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Relapsed or Refractory Diffuse Large B-Cell LymphomaPhase 2NCT05144841

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

A Phase 2 study testing Zilovertamab vedotin in people with Relapsed or Refractory Diffuse Large B-Cell Lymphoma, run by Merck Sharp & Dohme LLC at 71 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Zilovertamab vedotin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
71 sitesin 17 countries
Study dates
8 Jan 2022to 21 Apr 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Has received a diagnosis of Primary mediastinal B-cell lymphoma (PMBCL).
  • 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.
Show all 19Show fewer
  • 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).

Trial locations and contacts

71 sites in 17 countries.

71 sites in 17 countries

United States19 sites

  • University of Michigan ( Site 0200)

    Ann Arbor, Michigan, 48109

  • Northside Hospital ( Site 0206)

    Atlanta, Georgia, 30342

  • University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 0211)

    Baltimore, Maryland, 21201

  • Massachusetts General Hospital-Cancer Center Protocol Office ( Site 0203)

    Boston, Massachusetts, 02114

  • University of Chicago Medical Center ( Site 0207)

    Chicago, Illinois, 60637

  • University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0217)

    Cincinnati, Ohio, 45219

  • University Hospitals Cleveland Medical Center ( Site 0222)

    Cleveland, Ohio, 44106

  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C

    Columbus, Ohio, 43210

  • Karmanos Cancer Institute ( Site 0216)

    Detroit, Michigan, 48201

  • Franciscan St. Francis Health ( Site 0225)

    Indianapolis, Indiana, 46237

  • MEDICAL COLLEGE OF WISCONSIN ( Site 0234)

    Milwaukee, Wisconsin, 53226

  • Atlantic Health System Morristown Medical Center ( Site 0213)

    Morristown, New Jersey, 07960

  • St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0229)

    Orange, California, 92868

  • AHN West Penn Hospital ( Site 0212)

    Pittsburgh, Pennsylvania, 15224

  • Avera Cancer Institute- Research ( Site 0233)

    Sioux Falls, South Dakota, 57105

  • Saint Louis University Cancer Center ( Site 0209)

    St Louis, Missouri, 63110

  • New York Medical College ( Site 0215)

    Valhalla, New York, 10595

  • Georgetown University Medical Center ( Site 0204)

    Washington D.C., District of Columbia, 20007

  • Innovative Clinical Research Institute ( Site 0202)

    Whittier, California, 90603

Other trials in United States

China11 sites

  • Beijing Cancer hospital ( Site 2900)

    Beijing, Beijing Municipality, 100142

  • The First Hospital of Jilin University-Hematology ( Site 2910)

    Changchun, Jilin, 130021

  • Hunan Cancer Hospital ( Site 2905)

    Changsha, Hunan, 410013

  • West China Hospital of Sichuan University-Head and Neck Oncology ( Site 2911)

    Chengdu, Sichuan, 610041

  • SUN YAT-SEN UNIVERSITY CANCER CENTRE-Internal Medicine ( Site 2907)

    Guangzhou, Guangdong, 510030

  • The First Affiliated Hospital, Zhejiang University-Bone marrow transplant centre ( Site 2912)

    Hangzhou, Zhejiang, 310003

  • Fudan University Shanghai Cancer Center ( Site 2908)

    Shanghai, Shanghai Municipality, 200032

  • Shanghai East Hospital ( Site 2902)

    Shanghai, Shanghai Municipality, 200120

  • Tianjin Medical University Cancer Institute and Hospital-lymphoma ( Site 2901)

    Tianjin, Tianjin Municipality, 300060

  • Wuhan Union Hospital ( Site 2906)

    Wuhan, Hubei, 430022

  • Henan Cancer Hospital-hematology department ( Site 2903)

    Zhengzhou, Henan, 450008

Other trials in China

Turkey (Türkiye)6 sites

  • Ankara University Hospital Cebeci-hematology ( Site 2300)

    Ankara, 06100

  • Hacettepe Universitesi-Department of Hematology ( Site 2302)

    Ankara, 06230

  • Mega Medipol-Hematology ( Site 2308)

    Istanbul, 34214

  • Dokuz Eylül Üniversitesi-Hematology ( Site 2304)

    Izmir, 35340

  • Ondokuz Mayıs Universitesi ( Site 2306)

    Samsun, 55139

  • Karadeniz Teknik Universitesi Tip Fakultesi-Hematology ( Site 2307)

    Trabzon, 61080

Other trials in Turkey (Türkiye)

Poland5 sites

  • Szpitale Pomorskie Sp. z o. o.-Hematology and Bone Marrow Transplantation Department ( Site 1702)

    Gdynia, Pomeranian Voivodeship, 81-519

  • Pratia Onkologia ( Site 1701)

    Katowice, Silesian Voivodeship, 40-519

  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie-Oncology Department ( Site 1707)

    Krakow, Lesser Poland Voivodeship, 31-826

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( S

    Warsaw, Masovian Voivodeship, 02-781

  • Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site

    Wroclaw, Lower Silesian Voivodeship, 50-367

Other trials in Poland

Israel4 sites

  • Soroka Medical Center-Hematology Department ( Site 1403)

    Beersheba, 8410101

  • Shaare Zedek Medical Center ( Site 1404)

    Jerusalem, 9103102

  • Hadassah Medical Center ( Site 1402)

    Jerusalem, 9112001

  • Sourasky Medical Center ( Site 1400)

    Tel Aviv, 64239

Other trials in Israel

Italy4 sites

  • IRCCS - AOU di Bologna-Istituto di Ematologia "L. e A. Seragnoli" ( Site 1500)

    Bologna, 40138

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa di Ematologia ( Site 1501)

    Milan, Lombardy, 20133

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1502)

    Naples, 80131

  • Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1503)

    Rozzano, Milano, 20089

Other trials in Italy

Spain4 sites

  • Hospital Universitari Vall d'Hebron ( Site 2005)

    Barcelona, 08035

  • Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 2002)

    L'Hospitalet Del Llobregat, Barcelona, 08908

  • Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 2000)

    Madrid, 28040

  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca ( Site 2003)

    Salamanca, 37007

Other trials in Spain

Chile2 sites

  • Clínica Alemana de Santiago ( Site 2704)

    Santiago, Region M. de Santiago, 7650568

  • James Lind Centro de Investigación del Cáncer ( Site 2705)

    Temuco, Araucania, 4800827

Other trials in Chile

Czechia2 sites

  • Fakultní nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0800)

    Brno, Brno-mesto, 625 00

  • Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0801)

    Prague, 12808

Other trials in Czechia

France2 sites

  • Centre Hospitalier de la Côte Basque ( Site 1002)

    Bayonne, Aquitaine, 64109

  • Pitie Salpetriere University Hospital-Clinical haematology ( Site 1000)

    Paris, 75013

Other trials in France

Greece2 sites

  • Evangelismos General Hospital of Athens ( Site 1214)

    Athens, Attica, 106 76

  • General Hospital of Athens "Laiko"-Hematology Department ( Site 1213)

    Athens, Attica, 115 27

Other trials in Greece

Norway2 sites

  • Haukeland Universitetssjukehus ( Site 1601)

    Bergen, Hordaland, 5021

  • Oslo universitetssykehus, Radiumhospitalet ( Site 1600)

    Oslo, 0310

Other trials in Norway

South Korea2 sites

  • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 0601)

    Seoul, 03722

  • Samsung Medical Center ( Site 0600)

    Seoul, 06351

Other trials in South Korea

Sweden2 sites

  • Skånes Universitetssjukhus Lund ( Site 2100)

    Lund, Skåne County, 22185

  • Karolinska Universitetssjukhuset Solna ( Site 2102)

    Solna, Stockholm County, 171 64

Other trials in Sweden

Thailand2 sites

  • Faculty of Medicine Siriraj Hospital ( Site 0701)

    Bangkok, Bangkok, 10700

  • Maharaj Nakorn Chiang Mai Hospital ( Site 0702)

    Muang, Chiang Mai, 50200

Other trials in Thailand

Canada1 site

  • Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0100)

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Estonia1 site

  • North Estonia Medical Centre Foundation ( Site 0900)

    Tallinn, Harju, 13419

Other trials in Estonia

About this study

Official title: 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)

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.

Being tested
Zilovertamab vedotin
Medical subject headings
Recurrence, Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zilovertamab vedotinBiological

    Also called MK-2140

    IV infusion

Study groups in NCT05144841
Study groupRoleWhat they receive
Arm AExperimentalParticipants 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.
Receives: Biological: Zilovertamab vedotin
Arm BExperimentalParticipants 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.
Receives: Biological: Zilovertamab vedotin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) per Lugano Response Criteria

    ORR is percentage of participants with complete response (CR) or partial response (PR). ORR by cohort, relapsed or refractory (rr) DLBCL as assessed by BICR according to Lugano Response Criteria 2014 in participants treated with zilovertamab vedotin Q3W. CR is the complete radiologic response. PR is a partial response, >=50% decrease in sum of the product of the perpendicular diameters for multiple lesions for up to 6 target measurable nodes and extranodal sites.

    Measured: Up to approximately 50 months

Secondary outcomes (3)

  1. Duration of Response (DOR) per Lugano Response Criteria

    Duration of Response (DOR) is time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.

    Measured: Up to approximately 50 months

  2. Number of Participants Who Experience an Adverse Event (AE)

    An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented.

    Measured: Up to approximately 50 months

  3. Number of Participants Who Discontinue Study Treatment Due to an AE

    An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented.

    Measured: Up to approximately 50 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2021
  2. Study start8 Jan 2022
  3. Primary completion21 Apr 2026
  4. Study completion21 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05144841
Sponsor's protocol ID
2140-004
Other IDs
MK-2140-004, 2022-501243-33-00, U1111-1279-9073, 2021-003397-32
Status last verified
May 2026
First submitted
22 Nov 2021
Last updated
28 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zilovertamab vedotin in people with Relapsed or Refractory Diffuse Large B-Cell Lymphoma, run by Merck Sharp & Dohme LLC at 71 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, China, Turkey (Türkiye), Poland, Israel and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) per Lugano Response Criteria (time frame: Up to approximately 50 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05144841.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.

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