A Study to Evaluate Zilovertamab Vedotin (MK-2140) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-004)
NCT ID: NCT05144841
Last Updated: 2025-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
140 participants
INTERVENTIONAL
2022-01-08
2026-01-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Participants will receive treatment with zilovertamab vedotin 2.5 mg/kg via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks (Q3W)) until documented disease progression or any other discontinuation criterion is met.
MK-2140 (zilovertamab vedotin)
IV infusion of 2.5 mg/kg
Arm B
Participants will receive treatment with zilovertamab vedotin 2.25 mg/kg via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks (Q3W)) until documented disease progression or any other discontinuation criterion is met.
MK-2140 (zilovertamab vedotin)
IV infusion of 2.25 mg/kg
Interventions
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MK-2140 (zilovertamab vedotin)
IV infusion of 2.5 mg/kg
MK-2140 (zilovertamab vedotin)
IV infusion of 2.25 mg/kg
Eligibility Criteria
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Inclusion Criteria
* Has histologically confirmed diagnosis of DLBCL.
* Has radiographically measurable DLBCL per the Lugano Response Criteria.
* Should either be post- chimeric antigen receptor T cell therapy (CAR-T) failure or ineligible for CAR-T (for any reason).
* Life expectancy of at least 3 months.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before time of enrollment.
* Has adequate organ function.
Exclusion Criteria
* Has undergone solid organ transplant at any time.
* Has a history of any clinically significant cardiovascular conditions within 6 months of screening or serious cardiac arrhythmia requiring medication.
* Has known history of liver cirrhosis.
* Has pericardial effusion or clinically significant pleural effusion.
* 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.
* Transformed DLBCL from indolent lymphoma.
* In participants with prior allo-SCT, acute graft versus host disease (GVHD) or ongoing evidence of chronic GVHD.
* 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 28 days of start of study intervention. Participants.
must have recovered from all radiation-related toxicities.
* Has ongoing corticosteroid therapy (exceeding 30 mg daily of prednisone equivalent).
* 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.
* Has an active infection requiring systemic therapy.
* Has a known history of human immunodeficiency virus (HIV) infection.
* Has a known history of hepatitis B or known active hepatitis C virus (HCV).
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0229)
Orange, California, United States
Innovative Clinical Research Institute ( Site 0202)
Whittier, California, United States
Georgetown University Medical Center ( Site 0204)
Washington D.C., District of Columbia, United States
Northside Hospital ( Site 0206)
Atlanta, Georgia, United States
University of Chicago Medical Center ( Site 0207)
Chicago, Illinois, United States
Franciscan St. Francis Health ( Site 0225)
Indianapolis, Indiana, United States
University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 0211)
Baltimore, Maryland, United States
Massachusetts General Hospital-Cancer Center Protocol Office ( Site 0203)
Boston, Massachusetts, United States
University of Michigan ( Site 0200)
Ann Arbor, Michigan, United States
Karmanos Cancer Institute ( Site 0216)
Detroit, Michigan, United States
Saint Louis University Cancer Center ( Site 0209)
St Louis, Missouri, United States
Atlantic Health System Morristown Medical Center ( Site 0213)
Morristown, New Jersey, United States
New York Medical College ( Site 0215)
Valhalla, New York, United States
University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0217)
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center ( Site 0222)
Cleveland, Ohio, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
Columbus, Ohio, United States
AHN West Penn Hospital ( Site 0212)
Pittsburgh, Pennsylvania, United States
Avera Cancer Institute- Research ( Site 0233)
Sioux Falls, South Dakota, United States
MEDICAL COLLEGE OF WISCONSIN ( Site 0234)
Milwaukee, Wisconsin, United States
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0100)
Toronto, Ontario, Canada
Clínica Alemana de Santiago ( Site 2704)
Santiago, Region M. de Santiago, Chile
James Lind Centro de Investigación del Cáncer ( Site 2705)
Temuco, Región de la Araucanía, Chile
Beijing Cancer hospital ( Site 2900)
Beijing, Beijing Municipality, China
SUN YAT-SEN UNIVERSITY CANCER CENTRE-Internal Medicine ( Site 2907)
Guangzhou, Guangdong, China
Henan Cancer Hospital-hematology department ( Site 2903)
Zhengzhou, Henan, China
Wuhan Union Hospital ( Site 2906)
Wuhan, Hubei, China
Hunan Cancer Hospital ( Site 2905)
Changsha, Hunan, China
The First Hospital of Jilin University-Hematology ( Site 2910)
Changchun, Jilin, China
Fudan University Shanghai Cancer Center ( Site 2908)
Shanghai, Shanghai Municipality, China
Shanghai East Hospital ( Site 2902)
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University-Head and Neck Oncology ( Site 2911)
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital-lymphoma ( Site 2901)
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University-Bone marrow transplant centre ( Site 2912)
Hangzhou, Zhejiang, China
Fakultní nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0800)
Brno, Brno-mesto, Czechia
Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0801)
Prague, , Czechia
North Estonia Medical Centre Foundation ( Site 0900)
Tallinn, Harju, Estonia
Centre Hospitalier de la Côte Basque ( Site 1002)
Bayonne, Aquitaine, France
Pitie Salpetriere University Hospital-Clinical haematology ( Site 1000)
Paris, , France
Evangelismos General Hospital of Athens ( Site 1214)
Athens, Attica, Greece
General Hospital of Athens "Laiko"-Hematology Department ( Site 1213)
Athens, Attica, Greece
Soroka Medical Center-Hematology Department ( Site 1403)
Beersheba, , Israel
Shaare Zedek Medical Center ( Site 1404)
Jerusalem, , Israel
Hadassah Medical Center ( Site 1402)
Jerusalem, , Israel
Sourasky Medical Center ( Site 1400)
Tel Aviv, , Israel
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa di Ematologia ( Site 1501)
Milan, Lombardy, Italy
Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1503)
Rozzano, Milano, Italy
IRCCS - AOU di Bologna-Istituto di Ematologia "L. e A. Seragnoli" ( Site 1500)
Bologna, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1502)
Napoli, , Italy
Haukeland Universitetssjukehus ( Site 1601)
Bergen, Hordaland, Norway
Oslo universitetssykehus, Radiumhospitalet ( Site 1600)
Oslo, , Norway
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie-Oncology Department ( Site 1707)
Krakow, Lesser Poland Voivodeship, Poland
Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site
Wroclaw, Lower Silesian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( S
Warsaw, Masovian Voivodeship, Poland
Szpitale Pomorskie Sp. z o. o.-Hematology and Bone Marrow Transplantation Department ( Site 1702)
Gdynia, Pomeranian Voivodeship, Poland
Pratia Onkologia ( Site 1701)
Katowice, Silesian Voivodeship, Poland
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 0601)
Seoul, , South Korea
Samsung Medical Center ( Site 0600)
Seoul, , South Korea
Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 2002)
L'Hospitalet Del Llobregat, Barcelona, Spain
Hospital Universitari Vall d'Hebron ( Site 2005)
Barcelona, , Spain
Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 2000)
Madrid, , Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca ( Site 2003)
Salamanca, , Spain
Skånes Universitetssjukhus Lund ( Site 2100)
Lund, Skåne County, Sweden
Karolinska Universitetssjukhuset Solna ( Site 2102)
Solna, Stockholm County, Sweden
Faculty of Medicine Siriraj Hospital ( Site 0701)
Bangkok, Bangkok, Thailand
Maharaj Nakorn Chiang Mai Hospital ( Site 0702)
Muang, Chiang Mai, Thailand
Ankara University Hospital Cebeci-hematology ( Site 2300)
Ankara, , Turkey (Türkiye)
Hacettepe Universitesi-Department of Hematology ( Site 2302)
Ankara, , Turkey (Türkiye)
Mega Medipol-Hematology ( Site 2308)
Istanbul, , Turkey (Türkiye)
Dokuz Eylül Üniversitesi-Hematology ( Site 2304)
Izmir, , Turkey (Türkiye)
Ondokuz Mayıs Universitesi ( Site 2306)
Samsun, , Turkey (Türkiye)
Karadeniz Teknik Universitesi Tip Fakultesi-Hematology ( Site 2307)
Trabzon, , Turkey (Türkiye)
Countries
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Related Links
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Merck Oncology Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-2140-004
Identifier Type: OTHER
Identifier Source: secondary_id
2022-501243-33-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1279-9073
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-003397-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2140-004
Identifier Type: -
Identifier Source: org_study_id
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