A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010)
Status: Recruiting
Location: See all (223) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, based on local testing according to the WHO classification of neoplasms of the hematopoietic and lymphoid tissues
• Has positron emission tomography (PET) positive disease at screening, defined as 4 to 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 2 assessed within 7 days before randomization
• Has an ejection fraction ≥45% as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA)
• Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)
• Who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization
• Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
Locations
United States
Arizona
The University of Arizona Cancer Center - North Campus ( Site 0124)
RECRUITING
Tucson
California
Cancer Blood and Specialty Clinic ( Site 0109)
RECRUITING
Los Alamitos
Cedars-Sinai Medical Center ( Site 0115)
RECRUITING
Los Angeles
Florida
Bioresearch Partner ( Site 0157)
RECRUITING
Hialeah
Illinois
Cancer Care Specialists of Illinois ( Site 0152)
RECRUITING
O'fallon
Indiana
Fort Wayne Medical Oncology and Hematology ( Site 0149)
RECRUITING
Fort Wayne
Kansas
Cotton O'Neil Cancer Center ( Site 0108)
RECRUITING
Topeka
Kentucky
University of Kentucky ( Site 0106)
RECRUITING
Lexington
Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0163)
RECRUITING
Louisville
Michigan
Corewell Health ( Site 0130)
RECRUITING
Grand Rapids
Missouri
Truman Medical Center ( Site 0122)
RECRUITING
Kansas City
Nevada
Comprehensive Cancer Centers of Nevada ( Site 0113)
RECRUITING
Las Vegas
OptumCare Cancer Care ( Site 0121)
RECRUITING
Las Vegas
New York
New York Oncology Hematology, P.C. ( Site 0129)
RECRUITING
Albany
South Dakota
Sanford Cancer Center ( Site 0143)
RECRUITING
Sioux Falls
Tennessee
The University of Tennessee Medical Center ( Site 0142)
RECRUITING
Knoxville
Texas
Center for Oncology and Blood Disorders ( Site 0153)
RECRUITING
Houston
Virginia
University of Virginia Cancer Center ( Site 0138)
RECRUITING
Charlottesville
Virginia Cancer Institute ( Site 0148)
RECRUITING
Richmond
Blue Ridge Cancer Care ( Site 0132)
RECRUITING
Roanoke
Wisconsin
SSM Health Dean Medical Group ( Site 0140)
RECRUITING
Madison
Other Locations
Argentina
Hospital Aleman ( Site 0301)
RECRUITING
Buenos Aites
Hospital Italiano de Buenos Aires ( Site 0304)
RECRUITING
Caba
Clinica Adventista Belgrano ( Site 0309)
RECRUITING
Caba.
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0306)
RECRUITING
Mar Del Plata
Hospital Universitario Austral ( Site 0307)
RECRUITING
Pilar
Fundacion Estudios Clinicos ( Site 0311)
RECRUITING
Rosario
Clinica EL Castaño ( Site 0312)
RECRUITING
San Juan
C.I.C.E. 9 de Julio ( Site 0305)
RECRUITING
San Miguel De Tucumán
Australia
Royal Adelaide Hospital ( Site 3001)
RECRUITING
Adelaide
Grampians Health ( Site 3003)
RECRUITING
Ballarat
Townsville University Hospital ( Site 3006)
RECRUITING
Douglas
Royal Perth Hospital-Haematology ( Site 3004)
RECRUITING
Perth
Belgium
AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 1102)
RECRUITING
Mechelen
ASBL CHU Helora - Hôpital de Mons - Site Kennedy ( Site 1103)
RECRUITING
Mons
Brazil
CEONC ( Site 0412)
RECRUITING
Cascavel
Hospital Erasto Gaertner ( Site 0401)
RECRUITING
Curitiba
CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0403)
RECRUITING
Florianópolis
Liga Norte Riograndense Contra o Cancer ( Site 0407)
RECRUITING
Natal
Hope ( Site 0413)
RECRUITING
Ribeirão Preto
Clinica Advanze ( Site 0411)
RECRUITING
São Carlos
Hospital das Clinicas FMUSP ( Site 0402)
RECRUITING
São Paulo
Hospital Paulistano ( Site 0406)
RECRUITING
São Paulo
F. F. R. M. São Jose do Rio Preto ( Site 0404)
RECRUITING
Sjrp
Canada
Lakeridge Health - The R.S. McLaughlin Durham Regional Cancer Centre (MDRCC) ( Site 0206)
RECRUITING
Oshawa
Chile
Biocenter ( Site 0510)
RECRUITING
Concepción
IC La Serena Research ( Site 0504)
RECRUITING
La Serena
Bradfordhill ( Site 0502)
RECRUITING
Santiago
Centro de Estudios Clínicos SAGA ( Site 0508)
RECRUITING
Santiago
Clinica Inmunocel ( Site 0503)
RECRUITING
Santiago
Clínica RedSalud Vitacura ( Site 0512)
RECRUITING
Santiago
FALP ( Site 0501)
RECRUITING
Santiago
Oncocentro Valdivia ( Site 0506)
RECRUITING
Valdivia
Centro de Investigaciones ( Site 0511)
RECRUITING
Viña Del Mar
China
Beijing Cancer Hospital ( Site 3101)
RECRUITING
Beijing
Peking University Third Hospital ( Site 3102)
RECRUITING
Beijing
The First Hospital Of Jilin University ( Site 3103)
RECRUITING
Changchun
Sichuan Cancer Hospital. ( Site 3111)
RECRUITING
Chengdu
West China Hospital, Sichuan University ( Site 3110)
RECRUITING
Chengdu
Chongqing Cancer Hospital ( Site 3113)
RECRUITING
Chongqing
Fujian Provincial Cancer Hospital. ( Site 3119)
RECRUITING
Fuzhou
Sun Yat-sen University Cancer Center ( Site 3121)
RECRUITING
Guangzhou
Zhujiang Hospital of Southern Medical University ( Site 3122)
RECRUITING
Guangzhou
The Affiliated Hospital of Guizhou Medical University ( Site 3112)
RECRUITING
Guiyang
The First Affiliated Hospital, Zhejiang Medical University ( Site 3116)
RECRUITING
Hangzhou
Anhui Provincial Cancer Hospital ( Site 3124)
RECRUITING
Hefei
Shandong Cancer Hospital ( Site 3108)
RECRUITING
Jinan
Yunnan Province Cancer Hospital ( Site 3109)
RECRUITING
Kunming
LinYi Cancer Hospital ( Site 3104)
RECRUITING
Linyi
Jiangxi Cancer Hospital ( Site 3118)
RECRUITING
Nanchang
Affiliated Cancer Hospital of Guangxi Medical University ( Site 3123)
RECRUITING
Nanning
Affiliated Hospital of Nantong University ( Site 3117)
RECRUITING
Nantong
Fudan University Shanghai Cancer Center ( Site 3115)
RECRUITING
Shanghai
Shanxi Cancer Hospital ( Site 3106)
RECRUITING
Taiyuan
Institute of Hematology and Blood Diseases Hosp CAMS&PUMC ( Site 3105)
RECRUITING
Tianjin
Hubei Cancer Hospital ( Site 3125)
RECRUITING
Wuhan
1st Affil Hosp of Med College of Xi'an Jiaotong University ( Site 3107)
RECRUITING
Xi’an
The First Affiliated Hospital of Xiamen University ( Site 3120)
RECRUITING
Xiamen
Colombia
Hospital Universitario San Ignacio ( Site 0607)
ACTIVE_NOT_RECRUITING
Bogotá
Hospital Pablo Tobon Uribe ( Site 0604)
RECRUITING
Medellín
IMAT S.A.S ( Site 0603)
RECRUITING
Montería
Oncologos del Occidente ( Site 0601)
RECRUITING
Pereira
Fundación Valle del Lili ( Site 0602)
RECRUITING
Santiago De Cali
Denmark
Aalborg University Hospital ( Site 1302)
RECRUITING
Aalborg
Regionshospitalet Gødstrup ( Site 1301)
RECRUITING
Herning
France
Centre Hospitalier d'Avignon ( Site 1505)
RECRUITING
Avignon
Centre Hospitalier de la Cote Basque ( Site 1509)
RECRUITING
Bayonne
Centre Hospitalier Universitaire Estaing ( Site 1508)
RECRUITING
Clermont-ferrand
CHU Dijon Bourgogne ( Site 1516)
RECRUITING
Dijon
Centre Hospitalier de Dunkerque ( Site 1513)
RECRUITING
Dunkirk
CHD Vendee ( Site 1502)
RECRUITING
La Roche-sur-yon
Hopital Saint Louis, Centre Hospitalier de La Rochelle ( Site 1511)
RECRUITING
La Rochelle
CHU GRENOBLE ALPES ( Site 1518)
RECRUITING
La Tronche
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 1512)
RECRUITING
Limoges
Centre Hospitalier Régional Metz Thionville - Hôpital de Mercy ( Site 1515)
RECRUITING
Metz
Centre Antoine-Lacassagne ( Site 1514)
RECRUITING
Nice
Institut Curie - site Saint-Cloud ( Site 1501)
RECRUITING
Saint-cloud
HIA Sainte Anne ( Site 1506)
RECRUITING
Toulon
Greece
University General Hospital of Alexandroupoli ( Site 1601)
RECRUITING
Alexandroupoli
Attikon University General Hospital of Athens ( Site 1604)
RECRUITING
Athens
Evangelismos General Hospital of Athens ( Site 1602)
RECRUITING
Athens
General Hospital of Athens Laiko-Hematology Department ( Site 1603)
RECRUITING
Athens
Guatemala
CELAN,S.A ( Site 0702)
RECRUITING
Guatemala City
Cen Integral Onco Gastro y Hemato Onco Guatemala S.A. ( Site 0703)
RECRUITING
Guatemala City
MEDI-K ( Site 0701)
RECRUITING
Guatemala City
Hong Kong Special Administrative Region
Princess Margaret Hospital ( Site 3202)
RECRUITING
Hong Kong
Queen Mary Hospital ( Site 3201)
RECRUITING
Hong Kong
Hungary
Szabolcs Szatmár Bereg Vármegyei Oktatókórház ( Site 1704)
RECRUITING
Nyíregyháza
Israel
Carmel Hospital ( Site 1903)
RECRUITING
Haifa
Hadassah Medical Center ( Site 1901)
RECRUITING
Jerusalem
Sourasky Medical Center ( Site 1904)
RECRUITING
Tel Aviv
Poria Medical Center ( Site 1902)
RECRUITING
Tiberias
Italy
AOU delle Marche Ospedali Riuniti di Ancona ( Site 2011)
RECRUITING
Ancona
Azienda Ospedaliera Spedali Civili di Brescia-Hemathology ( Site 2001)
RECRUITING
Brescia
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia ( Site 2010)
RECRUITING
Candiolo
IEO Istituto Europeo di Oncologia ( Site 2009)
RECRUITING
Milan
IRCCS Ospedale San Raffaele ( Site 2012)
RECRUITING
Milan
Fondazione IRCCS San Gerardo dei Tintori ( Site 2008)
RECRUITING
Monza
Azienda Ospedaliero Universitaria Maggiore della Carità ( Site 2004)
RECRUITING
Novara
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO ( Site 2005)
RECRUITING
Palermo
Ospedale Santa Maria delle Croci ( Site 2006)
RECRUITING
Ravenna
IRCCS Crob ( Site 2002)
RECRUITING
Rionero In Vulture
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 2003)
RECRUITING
Roma
Japan
Juntendo University Hospital ( Site 3307)
RECRUITING
Bunkyo
Tokyo Metropolitan Komagome Hospital ( Site 3323)
RECRUITING
Bunkyo
Chiba Cancer Center ( Site 3314)
RECRUITING
Chiba
University of Yamanashi Hospital ( Site 3320)
RECRUITING
Chūō
Kyushu University Hospital ( Site 3313)
RECRUITING
Fukuoka
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital ( Site 3322)
RECRUITING
Hiroshima
Saitama Medical University Hospital ( Site 3305)
RECRUITING
Iruma-gun
Tokai University Hospital ( Site 3302)
RECRUITING
Isehara
Kanazawa University Hospital ( Site 3308)
RECRUITING
Kanazawa
Kobe City Medical Center General Hospital ( Site 3318)
RECRUITING
Kobe
University Hospital,Kyoto Prefectural University of Medicine ( Site 3315)
RECRUITING
Kyoto
National Hospital Organization Shikoku Cancer Center ( Site 3321)
RECRUITING
Matsuyama
University of Miyazaki Hospital ( Site 3319)
RECRUITING
Miyazaki
Nagoya University Hospital ( Site 3309)
RECRUITING
Nagoya
Okayama University Hospital ( Site 3311)
RECRUITING
Okayama
Osaka Metropolitan University Hospital ( Site 3317)
RECRUITING
Osaka
Kindai University Hospital ( Site 3310)
RECRUITING
Sayama
Tohoku University Hospital ( Site 3301)
RECRUITING
Sendai
Yamagata University Hospital ( Site 3312)
RECRUITING
Yamagata
Malaysia
Queen Elizabeth Hospital ( Site 3405)
RECRUITING
Kota Kinabalu
Sarawak General Hospital ( Site 3402)
RECRUITING
Kuching
Hospital Miri ( Site 3403)
RECRUITING
Miri
Sunway Medical Centre ( Site 3406)
RECRUITING
Petaling Jaya
Hospital Ampang ( Site 3404)
RECRUITING
Selangor Darul Ehsan
Mexico
Centro de Infusion Superare ( Site 0804)
RECRUITING
Mexico City
Health Pharma Professional Research S.A. de C.V. ( Site 0801)
RECRUITING
Mexico City
Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 0802)
RECRUITING
Monterrey
Centro de Investigacion Clinica Chapultepec ( Site 0803)
RECRUITING
Morelia
Centro de Investigacion Clinica de Oaxaca ( Site 0805)
RECRUITING
Oaxaca City
Grupo Ollin Care ( Site 0806)
RECRUITING
Pachuca
CIMAB SA de CV ( Site 0807)
RECRUITING
Torreón
Netherlands
Meander Medisch Centrum ( Site 2101)
RECRUITING
Amersfoort
Albert Schweitzer Ziekenhuis ( Site 2103)
RECRUITING
Dordrecht
Peru
Clínicas AUNA Sede Chiclayo ( Site 0904)
RECRUITING
Chiclayo
Clínica San Felipe ( Site 0906)
RECRUITING
Lima
Hospital Nacional Dos De Mayo ( Site 0905)
RECRUITING
Lima
Hospital Nacional Edgardo Rebagliati Martins ( Site 0903)
RECRUITING
Lima
INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 0901)
RECRUITING
Surquillo
Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2208)
RECRUITING
Gliwice
Pratia Onkologia Katowice ( Site 2204)
RECRUITING
Katowice
Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko-Mazurskim Centrum Onko ( Site 2205)
RECRUITING
Olsztyn
Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku ( Site 2210)
RECRUITING
Słupsk
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2201)
RECRUITING
Warsaw
Portugal
Unidade Local de Saude de Braga - Hospital de Braga ( Site 2306)
RECRUITING
Braga
Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 2302)
RECRUITING
Porto
Puerto Rico
BRCR Global - Mayaguez ( Site 1003)
RECRUITING
Mayagüez
Auxilio Mutuo Cancer Center ( Site 1001)
RECRUITING
San Juan
Republic of Korea
Pusan National University Hospital ( Site 3804)
RECRUITING
Busan
Chungnam National University Hospital ( Site 3801)
RECRUITING
Daejeon
National Cancer Center- Center for Hemotologic malignancy ( Site 3806)
RECRUITING
Goyang-si
Asan Medical Center ( Site 3803)
RECRUITING
Seoul
Samsung Medical Center ( Site 3807)
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System ( Site 3802)
RECRUITING
Seoul
St.Mary's H., Youido ( Site 3805)
RECRUITING
Seoul
Romania
Centrul de Diagnostic si Tratament Oncologic Brasov ( Site 2402)
RECRUITING
Brasov
Spitalul Clinic Colțea ( Site 2401)
RECRUITING
Bucharest
Institutul Oncologic Cluj ( Site 2404)
RECRUITING
Cluj-napoca
Spital Judetean Sibiu ( Site 2405)
RECRUITING
Sibiu
Singapore
National Cancer Centre Singapore ( Site 3701)
RECRUITING
Singapore
National University Hospital ( Site 3702)
RECRUITING
Singapore
South Africa
Groote Schuur Hospital ( Site 2504)
RECRUITING
Cape Town
Haemalife ( Site 2501)
RECRUITING
Cape Town
Netcare Pretoria East Hospital ( Site 2502)
RECRUITING
Pretoria
Spain
Hospital General Universitario Dr. Balmis ( Site 2604)
RECRUITING
Alicante
Hospital del Mar ( Site 2610)
RECRUITING
Barcelona
ICO L Hospitalet ( Site 2601)
RECRUITING
L'hospitalet De Llobregat
H. Insular de Gran Canaria ( Site 2606)
RECRUITING
Las Palmas De Gran Canaria
Hospital Universitario La Paz ( Site 2611)
RECRUITING
Madrid
Hospital Virgen de la Victoria ( Site 2609)
RECRUITING
Málaga
Hospital Universitario Virgen Macarena ( Site 2608)
RECRUITING
Seville
Hospital Universitario Miguel Servet ( Site 2607)
RECRUITING
Zaragoza
Switzerland
Kantonspital Baden ( Site 2703)
RECRUITING
Baden
Ospedale Regionale Bellinzona e Valli ( Site 2701)
RECRUITING
Bellinzona
Ospedale Italiano Lugano (OIL) ( Site 2705)
RECRUITING
Lugano
Cantonal Hospital St.Gallen-Oncology & Hematology ( Site 2702)
RECRUITING
Sankt Gallen
Taiwan
Chang Gung Memorial Hospital at Kaohsiung ( Site 3905)
RECRUITING
Kaohsiung City
National Cheng Kung University Hospital ( Site 3902)
RECRUITING
Tainan City
Mackay Memorial Hospital ( Site 3908)
RECRUITING
Taipei
National Taiwan University Hospital ( Site 3901)
RECRUITING
Taipei
Tri-Service General Hospital ( Site 3906)
RECRUITING
Taipei
Chang Gung Memorial Hospital - Linkou Branch ( Site 3903)
RECRUITING
Taoyuan
Thailand
Faculty of Medicine Siriraj Hospital ( Site 4001)
RECRUITING
Bangkoknoi
Maharaj Nakorn Chiang Mai Hospital ( Site 4002)
RECRUITING
Muang
Chulalongkorn University ( Site 4003)
RECRUITING
Pathumwan
Turkey
Baskent Universitesi Adana Dr. Turgut Noyan UAM ( Site 2809)
RECRUITING
Adana
Ankara University Faculty of Medicine ( Site 2801)
RECRUITING
Ankara
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi ( Site 2803)
RECRUITING
Ankara
Hacettepe Universite Hastaneleri ( Site 2810)
RECRUITING
Ankara
Antalya Egitim ve Arastirma Hastanesi ( Site 2805)
RECRUITING
Antalya
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi ( Site 2804)
RECRUITING
Istanbul
Ondokuz Mayıs Universitesi ( Site 2806)
RECRUITING
Korfez Mahallesi
Namık Kemal University Medical Faculty ( Site 2807)
RECRUITING
Suleymanpasa
Ukraine
MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( Site 2904)
RECRUITING
Cherkasy
Communal non-profit enterprise Regional clinical hospital of Ivano-Frankivsk Regional Council ( Site 2906)
RECRUITING
Ivano-frankivsk
Khmelnytskyi Regional Hospital ( Site 2907)
RECRUITING
Khmelnytskiy
Public Non-Profit Enterprise Kyiv City Clinical Hospital #9 under the Executive Body of Kyiv City Co ( Site 2905)
RECRUITING
Kyiv
SI National Research Center of Radiation Medicine, Hematology, Oncology ( Site 2901)
RECRUITING
Kyiv
SNPE National Cancer Institute ( Site 2902)
RECRUITING
Kyiv
Universal Clinic Oberig ( Site 2908)
RECRUITING
Kyiv
Institute of Blood Pathology and Transfusion Medicine AMS Ukraine ( Site 2903)
RECRUITING
Lviv
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2025-01-27
Estimated Completion Date: 2032-03-29
Participants
Target number of participants: 1046
Treatments
Experimental: Zilovertamab vedotin + Rituximab + Cyclophosphamide, Doxorubicin, Prednisone (R-CHP)
Participants receive a dose of zilovertamab vedotin (1.75 mg/kg) plus 750 mg/m\^2 cyclophosphamide, 50 mg/m\^2 doxorubicin, and 375 mg/m\^2 rituximab or rituximab biosimilar administered by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 6 cycles (up to approximately 4 months) plus 2 cycles of rituximab or biosimilar for participants with high risk DLBCL. Participants also receive 100 mg prednisone or prednisolone via oral tablet per day during Days 1-5 of each 21-day cycle for up to 6 cycles (up to approximately 4 months).
Active_comparator: Rituximab + Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (R-CHOP)
Participants receive 750 mg/m\^2 cyclophosphamide, 50 mg/m\^2 doxorubicin, and 375 mg/m\^2 rituximab or rituximab biosimilar, 1.4 mg/m\^2 vincristine administered by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 6 cycles (up to approximately 4 months) plus 2 cycles of rituximab or biosimilar for participants with high risk DLBCL. Participants also receive 100 mg prednisone or prednisolone via oral tablet per day during Days 1-5 of each 21-day cycle for up to 6 cycles (up to approximately 4 months).
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC