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)
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)
5 other identifiers
interventional
1,000
34 countries
255
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2025
Longer than P75 for phase_3
255 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2025
CompletedFirst Posted
Study publicly available on registry
February 24, 2025
CompletedStudy Start
First participant enrolled
March 16, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 18, 2030
April 13, 2026
April 1, 2026
5.2 years
February 18, 2025
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression-Free Survival (PFS) (sac-TMT versus treatment of physician's choice (TPC); sac-TMT plus pembrolizumab versus TPC)
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 ~37 months
Overall Survival (OS) (sac-TMT versus TPC)
OS is defined as the time from randomization to death due to any cause.
Up to ~61 months
Secondary Outcomes (11)
Overall Survival (OS) (sac-TMT plus pembrolizumab versus treatment of physician's choice (TPC); sac-TMT plus pembrolizumab versus sac-TMT)
Up to ~61 months
Progression-Free Survival (PFS) (sac-TMT plus pembrolizumab versus sac-TMT)
Up to ~37 months
Objective Response Rate (ORR) (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)
Up to ~37 months
Duration of Response (DOR)
Up to ~37 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)
Baseline and up to ~61 months
- +6 more secondary outcomes
Study Arms (3)
Arm A: Sacituzumab Tirumotecan
EXPERIMENTALParticipants receive sacituzumab tirumotecan intravenously (IV) at a dose of 4 mg/kg every 2 weeks (Q2W) until disease progression, toxicity or discontinuation.
Arm B: Sacituzumab Tirumotecan + Pembrolizumab
EXPERIMENTALParticipants 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).
Arm C: Treatment of Physician's Choice (TPC)
ACTIVE COMPARATORParticipants 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.
Interventions
IV Infusion
IV Infusion
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (255)
USA Mitchell Cancer Institute ( Site 0090)
Mobile, Alabama, 36604, United States
Ironwood Cancer & Research Centers ( Site 0036)
Chandler, Arizona, 85224, United States
City of Hope ( Site 0097)
Duarte, California, 91010, United States
City of Hope Lennar Foundation Cancer Center ( Site 0099)
Irvine, California, 92618, United States
UCLA Department of Medicine - Hematology & Oncology ( Site 0047)
Los Angeles, California, 90095, United States
UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0016)
San Francisco, California, 94158, United States
Yale New Haven Hospital ( Site 0001)
New Haven, Connecticut, 06520, United States
Washington Hospital Center ( Site 0098)
Washington D.C., District of Columbia, 20010-2975, United States
AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0007)
Altamonte Springs, Florida, 32701, United States
Florida Cancer Specialists - East ( Site 7000)
West Palm Beach, Florida, 33401, United States
University Cancer & Blood Center, LLC ( Site 0023)
Athens, Georgia, 30607, United States
St. Luke's Cancer Institute: Boise ( Site 0037)
Boise, Idaho, 83712, United States
University of Illinois Cancer Center ( Site 0044)
Chicago, Illinois, 60612, United States
MedStar Franklin Square Medical Center ( Site 0031)
Baltimore, Maryland, 21237, United States
MedStar Good Samaritan Hospital ( Site 0079)
Baltimore, Maryland, 21239, United States
MedStar Southern Maryland Hospital Center ( Site 0100)
Clinton, Maryland, 20735, United States
MedStar Montgomery Medical Center ( Site 0078)
Olney, Maryland, 20832, United States
Holy Cross Hospital ( Site 0091)
Silver Spring, Maryland, 20910, United States
Cancer & Hematology Centers of Western Michigan ( Site 0026)
Grand Rapids, Michigan, 49503, United States
Allina Health Cancer Institute ( Site 0069)
Minneapolis, Minnesota, 55407, United States
Comprehensive Cancer Centers of Nevada ( Site 0015)
Las Vegas, Nevada, 89119, United States
Renown Regional Medical Center ( Site 0005)
Reno, Nevada, 89502, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0082)
Hackensack, New Jersey, 07601, United States
New Mexico Oncology Hematology Consultants Ltd. ( Site 0019)
Albuquerque, New Mexico, 87109, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0073)
Mineola, New York, 11501, United States
Laura and Isaac Perlmutter Cancer Center ( Site 0003)
New York, New York, 10016, United States
UNC REX Cancer Center ( Site 0071)
Raleigh, North Carolina, 27607, United States
SCRI Oncology Partners ( Site 7004)
Nashville, Tennessee, 37203, United States
Tennessee Oncology ( Site 0018)
Nashville, Tennessee, 37203, United States
Texas Oncology - DFW ( Site 8007)
Dallas, Texas, 75231, United States
Texas Oncology - West Texas ( Site 8004)
El Paso, Texas, 79902, United States
Kelsey Research Foundation ( Site 0040)
Houston, Texas, 77005, United States
Kelsey-Seybold Clinic - North Houston Campus ( Site 0096)
Houston, Texas, 77014, United States
Texas Oncology - San Antonio ( Site 8001)
San Antonio, Texas, 78240, United States
University of Utah, Huntsman Cancer Institute ( Site 0056)
Salt Lake City, Utah, 84112, United States
Virginia Oncology Associates (VOA) ( Site 8002)
Norfolk, Virginia, 23502, United States
Fred Hutchinson Cancer Center ( Site 0042)
Seattle, Washington, 98109, United States
Instituto de Investigaciones Clinicas Mar del Plata ( Site 2401)
Mar del Plata, Buenos Aires, B7600FZN, Argentina
Instituto Alexander Fleming ( Site 2402)
Mar del Plata, Buenos Aires, C1426ANZ, Argentina
Hospital Italiano de Cordoba ( Site 2406)
Córdoba, Córdoba Province, X5004BAL, Argentina
Clinica Viedma ( Site 2403)
Viedma, Río Negro Province, R8500ACE, Argentina
Fundacion Estudios Clinicos ( Site 2405)
Rosario, Santa Fe Province, S2000DEJ, Argentina
Hospital Provincial del Centenario ( Site 2410)
Rosario, Santa Fe Province, S2002KDR, Argentina
Fundacion Centro Oncologico de Integración Regional ( Site 2400)
Mendoza, M5500AYB, Argentina
Blacktown Hospital ( Site 5500)
Blacktown, New South Wales, 2148, Australia
Peninsula Health Frankston Hospital ( Site 5501)
Frankston, Victoria, 3199, Australia
ZAS Sint Augustinus ( Site 3102)
Antwerp, Flanders, 2610, Belgium
Ziekenhuis Oost Limburg ( Site 3105)
Genk, Limburg, 3600, Belgium
AZ Maria Middelares ( Site 3103)
Ghent, Oost-Vlaanderen, 9000, Belgium
UZ Gent ( Site 3101)
Ghent, Oost-Vlaanderen, 9000, Belgium
Hospital de Câncer de Recife ( Site 2300)
Recife, Pernambuco, 50040-000, Brazil
Liga Norte Riograndense Contra o Cancer ( Site 2310)
Natal, Rio Grande do Norte, 59062-000, Brazil
Hospital Nossa Senhora da Conceição ( Site 2302)
Porto Alegre, Rio Grande do Sul, 91350-200, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 2307)
Barretos, São Paulo, 14784-400, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 2301)
São Jose Do Rio Preto, São Paulo, 15090-000, Brazil
IBCC - Núcleo de Pesquisa e Ensino ( Site 2306)
São Paulo, 04014-002, Brazil
Cross Cancer Institute ( Site 0216)
Edmonton, Alberta, T6G 1Z2, Canada
Lakeridge Health ( Site 0217)
Oshawa, Ontario, L1G 2B9, Canada
North York General Hospital ( Site 0209)
Toronto, Ontario, M2K 1E1, Canada
Princess Margaret Cancer Centre ( Site 0202)
Toronto, Ontario, M5G 2M9, Canada
CIUSSS- saguenay-Lac-Saint-Jean ( Site 0213)
Chicoutimi, Quebec, G7H 5H6, Canada
Centre Hospitalier de l'Université de Montréal ( Site 0208)
Montreal, Quebec, H2X 3E4, Canada
Jewish General Hospital ( Site 0203)
Montreal, Quebec, H3T 1E2, Canada
St. Marys Hospital Center ( Site 0201)
Montreal, Quebec, H3T 1M5, Canada
McGill University Health Centre ( Site 0204)
Montreal, Quebec, H4A 3J1, Canada
Hopital Du Saint-Sacrement ( Site 0210)
Québec, Quebec, G1S 4L8, Canada
Saskatoon Cancer Centre ( Site 0215)
Saskatoon, Saskatchewan, S7N 4H4, Canada
IC La Serena Research ( Site 2007)
La Serena, Coquimbo Region, 1720430, Chile
FALP ( Site 2000)
Santiago, Region M. de Santiago, 7500921, Chile
Clínica UC San Carlos de Apoquindo ( Site 2008)
Santiago, Region M. de Santiago, 7620002, Chile
Bradfordhill ( Site 2001)
Santiago, Region M. de Santiago, 8420383, Chile
ONCOCENTRO APYS ( Site 2005)
Viña del Mar, Región de Valparaíso, 2520598, Chile
Biocenter ( Site 2009)
Concepción, Región del Biobío, 4070196, Chile
The First Afflilated Hospital of Bengbu Medical College ( Site 5022)
Bengbu, Anhui, 233004, China
The First Affiliated Hospital of Chongqing Medical University ( Site 5039)
Chongqing, Chongqing Municipality, 400016, China
Chongqing University Three Gorges Hospital ( Site 5020)
Chongqing, Chongqing Municipality, 404000, China
The First Affiliated hospital of Xiamen University ( Site 5035)
Xiamen, Fujian, 361003, China
Sun Yat-Sen University Cancer Center ( Site 5014)
Guangzhou, Guangdong, 510060, China
Guangxi Medical University Affiliated Tumor Hospital. ( Site 5008)
Nanning, Guangxi, 530201, China
Henan Cancer Hospital ( Site 5001)
Zhengzhou, Henan, 450008, China
Tongji Hospital Tongji Medical Science & Technology ( Site 5007)
Wuhan, Hubei, 430030, China
Xiangyang Central Hospital ( Site 5017)
Xiangyang, Hubei, 441021, China
Hunan Cancer Hospital ( Site 5002)
Changsha, Hunan, 410013, China
Jiangsu Province Hospital ( Site 5009)
Nanjing, Jiangsu, 210029, China
Xuzhou Central Hospital ( Site 5036)
Xuzhou, Jiangsu, 221009, China
The First Hospital of Jilin University ( Site 5003)
Changchun, Jilin, 130021, China
The First Affiliated Hospital of Xi an Jiaotong University ( Site 5005)
Xi'an, Shaanxi, 710061, China
Jinan Central Hospital ( Site 5031)
Jinan, Shandong, 250013, China
LinYi Cancer Hospital ( Site 5021)
Linyi, Shandong, 276000, China
Shanxi Cancer Hospital ( Site 5043)
Taiyuan, Shanxi, 030000, China
Sichuan Cancer Hospital. ( Site 5018)
Chengdu, Sichuan, 610041, China
The Second People's Hospital of Neijiang ( Site 5016)
Neijiang, Sichuan, 641099, China
Affiliated Tumor Hospital of Xinjiang Medical University ( Site 5006)
Ürümqi, Xinjiang, 830011, China
The First Affiliated Hospital Zhejiang University School of Medicine ( Site 5026)
Hangzhou, Zhejiang, 310003, China
Zhejiang Cancer Hospital ( Site 5012)
Hangzhou, Zhejiang, 310022, China
The Second Affiliated hospital of Zhejiang University school of medicine ( Site 5024)
Hangzhou, Zhejiang, 310052, China
Taizhou Hospital of Zhejiang Province ( Site 5029)
Linhai, Zhejiang, 317000, China
Instituto de Cancerología ( Site 2206)
Medellín, Antioquia, 050021, Colombia
Centro Cancerologico del Caribe LTD ( Site 2209)
Barranquilla, Atlántico, 080002, Colombia
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 2203)
Bogotá, Bogota D.C., 110131, Colombia
IMAT S.A.S ( Site 2202)
Montería, Departamento de Córdoba, 230002, Colombia
Oncologos Del Occidente ( Site 2208)
Pereira, Risaralda Department, 660001, Colombia
Vseobecna fakultni nemocnice v Praze ( Site 3501)
Prague, Praha 2, 128 00, Czechia
Masarykuv onkologicky ustav ( Site 3500)
Brno, South Moravian, 656 53, Czechia
Fakultni nemocnice Olomouc ( Site 3502)
Olomouc, 77900, Czechia
Fakultni Thomayerova nemocnice ( Site 3506)
Prague, 140 59, Czechia
Fakultni nemocnice v Motole ( Site 3503)
Prague, 150 06, Czechia
Rigshospitalet University Hospital ( Site 3201)
Copenhagen, Capital Region, 2100, Denmark
Herlev og Gentofte Hospital. ( Site 3205)
Copenhagen, Capital Region, 2730, Denmark
Aarhus Universitets hospital ( Site 3204)
Aarhus, Central Jutland, 8200, Denmark
Odense Universitetshospital ( Site 3202)
Odense, Region Syddanmark, 5000, Denmark
Oulun yliopistollinen sairaala-Oncology and Hematology ( Site 3304)
Oulu, North Ostrobothnia, 90220, Finland
Tampereen yliopistollinen sairaala-Oncology ( Site 3302)
Tampere, Pirkanmaa, 33520, Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 3301)
Helsinki, Uusimaa, 00029, Finland
CENTRE LEON BERARD ( Site 3004)
Lyon, Auvergne-Rhône-Alpes, 69373, France
Clinique Francois Chenieux ( Site 3006)
Limoges, Haute-Vienne, 87000, France
Institut Regional du Cancer Montpellier ( Site 3009)
Montpellier, Herault, 34298, France
Institut De Cancerologie De L Ouest ( Site 3003)
Saint-Herblain, Loire-Atlantique, 44805, France
Institut Jean Godinot ( Site 3002)
Reims, Marne, 51100, France
Centre Henri Becquerel ( Site 3001)
Rouen, Seine-Maritime, 76038, France
HIA Sainte Anne ( Site 3007)
Toulon, Var, 83800, France
Groupe Hospitalier Paris Saint Joseph ( Site 3010)
Paris, 75014, France
Hôpital Européen Georges Pompidou ( Site 3011)
Paris, 75015, France
Universitatsklinikum Erlangen ( Site 4302)
Erlangen, Bavaria, 91054, Germany
Luisenkrankenhaus Düsseldorf ( Site 4305)
Düsseldorf, North Rhine-Westphalia, 40235, Germany
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinik für Senologie/ Brustzentrum ( Site 4304)
Essen, North Rhine-Westphalia, 45136, Germany
Caritas Klinikum Saarbruecken St. Theresia ( Site 4301)
Saarbrücken, Saarland, 66113, Germany
Universitaetsklinikum Leipzig ( Site 4307)
Leipzig, Saxony, 04103, Germany
HELIOS Klinikum Berlin-Buch ( Site 4303)
Berlin, 13125, Germany
Aretaieio Hospital ( Site 3900)
Athens, Attica, 115 28, Greece
University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 3903)
Heraklion, Irakleio, 715 00, Greece
General University Hospital of Larissa, Oncology Clinic ( Site 3902)
Larissa, Thessaly, 411 10, Greece
European Interbalkan Medical Center ( Site 3901)
Thessaloniki, 57001, Greece
Queen Mary Hospital ( Site 6000)
Hong Kong, 000000, Hong Kong
Békés Vármegyei Központi Kórház Pándy Kálmán Tagkórház-Megyei Onkológiai Centrum ( Site 3405)
Gyula, Bekes County, 5700, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Onkoterapias Klinika ( Site 3407)
Szeged, Csongrád megye, 6720, Hungary
Budapesti Uzsoki Utcai Kórház-Onkoradiológiai Osztály ( Site 3408)
Budapest, Pest County, 1145, Hungary
Rambam Health Care Campus ( Site 3700)
Haifa, 3109601, Israel
Shaare Zedek Medical Center ( Site 3704)
Jerusalem, 9103102, Israel
Rabin Medical Center ( Site 3702)
Petah Tikva, 4941492, Israel
Sheba Medical Center ( Site 3701)
Ramat Gan, 5265601, Israel
Sourasky Medical Center ( Site 3703)
Tel Aviv, 6423906, Israel
Istituto Nazionale Tumori Regina Elena ( Site 4607)
Rome, Roma, 00128, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 4605)
Bologna, 40138, Italy
Ospedale Policlinico San Martino ( Site 4606)
Genova, 16132, Italy
IRCCS Ospedale San Raffaele ( Site 4600)
Milan, 20132, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 4601)
Milan, 20133, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità ( Site 4604)
Novara, 28100, Italy
Istituto Oncologico Veneto IRCCS ( Site 4603)
Padova, 35128, Italy
Policlincio Gemelli ( Site 4602)
Roma, 00168, Italy
Aichi Cancer Center ( Site 5117)
Nagoya, Aichi-ken, 464-8681, Japan
Nagoya City University Hospital ( Site 5108)
Nagoya, Aichi-ken, 467-8602, Japan
National Hospital Organization Shikoku Cancer Center ( Site 5122)
Matsuyama, Ehime, 791-0280, Japan
Hokkaido University Hospital ( Site 5100)
Sapporo, Hokkaido, 060-8648, Japan
Kanazawa Medical University Hospital ( Site 5127)
Kahoku-gun, Ishikawa-ken, 920-0293, Japan
Tokai University Hospital ( Site 5107)
Isehara, Kanagawa, 259-1193, Japan
St. Marianna University Hospital ( Site 5124)
Kawasaki, Kanagawa, 216-8511, Japan
Kitasato University Hospital ( Site 5123)
Sagamihara, Kanagawa, 252-0375, Japan
Kanagawa Cancer Center ( Site 5106)
Yokohama, Kanagawa, 241-8515, Japan
Mie University Hospital ( Site 5109)
Tsu, Mie-ken, 514-8507, Japan
Naha Nishi Clinic ( Site 5125)
Naha, Okinawa, 901-0154, Japan
The University of Osaka Hospital ( Site 5111)
Suita, Osaka, 565-0871, Japan
Saitama Medical University International Medical Center ( Site 5116)
Hidaka, Saitama, 350-1298, Japan
Juntendo University Hospital ( Site 5104)
Bunkyo, Tokyo, 113-8431, Japan
Cancer Institute Hospital of JFCR ( Site 5102)
Koto, Tokyo, 135-8550, Japan
Toranomon Hospital ( Site 5126)
Minato, Tokyo, 105-8470, Japan
Showa Medical University Hospital ( Site 5103)
Shinagawa, Tokyo, 142-8666, Japan
Tokyo Medical University Hospital ( Site 5121)
Shinjuku, Tokyo, 160-0023, Japan
National Center for Global Health and Medicine ( Site 5105)
Shinjuku, Tokyo, 162-8655, Japan
Akita University Hospital ( Site 5115)
Akita, 010-8543, Japan
National Hospital Organization Kyushu Cancer Center ( Site 5119)
Fukuoka, 811-1395, Japan
Fukushima Medical University Hospital ( Site 5101)
Fukushima, 960-1295, Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 5113)
Hiroshima, 730-8518, Japan
Social medical corporation Hakuaikai Sagara Hospital ( Site 5114)
Kagoshima, 892-0833, Japan
Kyoto University Hospital ( Site 5110)
Kyoto, 606-8507, Japan
Okayama University Hospital ( Site 5118)
Okayama, 700-8558, Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 5112)
Osaka, 541-8567, Japan
National Cancer Institute ( Site 5401)
Putrajaya, Putrajaya, 62250, Malaysia
Sarawak General Hospital ( Site 5400)
Kuching, Sarawak, 93586, Malaysia
Pantai Hospital Kuala Lumpur ( Site 5402)
Kuala Lumpur, 59100, Malaysia
University Malaya Medical Centre ( Site 5403)
Kuala Lumpur, 59100, Malaysia
CIO - Centro de Inmuno-Oncología de Occidente ( Site 2504)
Guadalajara, Jalisco, 44630, Mexico
Grupo Médico ASSET ( Site 2507)
Mexico City, Mexico City, 03100, Mexico
COI Centro Oncologico Internacional S.A.P.I. de C.V. ( Site 2514)
Mexico City, Mexico City, 04700, Mexico
Centro Oncologico de Alta Especialidad, S.C. ( Site 2509)
Mexico City, Mexico City, 06140, Mexico
Higiea Oncologia ( Site 2505)
Mexico City, Mexico City, 11810, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 2501)
Monterrey, Nuevo León, 64460, Mexico
Oncare - Unidad Valle ( Site 2502)
San Pedro Garza García, Nuevo León, 66220, Mexico
Centro de Investigacion Clinica de Oaxaca ( Site 2503)
Oaxaca City, Oaxaca, 68020, Mexico
Centro de Investigación Oncológica Galerías SC ( Site 2511)
Aguascalientes, 20124, Mexico
Unidad de Mastologia Avanzada de Chihuahua S.A de C.V ( Site 2510)
Chihuahua City, 31123, Mexico
Centro Potosino de Investigación Médica ( Site 2512)
San Luis Potosí City, 78250, Mexico
Ziekenhuis Rijnstate ( Site 4501)
Arnhem, Gelderland, 6815 AD, Netherlands
Zuyderland Medical Centre ( Site 4507)
Sittard Geleen, Limburg, 6162BP, Netherlands
ETZ Elisabeth ( Site 4504)
Tilburg, North Brabant, 5022 GC, Netherlands
Deventer Ziekenhuis ( Site 4503)
Deventer, Overijssel, 7416 SE, Netherlands
Erasmus Medisch Centrum ( Site 4505)
Rotterdam, South Holland, 3015 GD, Netherlands
Meander Medisch Centrum ( Site 4500)
Amersfoort, Utrecht, 3813 TZ, Netherlands
Martini Ziekenhuis ( Site 4502)
Groningen, 9728 NT, Netherlands
Harbour Cancer & Wellness ( Site 5600)
Newmarket, Auckland, 1023, New Zealand
Bowen Icon Cancer Centre ( Site 5601)
Crofton Downs, Wellington Region, 6035, New Zealand
Clínica Internacional - Sede San Borja ( Site 2604)
Lima, 15036, Peru
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 2601)
Lima, 15036, Peru
Oncosalud ( Site 2600)
Lima, 15036, Peru
Hospital Militar Central Coronel Luis Arias Schereiber ( Site 2603)
Lima, 15076, Peru
Mary Mediatrix Medical Center ( Site 5702)
Lipa, Batangas, 4217, Philippines
THE MEDICAL CITY ILOILO ( Site 5704)
Iloilo City, 5000, Philippines
Wielkopolskie Centrum Onkologii-Oddział Onkologii Klinicznej i Immunoonkologii z Pododdziałem Dzien ( Site 3811)
Poznan, Greater Poland Voivodeship, 61-866, Poland
Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 3802)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland
Pratia MCM Krakow ( Site 3812)
Krakow, Lesser Poland Voivodeship, 30-727, Poland
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 3801)
Siedlce, Masovian Voivodeship, 08-110, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Piersi i Chirurgii ( Site 3803)
Warsaw, Masovian Voivodeship, 02-781, Poland
Mazowiecki Szpital Onkologiczny ( Site 3807)
Wieliszew, Masovian Voivodeship, 05-135, Poland
Bialostockie Centrum Onkologii ( Site 3810)
Bialystok, Podlaskie Voivodeship, 15-027, Poland
Szpitale Pomorskie Sp. z o. o. ( Site 3805)
Gdynia, Pomeranian Voivodeship, 81-519, Poland
Szpital Wojewodzki im.M.Kopernika. ( Site 3800)
Koszalin, West Pomeranian Voivodeship, 75-581, Poland
Institutul Oncologic Cluj ( Site 4701)
Cluj-Napoca, Cluj, 400015, Romania
S.C. Radiotherapy Center Cluj S.R.L ( Site 4705)
Comuna Floresti, Cluj, 407280, Romania
Centrul de Oncologie "Sfântul Nectarie" ( Site 4702)
Craiova, Dolj, 200542, Romania
Spitalul Municipal Schuller Ploiești ( Site 4707)
Ploieşti, Prahova, 100337, Romania
Cabinet Medical Oncomed ( Site 4704)
Timișoara, Timiș County, 300239, Romania
Spitalul Clinic Filantropia ( Site 4703)
Bucharest, 011171, Romania
Centrul Medical Neolife- Baneasa ( Site 4706)
Bucharest, 077190, Romania
National Cancer Center ( Site 5202)
Goyang-si, Kyonggi-do, 10408, South Korea
Seoul National University Bundang Hospital ( Site 5204)
Seongnam, Kyonggi-do, 13620, South Korea
Kyungpook National University Chilgok Hospital ( Site 5205)
Daegu, Kyongsangbuk-do, 41404, South Korea
Seoul National University Hospital ( Site 5200)
Seoul, 03080, South Korea
Severance Hospital Yonsei University Health System ( Site 5201)
Seoul, 03722, South Korea
Samsung Medical Center ( Site 5203)
Seoul, 06351, South Korea
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 4104)
Seville, Andalusia, 41013, Spain
ICO L Hospitalet ( Site 4101)
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Hospital Clinico San Carlos ( Site 4100)
Madrid, Madrid, Comunidad de, 28040, Spain
Hospital General Universitario de Valencia ( Site 4102)
Valencia, Valenciana, Comunitat, 46014, Spain
Parc de Salut Mar - Hospital del Mar ( Site 4106)
Barcelona, 08003, Spain
Hospital Beata María Ana ( Site 4105)
Madrid, 28007, Spain
Hospital Universitario Ramon y Cajal ( Site 4103)
Madrid, 28034, Spain
Taichung Veterans General Hospital ( Site 5303)
Taichung, 407, Taiwan
National Cheng Kung University Hospital ( Site 5304)
Tainan, 70403, Taiwan
National Taiwan University Hospital ( Site 5300)
Taipei, 100225, Taiwan
Mackay Memorial Hospital ( Site 5301)
Taipei, 104, Taiwan
Chang Gung Memorial Hospital ( Site 5302)
Taoyuan District, 333, Taiwan
Faculty of Medicine Siriraj Hospital ( Site 5800)
Bangkoknoi, Bangkok, 10700, Thailand
Songklanagarind hospital ( Site 5801)
Hat Yai, Changwat Songkhla, 90110, Thailand
Faculty of Medicine - Khon Kaen University ( Site 5802)
Khon Kaen, 40002, Thailand
Adana Medical Park Seyhan Hastanesi ( Site 4804)
Adana, 01140, Turkey (Türkiye)
Hacettepe Universite Hastaneleri ( Site 4800)
Ankara, 06230, Turkey (Türkiye)
Gazi University Health Research and Application Center Gazi Hospital ( Site 4805)
Ankara, 06560, Turkey (Türkiye)
Sakarya Egitim Arastirma Hsatanesi ( Site 4809)
Sakarya, 54290, Turkey (Türkiye)
Samsun Medical Park Hastanesi ( Site 4810)
Samsun, 55200, Turkey (Türkiye)
Royal Cornwall Hospital ( Site 4003)
Truro, Cornwall, TR13LJ, United Kingdom
St Bartholomew's Hospital ( Site 4001)
London, London, City of, EC1A7BE, United Kingdom
University College London Hospital ( Site 4007)
London, London, City of, NW1 2PG, United Kingdom
Nottingham University Hospital NHS Trust ( Site 4009)
Nottingham, Nottinghamshire, NG51PB, United Kingdom
Velindre Cancer Centre Hospital ( Site 4008)
Cardiff, CF142TL, United Kingdom
St. James s University Hospital ( Site 4004)
Leeds, LS9 7TF, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2025
First Posted
February 24, 2025
Study Start
March 16, 2025
Primary Completion (Estimated)
May 18, 2030
Study Completion (Estimated)
May 18, 2030
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf