A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010)

Last updated: May 8, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

3

Condition

Lymphoma

Hematologic Cancer

Lymphoma, B-cell

Treatment

Rituximab Biosimilar

Rituximab

Doxorubicin

Clinical Study ID

NCT06717347
2140-010
2024-515566-13-00
U1111-1309-3971
2024-515566-13
jRCT2061240099
MK-2140-010
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate if zilovertamab vedotin with standard treatment can help people live longer without the cancer growing or spreading than people who receive standard treatment alone.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), byprior biopsy, based on local testing according to the WHO classification ofneoplasms of the hematopoietic and lymphoid tissues

  • Has positron emission tomography (PET) positive disease at screening, defined as 4to 5 on the Lugano 5-point scale

  • Has received no prior treatment for their DLBCL

  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2assessed within 7 days before randomization

  • Has an ejection fraction ≥45% as determined by either echocardiogram (ECHO) ormultigated acquisition (MUGA)

  • Human immunodeficiency virus (HIV) infected participants must have well controlledHIV on antiretroviral therapy (ART)

  • Who are hepatitis B surface antigen (HBsAg) positive are eligible if they havereceived hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viralload prior to randomization

  • Participants with history of hepatitis C virus (HCV) infection are eligible if HCVviral load is undetectable at screening

Exclusion

Exclusion Criteria:

  • Has a history of transformation of indolent disease to DLBCL

  • Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zonelymphoma

  • Has Ann Arbor Stage I DLBCL

  • Has clinically significant (i.e., active) cardiovascular disease: cerebral vascularaccident/stroke (<6 months prior to enrollment), myocardial infarction (<6 monthsprior to enrollment), unstable angina, congestive heart failure (New York HeartAssociation Classification Class ≥II), or serious cardiac arrhythmia requiringmedication

  • Has clinically significant pericardial or pleural effusion

  • Has ongoing Grade >1 peripheral neuropathy

  • Has a demyelinating form of Charcot-Marie-Tooth disease

  • HIV-infected participants with a history of Kaposi's sarcoma and/or MulticentricCastleman's Disease

  • Has ongoing corticosteroid therapy

  • Has received a live or live-attenuated vaccine within 30 days before the first doseof study intervention. Administration of killed vaccines is allowed

  • Known additional malignancy that is progressing or has required active treatmentwithin the past 2 years

  • Known active central nervous system (CNS) lymphoma

  • Has active autoimmune disease that has required systemic treatment in the past 2years

  • Has active infection requiring systemic therapy

  • Has concurrent active HBV (defined as HBsAg positive and detectable HBV DNA) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA))infection

  • Has history of allogeneic tissue/solid organ transplant

Study Design

Total Participants: 1046
Treatment Group(s): 9
Primary Treatment: Rituximab Biosimilar
Phase: 3
Study Start date:
January 27, 2025
Estimated Completion Date:
March 29, 2032

Connect with a study center

  • Instituto de Investigaciones Clinicas Mar del Plata ( Site 0306)

    Mar del Plata, Buenos Aires B7600FZO
    Argentina

    Active - Recruiting

  • Instituto de Investigaciones Clinicas Mar del Plata ( Site 0306)

    Mar del Plata., Buenos Aires B7600FZO
    Argentina

    Site Not Available

  • Fundacion Estudios Clinicos ( Site 0311)

    Rosario., Santa Fe S2000CEJ
    Argentina

    Active - Recruiting

  • Hospital Italiano de Buenos Aires ( Site 0304)

    Caba, C1199ABB
    Argentina

    Active - Recruiting

  • ASBL CHU Helora - Hôpital de Mons - Site Kennedy ( Site 1103)

    Mons, Hainaut 7000
    Belgium

    Active - Recruiting

  • Hospital Erasto Gaertner ( Site 0401)

    Curitiba, Parana 82520-060
    Brazil

    Active - Recruiting

  • Liga Norte Riograndense Contra o Cancer ( Site 0407)

    Natal, Rio Grande Do Norte 59062-000
    Brazil

    Active - Recruiting

  • CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0403)

    Florianópolis, Santa Catarina 88020-210
    Brazil

    Active - Recruiting

  • Hope ( Site 0413)

    Ribeirao Preto, Sao Paulo 14026-610
    Brazil

    Active - Recruiting

  • Clinica Advanze ( Site 0411)

    Sao Carlos, Sao Paulo 13561-130
    Brazil

    Active - Recruiting

  • F. F. R. M. São Jose do Rio Preto ( Site 0404)

    Sjrp, Sao Paulo 15090-000
    Brazil

    Active - Recruiting

  • Biocenter ( Site 0510)

    Concepcion., Biobio 4070196
    Chile

    Active - Recruiting

  • Centro de Estudios Clínicos SAGA ( Site 0508)

    Santiago, Region M. De Santiago 7500653
    Chile

    Active - Recruiting

  • Beijing Cancer Hospital ( Site 3101)

    Beijing, Beijing 100142
    China

    Active - Recruiting

  • Chongqing Cancer Hospital ( Site 3113)

    Chongqing, Chongqing 400030
    China

    Active - Recruiting

  • Fujian Provincial Cancer Hospital. ( Site 3119)

    Fuzhou, Fujian 350014
    China

    Active - Recruiting

  • Zhujiang Hospital of Southern Medical University ( Site 3122)

    Guangzhou, Guangdong 510280
    China

    Active - Recruiting

  • Affiliated Cancer Hospital of Guangxi Medical University ( Site 3123)

    Nanning, Guangxi 530021
    China

    Active - Recruiting

  • The Affiliated Hospital of Guizhou Medical University ( Site 3112)

    Guiyang, Guizhou 550004
    China

    Active - Recruiting

  • Hubei Cancer Hospital ( Site 3125)

    Wuhan, Hubei 430079
    China

    Active - Recruiting

  • Affiliated Hospital of Nantong University ( Site 3117)

    Nantong, Jiangsu 226001
    China

    Active - Recruiting

  • Jiangxi Cancer Hospital ( Site 3118)

    Nanchang, Jiangxi 330029
    China

    Active - Recruiting

  • Shandong Cancer Hospital ( Site 3108)

    Jinan, Shandong 250117
    China

    Active - Recruiting

  • Sichuan Cancer Hospital. ( Site 3111)

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

  • West China Hospital, Sichuan University ( Site 3110)

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

  • Institute of Hematology and Blood Diseases Hosp CAMS&PUMC ( Site 3105)

    Tianjin, Tianjin 301617
    China

    Active - Recruiting

  • Yunnan Province Cancer Hospital ( Site 3109)

    Kunming, Yunnan 650118
    China

    Active - Recruiting

  • The First Affiliated Hospital, Zhejiang Medical University ( Site 3116)

    Hangzhou, Zhejiang 310009
    China

    Active - Recruiting

  • Hospital Pablo Tobon Uribe ( Site 0604)

    Medellin, Antioquia 050034
    Colombia

    Active - Recruiting

  • IMAT S.A.S ( Site 0603)

    Montería, Cordoba 230002
    Colombia

    Active - Recruiting

  • Hospital Universitario San Ignacio ( Site 0607)

    Bogota., Distrito Capital De Bogota 110231
    Colombia

    Active - Recruiting

  • Oncologos del Occidente ( Site 0601)

    Pereira., Risaralda 660001
    Colombia

    Active - Recruiting

  • Fundación Valle del Lili ( Site 0602)

    Cali, Valle Del Cauca 760032
    Colombia

    Active - Recruiting

  • Aalborg University Hospital ( Site 1302)

    Aalborg, Nordjylland 9000
    Denmark

    Active - Recruiting

  • CHU Dijon Bourgogne ( Site 1516)

    Dijon, Cote-d Or 21000
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 1512)

    Limoges, Limousin 87042
    France

    Active - Recruiting

  • Centre Hospitalier Régional Metz Thionville - Hôpital de Mercy ( Site 1515)

    Metz, Moselle 57085
    France

    Active - Recruiting

  • Centre Hospitalier de Dunkerque ( Site 1513)

    Dunkerque, Nord 59385
    France

    Active - Recruiting

  • Centre Hospitalier de la Cote Basque ( Site 1509)

    Bayonne, Pyrenees-Atlantiques 64100
    France

    Active - Recruiting

  • HIA Sainte Anne ( Site 1506)

    Toulon, Var 83800
    France

    Active - Recruiting

  • Centre Hospitalier d'Avignon ( Site 1505)

    Avignon, Vaucluse 84000
    France

    Active - Recruiting

  • CHD Vendee ( Site 1502)

    La Roche-sur-Yon, Vendee 85000
    France

    Active - Recruiting

  • Cen Integral Onco Gastro y Hemato Onco Guatemala S.A. ( Site 0703)

    Guatemala, 01010
    Guatemala

    Active - Recruiting

  • MEDI-K ( Site 0701)

    Guatemala, 01009
    Guatemala

    Active - Recruiting

  • CELAN,S.A ( Site 0702)

    Guatemala., 01010
    Guatemala

    Active - Recruiting

  • Princess Margaret Hospital ( Site 3202)

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Queen Mary Hospital ( Site 3201)

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Carmel Hospital ( Site 1903)

    Haifa, 3436212
    Israel

    Active - Recruiting

  • Hadassah Medical Center ( Site 1901)

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Sourasky Medical Center ( Site 1904)

    Tel Aviv, 6423906
    Israel

    Active - Recruiting

  • Poria Medical Center ( Site 1902)

    Tiberias, 15208
    Israel

    Active - Recruiting

  • Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia ( Site 2010)

    Candiolo, Torino 10060
    Italy

    Active - Recruiting

  • AOU delle Marche Ospedali Riuniti di Ancona ( Site 2011)

    Ancona, 60126
    Italy

    Active - Recruiting

  • IEO Istituto Europeo di Oncologia ( Site 2009)

    Milano, 20141
    Italy

    Active - Recruiting

  • Ospedale Santa Maria delle Croci ( Site 2006)

    Ravenna, 48121
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore (

    Roma, 00168
    Italy

    Active - Recruiting

  • Nagoya University Hospital ( Site 3309)

    Nagoya, Aichi 466-8560
    Japan

    Active - Recruiting

  • National Hospital Organization Shikoku Cancer Center ( Site 3321)

    Matsuyama, Ehime 791-0280
    Japan

    Active - Recruiting

  • Kobe City Medical Center General Hospital ( Site 3318)

    Kobe, Hyogo 650-0047
    Japan

    Active - Recruiting

  • Kanazawa University Hospital ( Site 3308)

    Kanazawa, Ishikawa 920-8641
    Japan

    Active - Recruiting

  • Tokai University Hospital ( Site 3302)

    Isehara, Kanagawa 259-1193
    Japan

    Active - Recruiting

  • Tohoku University Hospital ( Site 3301)

    Sendai, Miyagi 980-8574
    Japan

    Active - Recruiting

  • Kindai University Hospital ( Site 3310)

    Osakasayama, Osaka 589-8511
    Japan

    Active - Recruiting

  • Saitama Medical University Hospital ( Site 3305)

    Iruma-gun, Saitama 350-0495
    Japan

    Active - Recruiting

  • Juntendo University Hospital ( Site 3307)

    Bunkyo, Tokyo 113-8431
    Japan

    Active - Recruiting

  • University of Yamanashi Hospital ( Site 3320)

    Chuo, Yamanashi 409-3898
    Japan

    Active - Recruiting

  • Chiba Cancer Center ( Site 3314)

    Chiba, 260-8717
    Japan

    Active - Recruiting

  • Kyushu University Hospital ( Site 3313)

    Fukuoka, 812-8582
    Japan

    Active - Recruiting

  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital ( Site 3322)

    Hiroshima, 730-8619
    Japan

    Active - Recruiting

  • University Hospital,Kyoto Prefectural University of Medicine ( Site 3315)

    Kyoto, 602-8566
    Japan

    Active - Recruiting

  • University of Miyazaki Hospital ( Site 3319)

    Miyazaki, 889-1692
    Japan

    Active - Recruiting

  • Okayama University Hospital ( Site 3311)

    Okayama, 700-8558
    Japan

    Active - Recruiting

  • Osaka Metropolitan University Hospital ( Site 3317)

    Osaka, 545-8586
    Japan

    Active - Recruiting

  • Yamagata University Hospital ( Site 3312)

    Yamagata, 990-9585
    Japan

    Active - Recruiting

  • National Cancer Center- Center for Hemotologic malignancy ( Site 3806)

    Goyang-si, Kyonggi-do 10408
    Korea, Republic of

    Active - Recruiting

  • Pusan National University Hospital ( Site 3804)

    Busan, Pusan-Kwangyokshi 49241
    Korea, Republic of

    Active - Recruiting

  • Chungnam National University Hospital ( Site 3801)

    Daejeon, Taejon-Kwangyokshi 35015
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center ( Site 3807)

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System ( Site 3802)

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • St.Mary's H., Youido ( Site 3805)

    Seoul, 07345
    Korea, Republic of

    Active - Recruiting

  • Queen Elizabeth Hospital ( Site 3405)

    Kota Kinabalu, Sabah 88586
    Malaysia

    Active - Recruiting

  • Hospital Miri ( Site 3403)

    Miri, Sarawak 98000
    Malaysia

    Active - Recruiting

  • Meander Medisch Centrum ( Site 2101)

    Amersfoort, Utrecht 3813 TZ
    Netherlands

    Active - Recruiting

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2201)

    Warszawa, Mazowieckie 02-781
    Poland

    Active - Recruiting

  • Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku ( Site 2210)

    Słupsk, Pomorskie 76-200
    Poland

    Active - Recruiting

  • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2208)

    Gliwice, Slaskie 44-102
    Poland

    Active - Recruiting

  • Pratia Onkologia Katowice ( Site 2204)

    Katowice, Slaskie 40-519
    Poland

    Active - Recruiting

  • Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko-Mazurskim Centrum Onko

    Olsztyn, Warminsko-mazurskie 10-228
    Poland

    Active - Recruiting

  • BRCR Global - Mayaguez ( Site 1003)

    Mayaguez, 00682
    Puerto Rico

    Active - Recruiting

  • Auxilio Mutuo Cancer Center ( Site 1001)

    San Juan, 00918
    Puerto Rico

    Active - Recruiting

  • Institutul Oncologic Cluj ( Site 2404)

    Cluj-Napoca, Cluj 4003437
    Romania

    Active - Recruiting

  • Spital Judetean Sibiu ( Site 2405)

    Sibiu, 550245
    Romania

    Active - Recruiting

  • National Cancer Centre Singapore ( Site 3701)

    Singapore, Central Singapore 168583
    Singapore

    Active - Recruiting

  • Hospital Universitario Virgen Macarena ( Site 2608)

    Sevilla, Andalucia 41009
    Spain

    Active - Recruiting

  • H. Insular de Gran Canaria ( Site 2606)

    Las Palmas de Gran Canaria, Las Palmas 35016
    Spain

    Active - Recruiting

  • Hospital General Universitario Dr. Balmis ( Site 2604)

    Alicante, Valenciana, Comunitat 03010
    Spain

    Active - Recruiting

  • Hospital del Mar ( Site 2610)

    Barcelona, 08003
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz ( Site 2611)

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Virgen de la Victoria ( Site 2609)

    Malaga, 29010
    Spain

    Active - Recruiting

  • Ospedale Regionale Bellinzona e Valli ( Site 2701)

    Bellinzona, Ticino 6501
    Switzerland

    Active - Recruiting

  • National Cheng Kung University Hospital ( Site 3902)

    Tainan, 704
    Taiwan

    Active - Recruiting

  • Mackay Memorial Hospital ( Site 3908)

    Taipei, 10049
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital ( Site 3901)

    Taipei, 100
    Taiwan

    Active - Recruiting

  • Tri-Service General Hospital ( Site 3906)

    Taipei, 11490
    Taiwan

    Active - Recruiting

  • Chang Gung Memorial Hospital - Linkou Branch ( Site 3903)

    Taoyuan, 333
    Taiwan

    Active - Recruiting

  • MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( S

    Cherkasy, Cherkaska Oblast 18009
    Ukraine

    Active - Recruiting

  • Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council" ( Si

    Ivano-Frankivsk, Ivano-Frankivska Oblast 76008
    Ukraine

    Active - Recruiting

  • Khmelnytskyi Regional Hospital ( Site 2907)

    Khmelnytskiy, Khmelnytska Oblast 29000
    Ukraine

    Active - Recruiting

  • Institute of Blood Pathology and Transfusion Medicine AMS Ukraine ( Site 2903)

    Lviv, Lvivska Oblast 79057
    Ukraine

    Active - Recruiting

  • Public Non-Profit Enterprise Kyiv City Clinical Hospital #9 under the Executive Body of Kyiv City Co

    Kyiv, 04112
    Ukraine

    Active - Recruiting

  • SNPE National Cancer Institute ( Site 2902)

    Kyiv, 03022
    Ukraine

    Active - Recruiting

  • Universal Clinic Oberig ( Site 2908)

    Kyiv, 03057
    Ukraine

    Active - Recruiting

  • Cancer Blood and Specialty Clinic ( Site 0109)

    Los Alamitos, California 90720
    United States

    Active - Recruiting

  • Cancer Care Specialists of Illinois ( Site 0152)

    O'Fallon, Illinois 62269
    United States

    Active - Recruiting

  • Fort Wayne Medical Oncology and Hematology ( Site 0149)

    Fort Wayne, Indiana 46804
    United States

    Active - Recruiting

  • Cotton O'Neil Cancer Center ( Site 0108)

    Topeka, Kansas 66606
    United States

    Active - Recruiting

  • Truman Medical Center ( Site 0122)

    Kansas City, Missouri 64108
    United States

    Active - Recruiting

  • Comprehensive Cancer Centers of Nevada ( Site 0113)

    Las Vegas, Nevada 89169
    United States

    Active - Recruiting

  • OptumCare Cancer Care ( Site 0121)

    Las Vegas, Nevada 89102
    United States

    Active - Recruiting

  • New York Oncology Hematology, P.C. ( Site 0129)

    Albany, New York 12206
    United States

    Active - Recruiting

  • University of Virginia Cancer Center ( Site 0138)

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

  • Virginia Cancer Institute ( Site 0148)

    Richmond, Virginia 23229
    United States

    Active - Recruiting

  • Blue Ridge Cancer Care ( Site 0132)

    Roanoke, Virginia 24014
    United States

    Active - Recruiting

  • SSM Health Dean Medical Group ( Site 0140)

    Madison, Wisconsin 53715
    United States

    Active - Recruiting

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