Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)
A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice (TPC) in Participants With Triple-Negative Breast Cancer (TNBC) Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response (pCR) at Surgery
4 other identifiers
interventional
1,530
30 countries
295
Brief Summary
This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab compared to treatment of physician's choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery. The primary objective is to compare sacituzumab tirumotecan plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sacituzumab tirumotecan plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2024
Longer than P75 for phase_3
295 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
April 26, 2024
CompletedFirst Posted
Study publicly available on registry
May 1, 2024
CompletedStudy Start
First participant enrolled
June 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 16, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 14, 2037
June 8, 2026
June 1, 2026
6.5 years
April 26, 2024
June 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Invasive Disease-Free Survival (iDFS)
iDFS is the time from randomization to invasive local, regional, or distant recurrence, invasive contralateral breast cancer, or death due to any cause, whichever occurs first.
Up to ~77 months
Secondary Outcomes (8)
Overall Survival (OS)
Up to ~101 months
Distant recurrence-free survival (DRFS)
Up to ~101 months
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
Baseline and up to ~60 months
Change from baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score
Baseline and up to ~60 months
Change from baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score
Baseline and up to ~60 months
- +3 more secondary outcomes
Study Arms (2)
Pembrolizumab + sacituzumab tirumotecan
EXPERIMENTALParticipants receive pembrolizumab every 6 weeks (q6w) in combination with sacituzumab tirumotecan every 2 weeks (q2w) for 24 weeks. In addition, participants receive an antihistamine, an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to sacituzumab tirumotecan infusions.
Treatment of Physician's Choice
ACTIVE COMPARATORParticipants receive pembrolizumab q6w or pembrolizumab q6w in combination with capecitabine (twice daily \[BID\] on Days 1 to 14 and 22 to 35 every 42 days x 4 \[2 weeks 1, 1 week off\]) for 24 weeks.
Interventions
Pembrolizumab 400 mg intravenous (IV) infusion q6w
Capecitabine 1000 mg/m\^2 to 1250 mg/m\^2 by mouth BID
Sacituzumab tirumotecan 4 mg/kg IV infusion q2w
Eligibility Criteria
You may qualify if:
- Has centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
- Has no evidence of locoregional or distant relapse, as assessed by the treating physician
- Had neoadjuvant treatment based on the KEYNOTE-522 regimen (pembrolizumab with carboplatin/taxanes and pembrolizumab with anthracycline-based chemotherapy) followed by surgery according to National Comprehensive Cancer Network (NCCN) treatment guidelines for TNBC
- Had adequate excision and surgical removal of all clinically evident disease in the breast and/or lymph nodes and have adequately recovered from surgery
- Has non-pathologic complete response at surgery
- Is able to continue on adjuvant pembrolizumab
- Randomization must be conducted within 16 weeks from surgical resection
- Completed adjuvant radiation therapy (if indicated) and recovered before randomization
- Has provided tissue from the surgical resection for central laboratory determination of trophoblast cell surface antigen 2 (TROP2) status
- If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention (120 days for sacituzumab tirumotecan and 95 days for capecitabine \[no restriction for pembrolizumab\]): agrees to refrain from donating sperm AND is either abstinent and agrees to remain abstinent or uses highly effective contraception
- For females (assigned at birth), is not pregnant or breastfeeding and ≥1 of the following applies: is not a participant of childbearing potential (POCBP) OR is a POCBP and uses highly effective contraception after the last dose of study intervention (210 days for sacituzumab tirumotecan, 120 days for pembrolizumab, and 185 days for capecitabine). Abstains from breastfeeding during the study intervention period and for at least 120 days after study intervention
- Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline (except alopecia)
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before first dose of study treatment
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B birus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization
You may not qualify if:
- Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) and is eligible for adjuvant therapy with olaparib where olaparib is approved and available
- Has Grade \>2 peripheral neuropathy
- History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \>480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months prior to study intervention
- Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) or a topoisomerase I inhibitor-containing ADC
- Received anticancer therapy in the adjuvant phase including but not limited to chemotherapy, small molecule anticancer drugs, poly (adenosine diphosphate ribose) polymerase (PARP) inhibitors, ADCs, and/or immunotherapy, with the exception of adjuvant radiation therapy
- Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study. The required washout period before starting sacituzumab tirumotecan is 2 weeks
- Except for pembrolizumab as neoadjuvant therapy for early-stage TNBC: received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein-4 \[CTLA-4\], OX-40 \[cluster of differentiation (CD) 134\], or CD137)
- Except for chemotherapy as neoadjuvant therapy for early-stage TNBC: Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization
- Received prior radiotherapy within 3 weeks of start of study intervention or required corticosteroids for radiation related toxicities that cannot be discontinued before the first dose of study intervention
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
- Has known additional malignancy that is progressing or has required active treatment within the past 5 years
- Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (299)
Infirmary Cancer Care ( Site 0001)
Mobile, Alabama, 36607, United States
Ironwood Cancer & Research Centers-Research ( Site 0054)
Chandler, Arizona, 85224, United States
MemorialCare Orange Coast Medical Center ( Site 9501)
Fountain Valley, California, 92708, United States
Scripps Cancer Center ( Site 0052)
La Jolla, California, 92037, United States
Cancer and Blood Specialty Clinic ( Site 0008)
Los Alamitos, California, 90720, United States
Kaiser Permanente - Oakland ( Site 0079)
Oakland, California, 94611, United States
Profound Research LLC ( Site 0105)
Oceanside, California, 92056, United States
Kaiser Permanente - Roseville ( Site 0081)
Roseville, California, 95661, United States
Kaiser Permanente - San Francisco ( Site 0080)
San Francisco, California, 94115, United States
Kaiser Permanente - Santa Clara ( Site 0082)
Santa Clara, California, 95051, United States
Providence Medical Foundation ( Site 9543)
Santa Rosa, California, 95403, United States
Kaiser Permanente Vallejo Medical Center ( Site 0060)
Vallejo, California, 94589, United States
Kaiser Permanente - Walnut Creek ( Site 0078)
Walnut Creek, California, 94596, United States
Bass Medical Group ( Site 0089)
Walnut Creek, California, 94598, United States
Cancer Centers of Colorado St. Mary's Regional Hospital ( Site 0046)
Grand Junction, Colorado, 81501, United States
Yale Cancer Center ( Site 0053)
New Haven, Connecticut, 06510, United States
AdventHealth Altamonte Springs ( Site 0125)
Altamonte Springs, Florida, 32701, United States
Orlando Health Cancer Institute ( Site 0030)
Orlando, Florida, 32806, United States
Comprehensive Hematology Oncology ( Site 0091)
St. Petersburg, Florida, 33709, United States
Cleveland Clinic Martin North Hospital ( Site 0114)
Stuart, Florida, 34994, United States
Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0040)
Thomasville, Georgia, 31792, United States
Illinois Cancer Specialists (ICS) ( Site 8010)
Arlington Heights, Illinois, 60005, United States
Orchard Healthcare Research Inc. ( Site 0014)
Skokie, Illinois, 60077, United States
Northwest Cancer Center - Dyer Clinic ( Site 0097)
Dyer, Indiana, 46311, United States
Parkview Research Center at Parkview Regional Medical Center ( Site 0011)
Fort Wayne, Indiana, 46845, United States
Cancer Center of Kansas ( Site 0004)
Wichita, Kansas, 67214, United States
Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0044)
Edgewood, Kentucky, 41017, United States
CHRISTUS St. Frances Cabrini Hospital Center for Cancer Care ( Site 0109)
Alexandria, Louisiana, 71301, United States
Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic ( Site 0063)
Monroe, Louisiana, 71202, United States
Louisiana State University Health Sciences Shreveport ( Site 0029)
Shreveport, Louisiana, 71103, United States
Holy Cross Hospital ( Site 0069)
Silver Spring, Maryland, 20910, United States
University of Michigan ( Site 0103)
Ann Arbor, Michigan, 48109, United States
Profound Research LLC ( Site 0074)
Royal Oak, Michigan, 48073, United States
Metro-Minnesota Community Clinical Oncology ( Site 0031)
Saint Louis Park, Minnesota, 55426, United States
University of Mississippi Medical Center ( Site 0043)
Jackson, Mississippi, 39216, United States
SSM Health Cancer Care - Fenton ( Site 0088)
Fenton, Missouri, 63026, United States
Lake Regional Hospital ( Site 0009)
Osage Beach, Missouri, 65065, United States
Siteman Cancer Center ( Site 0099)
St Louis, Missouri, 63108, United States
Optum Care Cancer Center ( Site 9535)
Las Vegas, Nevada, 89102, United States
New Mexico Oncology Hematology Consultants Ltd. ( Site 0090)
Albuquerque, New Mexico, 87109, United States
CHRISTUS St. Vincent Regional Cancer Center ( Site 0118)
Santa Fe, New Mexico, 87505, United States
The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0135)
New York, New York, 10011, United States
Icahn School of Medicine at Mount Sinai ( Site 0123)
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center ( Site 0067)
New York, New York, 10065, United States
Clinical Research Alliance ( Site 0086)
Westbury, New York, 11590, United States
Levine Cancer Institute ( Site 0083)
Charlotte, North Carolina, 28204, United States
Cape Fear Valley Health System ( Site 0136)
Fayetteville, North Carolina, 28304, United States
Sanford Cancer Center Bismarck ( Site 0058)
Bismarck, North Dakota, 58501, United States
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0056)
Fargo, North Dakota, 58102, United States
Altru Cancer Center ( Site 0104)
Grand Forks, North Dakota, 58201, United States
Cleveland Clinic - Mercy Hospital ( Site 0057)
Canton, Ohio, 44708, United States
Tri-County Hematology & Oncology Associates, Inc. ( Site 0076)
Massillon, Ohio, 44646, United States
Taylor Cancer Research Center ( Site 9500)
Maumee, Ohio, 43537, United States
Genesis Healthcare System ( Site 0025)
Zanesville, Ohio, 43701, United States
Hightower Clinical, LLC ( Site 0085)
Oklahoma City, Oklahoma, 73102, United States
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0041)
Tulsa, Oklahoma, 74146, United States
Providence Portland Medical Center ( Site 0116)
Portland, Oregon, 97213, United States
Providence Oncology and Hematology Care Clinic - Westside ( Site 0126)
Portland, Oregon, 97225, United States
Sidney Kimmel Cancer Center at Jefferson ( Site 0049)
Philadelphia, Pennsylvania, 19107, United States
Cancer Care Associates Of York ( Site 9517)
York, Pennsylvania, 17403, United States
Sanford Cancer Center ( Site 0059)
Sioux Falls, South Dakota, 57104, United States
West Cancer Center and Research Institute ( Site 0084)
Germantown, Tennessee, 38138, United States
Baptist Cancer Center ( Site 0101)
Memphis, Tennessee, 38120, United States
One Oncology - Tennessee Oncology ( Site 0098)
Nashville, Tennessee, 37203, United States
SCRI Oncology Partners ( Site 7000)
Nashville, Tennessee, 37203, United States
Tennessee Oncology ( Site 0111)
Nashville, Tennessee, 37203, United States
Nashville General Hospital ( Site 0072)
Nashville, Tennessee, 37208, United States
Vanderbilt Health One Hundred Oaks ( Site 0042)
Nashville, Tennessee, 37212, United States
Hendrick Medical Center ( Site 0117)
Abilene, Texas, 79601, United States
Harrington Cancer Center ( Site 0061)
Amarillo, Texas, 79106, United States
Texas Oncology - DFW ( Site 8000)
Dallas, Texas, 75246, United States
Parkland Health & Hospital System ( Site 0096)
Dallas, Texas, 75390, United States
University of Texas Southwestern Medical Center ( Site 0032)
Dallas, Texas, 75390, United States
Texas Oncology - Northeast Texas ( Site 8005)
Flower Mound, Texas, 75028, United States
John Peter Smith Hospital ( Site 0106)
Fort Worth, Texas, 76104, United States
Oncology Consultants P.A. ( Site 0107)
Houston, Texas, 77030, United States
Laguna Clinical Research Associates LLC ( Site 0068)
Laredo, Texas, 78041, United States
Mays Cancer Center ( Site 0122)
San Antonio, Texas, 78229, United States
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0055)
Tyler, Texas, 75701, United States
Texas Oncology - Gulf Coast ( Site 8009)
Webster, Texas, 77598, United States
Intermountain Medical Center ( Site 0113)
Murray, Utah, 84107, United States
Mary Washington Hospital ( Site 0129)
Fredericksburg, Virginia, 22405, United States
Hematology Oncology Associates of Fredericksburg ( Site 9550)
Fredericksburg, Virginia, 22408, United States
Bon Secours Memorial Regional Medical Center-Oncology Research Department ( Site 0020)
Midlothian, Virginia, 23114, United States
Virginia Oncology Associates (VOA) ( Site 8008)
Norfolk, Virginia, 23502, United States
Virginia Cancer Institute ( Site 0034)
Richmond, Virginia, 23229, United States
Northwest Medical Specialties, PLLC ( Site 0093)
Tacoma, Washington, 98405, United States
SSM Health Dean Medical Group ( Site 0087)
Madison, Wisconsin, 53715, United States
Hospital Aleman-Oncology ( Site 0501)
Capital Federal, Buenos Aires, C1118AAT, Argentina
Hospital Británico de Buenos Aires-Oncology ( Site 0502)
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1280AEB, Argentina
Instituto de Oncología Angel H. Roffo ( Site 0503)
Buenos Aires, Buenos Aires F.D., C1417, Argentina
Instituto Alexander Fleming-Alexander Fleming ( Site 0509)
Buenos Aires, Buenos Aires F.D., C1426ANZ, Argentina
Sanatorio Parque ( Site 0512)
Rosario, Santa Fe Province, S2000DSV, Argentina
Sanatorio Finochietto ( Site 0513)
Buenos Aires, C1187AAN, Argentina
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0508)
Buenos Aires, C1431FWO, Argentina
Macquarie University-MQ Health Clinical Trials Unit ( Site 2703)
Macquarie University, New South Wales, 2109, Australia
Westmead Hospital ( Site 2700)
Westmead, New South Wales, 2145, Australia
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 2701)
Brisbane, Queensland, 4029, Australia
Frankston Hospital-Oncology and Haematology ( Site 2704)
Frankston, Victoria, 3199, Australia
Medizinische Universitaet Innsbruck ( Site 1200)
Innsbruck, Tyrol, 6020, Austria
Kepler Universitätsklinikum-Department for Oncology and Hematology ( Site 1206)
Linz, Upper Austria, 4020, Austria
Klinikum Wels-Grieskirchen ( Site 1205)
Wels, Upper Austria, 4600, Austria
Uniklinikum Salzburg-Universitätsklinik für Innere Medizin III der PMU mit Hämatologie, internistis ( Site 1202)
Salzburg, 5020, Austria
Medizinische Universität Wien-Universitätsklinik für Innere Medizin I, Klinische Abteilung für Onko ( Site 1201)
Vienna, 1090, Austria
Cliniques universitaires Saint-Luc-Medical Oncology ( Site 0901)
Brussels, Bruxelles-Capitale, Region de, 1200, Belgium
AZ Maria Middelares-IKG ( Site 0903)
Ghent, Oost-Vlaanderen, 9000, Belgium
Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0902)
Namur, 5530, Belgium
PRONUTRIR-CLINICAL RESEARCH ( Site 0609)
Fortaleza, Ceará, 60810-180, Brazil
Hospital Santa Rita de Cassia ( Site 0617)
Vitória, Espírito Santo, 29043-260, Brazil
Oncoclínica Oncologistas Associados-Clinical Research ( Site 0607)
Teresina, Piauí, 64049-200, Brazil
Hospital do Câncer Mãe de Deus ( Site 0604)
Porto Alegre, Rio Grande do Sul, 90110-270, Brazil
Instituto de Oncologia Saint Gallen ( Site 0614)
Santa Cruz do Sul, Rio Grande do Sul, 96830-180, Brazil
Instituto do Câncer Brasil - Unidade Taubaté ( Site 0608)
Taubaté, São Paulo, 12030-200, Brazil
IBCC - Núcleo de Pesquisa e Ensino ( Site 0601)
São Paulo, 04014-002, Brazil
Cross Cancer Institute ( Site 0407)
Edmonton, Alberta, T6G 1Z2, Canada
BC Cancer Vancouver ( Site 0404)
Vancouver, British Columbia, V5Z 4E6, Canada
CancerCare Manitoba ( Site 0411)
Winnipeg, Manitoba, R2H 2A6, Canada
The Moncton Hospital ( Site 0401)
Moncton, New Brunswick, E1C 6Z8, Canada
QEII Health Sciences Centre - Victoria General Site ( Site 0418)
Halifax, Nova Scotia, B3H 2Y9, Canada
Southlake Health ( Site 0413)
Newmarket, Ontario, L3Y 2P9, Canada
The Ottawa Hospital - General Campus ( Site 0414)
Ottawa, Ontario, K1H 8L6, Canada
North York General Hospital ( Site 0415)
Toronto, Ontario, M2K 1E1, Canada
Princess Margaret Cancer Centre ( Site 0400)
Toronto, Ontario, M5G 2M9, Canada
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0417)
Greenfield Park, Quebec, J4V 2H1, Canada
CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0419)
Montreal, Quebec, H1T 2M4, Canada
Centre Hospitalier de l'Université de Montréal ( Site 0403)
Montreal, Quebec, H2X 3E4, Canada
Jewish General Hospital ( Site 0416)
Montreal, Quebec, H3T 1E2, Canada
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0409)
Rimouski, Quebec, G5L 5T1, Canada
Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec ( Site 0406)
Trois-Rivières, Quebec, G8Z 3R9, Canada
Clinica Somer ( Site 3704)
Rionegro, Antioquia, 054040, Colombia
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 3700)
Bogotá, Bogota D.C., 110131, Colombia
Instituto Nacional De Cancerologia ( Site 3701)
Bogotá, Bogota D.C., 111511, Colombia
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 3705)
Valledupar, Cesar Department, 200001, Colombia
Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 1005)
Brno, Brno-mesto, 656 53, Czechia
Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1006)
Olomouc, Olomouc Region, 779 00, Czechia
Vseobecna fakultni nemocnice v Praze-Onkologická klinika VFN ( Site 1002)
Prague, Praha 2, 128 08, Czechia
Fakultni Thomayerova nemocnice - Onkologicka klinika 1. LF UK a FTN ( Site 1008)
Prague, Praha 4, 14059, Czechia
Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 1000)
Prague, Praha 5, 150 06, Czechia
Nemocnice Ceske Budejovice-Onkologicke oddeleni ( Site 1007)
České Budějovice, South Bohemian Region, 37001, Czechia
Herlev og Gentofte Hospital. ( Site 3203)
Herlev, Capital Region, 2730, Denmark
Aarhus Universitets hospital ( Site 3202)
Aarhus N, Central Jutland, 8200, Denmark
Aalborg Universitetshospital, Syd ( Site 3206)
Aalborg, North Denmark, 9000, Denmark
Odense Universitetshospital ( Site 3201)
Odense C, Region Syddanmark, 5000, Denmark
Sygehus Soenderjylland ( Site 3204)
Sønderborg, Region Syddanmark, 6400, Denmark
Vejle Sygehus. ( Site 3205)
Vejle, Region Syddanmark, 7100, Denmark
Kuopion Yliopistollinen Sairaala-Syöpäkeskus ( Site 1101)
Kuopio, Northern Savonia, 70210, Finland
Tampereen yliopistollinen sairaala ( Site 1102)
Tampere, Pirkanmaa, 33520, Finland
Turku University Hospital-Department of Oncology ( Site 1103)
Turku, Southwest Finland, 20520, Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1100)
Helsinki, Uusimaa, 00029, Finland
Centre Antoine-Lacassagne ( Site 1308)
Nice, Alpes-Maritimes, 06189, France
Centre Hospitalier de la Côte Basque ( Site 1315)
Bayonne, Aquitaine, 64109, France
CENTRE LEON BERARD ( Site 1300)
Lyon Cedex08, Auvergne-Rhône-Alpes, 69373, France
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 1307)
Clermont-Ferrand, Auvergne, 63011, France
Institut Paoli-Calmettes ( Site 1309)
Marseille, Bouches-du-Rhone, 13009, France
Centre François Baclesse ( Site 1318)
Caen, Calvados, 14076, France
Centre Georges François Leclerc ( Site 1312)
Dijon, Cote-d Or, 21079, France
CHU Besançon ( Site 1311)
Besançon, Doubs, 25000, France
Hôpital Privé Drôme-Ardèche ( Site 1301)
Valence, Drome, 26000, France
CHRU Brest - Hopital Cavale Blanche ( Site 1304)
Brest, Finistere, 29200, France
Clinique Tivoli Ducos ( Site 1322)
Bordeaux, Gironde, 33000, France
Hôpital Franco-Britannique - Fondation Cognacq-Jay ( Site 1321)
Levallois-Perret, Hauts-de-Seine, 92300, France
Institut de Cancérologie de l'Ouest ( Site 1305)
Saint-Herblain, Loire-Atlantique, 44805, France
Institut de Cancérologie de l'Ouest ( Site 1316)
Angers, Maine-et-Loire, 49055, France
Centre de Cancerologie Les Dentellieres ( Site 1306)
Valenciennes, Nord, 59300, France
Centre Hospitalier de Pau ( Site 1302)
Pau, Pyrenees-Atlantiques, 64046, France
Centre Henri Becquerel ( Site 1319)
Rouen, Seine-Maritime, 76038, France
Hôpital Tenon ( Site 1303)
Paris, 75020, France
Klinikum Ludwigsburg-Klinik für Geburtshilfe und Frauenheilkunde ( Site 1405)
Ludwigsburg, Baden-Wurttemberg, 71640, Germany
Universitaetsklinikum Tuebingen-Frauenklinik ( Site 1415)
Tübingen, Baden-Wurttemberg, 72076, Germany
Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1400)
Erlangen, Bavaria, 91054, Germany
Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Frauenklinik Brustzentrum ( Site 1402)
Munich, Bavaria, 80336, Germany
Klinikum Ernst von Bergmann-Frauenklinik ( Site 1408)
Potsdam, Brandenburg, 14467, Germany
Franziskus-Hospital Harderberg ( Site 1404)
Georgsmarienhütte, Lower Saxony, 49124, Germany
Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1409)
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinik für Senologie/ Brustzentrum ( Site 1401)
Essen, North Rhine-Westphalia, 45136, Germany
Evangelisches Krankenhaus Bethesda Mönchengladbach-Brustzentrum Niederrhein ( Site 1406)
Mönchengladbach, North Rhine-Westphalia, 41061, Germany
Universitätsmedizin Johannes Gutenberg Universität Mainz-Klinik und Poliklinik für Geburtshilfe und ( Site 1418)
Mainz, Rhineland-Palatinate, 55131, Germany
CaritasKlinikum Saarbruecken St. Theresia ( Site 1410)
Saarbrücken, Saarland, 66113, Germany
Universitätsklinikum Schleswig-Holstein ( Site 1411)
Lübeck, Schleswig-Holstein, 23538, Germany
Helios Klinikum Berlin-Buch-Klinik für Gynäkologie und Geburtshilfe ( Site 1413)
Berlin, 13125, Germany
UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 1509)
Pátrai, Achaia, 26504, Greece
Errikos Dunant Hospital Center-1st Medical Oncology Dept. ( Site 1508)
Athens, Attica, 115 26, Greece
Aretaieio Hospital Oncology Unit ( Site 1505)
Athens, Attica, 115 28, Greece
University General Hospital of Larissa ( Site 1503)
Larissa, Thessaly, 411 10, Greece
European Interbalkan Medical Center ( Site 1502)
Thessaloniki, 570 01, Greece
European Interbalkan Medical Center ( Site 1507)
Thessaloniki, 570 01, Greece
Queen Mary Hospital ( Site 3600)
Hong Kong, Hong Kong
Hong Kong United Oncology Centre ( Site 3601)
Kowloon, Hong Kong
Prince of Wales Hospital ( Site 3602)
Shatin, 000000, Hong Kong
Bon Secours Cork Hospital ( Site 1600)
Cork, T12 DV56, Ireland
St. Vincent's University Hospital-Medical Oncology Research Department ( Site 1601)
Dublin, D04 T6F4, Ireland
University College Hospital - Galway ( Site 1602)
Galway, Galway, Ireland
Soroka Medical Center-Oncology ( Site 1704)
Beersheba, 8410101, Israel
Shaare Zedek Medical Center ( Site 1706)
Jerusalem, 9103102, Israel
Hadassah Medical Center ( Site 1700)
Jerusalem, 9112001, Israel
Rabin Medical Center ( Site 1702)
Petah Tikva, 4941492, Israel
Sheba Medical Center-ONCOLOGY ( Site 1701)
Ramat Gan, 5265601, Israel
Sourasky Medical Center ( Site 1705)
Tel Aviv, 6423906, Israel
University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia ( Site 1803)
Naples, Campania, 80100, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Clinica Sperimentale di Senologia ( Site 1800)
Naples, Campania, 80131, Italy
Humanitas Istituto Clinico Catanese ( Site 1811)
Misterbianco, Catania, 95045, Italy
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1807)
Meldola (FC), Forli-Cesena, 47014, Italy
CRO-IRCCS ( Site 1808)
Aviano, Friuli Venezia Giulia, 33081, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1802)
Rome, Lazio, 00168, Italy
Azienda Ospedaliera Spedali Civili di Brescia ( Site 1812)
Brescia, Lombardy, 25123, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1801)
Milan, Lombardy, 20133, Italy
Istituto Europeo di Oncologia IRCCS-Divisione di Senologia Medica ( Site 1809)
Milan, Lombardy, 20141, Italy
Fondazione IRCCS San Gerardo dei Tintori ( Site 1813)
Monza, Lombardy, 20900, Italy
Azienda Ospedaliera Universitaria Careggi ( Site 1805)
Florence, Tuscany, 50134, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1810)
Bologna, 40138, Italy
Ospedale San Raffaele-Oncologia Medica ( Site 1814)
Milan, 20132, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità-SCDU ONCOLOGIA ( Site 1804)
Novara, 28100, Italy
Nagoya City University Hospital ( Site 3414)
Nagoya, Aichi-ken, 467-8602, Japan
National Cancer Center Hospital East ( Site 3403)
Kashiwa, Chiba, 277-8577, Japan
Hokkaido University Hospital ( Site 3400)
Sapporo, Hokkaido, 060-8648, Japan
Tokai University Hospital ( Site 3413)
Isehara, Kanagawa, 259-1193, Japan
St. Marianna University Hospital ( Site 3405)
Kawasaki, Kanagawa, 216-8511, Japan
Kitasato University Hospital ( Site 3411)
Sagamihara, Kanagawa, 252-0375, Japan
Kanagawa Cancer Center ( Site 3412)
Yokohama, Kanagawa, 241-8515, Japan
Mie University Hospital ( Site 3423)
Tsu, Mie-ken, 514-8507, Japan
Tohoku University Hospital ( Site 3422)
Sendai, Miyagi, 980-8574, Japan
The University of Osaka Hospital ( Site 3416)
Suita, Osaka, 565-0871, Japan
Saitama Medical University International Medical Center ( Site 3402)
Hidaka, Saitama, 350-1298, Japan
Juntendo University Hospital ( Site 3408)
Bunkyo, Tokyo, 113-8431, Japan
St.Luke's International Hospital ( Site 3427)
Chūō, Tokyo, 104-8560, Japan
Cancer Institute Hospital of JFCR ( Site 3404)
Koto, Tokyo, 135-8550, Japan
Showa Medical University Hospital ( Site 3406)
Shinagawa, Tokyo, 142-8666, Japan
Tokyo Medical University Hospital ( Site 3407)
Shinjuku, Tokyo, 160-0023, Japan
National Center for Global Health and Medicine ( Site 3409)
Shinjuku, Tokyo, 162-8655, Japan
Fukushima Medical University Hospital ( Site 3401)
Fukushima, 960-1295, Japan
Gifu University Hospital ( Site 3426)
Gifu, 501-1194, Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 3418)
Hiroshima, 730-8518, Japan
Social medical corporation Hakuaikai Sagara Hospital ( Site 3421)
Kagoshima, 892-0833, Japan
Kumamoto University Hospital ( Site 3420)
Kumamoto, 860-8556, Japan
Kyoto University Hospital ( Site 3415)
Kyoto, 606-8507, Japan
Okayama University Hospital ( Site 3425)
Okayama, 700-8558, Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 3417)
Osaka, 541-8567, Japan
Prince Court Medical Centre ( Site 2802)
Kuala Lumpur, 50450, Malaysia
Pantai Hospital Kuala Lumpur ( Site 2801)
Kuala Lumpur, 59100, Malaysia
CENEIT Oncologicos ( Site 0706)
Mexico City, Mexico City, 03100, Mexico
Grupo Médico ASSET ( Site 0705)
Mexico City, Mexico City, 03100, Mexico
Health Pharma Professional Research S.A. de C.V: ( Site 0709)
Mexico City, Mexico City, 03100, Mexico
COI Centro Oncologico Internacional S.A.P.I. de C.V. ( Site 0712)
Mexico City, Mexico City, 04700, Mexico
Oncare - Unidad Valle ( Site 0713)
San Pedro Garza García, Nuevo León, 66220, Mexico
CENTRO MEDICO ZAMBRANO HELLION ( Site 0711)
San Pedro Garza García, Nuevo León, 66278, Mexico
Drammen Sykehus, Vestre Viken HF ( Site 2001)
Drammen, Buskerud, 3004, Norway
Stavanger Universitetssykehus ( Site 2004)
Stavanger, Rogaland, 4011, Norway
Oslo universitetssykehus, Radiumhospitalet ( Site 2002)
Oslo, 0379, Norway
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2102)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Oddzial w Krakowie ( Site 2120)
Krakow, Lesser Poland Voivodeship, 31-115, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Piersi i Chirurgii ( Site 2100)
Warsaw, Masovian Voivodeship, 02-781, Poland
Mazowiecki Szpital Onkologiczny-BREAST CANCER ( Site 2101)
Wieliszew, Masovian Voivodeship, 05-135, Poland
Bialostockie Centrum Onkologii ( Site 2105)
Bialystok, Podlaskie Voivodeship, 15-027, Poland
Szpitale Pomorskie Sp. z o. o.-Oddział Onkologii Klinicznej ( Site 2113)
Gdynia, Pomeranian Voivodeship, 81-519, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach-Centrum Diagnostyki i Leczenia Chorob Piersi ( Site 2110)
Gliwice, Silesian Voivodeship, 44-102, Poland
Zachodniopomorskie Centrum Onkologii ( Site 2108)
Szczecin, West Pomeranian Voivodeship, 71-730, Poland
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch ( Site 2118)
Kielce, Świętokrzyskie Voivodeship, 25-734, Poland
Unidade Local de Saude Amadora/Sintra - Hospital Prof Dr Fernando Fonseca ( Site 2203)
Amadora, Lisbon District, 2720-276, Portugal
Fundacao Champalimaud ( Site 2200)
Lisbon, 1400-038, Portugal
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 2201)
Lisbon, 1649-035, Portugal
Instituto Portugues de Oncologia do Porto ( Site 2202)
Porto, 4200-072, Portugal
National Cancer Centre Singapore-Medical Oncology ( Site 3002)
Singapore, Central Singapore, 168583, Singapore
Seoul National University Hospital-Internal Medicine ( Site 3102)
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 3100)
Seoul, 03722, South Korea
Asan Medical Center-Department of Oncology ( Site 3103)
Seoul, 05505, South Korea
Gangnam Severance Hospital, Yonsei University Health System-Medical Oncology, Internal Medicine ( Site 3104)
Seoul, 06273, South Korea
Samsung Medical Center-Division of Hematology/Oncology ( Site 3101)
Seoul, 06351, South Korea
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 2304)
Seville, Andalusia, 41013, Spain
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2305)
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 2307)
A Coruña, La Coruna, 15006, Spain
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2301)
Madrid, Madrid, Comunidad de, 28034, Spain
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Medical Oncology ( Site 2308)
Majadahonda, Madrid, Comunidad de, 28222, Spain
Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2303)
Valencia, Valenciana, Comunitat, 46009, Spain
Hospital Universitari Vall d'Hebron-Oncology ( Site 2300)
Barcelona, 08035, Spain
Hospital Beata María Ana-oncology ( Site 2309)
Madrid, 28007, Spain
Hospital Clinico San Carlos-Oncology Department ( Site 2306)
Madrid, 28040, Spain
HOSPITAL CLINICO DE VALENCIA-Oncology ( Site 2302)
Valencia, 46010, Spain
Gävle sjukhus ( Site 3504)
Gävle, Gävleborg County, 801 87, Sweden
Capio St. Gorans Sjukhus ( Site 3503)
Stockholm, Stockholm County, 112 81, Sweden
Karolinska Universitetssjukhuset Solna ( Site 3500)
Stockholm, Stockholm County, 171 76, Sweden
Akademiska Sjukhuset ( Site 3501)
Uppsala, Uppsala County, 751 85, Sweden
Södra Älvsborg Sjukhus ( Site 3502)
Borås, Västra Götaland County, 501 82, Sweden
Sahlgrenska Universitetssjukhuset. ( Site 3505)
Gothenburg, Västra Götaland County, 413 45, Sweden
Spital Thun ( Site 2400)
Thun, Canton of Bern, 3600, Switzerland
Clinique Générale-Beaulieu ( Site 2406)
Geneva, Canton of Geneva, 1206, Switzerland
Brust-Zentrum ( Site 2401)
Zurich, Canton of Zurich, 8008, Switzerland
Kantonsspital Graubünden-Medizin ( Site 2404)
Chur, Kanton Graubünden, 7000, Switzerland
HFR Fribourg - Hôpital Cantonal ( Site 2402)
Fribourg, 1708, Switzerland
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 2501)
Adana, 01140, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi-oncology ( Site 2504)
Ankara, 06200, Turkey (Türkiye)
Memorial Ankara Hastanesi-Medical Oncology ( Site 2502)
Ankara, 06520, Turkey (Türkiye)
Medipol Mega Universite Hastanesi-oncology ( Site 2503)
Istanbul, 34214, Turkey (Türkiye)
Samsun Medical Park Hastanesi-medical oncology ( Site 2500)
Samsun, 55200, Turkey (Türkiye)
University Hospitals Bristol NHS Foundation Trust ( Site 2601)
Bristol, Bristol, City of, BS2 8ED, United Kingdom
The Royal Cornwall Hospital ( Site 2603)
Truro, England, TR1 3LJ, United Kingdom
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2602)
London, London, City of, EC1A 7BE, United Kingdom
University College London Hospital ( Site 2604)
London, London, City of, NW1 2PG, United Kingdom
Western General Hospital ( Site 2607)
Edinburgh, Midlothian, EH4 2XU, United Kingdom
St James's University Hospital-Leeds Cancer Centre ( Site 2608)
Leeds, LS9 7TF, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2024
First Posted
May 1, 2024
Study Start
June 24, 2024
Primary Completion (Estimated)
December 16, 2030
Study Completion (Estimated)
December 14, 2037
Last Updated
June 8, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf