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NCT05144841CompletedPhase 2

A Study to Evaluate Zilovertamab Vedotin (MK-2140) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-004)

A Phase 2 Open-label Clinical Study to Evaluate the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (waveLINE-004)

Source: ClinicalTrials.gov · Last updated 28 May 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate zilovertamab vedotin with respect to objective response rate and duration of response per Lugano Response Criteria as assessed by blinded independent central review (BICR). Safety and tolerability will also be evaluated in this Phase 2, single arm, interventional study.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
140 (actual)
First submitted
22 Nov 2021
Start date
8 Jan 2022
Primary completion date
21 Apr 2026
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT05144841
EU CT number
2022-501243-33-00
EudraCT number
2021-003397-32

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 140
  • From 8 Jan 2022 to the primary completion date, 21 Apr 2026
  • 71 sites in 17 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has received a diagnosis of Primary mediastinal B-cell lymphoma (PMBCL).
  • Has undergone solid organ transplant at any time.
  • 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.

Other illness

  • 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 a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
  • 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).

Other

  • Has pericardial effusion or clinically significant pleural effusion.
  • Has ongoing Grade \>1 peripheral neuropathy.
  • Transformed DLBCL from indolent lymphoma.
  • Has known active central nervous system (CNS) lymphoma involvement or active CNS involvement by lymphoma.

Who the study is looking for

  • Has relapsed or refractory (rr) DLBCL; has progressed after at least 2 lines of prior therapy; and has progressed after auto- stem cell transplant (SCT) or are auto-SCT ineligible. Must have received prior multiagent regimen that includes an alkylating agent. anthracycline, and anti-CD20 (cluster of differentiation 20) monoclonal antibody.
  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (71)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0100)
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
Clínica Alemana de Santiago ( Site 2704)
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SantiagoChileUnknown status
James Lind Centro de Investigación del Cáncer ( Site 2705)
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TemucoChileUnknown status
Beijing Cancer hospital ( Site 2900)
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BeijingChinaUnknown status
The First Hospital of Jilin University-Hematology ( Site 2910)
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ChangchunChinaUnknown status
Hunan Cancer Hospital ( Site 2905)
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ChangshaChinaUnknown status
West China Hospital of Sichuan University-Head and Neck Oncology ( Site 2911)
Coordinator of this site? Confirm its status
ChengduChinaUnknown status
SUN YAT-SEN UNIVERSITY CANCER CENTRE-Internal Medicine ( Site 2907)
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status
The First Affiliated Hospital, Zhejiang University-Bone marrow transplant centre ( Site 2912)
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status
Fudan University Shanghai Cancer Center ( Site 2908)
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ShanghaiChinaUnknown status
Shanghai East Hospital ( Site 2902)
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ShanghaiChinaUnknown status
Tianjin Medical University Cancer Institute and Hospital-lymphoma ( Site 2901)
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TianjinChinaUnknown status
Wuhan Union Hospital ( Site 2906)
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WuhanChinaUnknown status
Henan Cancer Hospital-hematology department ( Site 2903)
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ZhengzhouChinaUnknown status
Fakultni nemocnice Brno
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BrnoCzechiaCompleted
Vseobecna Fakultni Nemocnice V Praze
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Prague 2CzechiaCompleted
North Estonia Medical Centre Foundation
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TallinnEstoniaCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Catalan Institute of Oncology
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L'Hospitalet de LlobregatSpainCompleted
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainCompleted
Hospital Universitario De Salamanca
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SalamancaSpainCompleted
Centre Hospitalier de la Cote Basque
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BayonneFranceCompleted
Assistance Publique Hopitaux De Paris
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Paris Cedex 13FranceCompleted
Laiko General Hospital of Athens
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AthensGreeceCompleted
Evangelismos S A
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AthensGreeceCompleted
Soroka Medical Center-Hematology Department ( Site 1403)
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BeershebaIsraelUnknown status
Hadassah Medical Center ( Site 1402)
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JerusalemIsraelUnknown status
Shaare Zedek Medical Center ( Site 1404)
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JerusalemIsraelUnknown status
Sourasky Medical Center ( Site 1400)
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Tel AvivIsraelUnknown status
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyCompleted
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyCompleted
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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NaplesItalyCompleted
Humanitas Research Hospital
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RozzanoItalyCompleted
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 0601)
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SeoulSouth KoreaUnknown status
Samsung Medical Center ( Site 0600)
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SeoulSouth KoreaUnknown status
Helse Bergen HF
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BergenNorwayCompleted
Oslo University Hospital HF
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OsloNorwayCompleted
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
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CracowPolandCompleted
Szpitale Pomorskie Sp z o o
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GdyniaPolandCompleted
Pratia Hematologia Sp. Z o. o
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KatowicePolandCompleted
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandCompleted
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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WroclawPolandCompleted
Region Skane Skanes Universitetssjukhus
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LundSwedenCompleted
Karolinska University Hospital
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SolnaSwedenCompleted
Faculty of Medicine Siriraj Hospital ( Site 0701)
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BangkokThailandUnknown status
Maharaj Nakorn Chiang Mai Hospital ( Site 0702)
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MuangThailandUnknown status
University of Michigan ( Site 0200)
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Ann ArborUnited StatesUnknown status
Northside Hospital ( Site 0206)
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AtlantaUnited StatesUnknown status
University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 0211)
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BaltimoreUnited StatesUnknown status
Massachusetts General Hospital-Cancer Center Protocol Office ( Site 0203)
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BostonUnited StatesUnknown status
University of Chicago Medical Center ( Site 0207)
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ChicagoUnited StatesUnknown status
University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0217)
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CincinnatiUnited StatesUnknown status
University Hospitals Cleveland Medical Center ( Site 0222)
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ClevelandUnited StatesUnknown status
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
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ColumbusUnited StatesUnknown status
Karmanos Cancer Institute ( Site 0216)
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DetroitUnited StatesUnknown status
Franciscan St. Francis Health ( Site 0225)
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IndianapolisUnited StatesUnknown status
MEDICAL COLLEGE OF WISCONSIN ( Site 0234)
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MilwaukeeUnited StatesUnknown status
Atlantic Health System Morristown Medical Center ( Site 0213)
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MorristownUnited StatesUnknown status
St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0229)
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OrangeUnited StatesUnknown status
AHN West Penn Hospital ( Site 0212)
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PittsburghUnited StatesUnknown status
Avera Cancer Institute- Research ( Site 0233)
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Sioux FallsUnited StatesUnknown status
Saint Louis University Cancer Center ( Site 0209)
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St LouisUnited StatesUnknown status
New York Medical College ( Site 0215)
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ValhallaUnited StatesUnknown status
Georgetown University Medical Center ( Site 0204)
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Washington D.C.United StatesUnknown status
Innovative Clinical Research Institute ( Site 0202)
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WhittierUnited StatesUnknown status
Ankara University Hospital Cebeci-hematology ( Site 2300)
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AnkaraTurkey (Türkiye)Unknown status
Hacettepe Universitesi-Department of Hematology ( Site 2302)
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AnkaraTurkey (Türkiye)Unknown status
Mega Medipol-Hematology ( Site 2308)
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IstanbulTurkey (Türkiye)Unknown status
Dokuz Eylül Üniversitesi-Hematology ( Site 2304)
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IzmirTurkey (Türkiye)Unknown status
Ondokuz Mayıs Universitesi ( Site 2306)
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SamsunTurkey (Türkiye)Unknown status
Karadeniz Teknik Universitesi Tip Fakultesi-Hematology ( Site 2307)
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TrabzonTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.