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A Study of Zilovertamab Vedotin for Relapsed or Refractory Diffuse Large B-Cell Lymphoma

This study is testing a new treatment called zilovertamab vedotin (MK-2140) in combination with standard care for people with diffuse large B-cell lymphoma (DLBCL) that has come back or not responded to previous treatments (relapsed or refractory). Researchers want to see how safe and effective zilovertamab vedotin is when given with other common lymphoma medicines like rituximab, gemcitabine, oxaliplatin, or bendamustine. The study will enroll about 290 adults aged 18 or older who have DLBCL that can be measured on scans and are generally well enough to participate. Success in this study means seeing if the new combinations can help patients live longer without their cancer getting worse. The current status of this study is unclear.

Study design
This is a Phase 2/3, randomized, multi-site, open-label study designed to confirm the best dose and then expand to evaluate effectiveness. It plans to enroll about 290 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events and treatment discontinuation for up to about 68 months after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05139017

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

Recruiting
PHASE2Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~290 participants
Updated 2026-09-11 on ClinicalTrials.gov
What's tested:Zilovertamab vedotinRituximabGemcitabineOxaliplatinBendamustineGranulocyte Colony-Stimulating Factor (G-CSF)

At a glance

Recruiting sites
62 of 135 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants who experienced dose-limiting toxicities (DLTs) in Part 1
Measured over Up to ~6 weeks
+4 more outcomes measured

Conditions

DLBCL
Diffuse Large B-Cell Lymphoma

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Diffuse Large B-Cell Lymphoma

NCT05139017

Where you'd take part

This study runs at 135 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Aarhus Universitetshospital, Skejby ( Site 1701)

    Aarhus, Central Jutland, Denmarkstudy coordinator listed

    Recruiting

  • Alliance Cancer Specialists (ACS) ( Site 8001)

    Horsham, Pennsylvaniastudy coordinator listed

    Recruiting

  • Ankara University Hospital Cebeci-hematology ( Site 1901)

    Ankara, Turkey (Türkiye)study coordinator listed

    Recruiting

  • Bass Medical Group ( Site 0166)

    Walnut Creek, Californiastudy coordinator listed

    Recruiting

  • Beijing Cancer hospital ( Site 3000)

    Beijing, Beijing Municipality, Chinastudy coordinator listed

    Recruiting

  • Biocenter ( Site 2401)

    Concepción, Biobio, Chilestudy coordinator listed

    Recruiting

  • Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0163)

    Boca Raton, Floridastudy coordinator listed

    Recruiting

  • Bradfordhill ( Site 2403)

    Santiago, Region M. de Santiago, Chilestudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Eligibility criteria

Inclusion

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.
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.
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.

Exclusion

Not applicable with protocol amendment 4: Has history of transformation of indolent disease to DLBCL
Has received solid organ transplant at any time.
Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL).
Has clinically significant (ie, active) cardiovascular disease or serious cardiac arrhythmia requiring medication.
Has ongoing graft-versus-host disease (GVHD) of any grade, or is receiving treatment for their GVHD.
Has clinically significant pericardial or 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.
Has a demyelinating form of Charcot-Marie-Tooth disease.
Has contraindication to any of the study intervention components including but not limited to prior anaphylactic reaction.
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 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
Has ongoing corticosteroid therapy.
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. Participants with prior CNS involvement are eligible if their CNS disease is in radiographic, cytological (for cerebrospinal fluid disease), and clinical remission.
Has an active infection requiring systemic therapy.
Has a known history of human immunodeficiency virus (HIV) infection.
Has a known active Hepatitis C virus infection.
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.

What this trial measures

  • Number of participants who experienced dose-limiting toxicities (DLTs) in Part 1Up to ~6 weeks

    The CTCAE, Version 5.0 will be used to grade the severity of AEs in this study. DLTs will be reported for Part 1 of this study.

  • Number of participants who experienced an adverse event (AE)Up to ~68 months

    An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who experienced an AE will be reported.

  • Number of participants who discontinued study treatment due to an AEUp to ~68 months

    An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who discontinued study treatment due to an AE will be reported.

  • Overall survival (OS)Up to ~35 months

    OS, defined as the time from randomization to death due to any cause will be reported.

  • Progression-free survival (PFS)Up to ~35 months

    PFS, defined as the time from randomization to the first documented disease progression per Lugano response criteria as assessed by BICR or death due to any cause, whichever occurs first will be presented.