A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010)
A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010)
5 other identifiers
interventional
1,046
35 countries
253
Brief Summary
The purpose of this study is to evaluate if zilovertamab vedotin with standard treatment can help people live longer without the cancer growing or spreading than people who receive standard treatment alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2025
Longer than P75 for phase_3
253 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
December 2, 2024
CompletedFirst Posted
Study publicly available on registry
December 5, 2024
CompletedStudy Start
First participant enrolled
January 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 29, 2032
May 6, 2026
May 1, 2026
4.4 years
December 2, 2024
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS)
PFS is defined as the time from randomization to the first documented disease progression per Lugano response criteria by blinded independent central review (BICR) or death due to any cause, whichever occurs first.
Up to ~ 50 months
Secondary Outcomes (10)
Complete Response at End of Treatment (CR at EOT)
Up to ~ 32 months
Overall Survival (OS)
Up to ~ 74 months
Event-free Survival (EFS)
Up to ~ 74 months
Duration of Complete Response (DurCR)
Up to ~ 74 months
Number of Participants Who Experience an Adverse Event (AE)
Up to ~ 9 months
- +5 more secondary outcomes
Study Arms (2)
Zilovertamab vedotin + Rituximab + Cyclophosphamide, Doxorubicin, Prednisone (R-CHP)
EXPERIMENTALParticipants receive a dose of zilovertamab vedotin (1.75 mg/kg) plus 750 mg/m\^2 cyclophosphamide, 50 mg/m\^2 doxorubicin, and 375 mg/m\^2 rituximab or rituximab biosimilar administered by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 6 cycles (up to approximately 4 months) plus 2 cycles of rituximab or biosimilar for participants with high risk DLBCL. Participants also receive 100 mg prednisone, prednisolone, or methylprednisolone via oral tablet per day during Days 1-5 of each 21-day cycle for up to 6 cycles (up to approximately 4 months).
Rituximab + Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (R-CHOP)
ACTIVE COMPARATORParticipants receive 750 mg/m\^2 cyclophosphamide, 50 mg/m\^2 doxorubicin, and 375 mg/m\^2 rituximab or rituximab biosimilar, 1.4 mg/m\^2 vincristine administered by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 6 cycles (up to approximately 4 months) plus 2 cycles of rituximab or biosimilar for participants with high risk DLBCL. Participants also receive 100 mg prednisone, prednisolone, or methylprednisolone via oral tablet per day during Days 1-5 of each 21-day cycle for up to 6 cycles (up to approximately 4 months).
Interventions
IV infusion
IV infusion
IV infusion
IV infusion
IV infusion
Per Approved Product Label
Oral administration
IV infusion
Participants receive rescue medication per approved product label. The rescue medication is granulocyte colony-stimulating factor (G-CSF).
Per Approved Product Label
Eligibility Criteria
You may qualify if:
- Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, based on local testing according to the WHO classification of neoplasms of the hematopoietic and lymphoid tissues
- Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale
- Has received no prior treatment for their DLBCL
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization
- Has an ejection fraction ≥45% as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA)
- Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)
- Who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
You may not qualify if:
- Has a history of transformation of indolent disease to DLBCL
- Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma
- Has Ann Arbor Stage I DLBCL
- Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\<6 months prior to enrollment), myocardial infarction (\<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication
- Has clinically significant pericardial or pleural effusion
- Has ongoing Grade \>1 peripheral neuropathy
- Has a demyelinating form of Charcot-Marie-Tooth disease
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has ongoing corticosteroid therapy
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
- Known additional malignancy that is progressing or has required active treatment within the past 2 years
- Known active central nervous system (CNS) lymphoma
- Has active autoimmune disease that has required systemic treatment in the past 2 years
- Has active infection requiring systemic therapy
- Has concurrent active HBV (defined as HBsAg positive and detectable HBV DNA) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (253)
Banner MD Anderson Cancer Center ( Site 0165)
Gilbert, Arizona, 85234, United States
Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0167)
Phoenix, Arizona, 85006, United States
The University of Arizona Cancer Center - North Campus ( Site 0124)
Tucson, Arizona, 85719, United States
Providence Medical Foundation-Oncology ( Site 0168)
Fullerton, California, 92835, United States
Cancer Blood and Specialty Clinic ( Site 0109)
Los Alamitos, California, 90720, United States
Cedars-Sinai Medical Center ( Site 0115)
Los Angeles, California, 90048, United States
Pacific Hematology Oncology Associates ( Site 0131)
San Francisco, California, 94115, United States
Lutheran Hospital - Cancer Centers of Colorado ( Site 0180)
Golden, Colorado, 80401, United States
Clermont Oncology Center ( Site 0182)
Clermont, Florida, 34711, United States
Bioresearch Partner ( Site 0157)
Hialeah, Florida, 33013, United States
Orlando Health Cancer Institute ( Site 0169)
Ocoee, Florida, 34761, United States
Mid Florida Hematology and Oncology Center ( Site 0172)
Orange City, Florida, 32763, United States
Cancer Care Specialists of Illinois ( Site 0152)
O'Fallon, Illinois, 62269, United States
Fort Wayne Medical Oncology and Hematology ( Site 0149)
Fort Wayne, Indiana, 46804, United States
Cotton O'Neil Cancer Center ( Site 0108)
Topeka, Kansas, 66606, United States
University of Kentucky ( Site 0106)
Lexington, Kentucky, 40536, United States
Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0163)
Louisville, Kentucky, 40207, United States
CHRISTUS St. Frances Cabrini Hospital Center for Cancer Care ( Site 0184)
Alexandria, Louisiana, 71301, United States
Karmanos Cancer Institute ( Site 0174)
Detroit, Michigan, 48201, United States
Corewell Health ( Site 0130)
Grand Rapids, Michigan, 49503, United States
The University of Mississippi Medical Center ( Site 0161)
Jackson, Mississippi, 39216, United States
Circuit Clinical - SSM Health Cancer Care DePaul ( Site 0166)
Bridgeton, Missouri, 63044, United States
Truman Medical Center ( Site 0122)
Kansas City, Missouri, 64108, United States
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0178)
Billings, Montana, 59102, United States
OptumCare Cancer Care ( Site 0121)
Las Vegas, Nevada, 89102, United States
Comprehensive Cancer Centers of Nevada ( Site 0113)
Las Vegas, Nevada, 89169, United States
New York Oncology Hematology, P.C. ( Site 0129)
Albany, New York, 12206, United States
Icahn School of Medicine at Mount Sinai ( Site 0164)
New York, New York, 10029, United States
Prisma Health - Upstate ( Site 0158)
Greenville, South Carolina, 29605, United States
Sanford Cancer Center ( Site 0143)
Sioux Falls, South Dakota, 57104, United States
The University of Tennessee Medical Center ( Site 0142)
Knoxville, Tennessee, 37920, United States
Center for Oncology and Blood Disorders ( Site 0153)
Houston, Texas, 77030, United States
Houston Methodist Cancer Center ( Site 0154)
Houston, Texas, 77030, United States
University of Virginia Cancer Center ( Site 0138)
Charlottesville, Virginia, 22903, United States
Virginia Cancer Institute ( Site 0148)
Richmond, Virginia, 23229, United States
Blue Ridge Cancer Care ( Site 0132)
Roanoke, Virginia, 24014, United States
SSM Health Dean Medical Group ( Site 0140)
Madison, Wisconsin, 53715, United States
Clinica Adventista Belgrano ( Site 0309)
Caba., Buenos Aires, C1430EGF, Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0306)
Mar del Plata, Buenos Aires, B7600FZO, Argentina
Hospital Universitario Austral ( Site 0307)
Pilar, Buenos Aires, B1629AHJ, Argentina
Hospital Aleman ( Site 0301)
Buenos Aires, Buenos Aires F.D., C1118AAT, Argentina
Fundacion Estudios Clinicos ( Site 0311)
Rosario, Santa Fe Province, S2000CEJ, Argentina
C.I.C.E. 9 de Julio ( Site 0305)
San Miguel de Tucumán, Tucumán Province, T4000IKO, Argentina
Hospital Italiano de Buenos Aires ( Site 0304)
CABA, C1199ABB, Argentina
Clinica EL Castaño ( Site 0312)
San Juan, J5400ARW, Argentina
Townsville University Hospital ( Site 3006)
Douglas, Queensland, 4814, Australia
Royal Adelaide Hospital ( Site 3001)
Adelaide, South Australia, 5000, Australia
Grampians Health ( Site 3003)
Ballarat, Victoria, 3350, Australia
Northern Hospital ( Site 3002)
Melbourne, Victoria, 3076, Australia
Royal Perth Hospital-Haematology ( Site 3004)
Perth, Western Australia, 6000, Australia
AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 1102)
Mechelen, Antwerpen, 2800, Belgium
ASBL CHU Helora - Hôpital de Mons - Site Kennedy ( Site 1103)
Mons, Hainaut, 7000, Belgium
CEONC ( Site 0412)
Cascavel, Paraná, 85802-080, Brazil
Hospital Erasto Gaertner ( Site 0401)
Curitiba, Paraná, 82520-060, Brazil
Liga Norte Riograndense Contra o Cancer ( Site 0407)
Natal, Rio Grande do Norte, 59062-000, Brazil
CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0403)
Florianópolis, Santa Catarina, 88020-210, Brazil
Hope ( Site 0413)
Ribeirão Preto, São Paulo, 14026-610, Brazil
Clinica Advanze ( Site 0411)
São Carlos, São Paulo, 13561-130, Brazil
F. F. R. M. São Jose do Rio Preto ( Site 0404)
SJRP, São Paulo, 15090-000, Brazil
Hospital Paulistano ( Site 0406)
São Paulo, 01321-001, Brazil
Hospital das Clinicas FMUSP ( Site 0402)
São Paulo, 05403-010, Brazil
Queen Elizabeth II Health Sciences Centre ( Site 0207)
Halifax, Nova Scotia, B3H 2Y9, Canada
Lakeridge Health - The R.S. McLaughlin Durham Regional Cancer Centre (MDRCC) ( Site 0206)
Oshawa, Ontario, L1G 2B9, Canada
Sunnybrook Research Institute ( Site 0204)
Toronto, Ontario, M4N 3M5, Canada
Biocenter ( Site 0510)
Concepción, Biobio, 4070196, Chile
IC La Serena Research ( Site 0504)
La Serena, Coquimbo Region, 1720430, Chile
Oncocentro Valdivia ( Site 0506)
Valdivia, Los Ríos Region, 5112129, Chile
Centro de Estudios Clínicos SAGA ( Site 0508)
Santiago, Region M. de Santiago, 7500653, Chile
FALP ( Site 0501)
Santiago, Region M. de Santiago, 7500921, Chile
Clinica Inmunocel ( Site 0503)
Santiago, Region M. de Santiago, 7580206, Chile
Clínica RedSalud Vitacura ( Site 0512)
Santiago, Region M. de Santiago, 7650018, Chile
Bradfordhill ( Site 0502)
Santiago, Region M. de Santiago, 8420383, Chile
Centro de Investigaciones ( Site 0511)
Viña del Mar, Valparaiso, 2540488, Chile
Anhui Provincial Cancer Hospital ( Site 3124)
Hefei, Anhui, 230031, China
Peking University Third Hospital ( Site 3102)
Beijing, Beijing Municipality, 100096, China
Beijing Cancer Hospital ( Site 3101)
Beijing, Beijing Municipality, 100142, China
Chongqing Cancer Hospital ( Site 3113)
Chongqing, Chongqing Municipality, 400030, China
Fujian Provincial Cancer Hospital. ( Site 3119)
Fuzhou, Fujian, 350014, China
The First Affiliated Hospital of Xiamen University ( Site 3120)
Xiamen, Fujian, 361003, China
Sun Yat-sen University Cancer Center ( Site 3121)
Guangzhou, Guangdong, 510060, China
Zhujiang Hospital of Southern Medical University ( Site 3122)
Guangzhou, Guangdong, 510280, China
Affiliated Cancer Hospital of Guangxi Medical University ( Site 3123)
Nanning, Guangxi, 530021, China
The Affiliated Hospital of Guizhou Medical University ( Site 3112)
Guiyang, Guizhou, 550004, China
Hubei Cancer Hospital ( Site 3125)
Wuhan, Hubei, 430079, China
Affiliated Hospital of Nantong University ( Site 3117)
Nantong, Jiangsu, 226001, China
Jiangxi Cancer Hospital ( Site 3118)
Nanchang, Jiangxi, 330029, China
The First Hospital Of Jilin University ( Site 3103)
Changchun, Jilin, 130021, China
Shandong Cancer Hospital ( Site 3108)
Jinan, Shandong, 250117, China
LinYi Cancer Hospital ( Site 3104)
Linyi, Shandong, 276001, China
Fudan University Shanghai Cancer Center ( Site 3115)
Shanghai, Shanghai Municipality, 200032, China
Shanxi Cancer Hospital ( Site 3106)
Taiyuan, Shanxi, 030013, China
1st Affil Hosp of Med College of Xi'an Jiaotong University ( Site 3107)
Xi’an, Shanxi, 710061, China
Sichuan Cancer Hospital. ( Site 3111)
Chengdu, Sichuan, 610041, China
West China Hospital, Sichuan University ( Site 3110)
Chengdu, Sichuan, 610041, China
Institute of Hematology and Blood Diseases Hosp CAMS&PUMC ( Site 3105)
Tianjin, Tianjin Municipality, 301617, China
Yunnan Province Cancer Hospital ( Site 3109)
Kunming, Yunnan, 650118, China
The First Affiliated Hospital, Zhejiang Medical University ( Site 3116)
Hangzhou, Zhejiang, 310009, China
Hospital Pablo Tobon Uribe ( Site 0604)
Medellín, Antioquia, 050034, Colombia
Hospital Universitario San Ignacio ( Site 0607)
Bogotá, Bogota D.C., 110231, Colombia
IMAT S.A.S ( Site 0603)
Montería, Departamento de Córdoba, 230002, Colombia
Oncologos del Occidente ( Site 0601)
Pereira, Risaralda Department, 660001, Colombia
Fundación Valle del Lili ( Site 0602)
Cali, Valle del Cauca Department, 760032, Colombia
University College Hospital, Department of Haematology ( Site 1303)
Aarhus, Central Jutland, 8200, Denmark
Regionshospitalet Gødstrup ( Site 1301)
Herning, Central Jutland, 7400, Denmark
Aalborg University Hospital ( Site 1302)
Aalborg, North Denmark, 9000, Denmark
Centre Antoine-Lacassagne ( Site 1514)
Nice, Alpes-Maritimes, 06189, France
Hopital Saint Louis, Centre Hospitalier de La Rochelle ( Site 1511)
La Rochelle, Charente-Maritime, 17000, France
CHU Dijon Bourgogne ( Site 1516)
Dijon, Cote-d Or, 21000, France
CHU GRENOBLE ALPES ( Site 1518)
La Tronche, Isere, 38700, France
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 1512)
Limoges, Limousin, 87042, France
Centre Hospitalier Régional Metz Thionville - Hôpital de Mercy ( Site 1515)
Metz, Moselle, 57085, France
Centre Hospitalier de Dunkerque ( Site 1513)
Dunkirk, Nord, 59385, France
Centre Hospitalier Universitaire Estaing ( Site 1508)
Clermont-Ferrand, Puy-de-Dome, 63100, France
Centre Hospitalier de la Cote Basque ( Site 1509)
Bayonne, Pyrenees-Atlantiques, 64100, France
Centre Henri Becquerel ( Site 1517)
Rouen, Seine-Maritime, 76038, France
HIA Sainte Anne ( Site 1506)
Toulon, Var, 83800, France
Centre Hospitalier d'Avignon ( Site 1505)
Avignon, Vaucluse, 84000, France
CHD Vendee ( Site 1502)
La Roche-sur-Yon, Vendee, 85000, France
Institut Curie - site Saint-Cloud ( Site 1501)
Saint-Cloud, Île-de-France Region, 92210, France
Evangelismos General Hospital of Athens ( Site 1602)
Athens, Attica, 106 76, Greece
General Hospital of Athens "Laiko"-Hematology Department ( Site 1603)
Athens, Attica, 115 26, Greece
Attikon University General Hospital of Athens ( Site 1604)
Athens, Attica, 124 62, Greece
University General Hospital of Alexandroupoli ( Site 1601)
Alexandroupoli, Evros, 681 00, Greece
MEDI-K ( Site 0701)
Guatemala City, 01009, Guatemala
CELAN,S.A ( Site 0702)
Guatemala City, 01010, Guatemala
Cen Integral Onco Gastro y Hemato Onco Guatemala S.A. ( Site 0703)
Guatemala City, 01010, Guatemala
Princess Margaret Hospital ( Site 3202)
Hong Kong, Hong Kong
Queen Mary Hospital ( Site 3201)
Hong Kong, Hong Kong
Semmelweis University-Belgyógyászati és Hematológiai Klinika ( Site 1703)
Budapest, Hajdú-Bihar, 1088, Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 1702)
Debrecen, Hajdú-Bihar, 4032, Hungary
Szabolcs Szatmár Bereg Vármegyei Oktatókórház ( Site 1704)
Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary
Tolna Vármegyei Balassa János Kórház ( Site 1710)
Szekszárd, Tolna County, 7100, Hungary
Orszagos Onkologiai Intezet ( Site 1705)
Budapest, 1122, Hungary
Carmel Hospital ( Site 1903)
Haifa, 3436212, Israel
Hadassah Medical Center ( Site 1901)
Jerusalem, 9112001, Israel
Sourasky Medical Center ( Site 1904)
Tel Aviv, 6423906, Israel
Poria Medical Center ( Site 1902)
Tiberias, 15208, Israel
Fondazione IRCCS San Gerardo dei Tintori ( Site 2008)
Monza, Lombardy, 20900, Italy
IRCCS Crob ( Site 2002)
Rionero in Vulture, Potenza, 85028, Italy
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia ( Site 2010)
Candiolo, Torino, 10060, Italy
AOU delle Marche Ospedali Riuniti di Ancona ( Site 2011)
Ancona, 60126, Italy
Azienda Ospedaliera Spedali Civili di Brescia-Hemathology ( Site 2001)
Brescia, 25123, Italy
IRCCS Ospedale San Raffaele ( Site 2012)
Milan, 20132, Italy
IEO Istituto Europeo di Oncologia ( Site 2009)
Milan, 20141, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità ( Site 2004)
Novara, 28100, Italy
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO ( Site 2005)
Palermo, 90146, Italy
Ospedale Santa Maria delle Croci ( Site 2006)
Ravenna, 48121, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 2003)
Roma, 00168, Italy
Nagoya University Hospital ( Site 3309)
Nagoya, Aichi-ken, 466-8560, Japan
National Cancer Center Hospital East ( Site 3303)
Kashiwa, Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center ( Site 3321)
Matsuyama, Ehime, 791-0280, Japan
Kobe City Medical Center General Hospital ( Site 3318)
Kobe, Hyōgo, 650-0047, Japan
Kanazawa University Hospital ( Site 3308)
Kanazawa, Ishikawa-ken, 920-8641, Japan
Tokai University Hospital ( Site 3302)
Isehara, Kanagawa, 259-1193, Japan
Tohoku University Hospital ( Site 3301)
Sendai, Miyagi, 980-8574, Japan
Kindai University Hospital ( Site 3310)
Sakai, Osaka, 590-0197, Japan
Saitama Medical University Hospital ( Site 3305)
Iruma-gun, Saitama, 350-0495, Japan
Juntendo University Hospital ( Site 3307)
Bunkyo, Tokyo, 113-8431, Japan
Tokyo Metropolitan Komagome Hospital ( Site 3323)
Bunkyo, Tokyo, 113-8677, Japan
University of Yamanashi Hospital ( Site 3320)
Chūō, Yamanashi, 409-3898, Japan
Chiba Cancer Center ( Site 3314)
Chiba, 260-8717, Japan
Kyushu University Hospital ( Site 3313)
Fukuoka, 812-8582, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital ( Site 3322)
Hiroshima, 730-8619, Japan
University Hospital,Kyoto Prefectural University of Medicine ( Site 3315)
Kyoto, 602-8566, Japan
University of Miyazaki Hospital ( Site 3319)
Miyazaki, 889-1692, Japan
Okayama University Hospital ( Site 3311)
Okayama, 700-8558, Japan
Osaka Metropolitan University Hospital ( Site 3317)
Osaka, 545-8586, Japan
Yamagata University Hospital ( Site 3312)
Yamagata, 990-9585, Japan
Queen Elizabeth Hospital ( Site 3405)
Kota Kinabalu, Sabah, 88586, Malaysia
Sarawak General Hospital ( Site 3402)
Kuching, Sarawak, 93586, Malaysia
Hospital Miri ( Site 3403)
Miri, Sarawak, 98000, Malaysia
Sunway Medical Centre ( Site 3406)
Petaling Jaya, Selangor, 47500, Malaysia
Hospital Ampang ( Site 3404)
Selangor Darul Ehsan, Selangor, 68000, Malaysia
CIMAB SA de CV ( Site 0807)
Torreón, Coahuila, 27000, Mexico
Grupo Ollin Care ( Site 0806)
Pachuca, Hidalgo, 42000, Mexico
Health Pharma Professional Research S.A. de C.V. ( Site 0801)
Mexico City, Mexico City, 03100, Mexico
Centro de Infusion Superare ( Site 0804)
Mexico City, Mexico City, 03104, Mexico
Centro de Investigacion Clinica Chapultepec ( Site 0803)
Morelia, Michoacán, 58260, Mexico
Hospital Universitario ""Dr. Jose Eleuterio Gonzalez"" ( Site 0802)
Monterrey, Nuevo León, 64460, Mexico
Centro de Investigacion Clinica de Oaxaca ( Site 0805)
Oaxaca City, 68020, Mexico
Albert Schweitzer Ziekenhuis ( Site 2103)
Dordrecht, South Holland, 3318 AT, Netherlands
Meander Medisch Centrum ( Site 2101)
Amersfoort, Utrecht, 3813 TZ, Netherlands
Clínicas AUNA Sede Chiclayo ( Site 0904)
Chiclayo, Lambayeque, 14001, Peru
INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 0901)
Surquillo, Muni Metro de Lima, 15038, Peru
Clínica San Felipe ( Site 0906)
Lima, 15072, Peru
Hospital Nacional Edgardo Rebagliati Martins ( Site 0903)
Lima, 15072, Peru
Hospital Nacional Dos De Mayo ( Site 0905)
Lima, 15087, Peru
Pratia Onkologia Wroclaw ( Site 2211)
Wroclaw, Lower Silesian Voivodeship, 50-019, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2201)
Warsaw, Masovian Voivodeship, 02-781, Poland
Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku ( Site 2210)
Słupsk, Pomeranian Voivodeship, 76-200, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2208)
Gliwice, Silesian Voivodeship, 44-102, Poland
Pratia Onkologia Katowice ( Site 2204)
Katowice, Silesian Voivodeship, 40-519, Poland
Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko-Mazurskim Centrum Onko ( Site 2205)
Olsztyn, Warmian-Masurian Voivodeship, 10-228, Poland
Unidade Local de Saude de Braga - Hospital de Braga ( Site 2306)
Braga, 4710-243, Portugal
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 2308)
Lisbon, 1649-035, Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 2302)
Porto, 4200-072, Portugal
BRCR Global - Mayaguez ( Site 1003)
Mayagüez, 00682, Puerto Rico
Auxilio Mutuo Cancer Center ( Site 1001)
San Juan, 00918, Puerto Rico
Spitalul Clinic Colțea ( Site 2401)
Bucharest, Bucharest, 030171, Romania
Institutul Oncologic Cluj ( Site 2404)
Cluj-Napoca, Cluj, 4003437, Romania
Centrul de Diagnostic si Tratament Oncologic Brasov ( Site 2402)
Brasov, 500052, Romania
Spital Judetean Sibiu ( Site 2405)
Sibiu, 557260, Romania
National University Hospital ( Site 3702)
Singapore, Central Singapore, 119074, Singapore
National Cancer Centre Singapore ( Site 3701)
Singapore, Central Singapore, 168583, Singapore
LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 2506)
Pretoria, Gauteng, 0181, South Africa
Netcare Pretoria East Hospital ( Site 2502)
Pretoria, Gauteng, 0181, South Africa
Haemalife ( Site 2501)
Cape Town, Western Cape, 7580, South Africa
Groote Schuur Hospital ( Site 2504)
Cape Town, Western Cape, 7925, South Africa
National Cancer Center- Center for Hemotologic malignancy ( Site 3806)
Goyang-si, Kyonggi-do, 10408, South Korea
Pusan National University Hospital ( Site 3804)
Busan, Pusan-Kwangyokshi, 49241, South Korea
Chungnam National University Hospital ( Site 3801)
Daejeon, Taejon-Kwangyokshi, 35015, South Korea
Severance Hospital, Yonsei University Health System ( Site 3802)
Seoul, 03722, South Korea
Asan Medical Center ( Site 3803)
Seoul, 05505, South Korea
Samsung Medical Center ( Site 3807)
Seoul, 06351, South Korea
St.Mary's H., Youido ( Site 3805)
Seoul, 07345, South Korea
Hospital Universitario Virgen Macarena ( Site 2608)
Seville, Andalusia, 41009, Spain
ICO L Hospitalet ( Site 2601)
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
H. Insular de Gran Canaria ( Site 2606)
Las Palmas de Gran Canaria, Las Palmas, 35016, Spain
Hospital General Universitario Dr. Balmis ( Site 2604)
Alicante, Valenciana, Comunitat, 03010, Spain
Hospital del Mar ( Site 2610)
Barcelona, 08003, Spain
Hospital General Universitario 12 de Octubre ( Site 2605)
Madrid, 28041, Spain
Hospital Universitario La Paz ( Site 2611)
Madrid, 28046, Spain
Hospital Virgen de la Victoria ( Site 2609)
Málaga, 29010, Spain
Hospital Universitario Miguel Servet ( Site 2607)
Zaragoza, 50009, Spain
Kantonspital Baden ( Site 2703)
Baden, Canton of Aargau, 5404, Switzerland
Cantonal Hospital St.Gallen-Oncology & Hematology ( Site 2702)
Sankt Gallen, Canton of St. Gallen, 9000, Switzerland
Ospedale Regionale Bellinzona e Valli ( Site 2701)
Bellinzona, Canton Ticino, 6501, Switzerland
Ospedale Italiano Lugano (OIL) ( Site 2705)
Lugano, Canton Ticino, 6900, Switzerland
Chang Gung Memorial Hospital - Linkou Branch ( Site 3903)
Taoyuan City, Taoyuan, 333, Taiwan
Chang Gung Memorial Hospital at Kaohsiung ( Site 3905)
Kaohsiung City, 83301, Taiwan
National Cheng Kung University Hospital ( Site 3902)
Tainan, 704, Taiwan
National Taiwan University Hospital ( Site 3901)
Taipei, 10002, Taiwan
Mackay Memorial Hospital ( Site 3908)
Taipei, 10449, Taiwan
Tri-Service General Hospital ( Site 3906)
Taipei, 114, Taiwan
Faculty of Medicine Siriraj Hospital ( Site 4001)
Bangkoknoi, Bangkok, 10700, Thailand
Chulalongkorn University ( Site 4003)
Pathumwan, Bangkok, 10330, Thailand
Maharaj Nakorn Chiang Mai Hospital ( Site 4002)
Muang, Chiang Mai, 50200, Thailand
Ondokuz Mayıs Universitesi ( Site 2806)
Korfez Mahallesi, Samsun, 55270, Turkey (Türkiye)
Namık Kemal University Medical Faculty ( Site 2807)
Suleymanpasa, Tekirdas, 59030, Turkey (Türkiye)
Baskent Universitesi Adana Dr. Turgut Noyan UAM ( Site 2809)
Adana, 01120, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi ( Site 2803)
Ankara, 06200, Turkey (Türkiye)
Hacettepe Universite Hastaneleri ( Site 2810)
Ankara, 06230, Turkey (Türkiye)
Ankara University Faculty of Medicine ( Site 2801)
Ankara, 06620, Turkey (Türkiye)
Antalya Egitim ve Arastirma Hastanesi ( Site 2805)
Antalya, 7100, Turkey (Türkiye)
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi ( Site 2804)
Istanbul, 34722, Turkey (Türkiye)
MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( Site 2904)
Cherkasy, Cherkasy Oblast, 18009, Ukraine
Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council" ( Site 2906)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76008, Ukraine
Khmelnytskyi Regional Hospital ( Site 2907)
Khmelnytskiy, Khmelnytskyi Oblast, 29000, Ukraine
Institute of Blood Pathology and Transfusion Medicine AMS Ukraine ( Site 2903)
Lviv, Lviv Oblast, 79057, Ukraine
SNPE National Cancer Institute ( Site 2902)
Kyiv, 03022, Ukraine
Universal Clinic Oberig ( Site 2908)
Kyiv, 03057, Ukraine
SI National Research Center of Radiation Medicine, Hematology, Oncology ( Site 2901)
Kyiv, 03115, Ukraine
Public Non-Profit Enterprise Kyiv City Clinical Hospital #9 under the Executive Body of Kyiv City Co ( Site 2905)
Kyiv, 04112, Ukraine
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
December 2, 2024
First Posted
December 5, 2024
Study Start
January 27, 2025
Primary Completion (Estimated)
July 2, 2029
Study Completion (Estimated)
March 29, 2032
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf