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)
Who is this study for? Patients with relapsed or refractory diffuse large B-cell lymphoma
What treatments are being studied? Zilovertamab vedotin
Status: Recruiting
Location: See all (113) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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. 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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
Bass Medical Group ( Site 0166)
RECRUITING
Walnut Creek
Innovative Clinical Research Institute ( Site 0122)
COMPLETED
Whittier
Florida
Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0163)
RECRUITING
Boca Raton
Clermont Oncology Center ( Site 0174)
RECRUITING
Clermont
Kentucky
Saint Elizabeth Medical Center Edgewood ( Site 0165)
RECRUITING
Edgewood
University of Kentucky Chandler Medical Center ( Site 0158)
RECRUITING
Lexington
Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0133)
RECRUITING
Louisville
Louisiana
Louisiana State University Health Sciences Center New Orleans ( Site 0134)
COMPLETED
New Orleans
Massachusetts
Dana-Farber Cancer Institute-Lymphoma ( Site 0111)
RECRUITING
Boston
University of Massachusetts Medical School ( Site 0119)
RECRUITING
Worcester
Maryland
University of Maryland ( Site 0123)
RECRUITING
Baltimore
Montana
St. Vincent Frontier Cancer Center-Research ( Site 0108)
RECRUITING
Billings
New Jersey
Atlantic Health System ( Site 0116)
RECRUITING
Morristown
Nevada
Comprehensive Cancer Centers of Nevada ( Site 0168)
RECRUITING
Las Vegas
New York
New York Medical College ( Site 0113)
RECRUITING
Valhalla
Tennessee
Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 0156)
COMPLETED
Nashville
Virginia
Blue Ridge Cancer Care ( Site 0169)
RECRUITING
Roanoke
Other Locations
Argentina
Hospital Aleman ( Site 2200)
RECRUITING
Buenos Aites
Instituto Alexander Fleming ( Site 2201)
RECRUITING
Caba
Hospital Italiano de Buenos Aires ( Site 2203)
RECRUITING
Ciudad Autonoma De Buenos Aires
Hospital Privado Universitario de Córdoba ( Site 2202)
RECRUITING
Córdoba
Instituto de Investigaciones Clínicas Mar del Plata ( Site 2205)
RECRUITING
Mar Del Plata
Australia
Grampians Health ( Site 1802)
RECRUITING
Ballarat
Townsville University Hospital ( Site 1800)
RECRUITING
Douglas
Royal Perth Hospital-Haematology ( Site 1801)
RECRUITING
Perth
Brazil
Hospital Erasto Gaertner ( Site 2302)
RECRUITING
Curitiba
Liga Norte Riograndense Contra o Câncer ( Site 2305)
RECRUITING
Natal
Hospital Paulistano ( Site 2300)
RECRUITING
São Paulo
Pesquisa Clínica do Serviço de Hematologia do Hospital das Clínicas da FMUSP ( Site 2306)
RECRUITING
São Paulo
Canada
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0200)
COMPLETED
Toronto
Chile
Biocenter ( Site 2401)
RECRUITING
Concepción
IC La Serena Research ( Site 2405)
RECRUITING
La Serena
Bradfordhill ( Site 2403)
RECRUITING
Santiago
Clínica Inmunocel ( Site 2404)
RECRUITING
Santiago
Clínica RedSalud Vitacura ( Site 2409)
RECRUITING
Santiago
FALP-UIDO ( Site 2400)
RECRUITING
Santiago
Oncocentro Valdivia ( Site 2407)
RECRUITING
Valdivia
China
Beijing Cancer hospital ( Site 3000)
RECRUITING
Beijing
The First Hospital of Jilin University-Hematology ( Site 3012)
RECRUITING
Changchun
Sichuan Cancer hospital-Oncology ( Site 3021)
RECRUITING
Chengdu
West China Hospital of Sichuan University-Head and Neck Oncology ( Site 3016)
RECRUITING
Chengdu
Chongqing University Cancer Hospital-Medical Oncology ( Site 3025)
RECRUITING
Chongqing
Chongqing University Three Gorges Hospital ( Site 3026)
ACTIVE_NOT_RECRUITING
Chongqing
Sun Yat-sen University Cancer Center-Internal Medicine ( Site 3001)
RECRUITING
Guangzhou
Zhujiang Hospital ( Site 3002)
RECRUITING
Guangzhou
The First Affiliated Hospital Zhejiang University School of Medicine ( Site 3027)
RECRUITING
Hangzhou
Zhejiang Cancer Hospital ( Site 3014)
RECRUITING
Hangzhou
The First Affiliated Hospital of Henan University of Science &Technology ( Site 3029)
RECRUITING
Luoyang
Jiangxi Provincial Cancer Hospital ( Site 3005)
RECRUITING
Nanchang
The First Affiliated Hospital of Nanchang University ( Site 3004)
RECRUITING
Nanchang
Fudan University Shanghai Cancer Center ( Site 3009)
RECRUITING
Shanghai
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 3017)
RECRUITING
Wuhan
Henan Cancer Hospital-hematology department ( Site 3013)
RECRUITING
Zhengzhou
Colombia
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0801)
RECRUITING
Bogotá
Hospital Pablo Tobon Uribe ( Site 0804)
RECRUITING
Medellín
Instituto Médico de Alta Tecnologia S.A.S ( Site 0803)
RECRUITING
Montería
Oncologos del Occidente ( Site 0800)
RECRUITING
Pereira
Fundacion Valle del Lili ( Site 0802)
RECRUITING
Santiago De Cali
Costa Rica
CIMCA ( Site 2501)
RECRUITING
San José
Hospital Metropolitano - Sede Lindora ( Site 2500)
RECRUITING
Santa Ana
France
Pitie Salpetriere University Hospital-Clinical haematology ( Site 0700)
RECRUITING
Paris
centre hospitalier lyon sud-Service Hématologie ( Site 0702)
ACTIVE_NOT_RECRUITING
Pierre-bénite
Greece
University Hospital of Alexandroupolis ( Site 0903)
RECRUITING
Alexandroupoli
Evangelismos General Hospital of Athens ( Site 0900)
RECRUITING
Athens
Regional General Hospital of Athens Laiko ( Site 0901)
RECRUITING
Athens
Guatemala
CELAN,S.A ( Site 2603)
RECRUITING
Guatemala City
MEDI-K ( Site 2602)
RECRUITING
Guatemala City
Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 2601)
RECRUITING
Guatemala City
Hong Kong Special Administrative Region
Princess Margaret Hospital ( Site 3101)
RECRUITING
Hong Kong
Queen Mary Hospital ( Site 3100)
RECRUITING
Hong Kong
Israel
Emek Medical Center-Hematology Unit ( Site 1102)
COMPLETED
Afula
Carmel Hospital ( Site 1103)
COMPLETED
Haifa
Hadassah Medical Center ( Site 1100)
COMPLETED
Jerusalem
Italy
IRCCS - AOU di Bologna-Istituto di Ematologia L. e A. Seragnoli ( Site 1200)
COMPLETED
Bologna
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1202)
RECRUITING
Napoli
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -ISTITUTO DI EMATOLOGIA ( Site 1204)
COMPLETED
Roma
Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1203)
RECRUITING
Rozzano
Mexico
Medivest Centro de Investigación Integral ( Site 2704)
RECRUITING
Chihuahua City
Centro de Infusion Superare ( Site 2701)
RECRUITING
Mexico City
Health Pharma Professional Research S.A. de C.V: ( Site 2700)
RECRUITING
Mexico City
New Zealand
Aotearoa Clinical Trials ( Site 0501)
RECRUITING
Auckland
Peru
Clínicas AUNA Sede Chiclayo ( Site 2803)
RECRUITING
Chiclayo
Clínica San Felipe ( Site 2805)
RECRUITING
Lima
Hospital Nacional Dos De Mayo ( Site 2804)
RECRUITING
Lima
Hospital Nacional Edgardo Rebagliati Martins ( Site 2802)
RECRUITING
Lima
Poland
Szpitale Pomorskie Sp. z o. o.-Hematology and Bone Marrow Transplantation Department ( Site 1302)
COMPLETED
Gdynia
Pratia Onkologia Katowice ( Site 1306)
RECRUITING
Katowice
Pratia MCM Krakow ( Site 1303)
RECRUITING
Krakow
Centrum Onkologii Ziemi Lubelskiej-Oddzial Hematologii i Transplantacji Szpiku ( Site 1304)
COMPLETED
Lublin
Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku ( Site 1309)
RECRUITING
Słupsk
Specjalistyczny Szpital im. Dr Alfreda Sokolowskiego w Walbrzychu ( Site 1305)
RECRUITING
Wałbrzych
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( Site 1300)
RECRUITING
Warsaw
Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site 1301)
COMPLETED
Wroclaw
Republic of Korea
Samsung Medical Center ( Site 0300)
RECRUITING
Seoul
Seoul National University Hospital-Oncology ( Site 0302)
RECRUITING
Seoul
Thailand
Faculty of Medicine Siriraj Hospital-Division of Hematology, Department of Medicine ( Site 0400)
ACTIVE_NOT_RECRUITING
Bangkok
Maharaj Nakorn Chiang Mai Hospital ( Site 0401)
ACTIVE_NOT_RECRUITING
Chiang Mai
Chulalongkorn University ( Site 0402)
ACTIVE_NOT_RECRUITING
Pathumwan
Turkey
Ankara University Hospital Cebeci-hematology ( Site 1901)
RECRUITING
Ankara
Ege University Medicine of Faculty ( Site 1902)
RECRUITING
Bornova
Mega Medipol-Hematology ( Site 1909)
RECRUITING
Istanbul
Dokuz Eylül Üniversitesi-Hematology ( Site 1905)
RECRUITING
Izmir
Ondokuz Mayıs Universitesi ( Site 1907)
COMPLETED
Samsun
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi ( Site 1912)
RECRUITING
Yenimahalle
Ukraine
MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( Site 2000)
RECRUITING
Cherkasy
Communal non-profit enterprise Regional clinical hospital of Ivano-Frankivsk Regional Council ( Site 2004)
RECRUITING
Ivano-frankivsk
National Research Center for Radiation Medicine of National Academy of Medical Sciences of Ukraine ( Site 2005)
RECRUITING
Kyiv
Public Non-Profit Enterprise Kyiv City Clinical Hospital #9 under the Executive Body of Kyiv City Co ( Site 2003)
RECRUITING
Kyiv
State non-profit enterprise National Cancer Institute ( Site 2001)
RECRUITING
Kyiv
Institute of Blood Pathology and Transfusion Medicine AMS Ukraine ( Site 2002)
RECRUITING
Lviv
United Kingdom
Aberdeen Royal Infirmary ( Site 2104)
RECRUITING
Aberdeen
University College London Hospital-Cancer Clinical Trials Unit ( Site 2100)
RECRUITING
London-camden
The Royal Cornwall Hospital ( Site 2103)
RECRUITING
Truro
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2022-01-14
Estimated Completion Date: 2027-09-24
Participants
Target number of participants: 290
Treatments
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.
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.
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.
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.
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC