Actively Recruiting
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)
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-08
290
Participants Needed
124
Research Sites
297 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL)
- Radiographically measurable DLBCL per Lugano Response Criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 within 7 days before treatment
- Adequate organ function
- Able to provide new or archival tumor tissue sample not previously irradiated
- Relapsed or refractory DLBCL ineligible for or failed autologous stem-cell transplant (ASCT)
- Failed at least 1 prior therapy line
- Post-chimeric antigen receptor T (post-CAR-T) cell therapy failure or ineligible for CAR-T therapy
You will not qualify if you...
- History of transformation from indolent disease to DLBCL (not applicable after protocol amendment 4)
- Received solid organ transplant at any time
- Diagnosis of primary mediastinal B-cell lymphoma (PMBCL)
- Clinically significant active cardiovascular disease or serious cardiac arrhythmia requiring medication
- Ongoing graft-versus-host disease (GVHD) or receiving treatment for GVHD
- Clinically significant pericardial or pleural effusion
- Ongoing Grade >1 peripheral neuropathy
- History of a second malignancy unless treated with curative intent and no evidence of disease for 2 years
- Demyelinating form of Charcot-Marie-Tooth disease
- Contraindication to any study intervention including prior anaphylactic reaction
- Prior systemic anticancer therapy or investigational agents within 4 weeks before first dose
- Prior radiotherapy within 4 weeks before study intervention start, with recovery from toxicities
- Ongoing corticosteroid therapy
- Received live or live-attenuated vaccine within 30 days before first dose
- Participation in investigational agent or device study within 4 weeks before first dose
- Known active central nervous system lymphoma involvement or active CNS lymphoma
- Active infection requiring systemic therapy
- Known HIV infection
- Known active Hepatitis C virus infection
- Psychiatric or substance abuse disorder interfering with study cooperation
AI-Screening
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Trial Site Locations
Total: 124 locations
1
Palo Verde Hematology/ Oncology Center, Ltd. ( Site 0175)
Glendale, Arizona, United States, 85304
Actively Recruiting
2
Beverly Hills Cancer Center ( Site 0184)
Beverly Hills, California, United States, 90211
Actively Recruiting
3
Bass Medical Group ( Site 0166)
Walnut Creek, California, United States, 94598
Actively Recruiting
4
Innovative Clinical Research Institute ( Site 0122)
Whittier, California, United States, 90603
Completed
5
Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0163)
Boca Raton, Florida, United States, 33486
Actively Recruiting
6
Clermont Oncology Center ( Site 0174)
Clermont, Florida, United States, 34711
Actively Recruiting
7
BRP-Hialeah Hospital ( Site 0182)
Hialeah, Florida, United States, 33013
Actively Recruiting
8
Illinois Cancer Specialists ( Site 8000)
Niles, Illinois, United States, 60714
Actively Recruiting
9
Saint Elizabeth Medical Center Edgewood ( Site 0165)
Edgewood, Kentucky, United States, 41017
Actively Recruiting
10
University of Kentucky Chandler Medical Center ( Site 0158)
Lexington, Kentucky, United States, 40536
Actively Recruiting
11
Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0133)
Louisville, Kentucky, United States, 40207
Actively Recruiting
12
University of Maryland ( Site 0123)
Baltimore, Maryland, United States, 21201
Actively Recruiting
13
Dana-Farber Cancer Institute-Lymphoma ( Site 0111)
Boston, Massachusetts, United States, 02215
Actively Recruiting
14
University of Massachusetts Medical School ( Site 0119)
Worcester, Massachusetts, United States, 01655
Actively Recruiting
15
Corewell Health ( Site 0162)
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
16
St. Vincent Frontier Cancer Center-Research ( Site 0108)
Billings, Montana, United States, 59102
Actively Recruiting
17
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0188)
Grand Island, Nebraska, United States, 68803
Actively Recruiting
18
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0177)
Omaha, Nebraska, United States, 68130
Actively Recruiting
19
Comprehensive Cancer Centers of Nevada ( Site 0168)
Las Vegas, Nevada, United States, 89169
Actively Recruiting
20
Atlantic Health System ( Site 0116)
Morristown, New Jersey, United States, 07960
Completed
21
Presbyterian Rust Jorgensen Cancer ( Site 9506)
Rio Rancho, New Mexico, United States, 87124
Actively Recruiting
22
New York Medical College ( Site 0113)
Valhalla, New York, United States, 10595
Actively Recruiting
23
Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 0156)
Nashville, Tennessee, United States, 37232
Completed
24
Blue Ridge Cancer Care ( Site 0169)
Roanoke, Virginia, United States, 24014
Actively Recruiting
25
Hospital Italiano de Buenos Aires ( Site 2203)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1199ABB
Actively Recruiting
26
Instituto de Investigaciones Clínicas Mar del Plata ( Site 2205)
Mar del Plata, Buenos Aires, Argentina, B7600FZO
Actively Recruiting
27
Hospital Aleman ( Site 2200)
Buenos Aites, Buenos Aires F.D., Argentina, C1118AAT
Actively Recruiting
28
Hospital Privado Universitario de Córdoba ( Site 2202)
Córdoba, Córdoba Province, Argentina, X5016KEH
Actively Recruiting
29
Instituto Alexander Fleming ( Site 2201)
CABA, Argentina, C1426ANZ
Actively Recruiting
30
Townsville University Hospital ( Site 1800)
Douglas, Queensland, Australia, 4814
Actively Recruiting
31
Grampians Health ( Site 1802)
Ballarat, Victoria, Australia, 3350
Actively Recruiting
32
Royal Perth Hospital-Haematology ( Site 1801)
Perth, Western Australia, Australia, 6000
Actively Recruiting
33
Hospital Erasto Gaertner ( Site 2302)
Curitiba, Paraná, Brazil, 81520-060
Actively Recruiting
34
Liga Norte Riograndense Contra o Câncer ( Site 2305)
Natal, Rio Grande do Norte, Brazil, 59062-000
Actively Recruiting
35
Hospital Paulistano ( Site 2300)
São Paulo, Brazil, 01321-001
Actively Recruiting
36
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0200)
Toronto, Ontario, Canada, M5G 2M9
Completed
37
Biocenter ( Site 2401)
Concepción, Biobio, Chile, 4070196
Actively Recruiting
38
IC La Serena Research ( Site 2405)
La Serena, Coquimbo Region, Chile, 1720430
Actively Recruiting
39
Oncocentro Valdivia ( Site 2407)
Valdivia, Los Ríos Region, Chile, 5112129
Actively Recruiting
40
FALP-UIDO ( Site 2400)
Santiago, Region M. de Santiago, Chile, 7500921
Completed
41
Clínica Inmunocel ( Site 2404)
Santiago, Region M. de Santiago, Chile, 7580206
Actively Recruiting
42
Clínica RedSalud Vitacura ( Site 2409)
Santiago, Region M. de Santiago, Chile, 7650018
Actively Recruiting
43
Bradfordhill ( Site 2403)
Santiago, Region M. de Santiago, Chile, 8420383
Actively Recruiting
44
Beijing Cancer hospital ( Site 3000)
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
45
Chongqing University Cancer Hospital-Medical Oncology ( Site 3025)
Chongqing, Chongqing Municipality, China, 400030
Active, Not Recruiting
46
Chongqing University Three Gorges Hospital ( Site 3026)
Chongqing, Chongqing Municipality, China, 404199
Active, Not Recruiting
47
Sun Yat-sen University Cancer Center-Internal Medicine ( Site 3001)
Guangzhou, Guangdong, China, 510060
Actively Recruiting
48
Zhujiang Hospital ( Site 3002)
Guangzhou, Guangdong, China, 510280
Actively Recruiting
49
The First Affiliated Hospital of Henan University of Science &Technology ( Site 3029)
Luoyang, Henan, China, 471003
Active, Not Recruiting
50
Henan Cancer Hospital-hematology department ( Site 3013)
Zhengzhou, Henan, China, 450008
Actively Recruiting
51
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 3017)
Wuhan, Hubei, China, 430048
Actively Recruiting
52
The First Affiliated Hospital of Nanchang University ( Site 3004)
Nanchang, Jiangxi, China, 330006
Active, Not Recruiting
53
Jiangxi Provincial Cancer Hospital ( Site 3005)
Nanchang, Jiangxi, China, 330029
Actively Recruiting
54
The First Hospital of Jilin University-Hematology ( Site 3012)
Changchun, Jilin, China, 130021
Actively Recruiting
55
Fudan University Shanghai Cancer Center ( Site 3009)
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
56
West China Hospital of Sichuan University-Head and Neck Oncology ( Site 3016)
Chengdu, Sichuan, China, 610041
Actively Recruiting
57
Sichuan Cancer hospital-Oncology ( Site 3021)
Chengdu, Sichuan, China, 610042
Actively Recruiting
58
Zhejiang Cancer Hospital ( Site 3014)
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
59
The First Affiliated Hospital Zhejiang University School of Medicine ( Site 3027)
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
60
Hospital Pablo Tobon Uribe ( Site 0804)
Medellín, Antioquia, Colombia, 50034
Actively Recruiting
61
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0801)
Bogotá, Bogota D.C., Colombia, 110131
Actively Recruiting
62
Instituto Médico de Alta Tecnologia S.A.S ( Site 0803)
Montería, Departamento de Córdoba, Colombia, 230002
Actively Recruiting
63
Oncologos del Occidente ( Site 0800)
Pereira, Risaralda Department, Colombia, 660001
Actively Recruiting
64
Fundacion Valle del Lili ( Site 0802)
Cali, Valle del Cauca Department, Colombia, 760032
Actively Recruiting
65
Hospital Metropolitano - Sede Lindora ( Site 2500)
Santa Ana, Provincia de San José, Costa Rica, 10903
Actively Recruiting
66
CIMCA ( Site 2501)
San José, Costa Rica, 10103
Actively Recruiting
67
centre hospitalier lyon sud-Service Hématologie ( Site 0702)
Pierre-Bénite, Rhone, France, 69310
Completed
68
Pitie Salpetriere University Hospital-Clinical haematology ( Site 0700)
Paris, France, 75013
Active, Not Recruiting
69
Evangelismos General Hospital of Athens ( Site 0900)
Athens, Attica, Greece, 106 76
Actively Recruiting
70
Regional General Hospital of Athens "Laiko" ( Site 0901)
Athens, Attica, Greece, 115 26
Actively Recruiting
71
University Hospital of Alexandroupolis ( Site 0903)
Alexandroupoli, East Macedonia and Thrace, Greece, 681 00
Actively Recruiting
72
MEDI-K ( Site 2602)
Guatemala City, Guatemala, 01009
Actively Recruiting
73
Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 2601)
Guatemala City, Guatemala, 01010
Actively Recruiting
74
CELAN,S.A ( Site 2603)
Guatemala City, Guatemala, 1010
Actively Recruiting
75
Queen Mary Hospital ( Site 3100)
Hong Kong, Hong Kong, 000000
Actively Recruiting
76
Princess Margaret Hospital ( Site 3101)
Hong Kong, Hong Kong
Active, Not Recruiting
77
Emek Medical Center-Hematology Unit ( Site 1102)
Afula, Israel, 1834111
Completed
78
Carmel Hospital ( Site 1103)
Haifa, Israel, 3436212
Completed
79
Hadassah Medical Center ( Site 1100)
Jerusalem, Israel, 9112001
Completed
80
Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1203)
Rozzano, Milano, Italy, 20089
Actively Recruiting
81
IRCCS - AOU di Bologna-Istituto di Ematologia "L. e A. Seragnoli" ( Site 1200)
Bologna, Italy, 40138
Completed
82
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1202)
Naples, Italy, 80131
Actively Recruiting
83
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -ISTITUTO DI EMATOLOGIA ( Site 1204)
Roma, Italy, 00168
Completed
84
Hokkaido University Hospital ( Site 3202)
Sapporo, Hokkaido, Japan, 060-8648
Actively Recruiting
85
Tokyo Metropolitan Komagome Hospital ( Site 3200)
Bunkyo, Tokyo, Japan, 113-8677
Actively Recruiting
86
National Hospital Organization Kyushu Cancer Center ( Site 3204)
Fukuoka, Japan, 811-1395
Actively Recruiting
87
Fukushima Medical University Hospital ( Site 3207)
Fukushima, Japan, 960-1295
Actively Recruiting
88
Yamagata University Hospital ( Site 3206)
Yamagata, Japan, 990-9585
Actively Recruiting
89
Health Pharma Professional Research S.A. de C.V: ( Site 2700)
Mexico City, Mexico City, Mexico, 03100
Completed
90
Medivest Centro de Investigación Integral ( Site 2704)
Chihuahua City, Mexico, 31203
Completed
91
Centro de Infusion Superare ( Site 2701)
Mexico City, Mexico, 03104
Completed
92
Aotearoa Clinical Trials ( Site 0501)
Auckland, New Zealand, 2025
Actively Recruiting
93
Clínicas AUNA Sede Chiclayo ( Site 2803)
Chiclayo, Lambayeque, Peru, 14001
Actively Recruiting
94
INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 2800)
Surquillo, Muni Metro de Lima, Peru, 15038
Actively Recruiting
95
Clínica San Felipe ( Site 2805)
Lima, Peru, 15072
Actively Recruiting
96
Hospital Nacional Edgardo Rebagliati Martins ( Site 2802)
Lima, Peru, 15072
Actively Recruiting
97
Hospital Nacional Dos De Mayo ( Site 2804)
Lima, Peru, 15087
Actively Recruiting
98
Pratia MCM Krakow ( Site 1303)
Krakow, Lesser Poland Voivodeship, Poland, 30-727
Actively Recruiting
99
Specjalistyczny Szpital im. Dr Alfreda Sokolowskiego w Walbrzychu ( Site 1305)
Wałbrzych, Lower Silesian Voivodeship, Poland, 58-309
Actively Recruiting
100
Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site 1301)
Wroclaw, Lower Silesian Voivodeship, Poland, 50-367
Completed
101
Centrum Onkologii Ziemi Lubelskiej-Oddzial Hematologii i Transplantacji Szpiku ( Site 1304)
Lublin, Lublin Voivodeship, Poland, 20-090
Completed
102
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( Site 1300)
Warsaw, Masovian Voivodeship, Poland, 02-781
Actively Recruiting
103
Szpitale Pomorskie Sp. z o. o.-Hematology and Bone Marrow Transplantation Department ( Site 1302)
Gdynia, Pomeranian Voivodeship, Poland, 81-519
Completed
104
Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku ( Site 1309)
Słupsk, Pomeranian Voivodeship, Poland, 76-200
Actively Recruiting
105
Pratia Onkologia Katowice ( Site 1306)
Katowice, Silesian Voivodeship, Poland, 40-519
Actively Recruiting
106
Seoul National University Hospital-Oncology ( Site 0302)
Seoul, South Korea, 03080
Actively Recruiting
107
Samsung Medical Center ( Site 0300)
Seoul, South Korea, 06351
Completed
108
Faculty of Medicine Siriraj Hospital-Division of Hematology, Department of Medicine ( Site 0400)
Bangkok, Bangkok, Thailand, 10700
Active, Not Recruiting
109
Chulalongkorn University ( Site 0402)
Pathumwan, Bangkok, Thailand, 10330
Active, Not Recruiting
110
Maharaj Nakorn Chiang Mai Hospital ( Site 0401)
Chiang Mai, Thailand, 50200
Active, Not Recruiting
111
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi ( Site 1912)
Yenimahalle, Ankara, Turkey (Türkiye), 06200
Actively Recruiting
112
Ege University Medicine of Faculty ( Site 1902)
Bornova, İzmir, Turkey (Türkiye), 35100
Actively Recruiting
113
Ankara University Hospital Cebeci-hematology ( Site 1901)
Ankara, Turkey (Türkiye), 06100
Actively Recruiting
114
Mega Medipol-Hematology ( Site 1909)
Istanbul, Turkey (Türkiye), 34214
Actively Recruiting
115
Dokuz Eylül Üniversitesi-Hematology ( Site 1905)
Izmir, Turkey (Türkiye), 35340
Actively Recruiting
116
Ondokuz Mayıs Universitesi ( Site 1907)
Samsun, Turkey (Türkiye), 55139
Completed
117
MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( Site 2000)
Cherkasy, Cherkasy Oblast, Ukraine, 18009
Actively Recruiting
118
Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council" ( Site 2004)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76008
Actively Recruiting
119
Institute of Blood Pathology and Transfusion Medicine AMS Ukraine ( Site 2002)
Lviv, Lviv Oblast, Ukraine, 79057
Actively Recruiting
120
State non-profit enterprise National Cancer Institute ( Site 2001)
Kyiv, Ukraine, 03022
Actively Recruiting
121
National Research Center for Radiation Medicine of National Academy of Medical Sciences of Ukraine ( Site 2005)
Kyiv, Ukraine, 03115
Actively Recruiting
122
Aberdeen Royal Infirmary ( Site 2104)
Aberdeen, Aberdeen City, United Kingdom, AB25 2ZN
Actively Recruiting
123
The Royal Cornwall Hospital ( Site 2103)
Truro, England, United Kingdom, TR1 3LJ
Actively Recruiting
124
University College London Hospital-Cancer Clinical Trials Unit ( Site 2100)
London-Camden, London, City of, United Kingdom, NW1 2PG
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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