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)

June 2, 2026 updated by: Merck Sharp & Dohme LLC

A Phase 2/3 Multicenter, Open-label, Randomized, Active-Control Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (waveLINE-003)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

290

Phase

Phase 2
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

Name: Toll Free Number
Phone Number: 1-888-577-8839
Email: Trialsites@msd.com

Study Locations

Argentina
- - CABA, Argentina, C1426ANZ
    - Recruiting
    - Instituto Alexander Fleming ( Site 2201)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +541132218900
- Buenos Aires
  - Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1199ABB
    - Recruiting
    - Hospital Italiano de Buenos Aires ( Site 2203)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +541149590200
  - Mar del Plata, Buenos Aires, Argentina, B7600FZO
    - Recruiting
    - Instituto de Investigaciones Clínicas Mar del Plata ( Site 2205)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +542234963224
- Buenos Aires F.D.
  - Buenos Aites, Buenos Aires F.D., Argentina, C1118AAT
    - Recruiting
    - Hospital Aleman ( Site 2200)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +541148277000
- Córdoba Province
  - Córdoba, Córdoba Province, Argentina, X5016KEH
    - Recruiting
    - Hospital Privado Universitario de Córdoba ( Site 2202)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +543514688200
Australia
- Queensland
  - Douglas, Queensland, Australia, 4814
    - Recruiting
    - Townsville University Hospital ( Site 1800)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +61744333549
- Victoria
  - Ballarat, Victoria, Australia, 3350
    - Recruiting
    - Grampians Health ( Site 1802)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +61353208500
- Western Australia
  - Perth, Western Australia, Australia, 6000
    - Recruiting
    - Royal Perth Hospital-Haematology ( Site 1801)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +61892242405
Brazil
- - São Paulo, Brazil, 01321-001
    - Recruiting
    - Hospital Paulistano ( Site 2300)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +551131411083
- Paraná
  - Curitiba, Paraná, Brazil, 81520-060
    - Recruiting
    - Hospital Erasto Gaertner ( Site 2302)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +5541999846033
- Rio Grande do Norte
  - Natal, Rio Grande do Norte, Brazil, 59062-000
    - Recruiting
    - Liga Norte Riograndense Contra o Câncer ( Site 2305)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +55 (84) 99927-8442
Canada
- Ontario
  - Toronto, Ontario, Canada, M5G 2M9
    - Completed
    - Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0200)
Chile
- Biobio
  - Concepción, Biobio, Chile, 4070196
    - Recruiting
    - Biocenter ( Site 2401)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +56412858421
- Coquimbo Region
  - La Serena, Coquimbo Region, Chile, 1720430
    - Recruiting
    - IC La Serena Research ( Site 2405)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +56958646664
- Los Ríos Region
  - Valdivia, Los Ríos Region, Chile, 5112129
    - Recruiting
    - Oncocentro Valdivia ( Site 2407)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +56958537020
- Region M. de Santiago
  - Santiago, Region M. de Santiago, Chile, 7580206
    - Recruiting
    - Clínica Inmunocel ( Site 2404)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +56224376600
  - Santiago, Region M. de Santiago, Chile, 7650018
    - Recruiting
    - Clínica RedSalud Vitacura ( Site 2409)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 56223954044
  - Santiago, Region M. de Santiago, Chile, 8420383
    - Recruiting
    - Bradfordhill ( Site 2403)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +56229490970
  - Santiago, Region M. de Santiago, Chile, 7500921
    - Completed
    - FALP-UIDO ( Site 2400)
China
- Beijing Municipality
  - Beijing, Beijing Municipality, China, 100142
    - Recruiting
    - Beijing Cancer hospital ( Site 3000)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +8601088196698
- Chongqing Municipality
  - Chongqing, Chongqing Municipality, China, 404199
    - Active, not recruiting
    - Chongqing University Three Gorges Hospital ( Site 3026)
  - Chongqing, Chongqing Municipality, China, 400030
    - Active, not recruiting
    - Chongqing University Cancer Hospital-Medical Oncology ( Site 3025)
- Guangdong
  - Guangzhou, Guangdong, China, 510280
    - Recruiting
    - Zhujiang Hospital ( Site 3002)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +86-020-61643888
  - Guangzhou, Guangdong, China, 510060
    - Recruiting
    - Sun Yat-sen University Cancer Center-Internal Medicine ( Site 3001)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +86-020-87343272
- Henan
  - Luoyang, Henan, China, 471003
    - Active, not recruiting
    - The First Affiliated Hospital of Henan University of Science &Technology ( Site 3029)
  - Zhengzhou, Henan, China, 450008
    - Recruiting
    - Henan Cancer Hospital-hematology department ( Site 3013)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 0371-65588007
- Hubei
  - Wuhan, Hubei, China, 430048
    - Recruiting
    - Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 3017)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 027-85726685
- Jiangxi
  - Nanchang, Jiangxi, China, 330029
    - Recruiting
    - Jiangxi Provincial Cancer Hospital ( Site 3005)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 079188329441
  - Nanchang, Jiangxi, China, 330006
    - Active, not recruiting
    - The First Affiliated Hospital of Nanchang University ( Site 3004)
- Jilin
  - Changchun, Jilin, China, 130021
    - Recruiting
    - The First Hospital of Jilin University-Hematology ( Site 3012)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 13756948057
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, China, 200032
    - Recruiting
    - Fudan University Shanghai Cancer Center ( Site 3009)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 021 6417 5589
- Sichuan
  - Chengdu, Sichuan, China, 610041
    - Recruiting
    - West China Hospital of Sichuan University-Head and Neck Oncology ( Site 3016)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +8618980601027
  - Chengdu, Sichuan, China, 610041
    - Recruiting
    - Sichuan Cancer hospital-Oncology ( Site 3021)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +8613668112022
- Zhejiang
  - Hangzhou, Zhejiang, China, 310000
    - Recruiting
    - Zhejiang Cancer Hospital ( Site 3014)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 0571 8812 2222
  - Hangzhou, Zhejiang, China, 310003
    - Recruiting
    - The First Affiliated Hospital Zhejiang University School of Medicine ( Site 3027)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 0571-87236114
Colombia
- Antioquia
  - Medellín, Antioquia, Colombia, 50034
    - Recruiting
    - Hospital Pablo Tobon Uribe ( Site 0804)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 6044459753
- Bogota D.C.
  - Bogotá, Bogota D.C., Colombia, 110131
    - Recruiting
    - FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0801)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 3044921963
- Departamento de Córdoba
  - Montería, Departamento de Córdoba, Colombia, 230002
    - Recruiting
    - Instituto Médico de Alta Tecnologia S.A.S ( Site 0803)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 3135342052
- Risaralda Department
  - Pereira, Risaralda Department, Colombia, 660001
    - Recruiting
    - Oncologos del Occidente ( Site 0800)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +57 3187715522
- Valle del Cauca Department
  - Cali, Valle del Cauca Department, Colombia, 760032
    - Recruiting
    - Fundacion Valle del Lili ( Site 0802)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +576023319090
Costa Rica
- - San José, Costa Rica, 10103
    - Recruiting
    - CIMCA ( Site 2501)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +506 6041 6775
- Provincia de San José
  - Santa Ana, Provincia de San José, Costa Rica, 10903
    - Recruiting
    - Hospital Metropolitano - Sede Lindora ( Site 2500)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +506 8497 8912
Denmark
- Central Jutland
  - Aarhus, Central Jutland, Denmark, 8200
    - Recruiting
    - Aarhus Universitetshospital, Skejby ( Site 1701)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +4578450000
France
- - Paris, France, 75013
    - Active, not recruiting
    - Pitie Salpetriere University Hospital-Clinical haematology ( Site 0700)
- Rhone
  - Pierre-Bénite, Rhone, France, 69310
    - Active, not recruiting
    - centre hospitalier lyon sud-Service Hématologie ( Site 0702)
Greece
- Attica
  - Athens, Attica, Greece, 106 76
    - Recruiting
    - Evangelismos General Hospital of Athens ( Site 0900)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 0030 2132041721
  - Athens, Attica, Greece, 115 26
    - Recruiting
    - Regional General Hospital of Athens "Laiko" ( Site 0901)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 0030 2136060981
- East Macedonia and Thrace
  - Alexandroupoli, East Macedonia and Thrace, Greece, 681 00
    - Recruiting
    - University Hospital of Alexandroupolis ( Site 0903)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 0030 2551353739
Guatemala
- - Guatemala City, Guatemala, 01009
    - Recruiting
    - MEDI-K ( Site 2602)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +502 5366 8125
  - Guatemala City, Guatemala, 01010
    - Recruiting
    - Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 2601)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +502 3014 7611
  - Guatemala City, Guatemala, 1010
    - Recruiting
    - CELAN,S.A ( Site 2603)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +502 5200 2329
Hong Kong
- - Hong Kong, Hong Kong, 000000
    - Recruiting
    - Queen Mary Hospital ( Site 3100)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +85222553838
  - Hong Kong, Hong Kong
    - Active, not recruiting
    - Princess Margaret Hospital ( Site 3101)
Israel
- - Afula, Israel, 1834111
    - Completed
    - Emek Medical Center-Hematology Unit ( Site 1102)
  - Haifa, Israel, 3436212
    - Completed
    - Carmel Hospital ( Site 1103)
  - Jerusalem, Israel, 9112001
    - Completed
    - Hadassah Medical Center ( Site 1100)
Italy
- - Bologna, Italy, 40138
    - Completed
    - IRCCS - AOU di Bologna-Istituto di Ematologia "L. e A. Seragnoli" ( Site 1200)
  - Naples, Italy, 80131
    - Recruiting
    - Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1202)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 390815903382
  - Roma, Italy, 00168
    - Completed
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS -ISTITUTO DI EMATOLOGIA ( Site 1204)
- Milano
  - Rozzano, Milano, Italy, 20089
    - Recruiting
    - Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1203)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 0282244080
Japan
- - Fukuoka, Japan, 811-1395
    - Recruiting
    - National Hospital Organization Kyushu Cancer Center ( Site 3204)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +81-92-541-3231
  - Fukushima, Japan, 960-1295
    - Recruiting
    - Fukushima Medical University Hospital ( Site 3207)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +81-24-547-1111
  - Kyoto, Japan, 602-8566
    - Recruiting
    - University Hospital,Kyoto Prefectural University of Medicine ( Site 3209)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +81-75-251-5871
  - Yamagata, Japan, 990-9585
    - Recruiting
    - Yamagata University Hospital ( Site 3206)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +81-23-633-1122
- Hokkaido
  - Sapporo, Hokkaido, Japan, 060-8648
    - Recruiting
    - Hokkaido University Hospital ( Site 3202)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +81-11-716-1161
- Mie-ken
  - Tsu, Mie-ken, Japan, 514-8507
    - Recruiting
    - Mie University Hospital ( Site 3210)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +81-59-231-5246
- Osaka
  - Hirakata, Osaka, Japan, 573-1191
    - Recruiting
    - Kansai Medical University Hospital ( Site 3203)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +81-72-804-2808
- Tokyo
  - Bunkyo, Tokyo, Japan, 113-8677
    - Recruiting
    - Tokyo Metropolitan Komagome Hospital ( Site 3200)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +81-3-3823-2101
  - Minato, Tokyo, Japan, 105-8471
    - Recruiting
    - The Jikei University Hospital ( Site 3208)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +81-3-3433-1111
- Yamanashi
  - Chūō, Yamanashi, Japan, 409-3898
    - Recruiting
    - University of Yamanashi Hospital ( Site 3201)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +81-55-273-1111
Mexico
- - Chihuahua City, Mexico, 31203
    - Completed
    - Medivest Centro de Investigación Integral ( Site 2704)
  - Mexico City, Mexico, 03104
    - Completed
    - Centro de Infusion Superare ( Site 2701)
- Mexico City
  - Mexico City, Mexico City, Mexico, 03100
    - Completed
    - Health Pharma Professional Research S.A. de C.V: ( Site 2700)
New Zealand
- - Auckland, New Zealand, 2025
    - Recruiting
    - Aotearoa Clinical Trials ( Site 0501)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +64 9 277 1660
Peru
- - Lima, Peru, 15072
    - Recruiting
    - Clínica San Felipe ( Site 2805)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 511 2039900 Ext 131
  - Lima, Peru, 15072
    - Recruiting
    - Hospital Nacional Edgardo Rebagliati Martins ( Site 2802)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +51991895682
  - Lima, Peru, 15087
    - Recruiting
    - Hospital Nacional Dos De Mayo ( Site 2804)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +51944464618
- Lambayeque
  - Chiclayo, Lambayeque, Peru, 14001
    - Recruiting
    - Clínicas AUNA Sede Chiclayo ( Site 2803)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 51 74748333 Ext 7832
- Muni Metro de Lima
  - Surquillo, Muni Metro de Lima, Peru, 15038
    - Recruiting
    - INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 2800)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +512016500
Poland
- Lesser Poland Voivodeship
  - Krakow, Lesser Poland Voivodeship, Poland, 30-727
    - Recruiting
    - Pratia MCM Krakow ( Site 1303)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 0048602338290
- Lower Silesian Voivodeship
  - Wałbrzych, Lower Silesian Voivodeship, Poland, 58-309
    - Recruiting
    - Specjalistyczny Szpital im. Dr Alfreda Sokolowskiego w Walbrzychu ( Site 1305)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +48746489966
  - Wroclaw, Lower Silesian Voivodeship, Poland, 50-367
    - Completed
    - Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site 1301)
- Lublin Voivodeship
  - Lublin, Lublin Voivodeship, Poland, 20-090
    - Completed
    - Centrum Onkologii Ziemi Lubelskiej-Oddzial Hematologii i Transplantacji Szpiku ( Site 1304)
- Masovian Voivodeship
  - Warsaw, Masovian Voivodeship, Poland, 02-781
    - Recruiting
    - Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( Site 1300)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 0048225462366
- Pomeranian Voivodeship
  - Gdynia, Pomeranian Voivodeship, Poland, 81-519
    - Completed
    - Szpitale Pomorskie Sp. z o. o.-Hematology and Bone Marrow Transplantation Department ( Site 1302)
  - Słupsk, Pomeranian Voivodeship, Poland, 76-200
    - Recruiting
    - Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku ( Site 1309)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 59 84 60 390
- Silesian Voivodeship
  - Katowice, Silesian Voivodeship, Poland, 40-519
    - Recruiting
    - Pratia Onkologia Katowice ( Site 1306)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +48600388282
South Korea
- - Seoul, South Korea, 03080
    - Recruiting
    - Seoul National University Hospital-Oncology ( Site 0302)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 82220723559
  - Seoul, South Korea, 06351
    - Completed
    - Samsung Medical Center ( Site 0300)
Thailand
- - Chiang Mai, Thailand, 50200
    - Active, not recruiting
    - Maharaj Nakorn Chiang Mai Hospital ( Site 0401)
- Bangkok
  - Bangkok, Bangkok, Thailand, 10700
    - Active, not recruiting
    - Faculty of Medicine Siriraj Hospital-Division of Hematology, Department of Medicine ( Site 0400)
  - Pathumwan, Bangkok, Thailand, 10330
    - Active, not recruiting
    - Chulalongkorn University ( Site 0402)
Turkey (Türkiye)
- - Ankara, Turkey (Türkiye), 06100
    - Recruiting
    - Ankara University Hospital Cebeci-hematology ( Site 1901)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +90 505 502 50 50
  - Istanbul, Turkey (Türkiye), 34214
    - Recruiting
    - Mega Medipol-Hematology ( Site 1909)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 444 7 044
  - Izmir, Turkey (Türkiye), 35340
    - Recruiting
    - Dokuz Eylül Üniversitesi-Hematology ( Site 1905)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +905425151780
  - Samsun, Turkey (Türkiye), 55139
    - Completed
    - Ondokuz Mayıs Universitesi ( Site 1907)
- Ankara
  - Yenimahalle, Ankara, Turkey (Türkiye), 06200
    - Recruiting
    - Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi ( Site 1912)
    - Contact:
      
      Study Coordinator
      
      Phone Number: (0312) 336 09 09
- İzmir
  - Bornova, İzmir, Turkey (Türkiye), 35100
    - Recruiting
    - Ege University Medicine of Faculty ( Site 1902)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +905325566128
Ukraine
- - Kyiv, Ukraine, 03022
    - Recruiting
    - State non-profit enterprise National Cancer Institute ( Site 2001)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +380442571090
  - Kyiv, Ukraine, 03115
    - Completed
    - National Research Center for Radiation Medicine of National Academy of Medical Sciences of Ukraine ( Site 2005)
- Cherkasy Oblast
  - Cherkasy, Cherkasy Oblast, Ukraine, 18009
    - Recruiting
    - MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( Site 2000)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +380472370025
- Ivano-Frankivsk Oblast
  - Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76008
    - Recruiting
    - Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council" ( Site 2004)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 380974668727
- Lviv Oblast
  - Lviv, Lviv Oblast, Ukraine, 79057
    - Recruiting
    - Institute of Blood Pathology and Transfusion Medicine AMS Ukraine ( Site 2002)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 380322352276
United Kingdom
- Aberdeen City
  - Aberdeen, Aberdeen City, United Kingdom, AB25 2ZN
    - Completed
    - Aberdeen Royal Infirmary ( Site 2104)
- England
  - Truro, England, United Kingdom, TR1 3LJ
    - Recruiting
    - The Royal Cornwall Hospital ( Site 2103)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 44 01872 252527
- London, City of
  - London-Camden, London, City of, United Kingdom, NW1 2PG
    - Recruiting
    - University College London Hospital-Cancer Clinical Trials Unit ( Site 2100)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 02034472528
United States
- Arizona
  - Glendale, Arizona, United States, 85304
    - Recruiting
    - Palo Verde Hematology/ Oncology Center, Ltd. ( Site 0175)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 602-978-6255
- California
  - Beverly Hills, California, United States, 90211
    - Recruiting
    - Beverly Hills Cancer Center ( Site 0184)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 310-432-8900
  - Walnut Creek, California, United States, 94598
    - Recruiting
    - Bass Medical Group ( Site 0166)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 925-433-8786
  - Whittier, California, United States, 90603
    - Completed
    - Innovative Clinical Research Institute ( Site 0122)
- Florida
  - Boca Raton, Florida, United States, 33486
    - Recruiting
    - Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0163)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 561-955-4145
  - Clermont, Florida, United States, 34711
    - Recruiting
    - Clermont Oncology Center ( Site 0174)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 352-242-1366
  - Hialeah, Florida, United States, 33013
    - Recruiting
    - BRP-Hialeah Hospital ( Site 0182)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 833-489-4968
- Illinois
  - Niles, Illinois, United States, 60714
    - Recruiting
    - Illinois Cancer Specialists ( Site 8000)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 847-827-9060
- Kentucky
  - Edgewood, Kentucky, United States, 41017
    - Recruiting
    - Saint Elizabeth Medical Center Edgewood ( Site 0165)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 859-301-2000
  - Lexington, Kentucky, United States, 40536
    - Recruiting
    - University of Kentucky Chandler Medical Center ( Site 0158)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 859-257-3379
  - Louisville, Kentucky, United States, 40207
    - Recruiting
    - Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0133)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 502-629-3681
- Maryland
  - Baltimore, Maryland, United States, 21201
    - Recruiting
    - University of Maryland ( Site 0123)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 410-328-7996
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Recruiting
    - Dana-Farber Cancer Institute-Lymphoma ( Site 0111)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 617-632-2305
  - Worcester, Massachusetts, United States, 01655
    - Recruiting
    - University of Massachusetts Medical School ( Site 0119)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 774-455-4446
- Michigan
  - Grand Rapids, Michigan, United States, 49503
    - Recruiting
    - Corewell Health ( Site 0162)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 616-486-6180
- Montana
  - Billings, Montana, United States, 59102
    - Recruiting
    - St. Vincent Frontier Cancer Center-Research ( Site 0108)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 406-238-6290
- Nebraska
  - Grand Island, Nebraska, United States, 68803
    - Recruiting
    - Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0188)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 402-334-4773
  - Omaha, Nebraska, United States, 68130
    - Recruiting
    - Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0177)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 402-334-4773
- Nevada
  - Las Vegas, Nevada, United States, 89169
    - Recruiting
    - Comprehensive Cancer Centers of Nevada ( Site 0168)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 702-952-3400
- New Jersey
  - Morristown, New Jersey, United States, 07960
    - Completed
    - Atlantic Health System ( Site 0116)
- New Mexico
  - Rio Rancho, New Mexico, United States, 87124
    - Recruiting
    - Presbyterian Rust Jorgensen Cancer ( Site 9506)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 505-559-6100
- New York
  - Valhalla, New York, United States, 10595
    - Recruiting
    - New York Medical College ( Site 0113)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 914-594-2150
- Pennsylvania
  - Horsham, Pennsylvania, United States, 19044
    - Recruiting
    - Alliance Cancer Specialists (ACS) ( Site 8001)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 215-706-4176
- Tennessee
  - Knoxville, Tennessee, United States, 37909
    - Recruiting
    - Tennessee Cancer Specialists ( Site 7000)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 865-862-0998
  - Nashville, Tennessee, United States, 37232
    - Completed
    - Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 0156)
- Virginia
  - Roanoke, Virginia, United States, 24014
    - Recruiting
    - Blue Ridge Cancer Care ( Site 0169)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 540-982-0237

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Has a histologically confirmed diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL).
Has radiographically measurable DLBCL per the Lugano Response Criteria, as assessed locally by the investigator.
Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 within 7 days prior to study treatment initiation.
Has adequate organ function.
Is able to provide new or archival tumor tissue sample not previously irradiated.

Zilovertamab vedotin plus R-GemOx, or R-GemOx study arms:

Has relapsed or refractory DLBCL and is ineligible for or have failed autologous stem-cell transplant (ASCT) and have failed at least 1 line of prior therapy.
Has post-chimeric antigen receptor T (post-CAR-T) cell therapy failure or is ineligible for CAR-T cell therapy.

Not applicable with protocol amendment 4: Zilovertamab vedotin plus Bendamustine Rituximab (BR), and Bendamustine Rituximab study arms:

Has relapsed or refractory DLBCL and is ineligible for or have failed ASCT and have failed at least 2 lines of prior therapy.
Has post-CAR-T therapy failure or is ineligible for CAR-T cell therapy.

Exclusion Criteria:

Not applicable with protocol amendment 4: Has history of transformation of indolent disease to DLBCL
Has received solid organ transplant at any time.
Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL).
Has clinically significant (ie, active) cardiovascular disease or serious cardiac arrhythmia requiring medication.
Has ongoing graft-versus-host disease (GVHD) of any grade, or is receiving treatment for their GVHD.
Has clinically significant pericardial or pleural effusion.
Has ongoing Grade >1 peripheral neuropathy.
Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
Has a demyelinating form of Charcot-Marie-Tooth disease.
Has contraindication to any of the study intervention components including but not limited to prior anaphylactic reaction.
Has received prior systemic anticancer therapy, including investigational agents within 4 weeks prior to the first dose of study intervention.
Has received prior radiotherapy within 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
Has ongoing corticosteroid therapy.
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
Has known active central nervous system (CNS) lymphoma involvement or active CNS involvement by lymphoma. Participants with prior CNS involvement are eligible if their CNS disease is in radiographic, cytological (for cerebrospinal fluid disease), and clinical remission.
Has an active infection requiring systemic therapy.
Has a known history of human immunodeficiency virus (HIV) infection.
Has a known active Hepatitis C virus infection.
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.

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: Sequential Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ZV + R-GemOx (Part 1) Participants in this arm will receive doses of ZV (from 1.5 mg/Kg up to 2.5 mg/Kg) plus Rituximab 375 mg/m^2, Gemcitabine 1000 mg/m^2 and Oxaliplatin 100 mg/m^2 (R-GemOx) given intravenously on Day 1 of repeated 21-day cycles. Treatment will continue for up to 6 cycles.	Biological: Zilovertamab vedotin Intravenous (IV) Infusion 1.5 mg/kg, 1.75 mg/kg, 2.0 mg/kg, 2.25 mg/kg, 2.5 mg/kg Other Names: MK-2140 VLS-101 Biological: Rituximab IV Infusion 375 mg/m^2 Other Names: Rituxan®/mabthera Truxima® (rituximab-abbs) RUXIENCE®, RIABNI® Drug: Gemcitabine IV Infusion 1000 mg/m^2 Other Names: Gemzar® Drug: Oxaliplatin IV Infusion 100 mg/m^2 Other Names: Eloxatin® Drug: Granulocyte Colony-Stimulating Factor (G-CSF) Prophylactic G-CSF will be administered at each cycle of zilovertamab vedotin as per the institutional guidelines.
Experimental: ZV + R-GemOx (Part 2) Using the recommended Phase 2 dose (RP2D) dose of ZV plus R-GemOx from Part 1, participants will receive ZV plus R-GemOx given intravenously on Day 1 of repeated 21-day cycles. Treatment will continue for up to 6 cycles or until progressive disease or discontinuation.	Biological: Zilovertamab vedotin Intravenous (IV) Infusion 1.5 mg/kg, 1.75 mg/kg, 2.0 mg/kg, 2.25 mg/kg, 2.5 mg/kg Other Names: MK-2140 VLS-101 Biological: Rituximab IV Infusion 375 mg/m^2 Other Names: Rituxan®/mabthera Truxima® (rituximab-abbs) RUXIENCE®, RIABNI® Drug: Gemcitabine IV Infusion 1000 mg/m^2 Other Names: Gemzar® Drug: Oxaliplatin IV Infusion 100 mg/m^2 Other Names: Eloxatin® Drug: Granulocyte Colony-Stimulating Factor (G-CSF) Prophylactic G-CSF will be administered at each cycle of zilovertamab vedotin as per the institutional guidelines.
Active Comparator: R-GemOx (active control for Part 2) Participants will receive R-GemOx given intravenously on Day 1 of repeated 21-day cycles. Treatment will continue for up to 6 cycles or until progressive disease or discontinuation.	Biological: Rituximab IV Infusion 375 mg/m^2 Other Names: Rituxan®/mabthera Truxima® (rituximab-abbs) RUXIENCE®, RIABNI® Drug: Gemcitabine IV Infusion 1000 mg/m^2 Other Names: Gemzar® Drug: Oxaliplatin IV Infusion 100 mg/m^2 Other Names: Eloxatin®
Experimental: ZV + BR (Part 2) Using RP2D from Part 1, participants will receive ZV plus Rituximab 375 mg/m^2, given intravenously on Day 1 and Bendamustine 90 mg/m^2 given intravenously on Day 1 and 2, of repeated 21-day cycles. Treatment will continue for up to 6 cycles or until progressive disease or discontinuation.	Biological: Zilovertamab vedotin Intravenous (IV) Infusion 1.5 mg/kg, 1.75 mg/kg, 2.0 mg/kg, 2.25 mg/kg, 2.5 mg/kg Other Names: MK-2140 VLS-101 Biological: Rituximab IV Infusion 375 mg/m^2 Other Names: Rituxan®/mabthera Truxima® (rituximab-abbs) RUXIENCE®, RIABNI® Drug: Bendamustine IV Infusion 90 mg/m^2 Other Names: Bendeka® Treanda® Belrapzo® Drug: Granulocyte Colony-Stimulating Factor (G-CSF) Prophylactic G-CSF will be administered at each cycle of zilovertamab vedotin as per the institutional guidelines.
Active Comparator: Bendamustine Rituximab (BR) Participants will receive Rituximab 375 mg/m^2, given intravenously on Day 1 Bendamustine 90 mg/m^2 given intravenously on Day 1 and 2 of repeated 21-day cycles. Treatment will continue for up to 6 cycles or until progressive disease or discontinuation.	Biological: Rituximab IV Infusion 375 mg/m^2 Other Names: Rituxan®/mabthera Truxima® (rituximab-abbs) RUXIENCE®, RIABNI® Drug: Bendamustine IV Infusion 90 mg/m^2 Other Names: Bendeka® Treanda® Belrapzo®
Experimental: ZV + BR (Part 1) Participants in this arm will receive doses of ZV (from 1.5 mg/Kg up to 2.5 mg/Kg) plus Rituximab 375 mg/m^2, Bendamustine 90 mg/m^2 (BR) given intravenously on Day 1 and 2 of repeated 21-day cycles. Treatment will continue for up to 6 cycles.	Biological: Zilovertamab vedotin Intravenous (IV) Infusion 1.5 mg/kg, 1.75 mg/kg, 2.0 mg/kg, 2.25 mg/kg, 2.5 mg/kg Other Names: MK-2140 VLS-101 Biological: Rituximab IV Infusion 375 mg/m^2 Other Names: Rituxan®/mabthera Truxima® (rituximab-abbs) RUXIENCE®, RIABNI® Drug: Bendamustine IV Infusion 90 mg/m^2 Other Names: Bendeka® Treanda® Belrapzo® Drug: Granulocyte Colony-Stimulating Factor (G-CSF) Prophylactic G-CSF will be administered at each cycle of zilovertamab vedotin as per the institutional guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who experienced dose-limiting toxicities (DLTs) in Part 1 Time Frame: Up to ~6 weeks	The CTCAE, Version 5.0 will be used to grade the severity of AEs in this study. DLTs will be reported for Part 1 of this study.	Up to ~6 weeks
Overall survival (OS) Time Frame: Up to ~35 months	OS, defined as the time from randomization to death due to any cause will be reported.	Up to ~35 months
Number of participants who experienced an adverse event (AE) Time Frame: Up to ~68 months	An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who experienced an AE will be reported.	Up to ~68 months
Number of participants who discontinued study treatment due to an AE Time Frame: Up to ~68 months	An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who discontinued study treatment due to an AE will be reported.	Up to ~68 months
Progression-free survival (PFS) Time Frame: Up to ~35 months	PFS, defined as the time from randomization to the first documented disease progression per Lugano response criteria as assessed by BICR or death due to any cause, whichever occurs first will be presented.	Up to ~35 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR) Time Frame: Up to ~35 months	ORR, defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) per Lugano criteria as assessed by BICR will be presented.	Up to ~35 months
Duration of response (DOR) Time Frame: Up to ~35 months	DOR, defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first, will be reported.	Up to ~35 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)

January 14, 2022

Primary Completion (Estimated)

September 24, 2027

Study Completion (Estimated)

September 24, 2027

Study Registration Dates

First Submitted

November 11, 2021

First Submitted That Met QC Criteria

November 29, 2021

First Posted (Actual)

December 1, 2021

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

2140-003
VLS-101 (Other Identifier: Velos Bio)
MK-2140-003 (Other Identifier: MSD)
waveLINE-003 (Other Identifier: MSD)
2022-502646-27-00 (Registry Identifier: EU CT)
U1111-1285-0898 (Registry Identifier: UTN)
jRCT2011250068 (Registry Identifier: Japan Registry of Clinical Trial (jRCT))

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

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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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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