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Be Part of Research - Trial Details - 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)
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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

Open to: ALL

Age: 18.0 - N/A

London-Camden Aberdeen

Medical Conditions

Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jan 2022 Sep 2027

INTERVENTIONAL

Intervention Type : BIOLOGICAL
Intervention Description : Intravenous (IV) Infusion 1.5 mg/kg, 1.75 mg/kg, 2.0 mg/kg, 2.25 mg/kg, 2.5 mg/kg

Intervention Arm Group : ZV + BR (Part 1);ZV + BR (Part 2);ZV + R-GemOx (Part 1);ZV + R-GemOx (Part 2);

Intervention Type : BIOLOGICAL
Intervention Description : IV Infusion 375 mg/m\^2

Intervention Arm Group : Bendamustine Rituximab (BR);R-GemOx (active control for Part 2);ZV + BR (Part 1);ZV + BR (Part 2);ZV + R-GemOx (Part 1);ZV + R-GemOx (Part 2);

Intervention Type : DRUG
Intervention Description : IV Infusion 1000 mg/m\^2

Intervention Arm Group : R-GemOx (active control for Part 2);ZV + R-GemOx (Part 1);ZV + R-GemOx (Part 2);

Intervention Type : DRUG
Intervention Description : IV Infusion 100 mg/m\^2

Intervention Arm Group : R-GemOx (active control for Part 2);ZV + R-GemOx (Part 1);ZV + R-GemOx (Part 2);

Intervention Type : DRUG
Intervention Description : IV Infusion 90 mg/m\^2

Intervention Arm Group : Bendamustine Rituximab (BR);ZV + BR (Part 1);ZV + BR (Part 2);

Intervention Type : DRUG
Intervention Description : Prophylactic G-CSF will be administered at each cycle of zilovertamab vedotin as per the institutional guidelines.

Intervention Arm Group : ZV + BR (Part 1);ZV + BR (Part 2);ZV + R-GemOx (Part 1);ZV + R-GemOx (Part 2);



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • University College London Hospital-Cancer Clinical Trials Unit ( Site 2100)
    London-Camden
    London, City Of
    NW1 2PG
  • Aberdeen Royal Infirmary ( Site 2104)
    Aberdeen
    Aberdeen City
    AB25 2ZN

Toll Free Number 1-888-577-8839
Trialsites@msd.com



The study is sponsored by Merck Sharp & Dohme LLC



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Read full details for Trial ID: NCT05139017
Last updated 28 May 2025

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