A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)
Start Date
1/14/2022
Completion Date
9/24/2027
Summary
The purpose of this Phase 2/3, randomized, multisite, open-label, dose confirmation, and expansion study is to evaluate the safety, and efficacy of zilovertamab vedotin (ZV) in combination with standard of care options for the treatment of rrDLBCL. This study will be divided into 2 parts: Dose Confirmation (Part 1) and Efficacy Expansion (Part 2) and will enroll participants who are at least 18 years of age with rrDLBCL. The hypotheses are: ZV in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx) is superior to R-GemOx with respect to progression-free survival (PFS) per Lugano response criteria by blinded independent review committee (BICR); and that ZV in combination with bendamustine rituximab (BR) is superior to BR with respect to PFS per Lugano response criteria by BICR. With protocol amendment 4 (effective: 04-April-2024), enrollment in Cohort B (study arms Bendamustine Rituximab \[BR\] and ZV + BR) is discontinued. No efficacy outcome analysis and hypothesis testing will be conducted for Cohort B.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Zilovertamab vedotin
Rituximab
Gemcitabine
Oxaliplatin
Bendamustine
Granulocyte Colony-Stimulating Factor (G-CSF)
Conditions
Locations
Palo Verde Hematology/ Oncology Center, Ltd. ( Site 0175)
Glendale, Arizona 85304
United States
Beverly Hills Cancer Center ( Site 0184)
Beverly Hills, California 90211
United States
Bass Medical Group ( Site 0166)
Walnut Creek, California 94598
United States
Innovative Clinical Research Institute ( Site 0122)
Whittier, California 90603
United States
Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0163)
Boca Raton, Florida 33486
United States
Clermont Oncology Center ( Site 0174)
Clermont, Florida 34711
United States
BRP-Hialeah Hospital ( Site 0182)
Hialeah, Florida 33013
United States
Illinois Cancer Specialists ( Site 8000)
Niles, Illinois 60714
United States
Saint Elizabeth Medical Center Edgewood ( Site 0165)
Edgewood, Kentucky 41017
United States
University of Kentucky Chandler Medical Center ( Site 0158)
Lexington, Kentucky 40536
United States
Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0133)
Louisville, Kentucky 40207
United States
University of Maryland ( Site 0123)
Baltimore, Maryland 21201
United States
Dana-Farber Cancer Institute-Lymphoma ( Site 0111)
Boston, Massachusetts 02215
United States
University of Massachusetts Medical School ( Site 0119)
Worcester, Massachusetts 01655
United States
Corewell Health ( Site 0162)
Grand Rapids, Michigan 49503
United States
St. Vincent Frontier Cancer Center-Research ( Site 0108)
Billings, Montana 59102
United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0188)
Grand Island, Nebraska 68803
United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0177)
Omaha, Nebraska 68130
United States
Comprehensive Cancer Centers of Nevada ( Site 0168)
Las Vegas, Nevada 89169
United States
Atlantic Health System ( Site 0116)
Morristown, New Jersey 07960
United States
Presbyterian Rust Jorgensen Cancer ( Site 9506)
Rio Rancho, New Mexico 87124
United States
New York Medical College ( Site 0113)
Valhalla, New York 10595
United States
Alliance Cancer Specialists (ACS) ( Site 8001)
Horsham, Pennsylvania 19044
United States
Tennessee Cancer Specialists ( Site 7000)
Knoxville, Tennessee 37909
United States
Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 0156)
Nashville, Tennessee 37232
United States
Blue Ridge Cancer Care ( Site 0169)
Roanoke, Virginia 24014
United States
Hospital Italiano de Buenos Aires ( Site 2203)
Ciudad Autonoma de Buenos Aires, Buenos Aires C1199ABB
Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 2205)
Mar del Plata, Buenos Aires B7600FZO
Argentina
Hospital Aleman ( Site 2200)
Buenos Aites, Buenos Aires F.D. C1118AAT
Argentina
Hospital Privado Universitario de Córdoba ( Site 2202)
Córdoba, Córdoba Province X5016KEH
Argentina
Instituto Alexander Fleming ( Site 2201)
CABA, C1426ANZ
Argentina
Townsville University Hospital ( Site 1800)
Townsville, Queensland 4814
Australia
Grampians Health ( Site 1802)
Ballarat, Victoria 3350
Australia
Royal Perth Hospital-Haematology ( Site 1801)
Perth, Western Australia 6000
Australia
Hospital Erasto Gaertner ( Site 2302)
Curitiba, Paraná 81520-060
Brazil
Liga Norte Riograndense Contra o Câncer ( Site 2305)
Natal, Rio Grande do Norte 59062-000
Brazil
Hospital Paulistano ( Site 2300)
São Paulo, 01321-001
Brazil
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0200)
Toronto, Ontario M5G 2M9
Canada
Biocenter ( Site 2401)
Concepción, Biobio 4070196
Chile
IC La Serena Research ( Site 2405)
La Serena, Coquimbo Region 1720430
Chile
Oncocentro Valdivia ( Site 2407)
Valdivia, Los Ríos Region 5112129
Chile
FALP-UIDO ( Site 2400)
Santiago, Region M. de Santiago 7500921
Chile
Clínica Inmunocel ( Site 2404)
Santiago, Region M. de Santiago 7580206
Chile
Clínica RedSalud Vitacura ( Site 2409)
Santiago, Region M. de Santiago 7650018
Chile
Bradfordhill ( Site 2403)
Santiago, Region M. de Santiago 8420383
Chile
Beijing Cancer hospital ( Site 3000)
Beijing, Beijing Municipality 100142
China
Chongqing University Cancer Hospital-Medical Oncology ( Site 3025)
Chongqing, Chongqing Municipality 400030
China
Chongqing University Three Gorges Hospital ( Site 3026)
Chongqing, Chongqing Municipality 404199
China
Sun Yat-sen University Cancer Center-Internal Medicine ( Site 3001)
Guangzhou, Guangdong 510060
China
Zhujiang Hospital ( Site 3002)
Guangzhou, Guangdong 510280
China
The First Affiliated Hospital of Henan University of Science &Technology ( Site 3029)
Luoyang, Henan 471003
China
Henan Cancer Hospital-hematology department ( Site 3013)
Zhengzhou, Henan 450008
China
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 3017)
Wuhan, Hubei 430048
China
The First Affiliated Hospital of Nanchang University ( Site 3004)
Nanchang, Jiangxi 330006
China
Jiangxi Provincial Cancer Hospital ( Site 3005)
Nanchang, Jiangxi 330029
China
The First Hospital of Jilin University-Hematology ( Site 3012)
Changchun, Jilin 130021
China
Fudan University Shanghai Cancer Center ( Site 3009)
Shanghai, Shanghai Municipality 200032
China
Sichuan Cancer hospital-Oncology ( Site 3021)
Chengdu, Sichuan 610041
China
West China Hospital of Sichuan University-Head and Neck Oncology ( Site 3016)
Chengdu, Sichuan 610041
China
Zhejiang Cancer Hospital ( Site 3014)
Hangzhou, Zhejiang 310000
China
The First Affiliated Hospital Zhejiang University School of Medicine ( Site 3027)
Hangzhou, Zhejiang 310003
China
Hospital Pablo Tobon Uribe ( Site 0804)
Medellín, Antioquia 50034
Colombia
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0801)
Bogotá, Bogota D.C. 110131
Colombia
Instituto Médico de Alta Tecnologia S.A.S ( Site 0803)
Montería, Departamento de Córdoba 230002
Colombia
Oncologos del Occidente ( Site 0800)
Pereira, Risaralda Department 660001
Colombia
Fundacion Valle del Lili ( Site 0802)
Cali, Valle del Cauca Department 760032
Colombia
Hospital Metropolitano - Sede Lindora ( Site 2500)
Santa Ana, Provincia de San José 10903
Costa Rica
CIMCA ( Site 2501)
San José, 10103
Costa Rica
Aarhus Universitetshospital, Skejby ( Site 1701)
Aarhus, Central Jutland 8200
Denmark
centre hospitalier lyon sud-Service Hématologie ( Site 0702)
Pierre-Bénite, Rhone 69310
France
Pitie Salpetriere University Hospital-Clinical haematology ( Site 0700)
Paris, 75013
France
Evangelismos General Hospital of Athens ( Site 0900)
Athens, Attica 106 76
Greece
Regional General Hospital of Athens "Laiko" ( Site 0901)
Athens, Attica 115 26
Greece
University Hospital of Alexandroupolis ( Site 0903)
Alexandroupoli, East Macedonia and Thrace 681 00
Greece
MEDI-K ( Site 2602)
Guatemala City, 01009
Guatemala
Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 2601)
Guatemala City, 01010
Guatemala
CELAN,S.A ( Site 2603)
Guatemala City, 1010
Guatemala
Queen Mary Hospital ( Site 3100)
Hong Kong, 000000
Hong Kong
Princess Margaret Hospital ( Site 3101)
Hong Kong,
Hong Kong
Emek Medical Center-Hematology Unit ( Site 1102)
Afula, 1834111
Israel
Carmel Hospital ( Site 1103)
Haifa, 3436212
Israel
Hadassah Medical Center ( Site 1100)
Jerusalem, 9112001
Israel
Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1203)
Rozzano, Milano 20089
Italy
IRCCS - AOU di Bologna-Istituto di Ematologia "L. e A. Seragnoli" ( Site 1200)
Bologna, 40138
Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1202)
Naples, 80131
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -ISTITUTO DI EMATOLOGIA ( Site 1204)
Roma, 00168
Italy
Hokkaido University Hospital ( Site 3202)
Sapporo, Hokkaido 060-8648
Japan
Tokai University Hospital ( Site 3212)
Isehara, Kanagawa 259-1193
Japan
Mie University Hospital ( Site 3210)
Tsu, Mie-ken 514-8507
Japan
Kansai Medical University Hospital ( Site 3203)
Hirakata, Osaka 573-1191
Japan
Tokyo Metropolitan Komagome Hospital ( Site 3200)
Bunkyo, Tokyo 113-8677
Japan
The Jikei University Hospital ( Site 3208)
Minato, Tokyo 105-8471
Japan
University of Yamanashi Hospital ( Site 3201)
Chūō, Yamanashi 409-3898
Japan
National Hospital Organization Kyushu Cancer Center ( Site 3204)
Fukuoka, 811-1395
Japan
Fukushima Medical University Hospital ( Site 3207)
Fukushima, 960-1295
Japan
University Hospital,Kyoto Prefectural University of Medicine ( Site 3209)
Kyoto, 602-8566
Japan
University of Miyazaki Hospital ( Site 3211)
Miyazaki, 889-1692
Japan
Osaka Metropolitan University Hospital ( Site 3205)
Osaka, 545-8586
Japan
Yamagata University Hospital ( Site 3206)
Yamagata, 990-9585
Japan
Health Pharma Professional Research S.A. de C.V: ( Site 2700)
Mexico City, Mexico City 03100
Mexico
Medivest Centro de Investigación Integral ( Site 2704)
Chihuahua City, 31203
Mexico
Centro de Infusion Superare ( Site 2701)
Mexico City, 03104
Mexico
Aotearoa Clinical Trials ( Site 0501)
Auckland, 2025
New Zealand
Clínicas AUNA Sede Chiclayo ( Site 2803)
Chiclayo, Lambayeque 14001
Peru
INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 2800)
Surquillo, Muni Metro de Lima 15038
Peru
Clínica San Felipe ( Site 2805)
Lima, 15072
Peru
Hospital Nacional Edgardo Rebagliati Martins ( Site 2802)
Lima, 15072
Peru
Hospital Nacional Dos De Mayo ( Site 2804)
Lima, 15087
Peru
Pratia MCM Krakow ( Site 1303)
Krakow, Lesser Poland Voivodeship 30-727
Poland
Specjalistyczny Szpital im. Dr Alfreda Sokolowskiego w Walbrzychu ( Site 1305)
Wałbrzych, Lower Silesian Voivodeship 58-309
Poland
Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site 1301)
Wroclaw, Lower Silesian Voivodeship 50-367
Poland
Centrum Onkologii Ziemi Lubelskiej-Oddzial Hematologii i Transplantacji Szpiku ( Site 1304)
Lublin, Lublin Voivodeship 20-090
Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( Site 1300)
Warsaw, Masovian Voivodeship 02-781
Poland
Szpitale Pomorskie Sp. z o. o.-Hematology and Bone Marrow Transplantation Department ( Site 1302)
Gdynia, Pomeranian Voivodeship 81-519
Poland
Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku ( Site 1309)
Słupsk, Pomeranian Voivodeship 76-200
Poland
Pratia Onkologia Katowice ( Site 1306)
Katowice, Silesian Voivodeship 40-519
Poland
Seoul National University Hospital-Oncology ( Site 0302)
Seoul, 03080
South Korea
Samsung Medical Center ( Site 0300)
Seoul, 06351
South Korea
Faculty of Medicine Siriraj Hospital-Division of Hematology, Department of Medicine ( Site 0400)
Bangkok, Bangkok 10700
Thailand
Chulalongkorn University ( Site 0402)
Pathumwan, Bangkok 10330
Thailand
Maharaj Nakorn Chiang Mai Hospital ( Site 0401)
Chiang Mai, 50200
Thailand
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi ( Site 1912)
Yenimahalle, Ankara 06200
Turkey (Türkiye)
Ege University Medicine of Faculty ( Site 1902)
Bornova, İzmir 35100
Turkey (Türkiye)
Ankara University Hospital Cebeci-hematology ( Site 1901)
Ankara, 06100
Turkey (Türkiye)
Mega Medipol-Hematology ( Site 1909)
Istanbul, 34214
Turkey (Türkiye)
Dokuz Eylül Üniversitesi-Hematology ( Site 1905)
Izmir, 35340
Turkey (Türkiye)
Ondokuz Mayıs Universitesi ( Site 1907)
Samsun, 55139
Turkey (Türkiye)
MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( Site 2000)
Cherkasy, Cherkasy Oblast 18009
Ukraine
Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council" ( Site 2004)
Ivano-Frankivsk, Ivano-Frankivsk Oblast 76008
Ukraine
Institute of Blood Pathology and Transfusion Medicine AMS Ukraine ( Site 2002)
Lviv, Lviv Oblast 79057
Ukraine
State non-profit enterprise National Cancer Institute ( Site 2001)
Kyiv, 03022
Ukraine
National Research Center for Radiation Medicine of National Academy of Medical Sciences of Ukraine ( Site 2005)
Kyiv, 03115
Ukraine
Aberdeen Royal Infirmary ( Site 2104)
Aberdeen, Aberdeen City AB25 2ZN
United Kingdom
The Royal Cornwall Hospital ( Site 2103)
Truro, England TR1 3LJ
United Kingdom
University College London Hospital-Cancer Clinical Trials Unit ( Site 2100)
London-Camden, London, City of NW1 2PG
United Kingdom