AzTrials
AzTrials

DLBCLPhase 2/3NCT05139017

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)

A Phase 2/3 study testing Zilovertamab vedotin, Rituximab and Gemcitabine in people with DLBCL and Diffuse Large B-Cell Lymphoma, run by Merck Sharp & Dohme LLC at 135 sites in 26 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
DLBCL, Diffuse Large B-Cell Lymphoma
What is being tested?
Zilovertamab vedotin, Rituximab and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
290 participants
Where
135 sitesin 26 countries
Study dates
14 Jan 2022to 24 Sep 2027
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.
Show all 20Show fewer
  • 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.

Trial locations and contacts

135 sites in 26 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

135 sites in 26 countries

United States26 sites, 13 recruiting

  • University of Maryland ( Site 0123)

    Baltimore, Maryland, 21201

    Active, not recruiting

  • Beverly Hills Cancer Center ( Site 0184)

    Beverly Hills, California, 90211

    Active, not recruiting

  • St. Vincent Frontier Cancer Center-Research ( Site 0108)

    Billings, Montana, 59102

    Completed

  • Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0163)

    Boca Raton, Florida, 33486

    Study Coordinator, 561-955-4145

    Recruiting

  • Dana-Farber Cancer Institute-Lymphoma ( Site 0111)

    Boston, Massachusetts, 02215

    Active, not recruiting

  • Clermont Oncology Center ( Site 0174)

    Clermont, Florida, 34711

    Study Coordinator, 352-242-1366

    Recruiting

  • Saint Elizabeth Medical Center Edgewood ( Site 0165)

    Edgewood, Kentucky, 41017

    Study Coordinator, 859-301-2000

    Recruiting

  • Palo Verde Hematology/ Oncology Center, Ltd. ( Site 0175)

    Glendale, Arizona, 85304

    Study Coordinator, 602-978-6255

    Recruiting

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0188)

    Grand Island, Nebraska, 68803

    Study Coordinator, 402-334-4773

    Recruiting

  • Corewell Health ( Site 0162)

    Grand Rapids, Michigan, 49503

    Study Coordinator, 616-486-6180

    Recruiting

  • BRP-Hialeah Hospital ( Site 0182)

    Hialeah, Florida, 33013

    Study Coordinator, 833-489-4968

    Recruiting

  • Alliance Cancer Specialists (ACS) ( Site 8001)

    Horsham, Pennsylvania, 19044

    Study Coordinator, 215-706-4176

    Recruiting

  • Tennessee Cancer Specialists ( Site 7000)

    Knoxville, Tennessee, 37909

    Study Coordinator, 865-862-0998

    Recruiting

  • Comprehensive Cancer Centers of Nevada ( Site 0168)

    Las Vegas, Nevada, 89169

    Study Coordinator, 702-952-3400

    Recruiting

  • University of Kentucky Chandler Medical Center ( Site 0158)

    Lexington, Kentucky, 40536

    Active, not recruiting

  • Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0133)

    Louisville, Kentucky, 40207

    Active, not recruiting

  • Atlantic Health System ( Site 0116)

    Morristown, New Jersey, 07960

    Completed

  • Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 0156)

    Nashville, Tennessee, 37232

    Completed

  • Illinois Cancer Specialists ( Site 8000)

    Niles, Illinois, 60714

    Study Coordinator, 847-827-9060

    Recruiting

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0177)

    Omaha, Nebraska, 68130

    Study Coordinator, 402-334-4773

    Recruiting

  • Presbyterian Rust Jorgensen Cancer ( Site 9506)

    Rio Rancho, New Mexico, 87124

    Active, not recruiting

  • Blue Ridge Cancer Care ( Site 0169)

    Roanoke, Virginia, 24014

    Active, not recruiting

  • New York Medical College ( Site 0113)

    Valhalla, New York, 10595

    Completed

  • Bass Medical Group ( Site 0166)

    Walnut Creek, California, 94598

    Study Coordinator, 925-433-8786

    Recruiting

  • Innovative Clinical Research Institute ( Site 0122)

    Whittier, California, 90603

    Completed

  • University of Massachusetts Medical School ( Site 0119)

    Worcester, Massachusetts, 01655

    Active, not recruiting

Other trials in United States

China16 sites, 5 recruiting

  • Beijing Cancer hospital ( Site 3000)

    Beijing, Beijing Municipality, 100142

    Active, not recruiting

  • The First Hospital of Jilin University-Hematology ( Site 3012)

    Changchun, Jilin, 130021

    Active, not recruiting

  • Sichuan Cancer hospital-Oncology ( Site 3021)

    Chengdu, Sichuan, 610041

    Active, not recruiting

  • West China Hospital of Sichuan University-Head and Neck Oncology ( Site 3016)

    Chengdu, Sichuan, 610041

    Active, not recruiting

  • Chongqing University Cancer Hospital-Medical Oncology ( Site 3025)

    Chongqing, Chongqing Municipality, 400030

    Active, not recruiting

  • Chongqing University Three Gorges Hospital ( Site 3026)

    Chongqing, Chongqing Municipality, 404199

    Active, not recruiting

  • Sun Yat-sen University Cancer Center-Internal Medicine ( Site 3001)

    Guangzhou, Guangdong, 510060

    Active, not recruiting

  • Zhujiang Hospital ( Site 3002)

    Guangzhou, Guangdong, 510280

    Active, not recruiting

  • Zhejiang Cancer Hospital ( Site 3014)

    Hangzhou, Zhejiang, 310000

    Study Coordinator, 0571 8812 2222

    Recruiting

  • The First Affiliated Hospital Zhejiang University School of Medicine ( Site 3027)

    Hangzhou, Zhejiang, 310003

    Study Coordinator, 0571-87236114

    Recruiting

  • The First Affiliated Hospital of Henan University of Science &Technology ( Site 3029)

    Luoyang, Henan, 471003

    Active, not recruiting

  • The First Affiliated Hospital of Nanchang University ( Site 3004)

    Nanchang, Jiangxi, 330006

    Completed

  • Jiangxi Provincial Cancer Hospital ( Site 3005)

    Nanchang, Jiangxi, 330029

    Study Coordinator, 079188329441

    Recruiting

  • Fudan University Shanghai Cancer Center ( Site 3009)

    Shanghai, Shanghai Municipality, 200032

    Study Coordinator, 021 6417 5589

    Recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 3017)

    Wuhan, Hubei, 430048

    Active, not recruiting

  • Henan Cancer Hospital-hematology department ( Site 3013)

    Zhengzhou, Henan, 450008

    Study Coordinator, 0371-65588007

    Recruiting

Other trials in China

Japan13 sites, 13 recruiting

  • Tokyo Metropolitan Komagome Hospital ( Site 3200)

    Bunkyo, Tokyo, 113-8677

    Study Coordinator, +81-3-3823-2101

    Recruiting

  • University of Yamanashi Hospital ( Site 3201)

    Chūō, Yamanashi, 409-3898

    Study Coordinator, +81-55-273-1111

    Recruiting

  • National Hospital Organization Kyushu Cancer Center ( Site 3204)

    Fukuoka, 811-1395

    Study Coordinator, +81-92-541-3231

    Recruiting

  • Fukushima Medical University Hospital ( Site 3207)

    Fukushima, 960-1295

    Study Coordinator, +81-24-547-1111

    Recruiting

  • Kansai Medical University Hospital ( Site 3203)

    Hirakata, Osaka, 573-1191

    Study Coordinator, +81-72-804-2808

    Recruiting

  • Tokai University Hospital ( Site 3212)

    Isehara, Kanagawa, 259-1193

    Study Coordinator, +81-463-93-1121

    Recruiting

  • University Hospital,Kyoto Prefectural University of Medicine ( Site 3209)

    Kyoto, 602-8566

    Study Coordinator, +81-75-251-5871

    Recruiting

  • The Jikei University Hospital ( Site 3208)

    Minato, Tokyo, 105-8471

    Study Coordinator, +81-3-3433-1111

    Recruiting

  • University of Miyazaki Hospital ( Site 3211)

    Miyazaki, 889-1692

    Study Coordinator, +81-985-85-1510

    Recruiting

  • Osaka Metropolitan University Hospital ( Site 3205)

    Osaka, 545-8586

    Study Coordinator, +81-6-6645-2121

    Recruiting

  • Hokkaido University Hospital ( Site 3202)

    Sapporo, Hokkaido, 060-8648

    Study Coordinator, +81-11-716-1161

    Recruiting

  • Mie University Hospital ( Site 3210)

    Tsu, Mie-ken, 514-8507

    Study Coordinator, +81-59-231-5246

    Recruiting

  • Yamagata University Hospital ( Site 3206)

    Yamagata, 990-9585

    Study Coordinator, +81-23-633-1122

    Recruiting

Other trials in Japan

Poland8 sites, 1 recruiting

  • Szpitale Pomorskie Sp. z o. o.-Hematology and Bone Marrow Transplantation Department ( Site 1302)

    Gdynia, Pomeranian Voivodeship, 81-519

    Completed

  • Pratia Onkologia Katowice ( Site 1306)

    Katowice, Silesian Voivodeship, 40-519

    Active, not recruiting

  • Pratia MCM Krakow ( Site 1303)

    Krakow, Lesser Poland Voivodeship, 30-727

    Active, not recruiting

  • Centrum Onkologii Ziemi Lubelskiej-Oddzial Hematologii i Transplantacji Szpiku ( Site 1304)

    Lublin, Lublin Voivodeship, 20-090

    Completed

  • Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku ( Site 1309)

    Słupsk, Pomeranian Voivodeship, 76-200

    Study Coordinator, 59 84 60 390

    Recruiting

  • Specjalistyczny Szpital im. Dr Alfreda Sokolowskiego w Walbrzychu ( Site 1305)

    Wałbrzych, Lower Silesian Voivodeship, 58-309

    Active, not recruiting

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( Site 1300)

    Warsaw, Masovian Voivodeship, 02-781

    Active, not recruiting

  • Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site 1301)

    Wroclaw, Lower Silesian Voivodeship, 50-367

    Completed

Other trials in Poland

Chile7 sites, 2 recruiting

  • Biocenter ( Site 2401)

    Concepción, Biobio, 4070196

    Active, not recruiting

  • IC La Serena Research ( Site 2405)

    La Serena, Coquimbo Region, 1720430

    Active, not recruiting

  • FALP-UIDO ( Site 2400)

    Santiago, Region M. de Santiago, 7500921

    Completed

  • Clínica Inmunocel ( Site 2404)

    Santiago, Region M. de Santiago, 7580206

    Study Coordinator, +56224376600

    Recruiting

  • Clínica RedSalud Vitacura ( Site 2409)

    Santiago, Region M. de Santiago, 7650018

    Study Coordinator, 56223954044

    Recruiting

  • Bradfordhill ( Site 2403)

    Santiago, Region M. de Santiago, 8420383

    Active, not recruiting

  • Oncocentro Valdivia ( Site 2407)

    Valdivia, Los Ríos Region, 5112129

    Active, not recruiting

Other trials in Chile

Turkey (Türkiye)6 sites, 5 recruiting

  • Ankara University Hospital Cebeci-hematology ( Site 1901)

    Ankara, 06100

    Study Coordinator, +90 505 502 50 50

    Recruiting

  • Ege University Medicine of Faculty ( Site 1902)

    Bornova, İzmir, 35100

    Study Coordinator, +905325566128

    Recruiting

  • Mega Medipol-Hematology ( Site 1909)

    Istanbul, 34214

    Study Coordinator, 444 7 044

    Recruiting

  • Dokuz Eylül Üniversitesi-Hematology ( Site 1905)

    Izmir, 35340

    Study Coordinator, +905425151780

    Recruiting

  • Ondokuz Mayıs Universitesi ( Site 1907)

    Samsun, 55139

    Completed

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi ( Site 1912)

    Yenimahalle, Ankara, 06200

    Study Coordinator, (0312) 336 09 09

    Recruiting

Other trials in Turkey (Türkiye)

Argentina5 sites

  • Hospital Aleman ( Site 2200)

    Buenos Aites, Buenos Aires F.D., C1118AAT

    Active, not recruiting

  • Instituto Alexander Fleming ( Site 2201)

    CABA, C1426ANZ

    Active, not recruiting

  • Hospital Italiano de Buenos Aires ( Site 2203)

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199ABB

    Active, not recruiting

  • Hospital Privado Universitario de Córdoba ( Site 2202)

    Córdoba, Córdoba Province, X5016KEH

    Active, not recruiting

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 2205)

    Mar del Plata, Buenos Aires, B7600FZO

    Completed

Other trials in Argentina

Colombia5 sites

  • FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0801)

    Bogotá, Bogota D.C., 110131

    Active, not recruiting

  • Fundacion Valle del Lili ( Site 0802)

    Cali, Valle del Cauca Department, 760032

    Active, not recruiting

  • Hospital Pablo Tobon Uribe ( Site 0804)

    Medellín, Antioquia, 50034

    Active, not recruiting

  • Instituto Médico de Alta Tecnologia S.A.S ( Site 0803)

    Montería, Departamento de Córdoba, 230002

    Active, not recruiting

  • Oncologos del Occidente ( Site 0800)

    Pereira, Risaralda Department, 660001

    Active, not recruiting

Other trials in Colombia

Peru5 sites, 1 recruiting

  • Clínicas AUNA Sede Chiclayo ( Site 2803)

    Chiclayo, Lambayeque, 14001

    Active, not recruiting

  • Clínica San Felipe ( Site 2805)

    Lima, 15072

    Active, not recruiting

  • Hospital Nacional Edgardo Rebagliati Martins ( Site 2802)

    Lima, 15072

    Active, not recruiting

  • Hospital Nacional Dos De Mayo ( Site 2804)

    Lima, 15087

    Study Coordinator, +51944464618

    Recruiting

  • INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 2800)

    Surquillo, Muni Metro de Lima, 15038

    Active, not recruiting

Other trials in Peru

Ukraine5 sites

  • MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( Site 2000)

    Cherkasy, Cherkasy Oblast, 18009

    Active, not recruiting

  • Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council" ( Site 2004)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76008

    Active, not recruiting

  • State non-profit enterprise National Cancer Institute ( Site 2001)

    Kyiv, 03022

    Active, not recruiting

  • National Research Center for Radiation Medicine of National Academy of Medical Sciences of Ukraine ( Site 2005)

    Kyiv, 03115

    Completed

  • Institute of Blood Pathology and Transfusion Medicine AMS Ukraine ( Site 2002)

    Lviv, Lviv Oblast, 79057

    Active, not recruiting

Other trials in Ukraine

Italy4 sites

  • IRCCS - AOU di Bologna-Istituto di Ematologia "L. e A. Seragnoli" ( Site 1200)

    Bologna, 40138

    Completed

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1202)

    Naples, 80131

    Active, not recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -ISTITUTO DI EMATOLOGIA ( Site 1204)

    Roma, 00168

    Completed

  • Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1203)

    Rozzano, Milano, 20089

    Active, not recruiting

Other trials in Italy

Australia3 sites, 2 recruiting

  • Grampians Health ( Site 1802)

    Ballarat, Victoria, 3350

    Study Coordinator, +61353208500

    Recruiting

  • Royal Perth Hospital-Haematology ( Site 1801)

    Perth, Western Australia, 6000

    Study Coordinator, +61892242405

    Recruiting

  • Townsville University Hospital ( Site 1800)

    Townsville, Queensland, 4814

    Active, not recruiting

Other trials in Australia

Brazil3 sites, 2 recruiting

  • Hospital Erasto Gaertner ( Site 2302)

    Curitiba, Paraná, 81520-060

    Study Coordinator, +5541999846033

    Recruiting

  • Liga Norte Riograndense Contra o Câncer ( Site 2305)

    Natal, Rio Grande do Norte, 59062-000

    Study Coordinator, +55 (84) 99927-8442

    Recruiting

  • Hospital Paulistano ( Site 2300)

    São Paulo, 01321-001

    Active, not recruiting

Other trials in Brazil

Greece3 sites

  • University Hospital of Alexandroupolis ( Site 0903)

    Alexandroupoli, East Macedonia and Thrace, 681 00

    Active, not recruiting

  • Evangelismos General Hospital of Athens ( Site 0900)

    Athens, Attica, 106 76

    Active, not recruiting

  • Regional General Hospital of Athens "Laiko" ( Site 0901)

    Athens, Attica, 115 26

    Active, not recruiting

Other trials in Greece

Guatemala3 sites

  • MEDI-K ( Site 2602)

    Guatemala City, 01009

    Active, not recruiting

  • Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 2601)

    Guatemala City, 01010

    Active, not recruiting

  • CELAN,S.A ( Site 2603)

    Guatemala City, 1010

    Active, not recruiting

Other trials in Guatemala

Israel3 sites

  • Emek Medical Center-Hematology Unit ( Site 1102)

    Afula, 1834111

    Completed

  • Carmel Hospital ( Site 1103)

    Haifa, 3436212

    Completed

  • Hadassah Medical Center ( Site 1100)

    Jerusalem, 9112001

    Completed

Other trials in Israel

Mexico3 sites

  • Medivest Centro de Investigación Integral ( Site 2704)

    Chihuahua City, 31203

    Completed

  • Health Pharma Professional Research S.A. de C.V: ( Site 2700)

    Mexico City, Mexico City, 03100

    Completed

  • Centro de Infusion Superare ( Site 2701)

    Mexico City, 03104

    Completed

Other trials in Mexico

Thailand3 sites

  • Faculty of Medicine Siriraj Hospital-Division of Hematology, Department of Medicine ( Site 0400)

    Bangkok, Bangkok, 10700

    Active, not recruiting

  • Maharaj Nakorn Chiang Mai Hospital ( Site 0401)

    Muang, Chiang Mai, 50200

    Active, not recruiting

  • Chulalongkorn University ( Site 0402)

    Pathumwan, Bangkok, 10330

    Active, not recruiting

Other trials in Thailand

United Kingdom3 sites

  • Aberdeen Royal Infirmary ( Site 2104)

    Aberdeen, Aberdeen City, AB25 2ZN

    Completed

  • University College London Hospital-Cancer Clinical Trials Unit ( Site 2100)

    London-Camden, London, City of, NW1 2PG

    Completed

  • The Royal Cornwall Hospital ( Site 2103)

    Truro, England, TR1 3LJ

    Completed

Other trials in United Kingdom

Costa Rica2 sites

  • CIMCA ( Site 2501)

    San José, 10103

    Active, not recruiting

  • Hospital Metropolitano - Sede Lindora ( Site 2500)

    Santa Ana, Provincia de San José, 10903

    Active, not recruiting

Other trials in Costa Rica

France2 sites

  • Pitie Salpetriere University Hospital-Clinical haematology ( Site 0700)

    Paris, 75013

    Active, not recruiting

  • centre hospitalier lyon sud-Service Hématologie ( Site 0702)

    Pierre-Bénite, Rhone, 69310

    Active, not recruiting

Other trials in France

Hong Kong2 sites

  • Queen Mary Hospital ( Site 3100)

    Hong Kong, 000000

    Active, not recruiting

  • Princess Margaret Hospital ( Site 3101)

    Hong Kong

    Active, not recruiting

Other trials in Hong Kong

South Korea2 sites

  • Seoul National University Hospital-Oncology ( Site 0302)

    Seoul, 03080

    Active, not recruiting

  • Samsung Medical Center ( Site 0300)

    Seoul, 06351

    Completed

Other trials in South Korea

Canada1 site

  • Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0200)

    Toronto, Ontario, M5G 2M9

    Completed

Other trials in Canada

Denmark1 site

  • Aarhus Universitetshospital, Skejby ( Site 1701)

    Aarhus, Central Jutland, 8200

    Completed

Other trials in Denmark

New Zealand1 site

  • Aotearoa Clinical Trials ( Site 0501)

    Auckland, 2025

    Active, not recruiting

Other trials in New Zealand

About this study

Official title: 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.

Being tested
Zilovertamab vedotin, Rituximab, Gemcitabine, Oxaliplatin, Bendamustine
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zilovertamab vedotinBiological

    Also called MK-2140, VLS-101

    Intravenous (IV) Infusion 1.5 mg/kg, 1.75 mg/kg, 2.0 mg/kg, 2.25 mg/kg, 2.5 mg/kg

  • RituximabBiological

    Also called Rituxan®/mabthera, Truxima® (rituximab-abbs), RUXIENCE®, RIABNI®

    IV Infusion 375 mg/m^2

  • GemcitabineDrug

    Also called Gemzar®

    IV Infusion 1000 mg/m^2

  • OxaliplatinDrug

    Also called Eloxatin®

    IV Infusion 100 mg/m^2

  • BendamustineDrug

    Also called Bendeka®, Treanda®, Belrapzo®

    IV Infusion 90 mg/m^2

  • Granulocyte Colony-Stimulating Factor (G-CSF)Drug

    Prophylactic G-CSF will be administered at each cycle of zilovertamab vedotin as per the institutional guidelines.

Study groups in NCT05139017
Study groupRoleWhat they receive
ZV + R-GemOx (Part 1)ExperimentalParticipants 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.
Receives: Biological: Zilovertamab vedotin; Biological: Rituximab; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Granulocyte Colony-Stimulating Factor (G-CSF)
ZV + R-GemOx (Part 2)ExperimentalUsing 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.
Receives: Biological: Zilovertamab vedotin; Biological: Rituximab; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Granulocyte Colony-Stimulating Factor (G-CSF)
R-GemOx (active control for Part 2)Active comparatorParticipants 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.
Receives: Biological: Rituximab; Drug: Gemcitabine; Drug: Oxaliplatin
ZV + BR (Part 2)ExperimentalUsing 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.
Receives: Biological: Zilovertamab vedotin; Biological: Rituximab; Drug: Bendamustine; Drug: Granulocyte Colony-Stimulating Factor (G-CSF)
Bendamustine Rituximab (BR)Active comparatorParticipants 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.
Receives: Biological: Rituximab; Drug: Bendamustine
ZV + BR (Part 1)ExperimentalParticipants 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.
Receives: Biological: Zilovertamab vedotin; Biological: Rituximab; Drug: Bendamustine; Drug: Granulocyte Colony-Stimulating Factor (G-CSF)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants who experienced dose-limiting toxicities (DLTs) in Part 1

    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.

    Measured: Up to ~6 weeks

  2. Number of participants who experienced an adverse event (AE)

    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.

    Measured: Up to ~68 months

  3. Number of participants who discontinued study treatment due to an AE

    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.

    Measured: Up to ~68 months

  4. Overall survival (OS)

    OS, defined as the time from randomization to death due to any cause will be reported.

    Measured: Up to ~35 months

  5. Progression-free survival (PFS)

    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.

    Measured: Up to ~35 months

Secondary outcomes (2)

  1. Objective response rate (ORR)

    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.

    Measured: Up to ~35 months

  2. Duration of response (DOR)

    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.

    Measured: Up to ~35 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2021
  2. Study start14 Jan 2022
  3. Primary completion24 Sep 2027 (estimated)
  4. Study completion24 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
In Part 1, Dose Confirmation will be determined by modified toxicity probability interval (mTPI) design, where participants will be assigned to two treatment groups, cohort: A (zilovertamab vedotin in combinatio with R-GemOx) in parallel with cohort B (zilovertamab vedotin in combination with BR). Part 2 will be an Efficacy Expansion (cohorts A \& B) where all participants in each cohort will be assigned to 2 treatment groups for the duration of the study.
Masking
None (open label)
Enrolment
290 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05139017
Sponsor's protocol ID
2140-003
Other IDs
VLS-101, MK-2140-003, waveLINE-003, 2022-502646-27-00, U1111-1285-0898, jRCT2011250068
Status last verified
Oct 2026
First submitted
11 Nov 2021
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Zilovertamab vedotin, Rituximab and Gemcitabine in people with DLBCL and Diffuse Large B-Cell Lymphoma, run by Merck Sharp & Dohme LLC at 135 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 135 sites in United States, China, Japan, Poland, Chile and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants who experienced dose-limiting toxicities (DLTs) in Part 1 (time frame: Up to ~6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05139017.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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