A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011)

May 27, 2026 updated by: Merck Sharp & Dohme LLC

A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as a Monotherapy and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less Than 10 (TroFuse-011)

Researchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC). The main goal of this study is to learn if people treated with sacituzumab tirumotecan alone or with pembrolizumab live longer overall or without the cancer growing or spreading compared to people treated with chemotherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Mendoza, Argentina, M5500AYB
        • Recruiting
        • Fundacion Centro Oncologico de Integración Regional ( Site 2400)
        • Contact:
          • Study Coordinator
          • Phone Number: +54 9261 367 9497
    • Buenos Aires
      • Mar del Plata, Buenos Aires, Argentina, B7600FZN
        • Recruiting
        • Instituto de Investigaciones Clinicas Mar del Plata ( Site 2401)
        • Contact:
          • Study Coordinator
          • Phone Number: +54 9223 593 7663
      • Mar del Plata, Buenos Aires, Argentina, C1426ANZ
        • Recruiting
        • Instituto Alexander Fleming ( Site 2402)
        • Contact:
          • Study Coordinator
          • Phone Number: +541132218900
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, X5004BAL
        • Recruiting
        • Hospital Italiano de Cordoba ( Site 2406)
        • Contact:
          • Study Coordinator
          • Phone Number: +543514106550
    • Río Negro Province
      • Viedma, Río Negro Province, Argentina, R8500ACE
        • Recruiting
        • Clinica Viedma ( Site 2403)
        • Contact:
          • Study Coordinator
          • Phone Number: 54 9351 592 3598
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000DEJ
        • Recruiting
        • Fundacion Estudios Clinicos ( Site 2405)
        • Contact:
          • Study Coordinator
          • Phone Number: +54 9346 69 9922
      • Rosario, Santa Fe Province, Argentina, S2002KDR
        • Recruiting
        • Hospital Provincial del Centenario ( Site 2410)
        • Contact:
          • Study Coordinator
          • Phone Number: +543414307185
  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Recruiting
        • Blacktown Hospital ( Site 5500)
        • Contact:
          • Study Coordinator
          • Phone Number: +61298818000
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Recruiting
        • Peninsula Health Frankston Hospital ( Site 5501)
        • Contact:
          • Study Coordinator
          • Phone Number: +61397848520
  • Belgium
    • Flanders
      • Antwerp, Flanders, Belgium, 2610
        • Recruiting
        • ZAS Sint Augustinus ( Site 3102)
        • Contact:
          • Study Coordinator
          • Phone Number: 003234433759
    • Limburg
      • Genk, Limburg, Belgium, 3600
        • Recruiting
        • Ziekenhuis Oost Limburg ( Site 3105)
        • Contact:
          • Study Coordinator
          • Phone Number: 089 32 50 50
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • AZ Maria Middelares ( Site 3103)
        • Contact:
          • Study Coordinator
          • Phone Number: +32 9 246 95 16
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • UZ Gent ( Site 3101)
        • Contact:
          • Study Coordinator
          • Phone Number: 09 332 20 15
  • Brazil
      • São Paulo, Brazil, 04014-002
        • Recruiting
        • IBCC - Núcleo de Pesquisa e Ensino ( Site 2306)
        • Contact:
          • Study Coordinator
          • Phone Number: +55 11 98468-0001
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50040-000
        • Recruiting
        • Hospital de Câncer de Recife ( Site 2300)
        • Contact:
          • Study Coordinator
          • Phone Number: +558132178084
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59062-000
        • Recruiting
        • Liga Norte Riograndense Contra o Cancer ( Site 2310)
        • Contact:
          • Study Coordinator
          • Phone Number: +55 84 99817-0070
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
        • Recruiting
        • Hospital Nossa Senhora da Conceição ( Site 2302)
        • Contact:
          • Study Coordinator
          • Phone Number: +55 51 35160954
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • Recruiting
        • Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 2307)
        • Contact:
          • Study Coordinator
          • Phone Number: +55 17 3321-6637
      • São Jose Do Rio Preto, São Paulo, Brazil, 15090-000
        • Recruiting
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 2301)
        • Contact:
          • Study Coordinator
          • Phone Number: +55 (17) 3201-5054
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Recruiting
        • Cross Cancer Institute ( Site 0216)
        • Contact:
          • Study Coordinator
          • Phone Number: 7804328644
    • Ontario
      • Oshawa, Ontario, Canada, L1G 2B9
        • Recruiting
        • Lakeridge Health ( Site 0217)
        • Contact:
          • Study Coordinator
          • Phone Number: 905-576-8711
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre ( Site 0202)
        • Contact:
          • Study Coordinator
          • Phone Number: 416-946-2000
      • Toronto, Ontario, Canada, M2K 1E1
        • Recruiting
        • North York General Hospital ( Site 0209)
        • Contact:
          • Study Coordinator
          • Phone Number: 416-756-6000
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Recruiting
        • CIUSSS- saguenay-Lac-Saint-Jean ( Site 0213)
        • Contact:
          • Study Coordinator
          • Phone Number: 418-541-1000
      • Montreal, Quebec, Canada, H3T 1M5
        • Recruiting
        • St. Marys Hospital Center ( Site 0201)
        • Contact:
          • Study Coordinator
          • Phone Number: 514-891-6904
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital ( Site 0203)
        • Contact:
          • Study Coordinator
          • Phone Number: 514-340-8222
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre ( Site 0204)
        • Contact:
          • Study Coordinator
          • Phone Number: 514-299-6425
      • Montreal, Quebec, Canada, H2X 3E4
        • Recruiting
        • Centre Hospitalier de l'Université de Montréal ( Site 0208)
        • Contact:
          • Study Coordinator
          • Phone Number: 514-890-8444
      • Québec, Quebec, Canada, G1S 4L8
        • Recruiting
        • Hopital Du Saint-Sacrement ( Site 0210)
        • Contact:
          • Study Coordinator
          • Phone Number: 4186827511
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Recruiting
        • Saskatoon Cancer Centre ( Site 0215)
        • Contact:
          • Study Coordinator
          • Phone Number: 306-655-2662
  • Chile
    • Biobio
      • Concepción, Biobio, Chile, 4070196
        • Recruiting
        • Biocenter ( Site 2009)
        • Contact:
          • Study Coordinator
          • Phone Number: +56412858421
    • Coquimbo Region
      • La Serena, Coquimbo Region, Chile, 1720430
        • Recruiting
        • IC La Serena Research ( Site 2007)
        • Contact:
          • Study Coordinator
          • Phone Number: +56512386127
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7500921
        • Recruiting
        • FALP ( Site 2000)
        • Contact:
          • Study Coordinator
          • Phone Number: +56 9 6397 7440
      • Santiago, Region M. de Santiago, Chile, 7620002
        • Recruiting
        • Clínica UC San Carlos de Apoquindo ( Site 2008)
        • Contact:
          • Study Coordinator
          • Phone Number: +569 5504 3334
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Recruiting
        • Bradfordhill ( Site 2001)
        • Contact:
          • Study Coordinator
          • Phone Number: +56978878489
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2520598
        • Recruiting
        • ONCOCENTRO APYS ( Site 2005)
        • Contact:
          • Study Coordinator
          • Phone Number: +56 9 92369820
  • China
    • Anhui
      • Bengbu, Anhui, China, 233004
        • Recruiting
        • The First Afflilated Hospital of Bengbu Medical College ( Site 5022)
        • Contact:
          • Study Coordinator
          • Phone Number: 0552-3085746
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400016
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University ( Site 5039)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 023 89011606
      • Chongqing, Chongqing Municipality, China, 404000
        • Recruiting
        • Chongqing University Three Gorges Hospital ( Site 5020)
        • Contact:
          • Study Coordinator
          • Phone Number: 023-58103215
    • Fujian
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • The First Affiliated hospital of Xiamen University ( Site 5035)
        • Contact:
          • Study Coordinator
          • Phone Number: 0592-2137232
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-Sen University Cancer Center ( Site 5014)
        • Contact:
          • Study Coordinator
          • Phone Number: 020-87343990
    • Guangxi
      • Nanning, Guangxi, China, 530201
        • Recruiting
        • Guangxi Medical University Affiliated Tumor Hospital. ( Site 5008)
        • Contact:
          • Study Coordinator
          • Phone Number: +860771-5778582
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Henan Cancer Hospital ( Site 5001)
        • Contact:
          • Study Coordinator
          • Phone Number: 0371-65588404
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital Tongji Medical Science & Technology ( Site 5007)
        • Contact:
          • Study Coordinator
          • Phone Number: 027-83663940
      • Xiangyang, Hubei, China, 441021
        • Recruiting
        • Xiangyang Central Hospital ( Site 5017)
        • Contact:
          • Study Coordinator
          • Phone Number: 0710-2811523
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital ( Site 5002)
        • Contact:
          • Study Coordinator
          • Phone Number: 0731-88651669
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Jiangsu Province Hospital ( Site 5009)
        • Contact:
          • Study Coordinator
          • Phone Number: 02568308145
      • Xuzhou, Jiangsu, China, 221009
        • Recruiting
        • Xuzhou Central Hospital ( Site 5036)
        • Contact:
          • Study Coordinator
          • Phone Number: 051680812397
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University ( Site 5003)
        • Contact:
          • Study Coordinator
          • Phone Number: 0431-88783330
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi an Jiaotong University ( Site 5005)
        • Contact:
          • Study Coordinator
          • Phone Number: +8602985324094
    • Shandong
      • Jinan, Shandong, China, 250013
        • Recruiting
        • Jinan Central Hospital ( Site 5031)
        • Contact:
          • Study Coordinator
          • Phone Number: 053155865197
      • Linyi, Shandong, China, 276000
        • Recruiting
        • LinYi Cancer Hospital ( Site 5021)
        • Contact:
          • Study Coordinator
          • Phone Number: +8605398127192
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Recruiting
        • Shanxi Cancer Hospital ( Site 5043)
        • Contact:
          • Study Coordinator
          • Phone Number: 03514881611
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • Sichuan Cancer Hospital. ( Site 5018)
        • Contact:
          • Study Coordinator
          • Phone Number: 028-85420251
      • Neijiang, Sichuan, China, 641099
        • Recruiting
        • The Second People's Hospital of Neijiang ( Site 5016)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 0832 2380771
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830011
        • Recruiting
        • Affiliated Tumor Hospital of Xinjiang Medical University ( Site 5006)
        • Contact:
          • Study Coordinator
          • Phone Number: +8609917819133
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital ( Site 5012)
        • Contact:
          • Study Coordinator
          • Phone Number: 0571-88122222
      • Hangzhou, Zhejiang, China, 310052
        • Recruiting
        • The Second Affiliated hospital of Zhejiang University school of medicine ( Site 5024)
        • Contact:
          • Study Coordinator
          • Phone Number: 0571-89713252
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital Zhejiang University School of Medicine ( Site 5026)
        • Contact:
          • Study Coordinator
          • Phone Number: 0571-87236855
      • Linhai, Zhejiang, China, 317000
        • Recruiting
        • Taizhou Hospital of Zhejiang Province ( Site 5029)
        • Contact:
          • Study Coordinator
          • Phone Number: 0576-85190467
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 050021
        • Recruiting
        • Instituto de Cancerología ( Site 2206)
        • Contact:
          • Study Coordinator
          • Phone Number: +576043421010x1089
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 080002
        • Recruiting
        • Centro Cancerologico del Caribe LTD ( Site 2209)
        • Contact:
          • Study Coordinator
          • Phone Number: +57 3132121774
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia, 110131
        • Recruiting
        • FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 2203)
        • Contact:
          • Study Coordinator
          • Phone Number: +57 6017454421x90614
    • Departamento de Córdoba
      • Montería, Departamento de Córdoba, Colombia, 230002
        • Recruiting
        • IMAT S.A.S ( Site 2202)
        • Contact:
          • Study Coordinator
          • Phone Number: +576047862333
    • Risaralda Department
      • Pereira, Risaralda Department, Colombia, 660001
        • Recruiting
        • Oncologos Del Occidente ( Site 2208)
        • Contact:
          • Study Coordinator
          • Phone Number: 573154208077
  • Czechia
      • Olomouc, Czechia, 77900
        • Recruiting
        • Fakultni nemocnice Olomouc ( Site 3502)
        • Contact:
          • Study Coordinator
          • Phone Number: +420588444295
      • Prague, Czechia, 140 59
        • Recruiting
        • Fakultni Thomayerova nemocnice ( Site 3506)
        • Contact:
          • Study Coordinator
          • Phone Number: +420261083733
      • Prague, Czechia, 150 06
        • Recruiting
        • Fakultni nemocnice v Motole ( Site 3503)
        • Contact:
          • Study Coordinator
          • Phone Number: +420224434700
    • Moravian-Silesian Region
      • Ostrava - Poruba, Moravian-Silesian Region, Czechia, 708 52
        • Recruiting
        • Fakultni nemocnice Ostrava ( Site 3505)
        • Contact:
          • Study Coordinator
          • Phone Number: +420597372124
    • Praha 2
      • Prague, Praha 2, Czechia, 128 00
        • Recruiting
        • Vseobecna fakultni nemocnice v Praze ( Site 3501)
        • Contact:
          • Study Coordinator
          • Phone Number: +420224966764
    • South Moravian
      • Brno, South Moravian, Czechia, 656 53
        • Recruiting
        • Masarykuv onkologicky ustav ( Site 3500)
        • Contact:
          • Study Coordinator
          • Phone Number: +420543134003
  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2730
        • Recruiting
        • Herlev og Gentofte Hospital. ( Site 3205)
        • Contact:
          • Study Coordinator
          • Phone Number: +4538683868
      • Copenhagen, Capital Region, Denmark, 2100
        • Recruiting
        • Rigshospitalet University Hospital ( Site 3201)
        • Contact:
          • Study Coordinator
          • Phone Number: +4535453545
    • Central Jutland
      • Aarhus, Central Jutland, Denmark, 8200
        • Recruiting
        • Aarhus Universitets hospital ( Site 3204)
        • Contact:
          • Study Coordinator
          • Phone Number: + 4578450000
    • Region Syddanmark
      • Odense, Region Syddanmark, Denmark, 5000
        • Recruiting
        • Odense Universitetshospital ( Site 3202)
        • Contact:
          • Study Coordinator
          • Phone Number: +4566113333
  • Finland
    • North Ostrobothnia
      • Oulu, North Ostrobothnia, Finland, 90220
        • Recruiting
        • Oulun yliopistollinen sairaala-Oncology and Hematology ( Site 3304)
        • Contact:
          • Study Coordinator
          • Phone Number: +35883153038
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Recruiting
        • Tampereen yliopistollinen sairaala-Oncology ( Site 3302)
        • Contact:
          • Study Coordinator
          • Phone Number: +358331166764
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00029
        • Recruiting
        • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 3301)
        • Contact:
          • Study Coordinator
          • Phone Number: +358947174900
  • France
      • Paris, France, 75015
        • Recruiting
        • Hôpital Européen Georges Pompidou ( Site 3011)
        • Contact:
          • Study Coordinator
          • Phone Number: +33156093577
      • Paris, France, 75014
        • Recruiting
        • Groupe Hospitalier Paris Saint Joseph ( Site 3010)
        • Contact:
          • Study Coordinator
          • Phone Number: +33144123577
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, France, 69373
        • Recruiting
        • CENTRE LEON BERARD ( Site 3004)
        • Contact:
          • Study Coordinator
          • Phone Number: +33469856440
    • Haute-Vienne
      • Limoges, Haute-Vienne, France, 87000
        • Recruiting
        • Clinique Francois Chenieux ( Site 3006)
        • Contact:
          • Study Coordinator
          • Phone Number: +33555058606
    • Herault
      • Montpellier, Herault, France, 34298
        • Recruiting
        • Institut Regional du Cancer Montpellier ( Site 3009)
        • Contact:
          • Study Coordinator
          • Phone Number: +33(0)4 67 61 45 65
    • Loire-Atlantique
      • Saint-Herblain, Loire-Atlantique, France, 44805
        • Recruiting
        • Institut De Cancerologie De L Ouest ( Site 3003)
        • Contact:
          • Study Coordinator
          • Phone Number: +33240679900
    • Marne
      • Reims, Marne, France, 51100
        • Recruiting
        • Institut Jean Godinot ( Site 3002)
        • Contact:
          • Study Coordinator
          • Phone Number: +33326504444
    • Seine-Maritime
      • Rouen, Seine-Maritime, France, 76038
        • Recruiting
        • Centre Henri Becquerel ( Site 3001)
        • Contact:
          • Study Coordinator
          • Phone Number: +33232082575
    • Var
      • Toulon, Var, France, 83800
        • Recruiting
        • HIA Sainte Anne ( Site 3007)
        • Contact:
          • Study Coordinator
          • Phone Number: +33483162010
  • Germany
      • Berlin, Germany, 13125
        • Recruiting
        • HELIOS Klinikum Berlin-Buch ( Site 4303)
        • Contact:
          • Study Coordinator
          • Phone Number: +4930940153300
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Recruiting
        • Universitatsklinikum Erlangen ( Site 4302)
        • Contact:
          • Study Coordinator
          • Phone Number: +4991318544082
    • North Rhine-Westphalia
      • Düsseldorf, North Rhine-Westphalia, Germany, 40235
        • Recruiting
        • Luisenkrankenhaus Düsseldorf ( Site 4305)
        • Contact:
          • Study Coordinator
          • Phone Number: +4921144773360
      • Essen, North Rhine-Westphalia, Germany, 45136
        • Recruiting
        • Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinik für Senologie/ Brustzentrum ( Site 4304)
        • Contact:
          • Study Coordinator
          • Phone Number: +492011740
    • Saarland
      • Saarbrücken, Saarland, Germany, 66113
        • Recruiting
        • Caritas Klinikum Saarbruecken St. Theresia ( Site 4301)
        • Contact:
          • Study Coordinator
          • Phone Number: +496814061345
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Recruiting
        • Universitaetsklinikum Leipzig ( Site 4307)
        • Contact:
          • Study Coordinator
          • Phone Number: +4934197109
  • Greece
      • Thessaloniki, Greece, 57001
        • Recruiting
        • European Interbalkan Medical Center ( Site 3901)
        • Contact:
          • Study Coordinator
          • Phone Number: 0030 2313252011
    • Attica
      • Athens, Attica, Greece, 115 28
        • Recruiting
        • Aretaieio Hospital ( Site 3900)
        • Contact:
          • Study Coordinator
          • Phone Number: 0030 2107286444
    • Irakleio
      • Heraklion, Irakleio, Greece, 715 00
        • Recruiting
        • University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 3903)
        • Contact:
          • Study Coordinator
          • Phone Number: 0030 2810392091
    • Thessaly
      • Larissa, Thessaly, Greece, 411 10
        • Recruiting
        • General University Hospital of Larissa, Oncology Clinic ( Site 3902)
        • Contact:
          • Study Coordinator
          • Phone Number: 0030 2413501636
  • Hong Kong
      • Hong Kong, Hong Kong, 000000
        • Recruiting
        • Queen Mary Hospital ( Site 6000)
        • Contact:
          • Study Coordinator
          • Phone Number: 39103339
  • Hungary
      • Budapest, Hungary, 1122
        • Recruiting
        • Országos Onkológiai Intézet-B-Belgyógyászati Onkológiai Osztály ( Site 3406)
        • Contact:
          • Study Coordinator
          • Phone Number: +36122486003352
    • Bekes County
      • Gyula, Bekes County, Hungary, 5700
        • Recruiting
        • Békés Vármegyei Központi Kórház Pándy Kálmán Tagkórház-Megyei Onkológiai Centrum ( Site 3405)
        • Contact:
          • Study Coordinator
          • Phone Number: +36 66/526-526
    • Csongrád megye
      • Szeged, Csongrád megye, Hungary, 6720
        • Recruiting
        • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Onkoterapias Klinika ( Site 3407)
        • Contact:
          • Study Coordinator
          • Phone Number: +3662545404
    • Pest County
      • Budapest, Pest County, Hungary, 1145
        • Recruiting
        • Budapesti Uzsoki Utcai Kórház-Onkoradiológiai Osztály ( Site 3408)
        • Contact:
          • Study Coordinator
          • Phone Number: +36 1 467-3700/1245
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus ( Site 3700)
        • Contact:
          • Study Coordinator
          • Phone Number: +97247772688
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Shaare Zedek Medical Center ( Site 3704)
        • Contact:
          • Study Coordinator
          • Phone Number: +97226555999
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center ( Site 3702)
        • Contact:
          • Study Coordinator
          • Phone Number: +97239377377
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center ( Site 3701)
        • Contact:
          • Study Coordinator
          • Phone Number: +97235303030
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Sourasky Medical Center ( Site 3703)
        • Contact:
          • Study Coordinator
          • Phone Number: +97236974444
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 4605)
        • Contact:
          • Study Coordinator
          • Phone Number: 390512144547
      • Genova, Italy, 16132
        • Recruiting
        • Ospedale Policlinico San Martino ( Site 4606)
        • Contact:
          • Study Coordinator
          • Phone Number: +390105600387
      • Milan, Italy, 20132
        • Recruiting
        • IRCCS Ospedale San Raffaele ( Site 4600)
        • Contact:
          • Study Coordinator
          • Phone Number: 390226436530
      • Milan, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 4601)
        • Contact:
          • Study Coordinator
          • Phone Number: +39 02-2390-2849
      • Novara, Italy, 28100
        • Recruiting
        • Azienda Ospedaliero Universitaria Maggiore della Carità ( Site 4604)
        • Contact:
          • Study Coordinator
          • Phone Number: 3903213732148
      • Padova, Italy, 35128
        • Recruiting
        • Istituto Oncologico Veneto IRCCS ( Site 4603)
        • Contact:
          • Study Coordinator
          • Phone Number: 0498215523
      • Roma, Italy, 00168
        • Recruiting
        • Policlincio Gemelli ( Site 4602)
        • Contact:
          • Study Coordinator
          • Phone Number: 0630158545
    • Roma
      • Rome, Roma, Italy, 00128
        • Recruiting
        • Istituto Nazionale Tumori Regina Elena ( Site 4607)
        • Contact:
          • Study Coordinator
          • Phone Number: +39 0652665610
  • Japan
      • Akita, Japan, 010-8543
        • Recruiting
        • Akita University Hospital ( Site 5115)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-18-834-1111
      • Fukuoka, Japan, 811-1395
        • Recruiting
        • National Hospital Organization Kyushu Cancer Center ( Site 5119)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-92-541-3231
      • Fukushima, Japan, 960-1295
        • Recruiting
        • Fukushima Medical University Hospital ( Site 5101)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-24-547-1772
      • Hiroshima, Japan, 730-8518
        • Recruiting
        • Hiroshima City Hiroshima Citizens Hospital ( Site 5113)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-81-221-2291
      • Kagoshima, Japan, 892-0833
        • Recruiting
        • Social medical corporation Hakuaikai Sagara Hospital ( Site 5114)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-99-224-1800
      • Kyoto, Japan, 606-8507
        • Recruiting
        • Kyoto University Hospital ( Site 5110)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-75-751-3111
      • Okayama, Japan, 700-8558
        • Recruiting
        • Okayama University Hospital ( Site 5118)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-86-223-7151
      • Osaka, Japan, 541-8567
        • Recruiting
        • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 5112)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-06-6945-1181
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 467-8602
        • Recruiting
        • Nagoya City University Hospital ( Site 5108)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-52-851-5511
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Recruiting
        • Aichi Cancer Center ( Site 5117)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-52-762-6111
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • Recruiting
        • National Hospital Organization Shikoku Cancer Center ( Site 5122)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-89-999-1111
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital ( Site 5100)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-11-716-1161
    • Ishikawa-ken
      • Kahoku-gun, Ishikawa-ken, Japan, 920-0293
        • Recruiting
        • Kanazawa Medical University Hospital ( Site 5127)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-76-286-3511
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1193
        • Recruiting
        • Tokai University Hospital ( Site 5107)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-463-93-1121
      • Kawasaki, Kanagawa, Japan, 216-8511
        • Recruiting
        • St. Marianna University Hospital ( Site 5124)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-44-977-8111
      • Sagamihara, Kanagawa, Japan, 252-0375
        • Recruiting
        • Kitasato University Hospital ( Site 5123)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-42-778-8111
      • Yokohama, Kanagawa, Japan, 241-8515
        • Recruiting
        • Kanagawa Cancer Center ( Site 5106)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-45-520-2222
    • Mie-ken
      • Tsu, Mie-ken, Japan, 514-8507
        • Recruiting
        • Mie University Hospital ( Site 5109)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-59-231-5246
    • Okinawa
      • Naha, Okinawa, Japan, 901-0154
        • Recruiting
        • Naha Nishi Clinic ( Site 5125)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-98-858-5557
    • Osaka
      • Suita, Osaka, Japan, 565-0871
        • Recruiting
        • The University of Osaka Hospital ( Site 5111)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-6-6210-8290
    • Saitama
      • Hidaka, Saitama, Japan, 350-1298
        • Recruiting
        • Saitama Medical University International Medical Center ( Site 5116)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-42-984-4111
    • Tokyo
      • Bunkyo, Tokyo, Japan, 113-8431
        • Recruiting
        • Juntendo University Hospital ( Site 5104)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3813-3111
      • Koto, Tokyo, Japan, 135-8550
        • Recruiting
        • Cancer Institute Hospital of JFCR ( Site 5102)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3520-0111
      • Minato, Tokyo, Japan, 105-8470
        • Recruiting
        • Toranomon Hospital ( Site 5126)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3588-1111
      • Shinagawa, Tokyo, Japan, 142-8666
        • Recruiting
        • Showa Medical University Hospital ( Site 5103)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3784-8000
      • Shinjuku, Tokyo, Japan, 162-8655
        • Recruiting
        • National Center for Global Health and Medicine ( Site 5105)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3202-7181
      • Shinjuku, Tokyo, Japan, 160-0023
        • Recruiting
        • Tokyo Medical University Hospital ( Site 5121)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3342-6111
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • University Malaya Medical Centre ( Site 5403)
        • Contact:
          • Study Coordinator
          • Phone Number: +60479492351
      • Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • Pantai Hospital Kuala Lumpur ( Site 5402)
        • Contact:
          • Study Coordinator
          • Phone Number: +60322960888
    • Putrajaya
      • Putrajaya, Putrajaya, Malaysia, 62250
        • Recruiting
        • National Cancer Institute ( Site 5401)
        • Contact:
          • Study Coordinator
          • Phone Number: +60388925418
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Recruiting
        • Sarawak General Hospital ( Site 5400)
        • Contact:
          • Study Coordinator
          • Phone Number: +6082276820
  • Mexico
      • Aguascalientes, Mexico, 20124
        • Recruiting
        • Centro de Investigación Oncológica Galerías SC ( Site 2511)
        • Contact:
          • Study Coordinator
          • Phone Number: +524496890593
      • Chihuahua City, Mexico, 31123
        • Recruiting
        • Unidad de Mastologia Avanzada de Chihuahua S.A de C.V ( Site 2510)
        • Contact:
          • Study Coordinator
          • Phone Number: 526144253458712
      • San Luis Potosí City, Mexico, 78250
        • Recruiting
        • Centro Potosino de Investigación Médica ( Site 2512)
        • Contact:
          • Study Coordinator
          • Phone Number: 52 444 475 2715
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44630
        • Recruiting
        • CIO - Centro de Inmuno-Oncología de Occidente ( Site 2504)
        • Contact:
          • Study Coordinator
          • Phone Number: 3330447001
    • Mexico City
      • Mexico City, Mexico City, Mexico, 03100
        • Recruiting
        • Grupo Médico ASSET ( Site 2507)
        • Contact:
          • Study Coordinator
          • Phone Number: 2223813254
      • Mexico City, Mexico City, Mexico, 06140
        • Recruiting
        • Centro Oncologico de Alta Especialidad, S.C. ( Site 2509)
        • Contact:
          • Study Coordinator
          • Phone Number: +52 55 5286 5738
      • Mexico City, Mexico City, Mexico, 11810
        • Recruiting
        • Higiea Oncologia ( Site 2505)
        • Contact:
          • Study Coordinator
          • Phone Number: +525554137773
      • Mexico City, Mexico City, Mexico, 04700
        • Recruiting
        • COI Centro Oncologico Internacional S.A.P.I. de C.V. ( Site 2514)
        • Contact:
          • Study Coordinator
          • Phone Number: +525554248970
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Recruiting
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 2501)
        • Contact:
          • Study Coordinator
          • Phone Number: +528125761529
      • San Pedro Garza García, Nuevo León, Mexico, 66220
        • Recruiting
        • Oncare - Unidad Valle ( Site 2502)
        • Contact:
          • Study Coordinator
          • Phone Number: +528115337180
    • Oaxaca
      • Oaxaca City, Oaxaca, Mexico, 68020
        • Recruiting
        • Centro de Investigacion Clinica de Oaxaca ( Site 2503)
        • Contact:
          • Study Coordinator
          • Phone Number: +529516035559
  • Netherlands
      • Groningen, Netherlands, 9728 NT
        • Recruiting
        • Martini Ziekenhuis ( Site 4502)
        • Contact:
          • Study Coordinator
          • Phone Number: +31505246311
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6815 AD
        • Recruiting
        • Ziekenhuis Rijnstate ( Site 4501)
        • Contact:
          • Study Coordinator
          • Phone Number: +31880056201
    • Limburg
      • Sittard Geleen, Limburg, Netherlands, 6162BP
        • Recruiting
        • Zuyderland Medical Centre ( Site 4507)
        • Contact:
          • Study Coordinator
          • Phone Number: +31884590400
    • North Brabant
      • Tilburg, North Brabant, Netherlands, 5022 GC
        • Recruiting
        • ETZ Elisabeth ( Site 4504)
        • Contact:
          • Study Coordinator
          • Phone Number: +31132210425
    • Overijssel
      • Deventer, Overijssel, Netherlands, 7416 SE
        • Recruiting
        • Deventer Ziekenhuis ( Site 4503)
        • Contact:
          • Study Coordinator
          • Phone Number: +31570596437
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3015 GD
        • Recruiting
        • Erasmus Medisch Centrum ( Site 4505)
        • Contact:
          • Study Coordinator
          • Phone Number: +31107041733
    • Utrecht
      • Amersfoort, Utrecht, Netherlands, 3813 TZ
        • Recruiting
        • Meander Medisch Centrum ( Site 4500)
        • Contact:
          • Study Coordinator
          • Phone Number: +31338507278
  • New Zealand
    • Auckland
      • Newmarket, Auckland, New Zealand, 1023
        • Recruiting
        • Harbour Cancer & Wellness ( Site 5600)
        • Contact:
          • Study Coordinator
          • Phone Number: +64 9 220 3333
    • Wellington Region
      • Crofton Downs, Wellington Region, New Zealand, 6035
        • Recruiting
        • Bowen Icon Cancer Centre ( Site 5601)
        • Contact:
          • Study Coordinator
          • Phone Number: +64 9 479 2069
  • Peru
      • Lima, Peru, 15036
        • Recruiting
        • Oncosalud ( Site 2600)
        • Contact:
          • Study Coordinator
          • Phone Number: +5115137900
      • Lima, Peru, 15036
        • Recruiting
        • IPOR Instituto Peruano de Oncología & Radioterapia ( Site 2601)
        • Contact:
          • Study Coordinator
          • Phone Number: +51 997881134
      • Lima, Peru, 15036
        • Recruiting
        • Clínica Internacional - Sede San Borja ( Site 2604)
        • Contact:
          • Study Coordinator
          • Phone Number: +51 992004083
      • Lima, Peru, 15076
        • Recruiting
        • Hospital Militar Central Coronel Luis Arias Schereiber ( Site 2603)
        • Contact:
          • Study Coordinator
          • Phone Number: +5112443453
  • Philippines
      • Iloilo City, Philippines, 5000
        • Recruiting
        • THE MEDICAL CITY ILOILO ( Site 5704)
        • Contact:
          • Study Coordinator
          • Phone Number: +6333 3397340
    • Batangas
      • Lipa, Batangas, Philippines, 4217
        • Recruiting
        • Mary Mediatrix Medical Center ( Site 5702)
        • Contact:
          • Study Coordinator
          • Phone Number: (043) 773 6800
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 61-866
        • Recruiting
        • Wielkopolskie Centrum Onkologii-Oddział Onkologii Klinicznej i Immunoonkologii z Pododdziałem Dzien ( Site 3811)
        • Contact:
          • Study Coordinator
          • Phone Number: +48618850620
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
        • Recruiting
        • Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 3802)
        • Contact:
          • Study Coordinator
          • Phone Number: +48523743525
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-727
        • Recruiting
        • Pratia MCM Krakow ( Site 3812)
        • Contact:
          • Study Coordinator
          • Phone Number: +48122954100
    • Masovian Voivodeship
      • Siedlce, Masovian Voivodeship, Poland, 08-110
        • Recruiting
        • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 3801)
        • Contact:
          • Study Coordinator
          • Phone Number: +48256403301
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Piersi i Chirurgii ( Site 3803)
        • Contact:
          • Study Coordinator
          • Phone Number: 48225462522
      • Wieliszew, Masovian Voivodeship, Poland, 05-135
        • Recruiting
        • Mazowiecki Szpital Onkologiczny ( Site 3807)
        • Contact:
          • Study Coordinator
          • Phone Number: +48227661500
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-027
        • Recruiting
        • Bialostockie Centrum Onkologii ( Site 3810)
        • Contact:
          • Study Coordinator
          • Phone Number: +48733100322
    • Pomeranian Voivodeship
      • Gdynia, Pomeranian Voivodeship, Poland, 81-519
        • Recruiting
        • Szpitale Pomorskie Sp. z o. o. ( Site 3805)
        • Contact:
          • Study Coordinator
          • Phone Number: +48587260380
    • West Pomeranian Voivodeship
      • Koszalin, West Pomeranian Voivodeship, Poland, 75-581
        • Recruiting
        • Szpital Wojewodzki im.M.Kopernika. ( Site 3800)
        • Contact:
          • Study Coordinator
          • Phone Number: 48943488931
  • Romania
      • Bucharest, Romania, 077190
        • Recruiting
        • Centrul Medical Neolife- Baneasa ( Site 4706)
        • Contact:
          • Study Coordinator
          • Phone Number: +40219230
      • Bucharest, Romania, 011171
        • Recruiting
        • Spitalul Clinic Filantropia ( Site 4703)
        • Contact:
          • Study Coordinator
          • Phone Number: +40213188930
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Recruiting
        • Institutul Oncologic Cluj ( Site 4701)
        • Contact:
          • Study Coordinator
          • Phone Number: +40264598362
      • Comuna Floresti, Cluj, Romania, 407280
        • Recruiting
        • S.C. Radiotherapy Center Cluj S.R.L ( Site 4705)
        • Contact:
          • Study Coordinator
          • Phone Number: +40219368
    • Dolj
      • Craiova, Dolj, Romania, 200542
        • Recruiting
        • Centrul de Oncologie "Sfântul Nectarie" ( Site 4702)
        • Contact:
          • Study Coordinator
          • Phone Number: +40731604432
    • Prahova
      • Ploieşti, Prahova, Romania, 100337
        • Recruiting
        • Spitalul Municipal Schuller Ploiești ( Site 4707)
        • Contact:
          • Study Coordinator
          • Phone Number: +40723943507
    • Timiș County
      • Timișoara, Timiș County, Romania, 300239
        • Recruiting
        • Cabinet Medical Oncomed ( Site 4704)
        • Contact:
          • Study Coordinator
          • Phone Number: +40356460995
  • South Korea
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital ( Site 5200)
        • Contact:
          • Study Coordinator
          • Phone Number: +82220720850
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital Yonsei University Health System ( Site 5201)
        • Contact:
          • Study Coordinator
          • Phone Number: +82222288135
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center ( Site 5203)
        • Contact:
          • Study Coordinator
          • Phone Number: 82234106488
    • Kyonggi-do
      • Goyang-si, Kyonggi-do, South Korea, 10408
        • Recruiting
        • National Cancer Center ( Site 5202)
        • Contact:
          • Study Coordinator
          • Phone Number: +82319201623
      • Seongnam, Kyonggi-do, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital ( Site 5204)
        • Contact:
          • Study Coordinator
          • Phone Number: 82317877022
    • Taegu-Kwangyokshi
      • Daegu, Taegu-Kwangyokshi, South Korea, 41404
        • Recruiting
        • Kyungpook National University Chilgok Hospital ( Site 5205)
        • Contact:
          • Study Coordinator
          • Phone Number: 82532002625
  • Spain
      • Barcelona, Spain, 08003
        • Recruiting
        • Parc de Salut Mar - Hospital del Mar ( Site 4106)
        • Contact:
          • Study Coordinator
          • Phone Number: 34932483860
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital Beata María Ana ( Site 4105)
        • Contact:
          • Study Coordinator
          • Phone Number: 914097423/303
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal ( Site 4103)
        • Contact:
          • Study Coordinator
          • Phone Number: 913368263
    • Andalusia
      • Seville, Andalusia, Spain, 41013
        • Recruiting
        • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 4104)
        • Contact:
          • Study Coordinator
          • Phone Number: 34955013068
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Recruiting
        • ICO L Hospitalet ( Site 4101)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932607744
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos ( Site 4100)
        • Contact:
          • Study Coordinator
          • Phone Number: 34913303000/7768
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46014
        • Recruiting
        • Hospital General Universitario de Valencia ( Site 4102)
        • Contact:
          • Study Coordinator
          • Phone Number: 34963131800/438139
  • Taiwan
      • Taichung, Taiwan, 407
        • Recruiting
        • Taichung Veterans General Hospital ( Site 5303)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-4-2359-2525
      • Tainan, Taiwan, 70403
        • Recruiting
        • National Cheng Kung University Hospital ( Site 5304)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-6-235-3535
      • Taipei, Taiwan, 104
        • Recruiting
        • Mackay Memorial Hospital ( Site 5301)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-2-25433535
      • Taipei, Taiwan, 100225
        • Recruiting
        • National Taiwan University Hospital ( Site 5300)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-2-23123456
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital ( Site 5302)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-3-328-1200
  • Thailand
      • Khon Kaen, Thailand, 40002
        • Recruiting
        • Faculty of Medicine - Khon Kaen University ( Site 5802)
        • Contact:
          • Study Coordinator
          • Phone Number: +6643363746
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Recruiting
        • Faculty of Medicine Siriraj Hospital ( Site 5800)
        • Contact:
          • Study Coordinator
          • Phone Number: +6624192938
    • Changwat Songkhla
      • Hat Yai, Changwat Songkhla, Thailand, 90110
        • Recruiting
        • Songklanagarind hospital ( Site 5801)
        • Contact:
          • Study Coordinator
          • Phone Number: +6674451469
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01140
        • Recruiting
        • Adana Medical Park Seyhan Hastanesi ( Site 4804)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 5056166338
      • Ankara, Turkey (Türkiye), 06230
        • Recruiting
        • Hacettepe Universite Hastaneleri ( Site 4800)
        • Contact:
          • Study Coordinator
          • Phone Number: 903123052929
      • Ankara, Turkey (Türkiye), 06560
        • Recruiting
        • Gazi University Health Research and Application Center Gazi Hospital ( Site 4805)
        • Contact:
          • Study Coordinator
          • Phone Number: 903122158710
      • Sakarya, Turkey (Türkiye), 54290
        • Recruiting
        • Sakarya Egitim Arastirma Hsatanesi ( Site 4809)
        • Contact:
          • Study Coordinator
          • Phone Number: 90 505 478 5576
      • Samsun, Turkey (Türkiye), 55200
        • Recruiting
        • Samsun Medical Park Hastanesi ( Site 4810)
        • Contact:
          • Study Coordinator
          • Phone Number: 444 44 84
    • İzmir
      • Bornova, İzmir, Turkey (Türkiye), 35100
        • Recruiting
        • Ege Universitesi Hastanesi ( Site 4803)
        • Contact:
          • Study Coordinator
          • Phone Number: 0 232 343 4 343
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Recruiting
        • Queen Elizabeth Hospital Birmingham ( Site 4017)
        • Contact:
          • Study Coordinator
          • Phone Number: +441213718766
      • Cardiff, United Kingdom, CF142TL
        • Recruiting
        • Velindre Cancer Centre Hospital ( Site 4008)
        • Contact:
          • Study Coordinator
          • Phone Number: +442920615888
      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • St. James s University Hospital ( Site 4004)
        • Contact:
          • Study Coordinator
          • Phone Number: +441132068186
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR13LJ
        • Recruiting
        • Royal Cornwall Hospital ( Site 4003)
        • Contact:
          • Study Coordinator
          • Phone Number: +441872258342
    • London, City of
      • London, London, City of, United Kingdom, EC1A7BE
        • Recruiting
        • St Bartholomew's Hospital ( Site 4001)
        • Contact:
          • Study Coordinator
          • Phone Number: 02073777000
      • London, London, City of, United Kingdom, NW1 2PG
        • Recruiting
        • University College London Hospital ( Site 4007)
        • Contact:
          • Study Coordinator
          • Phone Number: +447977175703
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG51PB
        • Recruiting
        • Nottingham University Hospital NHS Trust ( Site 4009)
        • Contact:
          • Study Coordinator
          • Phone Number: +441159691169
    • Somerset
      • Taunton, Somerset, United Kingdom, TA1 5DA
        • Recruiting
        • Musgrove Park Hospital ( Site 4005)
        • Contact:
          • Study Coordinator
          • Phone Number: +441823343634
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36604
        • Recruiting
        • USA Mitchell Cancer Institute ( Site 0090)
        • Contact:
          • Study Coordinator
          • Phone Number: 251-410-4924
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Recruiting
        • Ironwood Cancer & Research Centers ( Site 0036)
        • Contact:
          • Study Coordinator
          • Phone Number: 623-312-3000
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope ( Site 0097)
        • Contact:
          • Study Coordinator
          • Phone Number: 626-218-9845
      • Irvine, California, United States, 92618
        • Recruiting
        • City of Hope Lennar Foundation Cancer Center ( Site 0099)
        • Contact:
          • Study Coordinator
          • Phone Number: 626-218-0720
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA Department of Medicine - Hematology & Oncology ( Site 0047)
        • Contact:
          • Study Coordinator
          • Phone Number: 650-283-5067
      • San Francisco, California, United States, 94158
        • Recruiting
        • UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0016)
        • Contact:
          • Study Coordinator
          • Phone Number: 415-353-7070
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Completed
        • Yale New Haven Hospital ( Site 0001)
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010-2975
        • Recruiting
        • Washington Hospital Center ( Site 0098)
        • Contact:
          • Study Coordinator
          • Phone Number: 202-877-8839
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Recruiting
        • AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0007)
        • Contact:
          • Study Coordinator
          • Phone Number: 407-303-2284
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health Cancer Institute ( Site 0012)
        • Contact:
          • Study Coordinator
          • Phone Number: 321-841-8284
      • West Palm Beach, Florida, United States, 33401
        • Recruiting
        • Florida Cancer Specialists - East ( Site 7000)
        • Contact:
          • Study Coordinator
          • Phone Number: 561-366-4100
    • Georgia
      • Athens, Georgia, United States, 30607
        • Recruiting
        • University Cancer & Blood Center, LLC ( Site 0023)
        • Contact:
          • Study Coordinator
          • Phone Number: 706-353-2990
    • Idaho
      • Boise, Idaho, United States, 83712
        • Recruiting
        • St. Luke's Cancer Institute: Boise ( Site 0037)
        • Contact:
          • Study Coordinator
          • Phone Number: 208-381-2711
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois Cancer Center ( Site 0044)
        • Contact:
          • Study Coordinator
          • Phone Number: 312-996-1581
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Recruiting
        • MedStar Franklin Square Medical Center ( Site 0031)
        • Contact:
          • Study Coordinator
          • Phone Number: 443-777-7147
      • Baltimore, Maryland, United States, 21239
        • Recruiting
        • MedStar Good Samaritan Hospital ( Site 0079)
        • Contact:
          • Study Coordinator
          • Phone Number: 443-777-7147
      • Clinton, Maryland, United States, 20735
        • Recruiting
        • MedStar Southern Maryland Hospital Center ( Site 0100)
        • Contact:
          • Study Coordinator
          • Phone Number: 301-877-4673
      • Olney, Maryland, United States, 20832
        • Recruiting
        • MedStar Montgomery Medical Center ( Site 0078)
        • Contact:
          • Study Coordinator
          • Phone Number: 301-774-8882
      • Silver Spring, Maryland, United States, 20910
        • Recruiting
        • Holy Cross Hospital ( Site 0091)
        • Contact:
          • Study Coordinator
          • Phone Number: 301-754-7552
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Cancer & Hematology Centers of Western Michigan ( Site 0026)
        • Contact:
          • Study Coordinator
          • Phone Number: 616-954-9800
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Allina Health Cancer Institute ( Site 0069)
        • Contact:
          • Study Coordinator
          • Phone Number: 763-577-7000
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Recruiting
        • Comprehensive Cancer Centers of Nevada ( Site 0015)
        • Contact:
          • Study Coordinator
          • Phone Number: 702-952-3350
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Renown Regional Medical Center ( Site 0005)
        • Contact:
          • Study Coordinator
          • Phone Number: 775-982-5050
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0082)
        • Contact:
          • Study Coordinator
          • Phone Number: 551-996-5900
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Recruiting
        • New Mexico Oncology Hematology Consultants Ltd. ( Site 0019)
        • Contact:
          • Study Coordinator
          • Phone Number: 505-842-8171
    • New York
      • Mineola, New York, United States, 11501
        • Recruiting
        • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0073)
        • Contact:
          • Study Coordinator
          • Phone Number: 516-663-9500
      • New York, New York, United States, 10016
        • Recruiting
        • Laura and Isaac Perlmutter Cancer Center ( Site 0003)
        • Contact:
          • Study Coordinator
          • Phone Number: 212-731-6126
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • UNC REX Cancer Center ( Site 0071)
        • Contact:
          • Study Coordinator
          • Phone Number: 919-784-7209
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners ( Site 7004)
        • Contact:
          • Study Coordinator
          • Phone Number: 615-329-7274
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology ( Site 0018)
        • Contact:
          • Study Coordinator
          • Phone Number: 877-836-6662
    • Texas
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Texas Oncology - DFW ( Site 8007)
        • Contact:
          • Study Coordinator
          • Phone Number: 214-739-4175
      • El Paso, Texas, United States, 79902
        • Recruiting
        • Texas Oncology - West Texas ( Site 8004)
        • Contact:
          • Study Coordinator
          • Phone Number: 915-747-4835
      • Houston, Texas, United States, 77014
        • Recruiting
        • Kelsey-Seybold Clinic - North Houston Campus ( Site 0096)
        • Contact:
          • Study Coordinator
          • Phone Number: 713-239-4510
      • Houston, Texas, United States, 77025
        • Recruiting
        • Kelsey-Seybold Clinic ( Site 0040)
        • Contact:
          • Study Coordinator
          • Phone Number: 713-239-4510
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Texas Oncology - San Antonio ( Site 8001)
        • Contact:
          • Study Coordinator
          • Phone Number: 210-419-2608
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • University of Utah, Huntsman Cancer Institute ( Site 0056)
        • Contact:
          • Study Coordinator
          • Phone Number: 801-587-7000
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Virginia Oncology Associates (VOA) ( Site 8002)
        • Contact:
          • Study Coordinator
          • Phone Number: 757-368-5033
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center ( Site 0042)
        • Contact:
          • Study Coordinator
          • Phone Number: 206-606-6329

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Has locally recurrent unresectable or metastatic TNBC that cannot be treated with curative intent
  • Has not received systemic treatment for locally recurrent unresectable or metastatic breast cancer
  • Participants previously treated for early-stage breast cancer must have completed all prior therapy for early-stage breast cancer with curative intent at least 6 months before the first disease recurrence
  • Is a candidate for treatment with pembrolizumab and one of the TPC options: paclitaxel or nab-paclitaxel or gemcitabine + carboplatin
  • Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline with the exception of alopecia or vitiligo. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible
  • Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
  • Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • Has breast cancer amenable to treatment with curative intent
  • Has TNBC with evaluable tumor programmed death ligand 1 (PD-L1) expression at combined positive score (CPS) ≥10
  • Has received prior systemic therapy for treatment of locally recurrent unresectable or metastatic breast cancer
  • Has Grade ≥2 peripheral neuropathy
  • Has 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
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
  • Has skin only metastatic disease
  • Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications
  • Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has known additional malignancy that is progressing or has required active treatment within the past 5 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable
  • Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments
  • Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (HCV) (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection
  • History of stem cell/solid organ transplant
  • Has not adequately recovered from major surgery or has ongoing surgical complications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm C: Treatment of Physician's Choice (TPC)
Participants receive physician's choice of chemotherapy agent(s): paclitaxel IV 80 mg/m^2 once every week (Q1W) OR paclitaxel IV 90 mg/m^2 on Days 1, 8, and 15, every 4 weeks (Q4W) OR nab-paclitaxel IV 100 mg/m^2 on Days 1, 8, and 15, Q4W OR gemcitabine IV 1000 mg/m^2 on Days 1 and 8, every 3 weeks (Q3W) PLUS carboplatin IV area under the curve (AUC) 2 mg/mL/min on Days 1 and 8, Q3W, until disease progression, toxicity or discontinuation.
Drug: Carboplatin
IV Infusion
Other Names:
  • Paraplatin
Drug: Gemcitabine
IV Infusion
Other Names:
  • Gemzar
Drug: Paclitaxel
IV Infusion
Other Names:
  • Taxol
  • Onxol
Drug: Nab-paclitaxel
IV Infusion
Other Names:
  • Abraxane
Experimental: Arm A: Sacituzumab Tirumotecan
Participants receive sacituzumab tirumotecan intravenously (IV) at a dose of 4 mg/kg every 2 weeks (Q2W) until disease progression, toxicity or discontinuation.
Biological: Sacituzumab tirumotecan
IV Infusion
Other Names:
  • MK-2870
  • Sac-TMT
Drug: Rescue Medication
Participants receive the following pre-medications before sacituzumab tirumotecan infusion: Histamine-1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion. Participants are also recommended to receive prophylactic steroid mouthwash (dexamethasone or equivalent).
Experimental: Arm B: Sacituzumab Tirumotecan + Pembrolizumab
Participants receive sacituzumab tirumotecan IV 4 mg/kg Q2W until disease progression, toxicity or discontinuation PLUS pembrolizumab IV 400 mg every 6 weeks (Q6W) for up to 18 administrations (up to ~2 years).
Biological: Pembrolizumab
IV Infusion
Other Names:
  • MK-3475
  • Keytruda®
Biological: Sacituzumab tirumotecan
IV Infusion
Other Names:
  • MK-2870
  • Sac-TMT
Drug: Rescue Medication
Participants receive the following pre-medications before sacituzumab tirumotecan infusion: Histamine-1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion. Participants are also recommended to receive prophylactic steroid mouthwash (dexamethasone or equivalent).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) (sac-TMT versus TPC)
Time Frame: Up to ~61 months
OS is defined as the time from randomization to death due to any cause.
Up to ~61 months
Progression-Free Survival (PFS) (sac-TMT versus treatment of physician's choice (TPC); sac-TMT plus pembrolizumab versus TPC)
Time Frame: Up to ~39 months
PFS is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on blinded independent central review (BICR) or death due to any cause, whichever occurs first. 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.
Up to ~39 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) (sac-TMT plus pembrolizumab versus treatment of physician's choice (TPC); sac-TMT plus pembrolizumab versus sac-TMT)
Time Frame: Up to ~61 months
OS is defined as the time from randomization to death due to any cause.
Up to ~61 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) (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)
Time Frame: Baseline and up to ~61 months
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status.
Baseline and up to ~61 months
Change from baseline in physical functioning score, on the EORTC QLQ-C30 (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)
Time Frame: Baseline and up to ~61 months
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of physical functioning.
Baseline and up to ~61 months
Change from baseline in emotional functioning score, on the EORTC QLQ-C30 (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)
Time Frame: Baseline and up to ~61 months
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their emotional functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of emotional functioning.
Baseline and up to ~61 months
Change from baseline in fatigue score, on the EORTC QLQ-C30 (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)
Time Frame: Baseline and up to ~61 months
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their fatigue are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better level of function.
Baseline and up to ~61 months
Change from baseline in diarrhea score, on the EORTC QLQ-C30 (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)
Time Frame: Baseline and up to ~61 months
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Have you had diarrhea?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better level of function.
Baseline and up to ~61 months
Number of participants who experience one or more adverse events (AEs)
Time Frame: Up to ~61 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to ~61 months
Number of participants who discontinue study treatment due to an AE
Time Frame: Up to ~61 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to ~61 months
Progression-Free Survival (PFS) (sac-TMT plus pembrolizumab versus sac-TMT)
Time Frame: Up to ~39 months
PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first. 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.
Up to ~39 months
Objective Response Rate (ORR) (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)
Time Frame: Up to ~39 months
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based on BICR.
Up to ~39 months
Duration of Response (DOR)
Time Frame: Up to ~39 months
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based on BICR, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 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 at least 5 mm. The appearance of one or more new lesions is also considered PD.
Up to ~39 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2025

Primary Completion (Estimated)

May 18, 2030

Study Completion (Estimated)

May 18, 2030

Study Registration Dates

First Submitted

February 18, 2025

First Submitted That Met QC Criteria

February 18, 2025

First Posted (Actual)

February 24, 2025

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2870-011
  • MK-2870-011 (Other Identifier: MSD)
  • TroFuse-011 (Other Identifier: MSD)
  • U1111-1311-2310 (Registry Identifier: UTN)
  • 2024-516834-36-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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