 49055, France
Centre Oscar Lambret ( Site 0921)
Lille, Nord, 59000, France
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 0901)
Clermont-Ferrand, Puy-de-Dome, 63011, France
Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen ( Site 0904)
Rouen, Seine-Maritime, 76038, France
Centre Hospitalier Universitaire de Poitiers-Pôle régional de cancérologie ( Site 0922)
Poitiers, Vienne, 86021, France
Institut Curie ( Site 0900)
Paris, 75248, France
Gustave Roussy ( Site 0914)
Villejuif, Île-de-France Region, 94805, France
Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1202)
Erlangen, Bavaria, 91054, Germany
Gynaekologisches Zentrum Bonn ( Site 1201)
Bonn, North Rhine-Westphalia, 53111, Germany
Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1204)
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinike für Senologie/ Brustzentrum ( Site 1200
Essen, North Rhine-Westphalia, 45136, Germany
Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur
Dresden, Saxony, 01307, Germany
Vivantes Klinikum Am Urban-Haematologie und Onkologie ( Site 1203)
Berlin, 10967, Germany
General Hospital of Athens Laiko-First Department of Internal Medicine ( Site 0305)
Athens, Attica, 115 26, Greece
Alexandra Hospital-ONCOLGOY DEPT. ( Site 0302)
Athens, Attica, 115 28, Greece
Hygeia Hospital-3rd Oncology Department ( Site 0304)
Marousi, Attica, 151 23, Greece
University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 0303)
Heraklion, Irakleio, 715 00, Greece
Euromedica General Clinic Thessaloniki-Oncology Unit ( Site 0301)
Thessaloniki, 546 45, Greece
CELAN,S.A ( Site 0151)
Guatemala City, 01010, Guatemala
Gastrosoluciones ( Site 0156)
Guatemala City, 01010, Guatemala
INTEGRA Cancer Institute ( Site 0155)
Guatemala City, 01010, Guatemala
Centro Medico Integral De Cancerología (CEMIC) ( Site 0154)
Quetzaltenango, 09002, Guatemala
Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 2807)
Pécs, Baranya, 7624, Hungary
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2804)
Kecskemét, Bács-Kiskun county, 6000, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Onkoterapias Klinika ( Site 2805)
Szeged, Csongrád megye, 6725, Hungary
St. James's Hospital ( Site 1530)
Dublin, D08 E9P6, Ireland
St. Vincent's University Hospital-Medical Oncology Research Department ( Site 1531)
Dublin, D4 YN63, Ireland
Assuta Ashdod Medical Center ( Site 1703)
Ashdod, 7747629, Israel
Soroka Medical Center-Oncology ( Site 1702)
Beersheba, 8400000, Israel
Bnai Zion Medical Center-Oncology ( Site 1704)
Haifa, 3339419, Israel
Sheba Medical Center-ONCOLOGY ( Site 1700)
Ramat Gan, 5265601, Israel
Sourasky Medical Center-Oncology ( Site 1701)
Tel Aviv, 6423906, Israel
Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1113)
Rome, Lazio, 00168, Italy
Ospedale San Raffaele-Oncologia Medica ( Site 1110)
Milan, Lombardy, 20132, Italy
Ospedale San Gerardo-ASST Monza-Research Unit Phase 1 ( Site 1115)
Monza, Lombardy, 20900, Italy
Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1114)
Rozzano, Milano, 20089, Italy
Instituto Tumori Giovanni Paolo II-ONCOLOGIA MEDICA ( Site 1112)
Bari, 70124, Italy
Ospedale Cannizzaro ( Site 1118)
Catania, 95126, Italy
Istituto Europeo di Oncologia IRCCS-Divisione di Senologia Medica ( Site 1111)
Milan, 20141, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1116)
Naples, 80131, Italy
Istituto Oncologico Veneto IRCCS ( Site 1117)
Padua, 35128, Italy
Hyogo Medical University Hospital ( Site 2201)
Nishinomiya, Hyōgo, 663-8501, Japan
St. Marianna University School of Medicine Hospital ( Site 2205)
Kawasaki, Kanagawa, 216-8511, Japan
Kitasato University Hospital ( Site 2204)
Sagamihara, Kanagawa, 252-0375, Japan
Osaka University Hospital ( Site 2211)
Suita, Osaka, 565-0871, Japan
Saitama Medical University International Medical Center ( Site 2208)
Hidaka, Saitama, 350-1298, Japan
Tokyo Medical University Hospital ( Site 2206)
Shinjuku-ku, Tokyo, 160-0023, Japan
Chiba University Hospital ( Site 2212)
Chiba, 260-8677, Japan
National Hospital Organization Kyushu Cancer Center ( Site 2209)
Fukuoka, 811-1395, Japan
Fukushima Medical University ( Site 2200)
Fukushima, 960-1295, Japan
Kumamoto University ( Site 2203)
Kumamoto, 860-8556, Japan
St. Luke's International Hospital ( Site 2207)
Tokyo, 104-8560, Japan
Juntendo University Hospital ( Site 2210)
Tokyo, 113-8431, Japan
University Malaya Medical Centre ( Site 2505)
Lembah Pantai, Kuala Lumpur, 59100, Malaysia
Hospital Pulau Pinang ( Site 2504)
George Town, Pulau Pinang, 10990, Malaysia
Sarawak General Hospital-Radiotherapy Unit ( Site 2501)
Kuching, Sarawak, 93586, Malaysia
Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 2506)
Kuala Lumpur, 50586, Malaysia
Pantai Hospital Kuala Lumpur-Cancer Centre ( Site 2503)
Kuala Lumpur, 59100, Malaysia
Hospital Civil Fray Antonio Alcalde-Oncology ( Site 0262)
Guadalajara, Jalisco, 44280, Mexico
Samadhi Centro Oncológico ( Site 0258)
Mexico City, Mexico City, 04739, Mexico
Filios Alta Medicina ( Site 0253)
Monterrey, Nuevo León, 64460, Mexico
Centro Estatal de Cancerologia-Investigación ( Site 0256)
Chihuahua City, 31000, Mexico
Centro de Investigacion Clinica de Oaxaca ( Site 0252)
Oaxaca City, 68020, Mexico
Radboudumc-Medical Oncology ( Site 1360)
Nijmegen, Gelderland, 6525 GA, Netherlands
Maastricht UMC+-Medical Oncology ( Site 1353)
Maastricht, Limburg, 6229 HX, Netherlands
Jeroen Bosch Hospital ( Site 1359)
's-Hertogenbosch, North Brabant, 5223 GZ, Netherlands
Elisabeth-TweeSteden Ziekenhuis-Internal Medicine ( Site 1357)
Tilburg, North Brabant, 5022 GC, Netherlands
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) ( Site 1351)
Amsterdam, North Holland, 1066 CX, Netherlands
Leids Universitair Medisch Centrum-Medical Oncology ( Site 1356)
Leiden, South Holland, 2333 ZA, Netherlands
Haaglanden MC - locatie Antoniushove-Medical oncology ( Site 1355)
Leidschendam, South Holland, 2501 ck, Netherlands
Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1354)
Schiedam, South Holland, 3118JH, Netherlands
Meander Medisch Centrum ( Site 1358)
Amersfoort, Utrecht, 3813TZ, Netherlands
East Avenue Medical Center ( Site 0802)
Quezon City, National Capital Region, 1500, Philippines
CARDINAL SANTOS MEDICAL CENTER-Research Room ( Site 0800)
San Juan City, National Capital Region, 1502, Philippines
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1813)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland
Pratia MCM Krakow ( Site 1809)
Krakow, Lesser Poland Voivodeship, 30-727, Poland
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1818)
Siedlce, Masovian Voivodeship, 08-110, Poland
Luxmed Onkologia sp. z o. o. ( Site 1820)
Warsaw, Masovian Voivodeship, 01-748, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Piersi i Chirurgii (
Warsaw, Masovian Voivodeship, 02-781, Poland
Lux med onkologia sp. z o.o. ( Site 1808)
Warsaw, Masovian Voivodeship, 04-125, Poland
Wojskowy Instytut Medyczny-Klinika Onkologii ( Site 1803)
Warsaw, Masovian Voivodeship, 04-141, Poland
Mazowiecki Szpital Onkologiczny-BREAST CANCER ( Site 1821)
Wieliszew, Masovian Voivodeship, 05-135, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1819)
Przemyśl, Podkarpackie Voivodeship, 37-700, Poland
Bialostockie Centrum Onkologii-Oddzial Onkologii Klinicznej ( Site 1812)
Bialystok, Podlaskie Voivodeship, 15-027, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach-Breast Unit ( Site 1811)
Gliwice, Silesian Voivodeship, 44-101, Poland
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1815)
Koszalin, West Pomeranian Voivodeship, 75-581, Poland
Champalimaud Foundation ( Site 1006)
Lisbon, Lisbon District, 1400-038, Portugal
Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria ( Site 1004)
Lisbon, Lisbon District, 1649-035, Portugal
UNIDADE LOCAL DE SAUDE DE MATOSINHOS ( Site 1007)
Matosinhos Municipality, Porto District, 4464-513, Portugal
Centro Hospitalar do Porto - Hospital de Santo António-Oncology Service ( Site 1003)
Porto, 4099-001, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 1005)
Porto, 4200-072, Portugal
Cardiomed SRL Cluj-Napoca ( Site 2902)
Cluj-Napoca, Cluj, 400015, Romania
Institutul Oncologic-Day Hospital Unit ( Site 2905)
Cluj-Napoca, Cluj, 400015, Romania
Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2901)
Craiova, Dolj, 200542, Romania
Oncopremium Team-Oncology ( Site 2903)
Baia Mare, Maramureş, 430291, Romania
Sigmedical Services SRL ( Site 2904)
Suceava, 720214, Romania
Arkhangelsk Clinical Oncological Dispensary-Chemotherapy department ( Site 1902)
Arkhangelsk, Arkhangelskaya oblast, 163045, Russia
Moscow Clinical Research Center-Chemotherapy department ( Site 1903)
Moscow, Moscow, 111123, Russia
Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF ( Site 1901)
Moscow, Moscow, 115478, Russia
Central Clinical Hospital of the Presidential Administrative Department ( Site 1904)
Moscow, Moscow, 121359, Russia
Podolsk Regional Clinical Hospital ( Site 1907)
Podolsk, Moscow Oblast, 142110, Russia
Nizhegorodsky Regional Oncology Dispensary-chemotherapy ( Site 1912)
Nizhny Novgorod, Nizhny Novgorod Oblast, 603081, Russia
Ryazan Regional Clinical Oncology Center-Oncology #1 ( Site 1906)
Ryazan, Ryazan Oblast, 390046, Russia
St. Petersburg Clinical Hospital of Russian Academy Of Sciences-Medical Oncology ( Site 1905)
Saint Petersburg, Sankt-Peterburg, 194017, Russia
N.N.Petrov Research Institute of Oncology ( Site 1900)
Saint Petersburg, Sankt-Peterburg, 197758, Russia
National Cancer Center-Center for Breast Cancer ( Site 2404)
Goyang-si, Kyonggi-do, 10408, South Korea
Seoul National University Bundang Hospital ( Site 2406)
Seongnam, Kyonggi-do, 13620, South Korea
Seoul National University Hospital-Internal Medicine ( Site 2403)
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System ( Site 2400)
Seoul, 03722, South Korea
Asan Medical Center ( Site 2402)
Seoul, 05505, South Korea
Samsung Medical Center-Division of Hematology/Oncology ( Site 2401)
Seoul, 06351, South Korea
Hospital Quiron Barcelona ( Site 1326)
Barcelona, Catalonia, 08023, Spain
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1323)
Pozuelo de Alarcón, Madrid, 28223, Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1333)
Madrid, Madrid, Comunidad de, 28007, Spain
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1320)
Madrid, Madrid, Comunidad de, 28034, Spain
Fundación Instituto Valenciano de Oncología-Oncologico ( Site 1332)
Valencia, Valenciana, Comunitat, 46009, Spain
Karolinska Universitetssjukhuset Solna-Tema Cancer - ME Bröst- endokrina tumörer och sarkom ( Site 1
Stockholm, Stockholm County, 171 76, Sweden
Södra Älvsborg Sjukhus ( Site 1406)
Borås, Västra Götaland County, 501 82, Sweden
Ege University Medicine of Faculty ( Site 2004)
Bornova, İzmir, 35100, Turkey (Türkiye)
I.E.U. Medical Point Hastanesi-Oncology ( Site 2016)
Izmir, Karsiyaka, İzmir, 009035575, Turkey (Türkiye)
Baskent University Dr. Turgut Noyan Research and Training Center ( Site 2013)
Adana, 01250, Turkey (Türkiye)
Hacettepe Universitesi-oncology hospital ( Site 2000)
Ankara, 06230, Turkey (Türkiye)
Memorial Ankara Hastanesi-Medical Oncology ( Site 2002)
Ankara, 06520, Turkey (Türkiye)
Gazi Universitesi-Oncology ( Site 2010)
Ankara, 06560, Turkey (Türkiye)
ANKARA ŞEHİR HASTANESİ-Medical Oncology ( Site 2014)
Ankara, 06800, Turkey (Türkiye)
Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 2009)
Antalya, 07059, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 2012)
Istanbul, 34668, Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2005)
Istanbul, 34722, Turkey (Türkiye)
İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi-Medical Oncology Department
Malatya, 44280, Turkey (Türkiye)
The Royal Cornwall Hospital ( Site 1507)
Truro, Cornwall, TR1 3LJ, United Kingdom
Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 1502)
Leicester, England, United Kingdom
St Bartholomew's Hospital ( Site 1508)
London, England, EC1A 7BE, United Kingdom
The Christie ( Site 1510)
Manchester, England, M20 4BX, United Kingdom
Blackpool Victoria Hospital ( Site 1503)
Blackpool, Lancashire, FY38NR, United Kingdom
Guy's & St Thomas' NHS Foundation Trust ( Site 1501)
London, London, City of, SE1 9RT, United Kingdom
North West Cancer Centre ( Site 1511)
Londonderry, London, City of, BT47 6SB, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2021
First Posted
May 20, 2021
Study Start
June 18, 2021
Primary Completion (Estimated)
December 18, 2027
Study Completion (Estimated)
December 18, 2027
Last Updated
March 11, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf