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
Status: Recruiting
Location: See all (249) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
Ironwood Cancer & Research Centers ( Site 0066)
RECRUITING
Chandler
Banner MD Anderson Cancer Center-Oncology ( Site 0004)
RECRUITING
Gilbert
California
Providence Medical Foundation-Oncology ( Site 0020)
RECRUITING
Fullerton
Moores Cancer Center ( Site 0059)
RECRUITING
La Jolla
Cancer and Blood Specialty Clinic ( Site 0001)
RECRUITING
Los Alamitos
Colorado
University of Colorado Anschutz Medical Campus ( Site 0061)
RECRUITING
Aurora
UCHealth Cherry Creek Medical Center ( Site 0094)
RECRUITING
Denver
University of Colorado Health - Highlands Ranch Hospital ( Site 0095)
RECRUITING
Highlands Ranch
Connecticut
Yale Cancer Center ( Site 0060)
RECRUITING
New Haven
Stamford Hospital ( Site 0049)
RECRUITING
Stamford
Florida
AdventHealth Altamonte Springs ( Site 0021)
RECRUITING
Altamonte Springs
University of Florida College of Medicine ( Site 0063)
RECRUITING
Gainesville
Orlando Health Cancer Institute ( Site 0011)
RECRUITING
Orlando
Georgia
Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0032)
RECRUITING
Thomasville
Illinois
University of Chicago Medical Center ( Site 0067)
RECRUITING
Chicago
Kentucky
Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0053)
RECRUITING
Edgewood
Louisiana
Mary Bird Perkins Cancer Center-Breast & GYN Pavilion ( Site 0042)
RECRUITING
Baton Rouge
Massachusetts
Dana-Farber Cancer Institute-Breast Oncology Center ( Site 0037)
RECRUITING
Boston
Maryland
Greenebaum Comprehensive Cancer Center ( Site 0036)
RECRUITING
Baltimore
Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0028)
RECRUITING
Baltimore
Holy Cross Hospital ( Site 0073)
RECRUITING
Silver Spring
Michigan
Henry Ford Health ( Site 0002)
RECRUITING
Detroit
Missouri
Saint Luke's Cancer Institute ( Site 0027)
RECRUITING
Kansas City
Washington University School of Medicine ( Site 0076)
RECRUITING
St Louis
North Carolina
Levine Cancer Institute ( Site 0014)
RECRUITING
Charlotte
New York
NYU Langone Health - Brooklyn ( Site 0089)
RECRUITING
Brooklyn
NYU Langone Hospital - Long Island ( Site 0090)
RECRUITING
Mineola
Laura and Isaac Perlmutter Cancer Center-Hematology and Oncology ( Site 0068)
RECRUITING
New York
Hematology Oncology Associates of Rockland ( Site 0054)
RECRUITING
Nyack
Stony Brook University-Cancer Center ( Site 0034)
RECRUITING
Stony Brook
Ohio
Zangmeister Cancer Center ( Site 7000)
RECRUITING
Columbus
Oregon
Providence Portland Medical Center ( Site 0044)
RECRUITING
Portland
Providence St. Vincent Medical Center ( Site 0081)
RECRUITING
Portland
Pennsylvania
Thomas Jefferson University - Clinical Research Institute ( Site 0056)
RECRUITING
Philadelphia
Texas
Texas Oncology-Dallas Presbyterian Hospital ( Site 8000)
RECRUITING
Dallas
UT Southwestern Medical Center ( Site 0050)
RECRUITING
Dallas
The Center for Cancer and Blood Disorders ( Site 0041)
RECRUITING
Fort Worth
Texas Oncology - San Antonio ( Site 8002)
RECRUITING
San Antonio
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0057)
RECRUITING
Tyler
Virginia
Inova Schar Cancer Institute ( Site 0025)
RECRUITING
Fairfax
Bon Secours St. Francis Medical Center-Oncology Research ( Site 0015)
RECRUITING
Midlothian
VCU Health Adult Outpatient Pavillion ( Site 0070)
RECRUITING
Richmond
Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 8001)
RECRUITING
Roanoke
Wisconsin
University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0040)
RECRUITING
Madison
Other Locations
Argentina
Centro de Educación Médica e Investigaciones clínicas Dr. Norberto Quirno (CEMIC) ( Site 0383)
RECRUITING
Buenos Aires
Hospital Aleman-Oncology ( Site 0386)
RECRUITING
Buenos Aires
Instituto Alexander Fleming-Alexander Fleming ( Site 0382)
RECRUITING
Buenos Aires
Hospital Italiano de Córdoba ( Site 0385)
RECRUITING
Córdoba
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0387)
RECRUITING
La Rioja
Fundacion Estudios Clinicos-Oncology ( Site 0384)
RECRUITING
Rosario
Australia
Frankston Hospital-Oncology and Haematology ( Site 2003)
COMPLETED
Frankston
Macquarie University-MQ Health Clinical Trials Unit ( Site 2002)
RECRUITING
Macquarie University
Fiona Stanley Hospital-Medical Oncology ( Site 2004)
RECRUITING
Murdoch
Westmead Hospital ( Site 2000)
RECRUITING
Westmead
Belgium
Institut Jules Bordet-Medicine Oncology ( Site 1104)
RECRUITING
Anderlecht
Cliniques universitaires Saint-Luc-Medical Oncology ( Site 1103)
RECRUITING
Brussels
AZ Maria Middelares-IKG ( Site 1106)
RECRUITING
Ghent
Jessa Ziekenhuis-Limburgs Oncologisch Centrum ( Site 1105)
RECRUITING
Hasselt
Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 1107)
RECRUITING
Namur
Brazil
Hospital do Câncer Mãe de Deus ( Site 0404)
RECRUITING
Porto Alegre
Hospital Moinhos de Vento ( Site 0403)
RECRUITING
Porto Alegre
Instituto de Oncologia Saint Gallen ( Site 0412)
RECRUITING
Santa Cruz Do Sul
IBCC - Núcleo de Pesquisa e Ensino ( Site 0401)
RECRUITING
São Paulo
Instituto do Câncer Brasil - Unidade Taubaté ( Site 0408)
RECRUITING
Taubaté
Oncoclínica Oncologistas Associados-Clinical Research ( Site 0407)
RECRUITING
Teresina
Canada
CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0301)
RECRUITING
Montreal
Jewish General Hospital ( Site 0303)
RECRUITING
Montreal
Southlake Regional Health Centre ( Site 0311)
RECRUITING
Newmarket
CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0302)
RECRUITING
Québec
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0308)
RECRUITING
Rimouski
BC Cancer Surrey ( Site 0315)
RECRUITING
Surrey
Princess Margaret Cancer Centre ( Site 0310)
RECRUITING
Toronto
Chile
Bradford Hill Norte ( Site 0456)
RECRUITING
Antofagasta
Bradfordhill ( Site 0452)
RECRUITING
Santiago
Clínica RedSalud Vitacura ( Site 0455)
RECRUITING
Santiago
FALP-UIDO ( Site 0451)
RECRUITING
Santiago
Oncovida ( Site 0453)
RECRUITING
Santiago
Pontificia Universidad Catolica de Chile ( Site 0454)
RECRUITING
Santiago
Colombia
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0507)
RECRUITING
Bogotá
Fundacion Colombiana de Cancerología Clinica Vida ( Site 0506)
RECRUITING
Medellín
IMAT S.A.S ( Site 0502)
RECRUITING
Montería
Fundación Valle del Lili ( Site 0508)
RECRUITING
Santiago De Cali
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0501)
RECRUITING
Valledupar
Costa Rica
CIMCA ( Site 0551)
RECRUITING
San José
ICIMED ( Site 0552)
RECRUITING
San José
Hospital Metropolitano - Sede Lindora ( Site 0550)
COMPLETED
Santa Ana
Denmark
Rigshospitalet ( Site 1180)
RECRUITING
Copenhagen
Nordsjællands Hospital - Hillerød ( Site 1184)
RECRUITING
Hillerød
Næstved Sygehus ( Site 1182)
RECRUITING
Næstved
Odense Universitetshospital ( Site 1181)
RECRUITING
Odense C
Vejle Sygehus ( Site 1183)
RECRUITING
Vejle
France
Centre François Baclesse ( Site 1250)
RECRUITING
Caen
Hopital Prive Jean Mermoz-Oncology ( Site 1246)
RECRUITING
Lyon
Centre de Cancérologie du Grand Montpellier ( Site 1244)
RECRUITING
Montpellier
Hôpital privé du Confluent SAS-Service d'oncologie médicale ( Site 1242)
RECRUITING
Nantes
Institut Curie-Oncology medical Department ( Site 1240)
RECRUITING
Paris
Pitie Salpetriere University Hospital ( Site 1249)
RECRUITING
Paris
Centre Hospitalier Universitaire de Poitiers-Pôle régional de cancérologie ( Site 1243)
RECRUITING
Poitiers
Germany
Helios Klinikum Berlin-Buch-Klinik für Gynäkologie und Geburtshilfe ( Site 1314)
RECRUITING
Berlin
Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1311)
RECRUITING
Düsseldorf
Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1301)
RECRUITING
Erlangen
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinik für Senologie/ Brustzentrum ( Site 1300)
RECRUITING
Essen
SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1315)
RECRUITING
Gera
CaritasKlinikum Saarbrücken St. Theresia ( Site 1304)
RECRUITING
Saarbrücken
Greece
Aretaieio Hospital Oncology Unit ( Site 1345)
RECRUITING
Athens
Errikos Dunant Hospital Center ( Site 1348)
RECRUITING
Athens
University General Hospital of Larissa ( Site 1343)
RECRUITING
Larissa
Hygeia Hospital ( Site 1346)
RECRUITING
Marousi
Agios Loukas Clinic ( Site 1347)
RECRUITING
Thessaloniki
European Interbalkan Medical Center ( Site 1341)
RECRUITING
Thessaloniki
Hong Kong Special Administrative Region
Queen Mary Hospital ( Site 2040)
RECRUITING
Hksar
Prince of Wales Hospital ( Site 2041)
RECRUITING
Shatin
Hungary
Budapesti Uzsoki Utcai Kórház-Onkoradiológiai Osztály ( Site 1373)
RECRUITING
Budapest
Semmelweis Egyetem-Belgyógyászati és Onkológiai Klinika ( Site 1381)
RECRUITING
Budapest
Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 1375)
RECRUITING
Debrecen
Somogy Vármegyei Kaposi Mór Oktató Kórház-Oncology center ( Site 1371)
RECRUITING
Kaposvár
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Onkoterápiás Klinika ( Site 1379)
RECRUITING
Szeged
Zala Vármegyei Szent Rafael Kórház-Onkológiai osztály ( Site 1372)
RECRUITING
Zalaegerszeg
India
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute-Centre for cancer ( Site 2056)
RECRUITING
Mumbai
Tata Memorial Hospital-Medical Oncology ( Site 2053)
RECRUITING
Mumbai
All India Institute of Medical Sciences ( Site 2051)
RECRUITING
New Delhi
Rajiv Gandhi Cancer Institute And Research Centre-Department of Clinical Research ( Site 2052)
RECRUITING
New Delhi
Ireland
Bon Secours Cork Hospital ( Site 1422)
RECRUITING
Cork
Mater Misericordiae University Hospital-Clinical Trials Research Unit ( Site 1423)
RECRUITING
Dublin
St. Vincent's University Hospital-Medical Oncology Research Department ( Site 1420)
RECRUITING
Dublin
Israel
Rambam Health Care Campus-Oncology Division ( Site 1452)
RECRUITING
Haifa
Hadassah Medical Center ( Site 1451)
RECRUITING
Jerusalem
Rabin Medical Center ( Site 1453)
RECRUITING
Petah Tikva
Sheba Medical Center ( Site 1450)
RECRUITING
Ramat Gan
Italy
CRO-IRCCS ( Site 1478)
RECRUITING
Aviano
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1474)
RECRUITING
Bologna
Ospedale San Martino ( Site 1479)
RECRUITING
Genova
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori ( Site 1480)
RECRUITING
Meldola
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1472)
RECRUITING
Milan
Istituto Europeo di Oncologia IRCCS-Divisione di Senologia Medica ( Site 1475)
RECRUITING
Milan
Ospedale San Raffaele-Oncologia Medica ( Site 1471)
RECRUITING
Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1477)
RECRUITING
Roma
Istituto Clinico Humanitas ( Site 1476)
RECRUITING
Rozzano
Japan
Juntendo University Hospital ( Site 2468)
RECRUITING
Bunkyo
Fukushima Medical University Hospital ( Site 2461)
RECRUITING
Fukushima
Gifu University Hospital ( Site 2486)
RECRUITING
Gifu
Saitama Medical University International Medical Center ( Site 2462)
RECRUITING
Hidaka
Hiroshima City Hiroshima Citizens Hospital ( Site 2478)
RECRUITING
Hiroshima
Tokai University Hospital ( Site 2473)
RECRUITING
Isehara
Social medical corporation Hakuaikai Sagara Hospital ( Site 2481)
RECRUITING
Kagoshima
National Cancer Center Hospital East ( Site 2463)
RECRUITING
Kashiwa
St. Marianna University Hospital ( Site 2465)
RECRUITING
Kawasaki
Cancer Institute Hospital of JFCR ( Site 2464)
RECRUITING
Koto
Kumamoto University Hospital ( Site 2480)
RECRUITING
Kumamoto
Kyoto University Hospital ( Site 2475)
RECRUITING
Kyoto
Nagoya City University Hospital ( Site 2474)
RECRUITING
Nagoya
Okayama University Hospital ( Site 2485)
RECRUITING
Okayama
Osaka International Cancer Institute ( Site 2477)
RECRUITING
Osaka
Kitasato University Hospital ( Site 2471)
RECRUITING
Sagamihara
Hokkaido University Hospital ( Site 2460)
RECRUITING
Sapporo
Tohoku University Hospital ( Site 2482)
RECRUITING
Sendai
Showa Medical University Hospital ( Site 2466)
RECRUITING
Shinagawa
National Center for Global Health and Medicine ( Site 2469)
RECRUITING
Shinjuku
Tokyo Medical University Hospital ( Site 2467)
RECRUITING
Shinjuku
The University of Osaka Hospital ( Site 2476)
RECRUITING
Suita
Mie University Hospital ( Site 2483)
RECRUITING
Tsu
Kanagawa Cancer Center ( Site 2472)
RECRUITING
Yokohama
Malaysia
Hospital Sultan Ismail ( Site 2153)
RECRUITING
Johor Bahru
Pantai Hospital Kuala Lumpur ( Site 2151)
RECRUITING
Kuala Lumpur
Sarawak General Hospital ( Site 2154)
RECRUITING
Kuching
Mexico
CIO - Centro de Inmuno-Oncología de Occidente ( Site 0592)
RECRUITING
Guadalajara
Grupo Médico ASSET-Clinical Research ( Site 0596)
RECRUITING
Mexico City
Health Pharma Professional Research S.A. de C.V: ( Site 0598)
RECRUITING
Mexico City
INCAN-TUMORES MAMARIOS ( Site 0597)
RECRUITING
Mexico City
Hospital Universitario Dr. Jose Eleuterio Gonzalez-Servicio de Oncología ( Site 0590)
RECRUITING
Monterrey
CENTRO MEDICO ZAMBRANO HELLION-Centro de Cáncer de Mama ( Site 0595)
RECRUITING
San Pedro Garza García
Netherlands
Meander Medisch Centrum ( Site 1521)
RECRUITING
Amersfoort
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 1520)
RECRUITING
Amsterdam
Ziekenhuis Rijnstate-Rijnstate Centrum Oncologisch Onderzoek ( Site 1524)
RECRUITING
Arnhem
Amphia Ziekenhuis, locatie Breda Molengracht-oncologie ( Site 1523)
RECRUITING
Breda
Catharina Ziekenhuis ( Site 1526)
RECRUITING
Eindhoven
Maastricht UMC+-Medical Oncology ( Site 1522)
RECRUITING
Maastricht
Isala, locatie Zwolle ( Site 1525)
RECRUITING
Zwolle
New Zealand
Auckland City Hospital ( Site 2031)
RECRUITING
Auckland
Peru
Clinica Vallesur - AUNA ( Site 0652)
RECRUITING
Arequipa
Hospital Militar Central Luis Arias Schereiber ( Site 0651)
RECRUITING
Jesús María
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0653)
RECRUITING
Lima
Oncosalud ( Site 0650)
RECRUITING
Lima
Philippines
Metro Davao Medical and Research Center ( Site 2202)
RECRUITING
Davao City
ST. LUKE'S MEDICAL CENTER-Medicine ( Site 2200)
RECRUITING
Quezon City
Poland
Bialostockie Centrum Onkologii ( Site 1585)
RECRUITING
Bialystok
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1582)
RECRUITING
Bydgoszcz
Szpitale Pomorskie Sp. z o. o.-Oddział Onkologii Klinicznej ( Site 1593)
RECRUITING
Gdynia
Narodowy Instytut Onkologii - Oddzial w Gliwicach-Centrum Diagnostyki i Leczenia Chorob Piersi ( Site 1590)
RECRUITING
Gliwice
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch ( Site 1595)
RECRUITING
Kielce
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1583)
RECRUITING
Koszalin
Mrukmed-Mrukmed ( Site 1592)
RECRUITING
Rzeszów
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1584)
RECRUITING
Siedlce
Zachodniopomorskie Centrum Onkologii ( Site 1588)
RECRUITING
Szczecin
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Piersi i Chirurgii ( Site 1580)
RECRUITING
Warsaw
Mazowiecki Szpital Onkologiczny ( Site 1581)
RECRUITING
Wieliszew
Portugal
Unidade Local de Saude Amadora/Sintra - Hospital Prof Dr Fernando Fonseca ( Site 1663)
RECRUITING
Lisbon
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 1661)
RECRUITING
Lisbon
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 1662)
RECRUITING
Porto
Puerto Rico
Puerto Rico Medical Research Center LLC ( Site 0675)
COMPLETED
Hato Rey
UPR Comprehensive Cancer Center-Comprehensive Cancer Center Hospital ( Site 0677)
RECRUITING
San Juan
Republic of Korea
Asan Medical Center-Department of Oncology ( Site 2352)
RECRUITING
Seoul
Samsung Medical Center-Division of Hematology/Oncology ( Site 2351)
RECRUITING
Seoul
Seoul National University Hospital-Internal Medicine ( Site 2353)
ACTIVE_NOT_RECRUITING
Seoul
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 2350)
RECRUITING
Seoul
Romania
Centrul Medical Neolife- Baneasa ( Site 1704)
RECRUITING
Bucharest
Spitalul Clinic Filantropia ( Site 1703)
RECRUITING
Bucharest
Institutul Oncologic Cluj ( Site 1701)
RECRUITING
Cluj-napoca
SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 1702)
RECRUITING
Florești
Singapore
Mount Alvernia ICON Cancer Center ( Site 2251)
RECRUITING
Singapore
National University Hospital ( Site 2250)
RECRUITING
Singapore
South Africa
Wits Clinical Research ( Site 2903)
RECRUITING
Johannesburg
CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2905)
RECRUITING
Port Elizabeth
Curo Oncology ( Site 2908)
RECRUITING
Pretoria
Cancercare Rondebosch Oncology-Clinical trials ( Site 2904)
RECRUITING
Rondebosch
Sandton Oncology Medical Group (Pty) Ltd ( Site 2911)
RECRUITING
Sandton
Spain
Hospital Universitari Vall d'Hebron-Oncology ( Site 1750)
RECRUITING
Barcelona
Hospital Universitario Reina Sofia-Oncologia Medica ( Site 1754)
RECRUITING
Córdoba
Hospital Beata María Ana-oncology ( Site 1755)
RECRUITING
Madrid
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 1756)
RECRUITING
Madrid
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1758)
RECRUITING
Pozuelo De Alarcón
Hospital Universitario Virgen Macarena ( Site 1757)
RECRUITING
Seville
HOSPITAL CLINICO DE VALENCIA-Oncology ( Site 1752)
RECRUITING
Valencia
Sweden
Södra Älvsborgs Sjukhus Borås ( Site 1803)
RECRUITING
Borås
Karolinska Universitetssjukhuset Solna ( Site 1801)
RECRUITING
Stockholm
Akademiska sjukhuset ( Site 1802)
RECRUITING
Uppsala
Switzerland
University Hospital Basel-Gynecology & Gynecologic Oncology ( Site 1844)
RECRUITING
Basel
Spital Thun ( Site 1840)
RECRUITING
Thun
Brust-Zentrum ( Site 1841)
RECRUITING
Zurich
Taiwan
Changhua Christian Hospital ( Site 2410)
COMPLETED
Changhua
Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 2413)
RECRUITING
Kaohsiung City
National Cheng Kung University Hospital-Surgery ( Site 2411)
RECRUITING
Tainan City
Mackay Memorial Hospital ( Site 2412)
RECRUITING
Taipei
National Taiwan University Hospital-Oncology ( Site 2415)
RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch-General Surgery ( Site 2414)
RECRUITING
Taoyuan District
Turkey
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 1876)
RECRUITING
Adana
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1871)
RECRUITING
Ankara
Hacettepe Universite Hastaneleri-oncology hospital ( Site 1870)
RECRUITING
Ankara
Memorial Ankara Hastanesi-Medical Oncology ( Site 1874)
RECRUITING
Ankara
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1872)
RECRUITING
Istanbul
Samsun Medical Park Hastanesi-medical oncology ( Site 1873)
RECRUITING
Samsun
Medipol Mega Universite Hastanesi-oncology ( Site 1875)
RECRUITING
Stanbul
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi ( Site 1878)
RECRUITING
Yenimahalle
United Kingdom
Blackpool Victoria Hospital ( Site 1941)
RECRUITING
Blackpool
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1940)
RECRUITING
London
University College London Hospital-Cancer Clinical Trials Unit ( Site 1942)
RECRUITING
London
North West Cancer Centre ( Site 1944)
RECRUITING
Londonderry
City Hospital, Nottingham University Hospitals NHS Trust ( Site 1945)
RECRUITING
Nottingham
The Royal Cornwall Hospital ( Site 1943)
RECRUITING
Truro
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2024-04-14
Estimated Completion Date: 2031-04-12
Participants
Target number of participants: 1200
Treatments
Experimental: Arm A: Sacituzumab tirumotecan
Participants receive 4 mg/kg of sacituzumab tirumotecan once every 2 weeks (Q2W) via intravenous (IV) infusion until progressive disease or discontinuation.
Experimental: Arm B:Pembrolizumab + Sacituzumab tirumotecan
Participants 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).
Active_comparator: Arm C: Treatment of Physician's Choice (TPC)
At 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.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC