A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)
An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer
5 other identifiers
interventional
1,200
39 countries
256
Brief Summary
The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer. The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2024
Longer than P75 for phase_3
256 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
March 7, 2024
CompletedFirst Posted
Study publicly available on registry
March 15, 2024
CompletedStudy Start
First participant enrolled
April 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 11, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 12, 2031
June 8, 2026
June 1, 2026
3.2 years
March 7, 2024
June 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS) ( sacituzumab tirumotecan versus treatment of physician's choice [TPC]; pembrolizumab + sacituzumab tirumotecan versus TPC)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). 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. PFS as assessed by blinded independent central review (BICR) will be presented.
Up to ~38 months
Secondary Outcomes (16)
Overall Survival (OS)
Up to ~77 months
Progression-Free Survival (PFS) (pembrolizumab + sacituzumab tirumotecan + versus sacituzumab tirumotecan)
Up to ~57 months
Objective Response Rate (ORR)
Up to ~57 months
Duration of Response (DOR)
Up to ~57 months
Change from baseline in global health status/quality of life scores, on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Baseline and up to ~77 months
- +11 more secondary outcomes
Study Arms (3)
Arm A: Sacituzumab tirumotecan
EXPERIMENTALParticipants receive 4 mg/kg of sacituzumab tirumotecan once every 2 weeks (Q2W) via intravenous (IV) infusion until progressive disease or discontinuation.
Arm B:Pembrolizumab + Sacituzumab tirumotecan
EXPERIMENTALParticipants receive 4 mg/kg of sacituzumab tirumotecan Q2W via IV infusion until progressive disease or discontinuation PLUS 400 mg of pembrolizumab once every 6 weeks (Q6W) via IV infusion for up to 18 administrations (up to \~2 years).
Arm C: Treatment of Physician's Choice (TPC)
ACTIVE COMPARATORAt the physician's discretion, participants receive chemotherapy of 80 mg/m\^2 of paclitaxel once every week (Q1W) via IV infusion OR 90 mg/m\^2 of paclitaxel once every 4 weeks (Q4W) via IV infusion OR 100 mg/m\^2 of nab-paclitaxel Q4W via IV infusion OR 1000 mg/m\^2 of capecitabine every 3 weeks (Q3W) orally OR 50 mg/m\^2 of liposomal doxorubicin once every 4 weeks (Q4W) via IV infusion, until progressive disease or discontinuation.
Interventions
IV infusion
IV infusion
IV infusion
Eligibility Criteria
You may qualify if:
- Has unresectable locally advanced or metastatic centrally-confirmed hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer
- Has radiographic disease progression on one or more lines of endocrine therapy for unresectable locally advanced/metastatic HR+/HER2- breast cancer, with one in combination with a CDK4/6 inhibitor
- Is a chemotherapy candidate
- Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
- Has adequate organ function
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
- Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
- Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
You may not qualify if:
- Has breast cancer amenable to treatment with curative intent
- Has experienced an early recurrence (\<6 months after completing adjuvant/neoadjuvant chemotherapy) and therefore is eligible to receive second-line (2L) treatment
- Has symptomatic advanced/metastatic visceral spread at risk of rapidly evolving into life-threatening complications
- Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer
- Active autoimmune disease that has required systemic treatment in the past 2 years
- History of (noninfectious) pneumonitis/interstitial lung disease that requires steroids, or has current pneumonitis/interstitial lung disease
- Has an active infection requiring systemic therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (259)
Ironwood Cancer & Research Centers ( Site 0066)
Chandler, Arizona, 85224, United States
Banner MD Anderson Cancer Center-Oncology ( Site 0004)
Gilbert, Arizona, 85234, United States
Providence Medical Foundation-Oncology ( Site 0020)
Fullerton, California, 92835, United States
Moores Cancer Center ( Site 0059)
La Jolla, California, 92093-0698, United States
Cancer and Blood Specialty Clinic ( Site 0001)
Los Alamitos, California, 90720, United States
University of Colorado Anschutz Medical Campus ( Site 0061)
Aurora, Colorado, 80045, United States
UCHealth Cherry Creek Medical Center ( Site 0094)
Denver, Colorado, 80206, United States
University of Colorado Health - Highlands Ranch Hospital ( Site 0095)
Highlands Ranch, Colorado, 80129, United States
Yale Cancer Center ( Site 0060)
New Haven, Connecticut, 06510, United States
Stamford Hospital ( Site 0049)
Stamford, Connecticut, 06902, United States
AdventHealth Altamonte Springs ( Site 0021)
Altamonte Springs, Florida, 32701, United States
University of Florida College of Medicine ( Site 0063)
Gainesville, Florida, 32610, United States
Orlando Health Cancer Institute ( Site 0011)
Orlando, Florida, 32806, United States
Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0032)
Thomasville, Georgia, 31792, United States
Rush University Medical Center ( Site 0079)
Chicago, Illinois, 60607, United States
University of Chicago Medical Center ( Site 0067)
Chicago, Illinois, 60637, United States
Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0053)
Edgewood, Kentucky, 41017, United States
Mary Bird Perkins Cancer Center-Breast & GYN Pavilion ( Site 0042)
Baton Rouge, Louisiana, 70817, United States
Greenebaum Comprehensive Cancer Center ( Site 0036)
Baltimore, Maryland, 21201, United States
Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0028)
Baltimore, Maryland, 21202, United States
Holy Cross Hospital ( Site 0073)
Silver Spring, Maryland, 20910, United States
Dana-Farber Cancer Institute-Breast Oncology Center ( Site 0037)
Boston, Massachusetts, 02215, United States
Henry Ford Health ( Site 0002)
Detroit, Michigan, 48202, United States
Saint Luke's Cancer Institute ( Site 0027)
Kansas City, Missouri, 64111, United States
Washington University School of Medicine ( Site 0076)
St Louis, Missouri, 63110, United States
NYU Langone Health - Brooklyn ( Site 0089)
Brooklyn, New York, 11220, United States
NYU Langone Hospital - Long Island ( Site 0090)
Mineola, New York, 11501, United States
Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0068)
New York, New York, 10016, United States
Hematology Oncology Associates of Rockland ( Site 0054)
Nyack, New York, 10960, United States
Stony Brook University-Cancer Center ( Site 0034)
Stony Brook, New York, 11794, United States
Levine Cancer Institute ( Site 0014)
Charlotte, North Carolina, 28204, United States
Zangmeister Cancer Center ( Site 7000)
Columbus, Ohio, 43219, United States
Providence Portland Medical Center ( Site 0044)
Portland, Oregon, 97213, United States
Providence St. Vincent Medical Center ( Site 0081)
Portland, Oregon, 97225, United States
Thomas Jefferson University - Clinical Research Institute ( Site 0056)
Philadelphia, Pennsylvania, 19107, United States
Texas Oncology-Dallas Presbyterian Hospital ( Site 8000)
Dallas, Texas, 75231, United States
Parkland Health and Hospital System ( Site 0069)
Dallas, Texas, 75235, United States
UT Southwestern Medical Center ( Site 0050)
Dallas, Texas, 75390, United States
The Center for Cancer and Blood Disorders ( Site 0041)
Fort Worth, Texas, 76104, United States
Texas Oncology - San Antonio ( Site 8002)
San Antonio, Texas, 78240, United States
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0057)
Tyler, Texas, 75701, United States
Inova Schar Cancer Institute ( Site 0025)
Fairfax, Virginia, 22031, United States
Bon Secours St. Francis Medical Center-Oncology Research ( Site 0015)
Midlothian, Virginia, 23114, United States
VCU Health Adult Outpatient Pavillion ( Site 0070)
Richmond, Virginia, 23219, United States
Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 8001)
Roanoke, Virginia, 24014, United States
University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0040)
Madison, Wisconsin, 53792, United States
Instituto Alexander Fleming-Alexander Fleming ( Site 0382)
Buenos Aires, Buenos Aires F.D., C1426ANZ, Argentina
Fundacion Estudios Clinicos-Oncology ( Site 0384)
Rosario, Santa Fe Province, S2000DEJ, Argentina
Hospital Aleman-Oncology ( Site 0386)
Buenos Aires, C1118AAT, Argentina
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0383)
Buenos Aires, C1431FWO, Argentina
Hospital Italiano de Córdoba ( Site 0385)
Córdoba, X5004BAL, Argentina
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0387)
La Rioja, F5300COE, Argentina
Macquarie University-MQ Health Clinical Trials Unit ( Site 2002)
Macquarie University, New South Wales, 2109, Australia
Westmead Hospital ( Site 2000)
Westmead, New South Wales, 2145, Australia
Frankston Hospital-Oncology and Haematology ( Site 2003)
Frankston, Victoria, 3199, Australia
Fiona Stanley Hospital-Medical Oncology ( Site 2004)
Murdoch, Western Australia, 6150, Australia
Institut Jules Bordet-Medicine Oncology ( Site 1104)
Anderlecht, Bruxelles-Capitale, Region de, 1070, Belgium
Cliniques universitaires Saint-Luc-Medical Oncology ( Site 1103)
Brussels, Bruxelles-Capitale, Region de, 1200, Belgium
Jessa Ziekenhuis-Limburgs Oncologisch Centrum ( Site 1105)
Hasselt, Limburg, 3500, Belgium
AZ Maria Middelares-IKG ( Site 1106)
Ghent, Oost-Vlaanderen, 9000, Belgium
Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 1107)
Namur, 5530, Belgium
Oncoclínica Oncologistas Associados-Clinical Research ( Site 0407)
Teresina, Piauí, 64049-200, Brazil
Hospital Moinhos de Vento ( Site 0403)
Porto Alegre, Rio Grande do Sul, 90035-001, Brazil
Hospital do Câncer Mãe de Deus ( Site 0404)
Porto Alegre, Rio Grande do Sul, 90110-270, Brazil
Instituto de Oncologia Saint Gallen ( Site 0412)
Santa Cruz do Sul, Rio Grande do Sul, 96830-180, Brazil
Instituto do Câncer Brasil - Unidade Taubaté ( Site 0408)
Taubaté, São Paulo, 12030-200, Brazil
IBCC - Núcleo de Pesquisa e Ensino ( Site 0401)
São Paulo, 04014-012, Brazil
BC Cancer Surrey ( Site 0315)
Surrey, British Columbia, V3V 1Z2, Canada
Southlake Health ( Site 0311)
Newmarket, Ontario, L3Y 2P9, Canada
Princess Margaret Cancer Centre ( Site 0310)
Toronto, Ontario, M5G 2M9, Canada
CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0301)
Montreal, Quebec, H1T 2M4, Canada
Jewish General Hospital ( Site 0303)
Montreal, Quebec, H3T 1E2, Canada
CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0302)
Québec, Quebec, G1S 4L8, Canada
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0308)
Rimouski, Quebec, G5L 5T1, Canada
FALP-UIDO ( Site 0451)
Santiago, Region M. de Santiago, 7500921, Chile
Oncovida ( Site 0453)
Santiago, Region M. de Santiago, 7500994, Chile
Clínica RedSalud Vitacura ( Site 0455)
Santiago, Region M. de Santiago, 7650018, Chile
Pontificia Universidad Catolica de Chile ( Site 0454)
Santiago, Region M. de Santiago, 832000, Chile
Bradfordhill ( Site 0452)
Santiago, Region M. de Santiago, 8420383, Chile
Bradford Hill Norte ( Site 0456)
Antofagasta, 1263521, Chile
Fundacion Colombiana de Cancerología Clinica Vida ( Site 0506)
Medellín, Antioquia, 050030, Colombia
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0507)
Bogotá, Bogota D.C., 110131, Colombia
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0501)
Valledupar, Cesar Department, 200001, Colombia
IMAT S.A.S ( Site 0502)
Montería, Departamento de Córdoba, 23002, Colombia
Fundación Valle del Lili ( Site 0508)
Cali, Valle del Cauca Department, 760032, Colombia
CIMCA ( Site 0551)
San José, Provincia de San José, 10103, Costa Rica
Hospital Metropolitano - Sede Lindora ( Site 0550)
Santa Ana, Provincia de San José, 10903, Costa Rica
ICIMED ( Site 0552)
San José, 10108, Costa Rica
Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 1134)
Ostrava-Poruba, Moravian-Silesian Region, 708 52, Czechia
Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1132)
Olomouc, Olomouc Region, 779 00, Czechia
Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 1136)
Prague, Praha 5, 150 06, Czechia
Nemocnice Ceske Budejovice-Onkologicke oddeleni ( Site 1138)
České Budějovice, South Bohemian Region, 370 01, Czechia
Fakultni nemocnice Kralovske Vinohrady-Onkologická klinika ( Site 1135)
Prague, 100 34, Czechia
Rigshospitalet ( Site 1180)
Copenhagen, Capital Region, 2100, Denmark
Nordsjællands Hospital - Hillerød ( Site 1184)
Hillerød, Capital Region, 3400, Denmark
Næstved Sygehus ( Site 1182)
Næstved, Region Sjælland, 4700, Denmark
Odense Universitetshospital ( Site 1181)
Odense, Region Syddanmark, 5000, Denmark
Vejle Sygehus ( Site 1183)
Vejle, Region Syddanmark, 7100, Denmark
Hopital Prive Jean Mermoz-Oncology ( Site 1246)
Lyon, Auvergne-Rhône-Alpes, 69008, France
Centre François Baclesse ( Site 1250)
Caen, Calvados, 14076, France
Centre de Cancérologie du Grand Montpellier ( Site 1244)
Montpellier, Languedoc-Roussillon, 34070, France
Hôpital privé du Confluent SAS-Service d'oncologie médicale ( Site 1242)
Nantes, Loire-Atlantique, 44277, France
Centre Hospitalier Universitaire de Poitiers-Pôle régional de cancérologie ( Site 1243)
Poitiers, Vienne, 86021, France
Pitie Salpetriere University Hospital ( Site 1249)
Paris, 75013, France
Institut Curie-Oncology medical Department ( Site 1240)
Paris, 75248, France
Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1301)
Erlangen, Bavaria, 91054, Germany
Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Frauenklinik Brustzentrum ( Site 1303)
München, Bavaria, 80336, Germany
Klinikum Ernst von Bergmann-Frauenklinik ( Site 1305)
Potsdam, Brandenburg, 14467, Germany
Franziskus-Hospital Harderberg ( Site 1308)
Georgsmarienhütte, Lower Saxony, 49124, Germany
Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1311)
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinik für Senologie/ Brustzentrum ( Site 1300)
Essen, North Rhine-Westphalia, 45136, Germany
CaritasKlinikum Saarbruecken St. Theresia ( Site 1304)
Saarbrücken, Saarland, 66113, Germany
SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1315)
Gera, Thuringia, 07548, Germany
Helios Klinikum Berlin-Buch-Klinik für Gynäkologie und Geburtshilfe ( Site 1314)
Berlin, 13125, Germany
Errikos Dunant Hospital Center ( Site 1348)
Athens, Attica, 115 26, Greece
Aretaieio Hospital Oncology Unit ( Site 1345)
Athens, Attica, 115 28, Greece
Hygeia Hospital ( Site 1346)
Marousi, Attica, 151 23, Greece
University General Hospital of Larissa ( Site 1343)
Larissa, Thessaly, 411 10, Greece
St. LUKE'S HOSPITAL S.A. ( Site 1347)
Thessaloniki, 552 36, Greece
European Interbalkan Medical Center ( Site 1341)
Thessaloniki, 57001, Greece
Queen Mary Hospital ( Site 2040)
Hksar, Hong Kong
Prince of Wales Hospital ( Site 2041)
Shatin, Hong Kong
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Onkoterápiás Klinika ( Site 1379)
Szeged, Csongrád megye, 6720, Hungary
Somogy Vármegyei Kaposi Mór Oktató Kórház-Oncology center ( Site 1371)
Kaposvár, Somogy County, 7400, Hungary
Zala Vármegyei Szent Rafael Kórház-Onkológiai osztály ( Site 1372)
Zalaegerszeg, Zala County, 8900, Hungary
Semmelweis Egyetem-Belgyógyászati és Onkológiai Klinika ( Site 1381)
Budapest, 1082, Hungary
Budapesti Uzsoki Utcai Kórház-Onkoradiológiai Osztály ( Site 1373)
Budapest, 1145, Hungary
Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 1375)
Debrecen, 4032, Hungary
Tata Memorial Hospital-Medical Oncology ( Site 2053)
Mumbai, Maharashtra, 400012, India
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute-Centre for cancer ( Site 2056)
Mumbai, Maharashtra, 400053, India
All India Institute of Medical Sciences ( Site 2051)
New Delhi, National Capital Territory of Delhi, 110029, India
Rajiv Gandhi Cancer Institute And Research Centre-Department of Clinical Research ( Site 2052)
New Delhi, National Capital Territory of Delhi, 110085, India
Bon Secours Cork Hospital ( Site 1422)
Cork, T12 DV56, Ireland
St. Vincent's University Hospital-Medical Oncology Research Department ( Site 1420)
Dublin, D04 T6F4, Ireland
Mater Misericordiae University Hospital-Clinical Trials Research Unit ( Site 1423)
Dublin, D07 R2WY, Ireland
Rambam Health Care Campus-Oncology Division ( Site 1452)
Haifa, 3109601, Israel
Hadassah Medical Center ( Site 1451)
Jerusalem, 9112001, Israel
Rabin Medical Center ( Site 1453)
Petah Tikva, 4941492, Israel
Sheba Medical Center ( Site 1450)
Ramat Gan, 5265601, Israel
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1480)
Meldola, Forli-Cesena, 47014, Italy
CRO-IRCCS ( Site 1478)
Aviano, Friuli Venezia Giulia, 33081, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1472)
Milan, Lombardy, 20133, Italy
Istituto Europeo di Oncologia IRCCS-Divisione di Senologia Medica ( Site 1475)
Milan, Lombardy, 20141, Italy
Istituto Clinico Humanitas ( Site 1476)
Rozzano, Milano, 20089, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1474)
Bologna, 40138, Italy
Ospedale San Martino ( Site 1479)
Genova, 16132, Italy
Ospedale San Raffaele-Oncologia Medica ( Site 1471)
Milan, 20132, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1477)
Roma, 00168, Italy
Nagoya City University Hospital ( Site 2474)
Nagoya, Aichi-ken, 467-8602, Japan
National Cancer Center Hospital East ( Site 2463)
Kashiwa, Chiba, 277-8577, Japan
Hokkaido University Hospital ( Site 2460)
Sapporo, Hokkaido, 060-8648, Japan
Tokai University Hospital ( Site 2473)
Isehara, Kanagawa, 259-1193, Japan
St. Marianna University Hospital ( Site 2465)
Kawasaki, Kanagawa, 216-8511, Japan
Kitasato University Hospital ( Site 2471)
Sagamihara, Kanagawa, 252-0375, Japan
Kanagawa Cancer Center ( Site 2472)
Yokohama, Kanagawa, 241-8515, Japan
Mie University Hospital ( Site 2483)
Tsu, Mie-ken, 514-8507, Japan
Tohoku University Hospital ( Site 2482)
Sendai, Miyagi, 980-8574, Japan
The University of Osaka Hospital ( Site 2476)
Suita, Osaka, 565-0871, Japan
Saitama Medical University International Medical Center ( Site 2462)
Hidaka, Saitama, 350-1298, Japan
Juntendo University Hospital ( Site 2468)
Bunkyo, Tokyo, 113-8431, Japan
Cancer Institute Hospital of JFCR ( Site 2464)
Koto, Tokyo, 135-8550, Japan
Showa Medical University Hospital ( Site 2466)
Shinagawa, Tokyo, 142-8666, Japan
Tokyo Medical University Hospital ( Site 2467)
Shinjuku, Tokyo, 160-0023, Japan
National Center for Global Health and Medicine ( Site 2469)
Shinjuku, Tokyo, 162-8655, Japan
Fukushima Medical University Hospital ( Site 2461)
Fukushima, 960-1295, Japan
Gifu University Hospital ( Site 2486)
Gifu, 501-1194, Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 2478)
Hiroshima, 730-8518, Japan
Social medical corporation Hakuaikai Sagara Hospital ( Site 2481)
Kagoshima, 892-0833, Japan
Kumamoto University Hospital ( Site 2480)
Kumamoto, 860-8556, Japan
Kyoto University Hospital ( Site 2475)
Kyoto, 606-8507, Japan
Okayama University Hospital ( Site 2485)
Okayama, 700-8558, Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 2477)
Osaka, 541-8567, Japan
Hospital Sultan Ismail ( Site 2153)
Johor Bahru, Johor, 81100, Malaysia
Sarawak General Hospital ( Site 2154)
Kuching, Sarawak, 93586, Malaysia
Pantai Hospital Kuala Lumpur ( Site 2151)
Kuala Lumpur, 59100, Malaysia
CIO - Centro de Inmuno-Oncología de Occidente ( Site 0592)
Guadalajara, Jalisco, 44630, Mexico
Grupo Médico ASSET-Clinical Research ( Site 0596)
Mexico City, Mexico City, 03100, Mexico
Health Pharma Professional Research S.A. de C.V: ( Site 0598)
Mexico City, Mexico City, 03100, Mexico
INCAN-TUMORES MAMARIOS ( Site 0597)
Mexico City, Mexico City, 14080, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Servicio de Oncología ( Site 0590)
Monterrey, Nuevo León, 64460, Mexico
CENTRO MEDICO ZAMBRANO HELLION-Centro de Cáncer de Mama ( Site 0595)
San Pedro Garza García, Nuevo León, 66278, Mexico
Ziekenhuis Rijnstate-Rijnstate Centrum Oncologisch Onderzoek ( Site 1524)
Arnhem, Gelderland, 6815 AD, Netherlands
Maastricht UMC+-Medical Oncology ( Site 1522)
Maastricht, Limburg, 6229 HX, Netherlands
Amphia Ziekenhuis, locatie Breda Molengracht-oncologie ( Site 1523)
Breda, North Brabant, 4800 RK, Netherlands
Catharina Ziekenhuis ( Site 1526)
Eindhoven, North Brabant, 5623 EJ, Netherlands
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 1520)
Amsterdam, North Holland, 1066 CX, Netherlands
Isala, locatie Zwolle ( Site 1525)
Zwolle, Overijssel, 8025 AB, Netherlands
Meander Medisch Centrum ( Site 1521)
Amersfoort, Utrecht, 3813 TZ, Netherlands
Auckland City Hospital ( Site 2031)
Auckland, 1023, New Zealand
Clinica Vallesur - AUNA ( Site 0652)
Arequipa, Ariqipa, 15036, Peru
Hospital Militar Central Luis Arias Schereiber ( Site 0651)
Jesús María, Lima, 18, Peru
Oncosalud ( Site 0650)
Lima, Muni Metro de Lima, 15036, Peru
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0653)
Lima, 15036, Peru
Metro Davao Medical and Research Center ( Site 2202)
Davao City, Davao Del Sur, 8000, Philippines
ST. LUKE'S MEDICAL CENTER-Medicine ( Site 2200)
Quezon City, National Capital Region, 1102, Philippines
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1582)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1584)
Siedlce, Masovian Voivodeship, 08-110, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Piersi i Chirurgii ( Site 1580)
Warsaw, Masovian Voivodeship, 02-781, Poland
Mazowiecki Szpital Onkologiczny ( Site 1581)
Wieliszew, Masovian Voivodeship, 05-135, Poland
Mrukmed-Mrukmed ( Site 1592)
Rzeszów, Podkarpackie Voivodeship, 35-021, Poland
Bialostockie Centrum Onkologii ( Site 1585)
Bialystok, Podlaskie Voivodeship, 15-027, Poland
Szpitale Pomorskie Sp. z o. o.-Oddział Onkologii Klinicznej ( Site 1593)
Gdynia, Pomeranian Voivodeship, 81-519, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach-Centrum Diagnostyki i Leczenia Chorob Piersi ( Site 1590)
Gliwice, Silesian Voivodeship, 44-102, Poland
Szpital Wojewódzki w Koszalinie. ( Site 1583)
Poland, West Pomeranian Voivodeship, 75-581, Poland
Zachodniopomorskie Centrum Onkologii ( Site 1588)
Szczecin, West Pomeranian Voivodeship, 71-730, Poland
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch ( Site 1595)
Kielce, Świętokrzyskie Voivodeship, 25-734, Poland
Unidade Local de Saude Amadora/Sintra - Hospital Prof Dr Fernando Fonseca ( Site 1663)
Lisbon, Lisbon District, 2720-276, Portugal
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 1661)
Lisbon, 1649-035, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 1662)
Porto, 4200-072, Portugal
Puerto Rico Medical Research Center LLC ( Site 0675)
Hato Rey, 00917, Puerto Rico
UPR Comprehensive Cancer Center-Comprehensive Cancer Center Hospital ( Site 0677)
San Juan, 00935, Puerto Rico
Spitalul Clinic Filantropia ( Site 1703)
Bucharest, Bucharest, 011171, Romania
SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 1702)
Florești, Cluj, 407280, Romania
Centrul Medical Neolife- Baneasa ( Site 1704)
Bucharest, 077190, Romania
Institutul Oncologic Cluj ( Site 1701)
Cluj-Napoca, 400015, Romania
National University Hospital ( Site 2250)
Singapore, Central Singapore, 119074, Singapore
Mount Alvernia ICON Cancer Center ( Site 2251)
Singapore, North East, 574623, Singapore
CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2905)
Port Elizabeth, Eastern Cape, 6055, South Africa
Wits Clinical Research ( Site 2903)
Johannesburg, Gauteng, 2196, South Africa
Curo Oncology ( Site 2908)
Pretoria, Gauteng, 0084, South Africa
Sandton Oncology Medical Group (Pty) Ltd ( Site 2911)
Sandton, Gauteng, 2196, South Africa
Cancercare Rondebosch Oncology-Clinical trials ( Site 2904)
Cape Town, Western Cape, 7700, South Africa
Seoul National University Hospital-Internal Medicine ( Site 2353)
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 2350)
Seoul, 03722, South Korea
Asan Medical Center-Department of Oncology ( Site 2352)
Seoul, 05505, South Korea
Samsung Medical Center-Division of Hematology/Oncology ( Site 2351)
Seoul, 06351, South Korea
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1758)
Pozuelo de Alarcón, Madrid, 28223, Spain
HOSPITAL CLINICO DE VALENCIA-Oncology ( Site 1752)
Valencia, Valenciana, Comunitat, 46010, Spain
Hospital Universitari Vall d'Hebron-Oncology ( Site 1750)
Barcelona, 08035, Spain
Hospital Universitario Reina Sofia-Oncologia Medica ( Site 1754)
Córdoba, 14004, Spain
Hospital Beata María Ana-oncology ( Site 1755)
Madrid, 28007, Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 1756)
Madrid, 28009, Spain
Hospital Universitario Virgen Macarena ( Site 1757)
Seville, 41009, Spain
Karolinska Universitetssjukhuset Solna ( Site 1801)
Stockholm, Stockholm County, 171 76, Sweden
Akademiska sjukhuset ( Site 1802)
Uppsala, Uppsala County, 75185, Sweden
Södra Älvsborgs Sjukhus Borås ( Site 1803)
Borås, Västra Götaland County, 501 82, Sweden
University Hospital Basel-Gynecology & Gynecologic Oncology ( Site 1844)
Basel, Canton of Basel-City, 4031, Switzerland
Spital Thun ( Site 1840)
Thun, Canton of Bern, 3600, Switzerland
Brust-Zentrum ( Site 1841)
Zurich, Canton of Zurich, 8008, Switzerland
Changhua Christian Hospital ( Site 2410)
Changhua, 50006, Taiwan
Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 2413)
Kaohsiung City, 83301, Taiwan
National Cheng Kung University Hospital-Surgery ( Site 2411)
Tainan, 704, Taiwan
National Taiwan University Hospital-Oncology ( Site 2415)
Taipei, 10002, Taiwan
Mackay Memorial Hospital ( Site 2412)
Taipei, 10449, Taiwan
Chang Gung Medical Foundation-Linkou Branch-General Surgery ( Site 2414)
Taoyuan, 333, Taiwan
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi ( Site 1878)
Yenimahalle, Ankara, 06200, Turkey (Türkiye)
Medipol Mega Universite Hastanesi-oncology ( Site 1875)
Stanbul, Istanbul, 34214, Turkey (Türkiye)
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 1876)
Adana, 01140, Turkey (Türkiye)
Hacettepe Universite Hastaneleri-oncology hospital ( Site 1870)
Ankara, 06230, Turkey (Türkiye)
Memorial Ankara Hastanesi-Medical Oncology ( Site 1874)
Ankara, 06520, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1871)
Ankara, 06800, Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1872)
Istanbul, 34722, Turkey (Türkiye)
Samsun Medical Park Hastanesi-medical oncology ( Site 1873)
Samsun, 55200, Turkey (Türkiye)
North West Cancer Centre ( Site 1944)
Londonderry, Derry and Strabane, BT47 6SB, United Kingdom
The Royal Cornwall Hospital ( Site 1943)
Truro, England, TR1 3LJ, United Kingdom
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1940)
London, London, City of, EC1A 7BE, United Kingdom
University College London Hospital-Cancer Clinical Trials Unit ( Site 1942)
London, London, City of, NW1 2PG, United Kingdom
Blackpool Victoria Hospital ( Site 1941)
Blackpool, FY3 8NR, United Kingdom
City Hospital, Nottingham University Hospitals NHS Trust ( Site 1945)
Nottingham, NG5 1PB, 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
March 7, 2024
First Posted
March 15, 2024
Study Start
April 14, 2024
Primary Completion (Estimated)
July 11, 2027
Study Completion (Estimated)
April 12, 2031
Last Updated
June 8, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf