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Looking for participantsPhase2/Phase3

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)

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT05139017

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Zilovertamab vedotin (biological), Rituximab (biological), Gemcitabine (drug), Oxaliplatin (drug)
How long the study runs
Study runs about 68 months (dates as stated)
About the drug or intervention
Zilovertamab vedotin — biological: Intravenous (IV) Infusion 1.5 mg/kg, 1.75 mg/kg, 2.0 mg/kg, 2.25 mg/kg, 2.5 mg/kg · Rituximab — biological: IV Infusion 375 mg/m\^2 · Gemcitabine — drug: IV Infusion 1000 mg/m\^2 · Oxaliplatin — drug: IV Infusion 100 mg/m\^2 · Bendamustine — drug: IV Infusion 90 mg/m\^2 · Granulocyte Colony-Stimulating Factor (G-CSF) — drug: Prophylactic G-CSF will be administered at each cycle of zilovertamab vedotin as per the institutional guidelines.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
290
Started
2022-01-14
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for dlbcl
  • • Phase2/Phase3 - 290 participants
  • • The purpose of this Phase 2/3, randomized, multisite, open-label, dose confirmation, and expansion study is to evaluate the safety, and efficacy of zilovertamab vedotin (ZV) in combination with standard of care options for the treatment of rrDLBCL

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with dlbcl

Where?

  • • Aberdeen - Aberdeen Royal Infirmary ( Site 2104)
  • • Truro - The Royal Cornwall Hospital ( Site 2103)
  • • London-Camden - University College London Hospital-Cancer Clinical Trials Unit ( Site 2100)

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The purpose of this Phase 2/3, randomized, multisite, open-label, dose confirmation, and expansion study is to evaluate the safety, and efficacy of zilovertamab vedotin (ZV) in combination with standard of care options for the treatment of rrDLBCL. This study will be divided into 2 parts: Dose Confirmation (Part 1) and Efficacy Expansion (Part 2) and will enroll participants who are at least 18 years of age with rrDLBCL. The hypotheses are: ZV in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx) is superior to R-GemOx with respect to progression-free survival (PFS) per Lugano response criteria by blinded independent review committee (BICR); and that ZV in combination with bendamustine rituximab (BR) is superior to BR with respect to PFS per Lugano response criteria by BICR. With protocol amendment 4 (effective: 04-April-2024), enrollment in Cohort B (study arms Bendamustine Rituximab \[BR\] and ZV + BR) is discontinued. No efficacy outcome analysis and hypothesis testing will be conducted for Cohort B.

DLBCLDiffuse Large B-Cell Lymphoma

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Has a confirmed by a biopsy 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 activity scale (ECOG) Performance Status of 0 to 2 within 7 days prior to study treatment...
  • ✓Has healthy organ.
  • ✓Is able to provide new or archival tumor tissue sample not previously irradiated.

Who cannot take part

  • ✗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 heart arrhythmia requiring medication.
  • ✗Has ongoing graft-versus-host disease (GVHD) of any grade, or is receiving treatment for their GVHD.
See the full criteria
Inclusion Criteria: * 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. Zilovertamab vedotin plus R-GemOx, or R-GemOx study arms: * 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. Not applicable with protocol amendment 4: Zilovertamab vedotin plus Bendamustine Rituximab (BR), and Bendamustine Rituximab study arms: * 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 Criteria: * 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.

Where Is This Study? (3 UK sites)

Aberdeen Royal Infirmary ( Site 2104)

Aberdeen AB25 2ZN, United Kingdom

COMPLETED

The Royal Cornwall Hospital ( Site 2103)

Truro TR1 3LJ, United Kingdom

COMPLETED
Hospital R&D contact (matched)

Abi Weeks

rch-tr.CornwallResearch@nhs.net01872 25 6424

University College London Hospital-Cancer Clinical Trials Unit ( Site 2100)

London-Camden NW1 2PG, United Kingdom

COMPLETED

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10