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CompletedNCT05144841Updated May 28, 2026

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

A Phase 2 interventional study of Zilovertamab vedotin in Relapsed or Refractory Diffuse Large B-Cell Lymphoma, sponsored by Merck Sharp & Dohme LLC. Completed at 71 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-28.

Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
140
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Relapsed or Refractory Diffuse Large B-Cell Lymphoma
03

In context

Recurrence

4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.

This study's enrollment of 140 is above the median of 50 across 3,374 interventional studies indexed under Recurrence.

Browse Recurrence studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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).
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (actual)

Study arms

  • Experimental
    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.

    Biological: Zilovertamab vedotin

  • Experimental
    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.

    Biological: Zilovertamab vedotin

Interventions

  • BiologicalZilovertamab vedotin

    IV infusion

    Also known as: MK-2140

06

What researchers measure

Primary outcomes

  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.

    Time frame: Up to approximately 50 months

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Up to approximately 50 months

07

Study locations

71 sites
  • St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0229)
    Orange, California 92868, United States
  • Innovative Clinical Research Institute ( Site 0202)
    Whittier, California 90603, United States
  • Georgetown University Medical Center ( Site 0204)
    Washington D.C., District of Columbia 20007, United States
  • Northside Hospital ( Site 0206)
    Atlanta, Georgia 30342, United States
  • University of Chicago Medical Center ( Site 0207)
    Chicago, Illinois 60637, United States
  • Franciscan St. Francis Health ( Site 0225)
    Indianapolis, Indiana 46237, United States
  • University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 0211)
    Baltimore, Maryland 21201, United States
  • Massachusetts General Hospital-Cancer Center Protocol Office ( Site 0203)
    Boston, Massachusetts 02114, United States
  • University of Michigan ( Site 0200)
    Ann Arbor, Michigan 48109, United States
  • Karmanos Cancer Institute ( Site 0216)
    Detroit, Michigan 48201, United States
  • Saint Louis University Cancer Center ( Site 0209)
    St Louis, Missouri 63110, United States
  • Atlantic Health System Morristown Medical Center ( Site 0213)
    Morristown, New Jersey 07960, United States
  • New York Medical College ( Site 0215)
    Valhalla, New York 10595, United States
  • University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0217)
    Cincinnati, Ohio 45219, United States
  • University Hospitals Cleveland Medical Center ( Site 0222)
    Cleveland, Ohio 44106, United States
  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
    Columbus, Ohio 43210, United States
  • AHN West Penn Hospital ( Site 0212)
    Pittsburgh, Pennsylvania 15224, United States
  • Avera Cancer Institute- Research ( Site 0233)
    Sioux Falls, South Dakota 57105, United States
  • MEDICAL COLLEGE OF WISCONSIN ( Site 0234)
    Milwaukee, Wisconsin 53226, United States
  • Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0100)
    Toronto, Ontario M5G 2M9, Canada
  • James Lind Centro de Investigación del Cáncer ( Site 2705)
    Temuco, Araucania 4800827, Chile
  • Clínica Alemana de Santiago ( Site 2704)
    Santiago, Region M. de Santiago 7650568, Chile
  • Beijing Cancer hospital ( Site 2900)
    Beijing, Beijing Municipality 100142, China
  • SUN YAT-SEN UNIVERSITY CANCER CENTRE-Internal Medicine ( Site 2907)
    Guangzhou, Guangdong 510030, China
  • Henan Cancer Hospital-hematology department ( Site 2903)
    Zhengzhou, Henan 450008, China
  • Wuhan Union Hospital ( Site 2906)
    Wuhan, Hubei 430022, China
  • Hunan Cancer Hospital ( Site 2905)
    Changsha, Hunan 410013, China
  • The First Hospital of Jilin University-Hematology ( Site 2910)
    Changchun, Jilin 130021, China
  • Fudan University Shanghai Cancer Center ( Site 2908)
    Shanghai, Shanghai Municipality 200032, China
  • Shanghai East Hospital ( Site 2902)
    Shanghai, Shanghai Municipality 200120, China
  • West China Hospital of Sichuan University-Head and Neck Oncology ( Site 2911)
    Chengdu, Sichuan 610041, China
  • Tianjin Medical University Cancer Institute and Hospital-lymphoma ( Site 2901)
    Tianjin, Tianjin Municipality 300060, China
  • The First Affiliated Hospital, Zhejiang University-Bone marrow transplant centre ( Site 2912)
    Hangzhou, Zhejiang 310003, China
  • Fakultní nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0800)
    Brno, Brno-mesto 625 00, Czechia
  • Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0801)
    Prague, 12808, Czechia
  • North Estonia Medical Centre Foundation ( Site 0900)
    Tallinn, Harju 13419, Estonia
  • Centre Hospitalier de la Côte Basque ( Site 1002)
    Bayonne, Aquitaine 64109, France
  • Pitie Salpetriere University Hospital-Clinical haematology ( Site 1000)
    Paris, 75013, France
  • Evangelismos General Hospital of Athens ( Site 1214)
    Athens, Attica 106 76, Greece
  • General Hospital of Athens "Laiko"-Hematology Department ( Site 1213)
    Athens, Attica 115 27, Greece
  • Soroka Medical Center-Hematology Department ( Site 1403)
    Beersheba, 8410101, Israel
  • Shaare Zedek Medical Center ( Site 1404)
    Jerusalem, 9103102, Israel
  • Hadassah Medical Center ( Site 1402)
    Jerusalem, 9112001, Israel
  • Sourasky Medical Center ( Site 1400)
    Tel Aviv, 64239, Israel
  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa di Ematologia ( Site 1501)
    Milan, Lombardy 20133, Italy
  • Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1503)
    Rozzano, Milano 20089, Italy
  • IRCCS - AOU di Bologna-Istituto di Ematologia "L. e A. Seragnoli" ( Site 1500)
    Bologna, 40138, Italy
  • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1502)
    Naples, 80131, Italy
  • Haukeland Universitetssjukehus ( Site 1601)
    Bergen, Hordaland 5021, Norway
  • Oslo universitetssykehus, Radiumhospitalet ( Site 1600)
    Oslo, 0310, Norway
  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie-Oncology Department ( Site 1707)
    Krakow, Lesser Poland Voivodeship 31-826, Poland
  • Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site
    Wroclaw, Lower Silesian Voivodeship 50-367, Poland
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( S
    Warsaw, Masovian Voivodeship 02-781, Poland
  • Szpitale Pomorskie Sp. z o. o.-Hematology and Bone Marrow Transplantation Department ( Site 1702)
    Gdynia, Pomeranian Voivodeship 81-519, Poland
  • Pratia Onkologia ( Site 1701)
    Katowice, Silesian Voivodeship 40-519, Poland
  • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 0601)
    Seoul, 03722, South Korea
  • Samsung Medical Center ( Site 0600)
    Seoul, 06351, South Korea
  • Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 2002)
    L'Hospitalet Del Llobregat, Barcelona 08908, Spain
  • Hospital Universitari Vall d'Hebron ( Site 2005)
    Barcelona, 08035, Spain
  • Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 2000)
    Madrid, 28040, Spain
  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca ( Site 2003)
    Salamanca, 37007, Spain
  • Skånes Universitetssjukhus Lund ( Site 2100)
    Lund, Skåne County 22185, Sweden
  • Karolinska Universitetssjukhuset Solna ( Site 2102)
    Solna, Stockholm County 171 64, Sweden
  • Faculty of Medicine Siriraj Hospital ( Site 0701)
    Bangkok, Bangkok 10700, Thailand
  • Maharaj Nakorn Chiang Mai Hospital ( Site 0702)
    Muang, Chiang Mai 50200, Thailand
  • Ankara University Hospital Cebeci-hematology ( Site 2300)
    Ankara, 06100, Turkey (Türkiye)
  • Hacettepe Universitesi-Department of Hematology ( Site 2302)
    Ankara, 06230, Turkey (Türkiye)
  • Mega Medipol-Hematology ( Site 2308)
    Istanbul, 34214, Turkey (Türkiye)
  • Dokuz Eylül Üniversitesi-Hematology ( Site 2304)
    Izmir, 35340, Turkey (Türkiye)
  • Ondokuz Mayıs Universitesi ( Site 2306)
    Samsun, 55139, Turkey (Türkiye)
  • Karadeniz Teknik Universitesi Tip Fakultesi-Hematology ( Site 2307)
    Trabzon, 61080, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05144841
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Dec 3, 2021
Start date
Jan 8, 2022
Primary completion
Apr 21, 2026
Completion
Apr 21, 2026
Last update
May 28, 2026

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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