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Study Comparing Zilovertamab Vedotin with Drug Combination for Untreated Patients with Diffuse Large B-Cell Lymphoma

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called Diffuse Large B-Cell Lymphoma (DLBCL), specifically the germinal center B-cell (GCB) subtype. The study is investigating the effectiveness and safety of a new treatment combination for people who have not received any prior treatment for this condition. The main treatment being tested is called Zilovertamab vedotin (also known by its code name MK-2140), which will be combined with a regimen known as R-CHP. This regimen includes the medications Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, and Prednisone. The study will compare this combination to another treatment that includes Polatuzumab vedotin with the same R-CHP regimen.

The purpose of the study is to see how well these treatments work in achieving a complete response, which means the disappearance of all signs of cancer in response to treatment. Participants will receive the treatments through intravenous infusions, which means the medication is given directly into a vein, and some medications will be taken orally. The study will monitor participants over a period to assess the effectiveness of the treatments and any side effects that may occur.

Throughout the study, participants will be closely observed to track their health and any changes in their condition. The study aims to provide valuable information on the potential benefits and risks of these treatment combinations for people with this specific type of lymphoma. The ultimate goal is to improve treatment options and outcomes for individuals diagnosed with Diffuse Large B-Cell Lymphoma.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be randomly assigned to one of two treatment groups. This means you will receive either zilovertamab vedotin plus R-CHP or polatuzumab vedotin plus R-CHP. The assignment is random, similar to flipping a coin, to ensure fairness and objectivity.

  2. Step 2

    Treatment administration

    If you are in the zilovertamab vedotin group, you will receive this medication through an intravenous infusion. This means the medicine will be given directly into your vein using a needle.

    You will also receive rituximab, doxorubicin hydrochloride, and cyclophosphamide through intravenous infusion. Additionally, you will take prednisolone orally, which means you will swallow it in pill form.

    If you are in the polatuzumab vedotin group, you will receive this medication through an intravenous infusion, along with rituximab, doxorubicin hydrochloride, and cyclophosphamide. You will also take prednisolone orally.

  3. Step 3

    Treatment schedule

    The treatment will be administered in cycles. Each cycle lasts for a specific period, during which you will receive the medications on certain days. The exact schedule will be provided to you by the study team.

    The duration of the treatment will depend on your response to the medications and the overall study plan. Regular assessments will be conducted to monitor your progress.

  4. Step 4

    Monitoring and assessments

    Throughout the study, you will undergo regular health assessments. These may include physical exams, blood tests, and imaging tests like PET scans to evaluate how the treatment is affecting your condition.

    The study team will monitor for any side effects or adverse reactions to the medications. It is important to report any new symptoms or concerns to the study team promptly.

  5. Step 5

    End of treatment evaluation

    At the end of the treatment period, a comprehensive evaluation will be conducted to determine the effectiveness of the treatment. This will include assessing the response of your lymphoma to the medications.

    The results will be compared to the criteria set by the study to determine the success of the treatment.

Who can join the trial?

7 criteria

  • Must have a confirmed diagnosis of the germinal center B-cell (GCB) subtype of Diffuse Large B-Cell Lymphoma (DLBCL) through a previous biopsy.
  • Must have a positive result on a positron emission tomography (PET) scan at screening, which is a type of imaging test that helps show how your tissues and organs are functioning. The result should be rated as 4 to 5 on the Lugano 5-point scale, a system used to assess lymphoma.
  • Must not have received any prior treatment for their DLBCL.
  • If infected with human immunodeficiency virus (HIV), the virus must be well controlled with antiretroviral therapy (ART), which is medication used to treat HIV.
  • If positive for hepatitis B surface antigen (HBsAg), must have received hepatitis B virus (HBV) antiviral therapy and have an undetectable HBV viral load before starting the study. This means the virus is not actively reproducing in the body.
  • If there is a history of hepatitis C virus (HCV) infection, the HCV viral load must be undetectable at screening, indicating the virus is not actively present in the body.
  • Both male and female participants are eligible.

Who cannot join the trial?

9 criteria

  • Patients with any other type of cancer that is not Diffuse Large B-Cell Lymphoma (DLBCL).
  • Patients who have previously received treatment with the drugs zilovertamab vedotin or polatuzumab vedotin.
  • Patients who are pregnant or breastfeeding.
  • Patients with severe uncontrolled illnesses, such as heart disease or infections.
  • Patients who have had a major surgery within the last 4 weeks.
  • Patients with known allergies to any of the study drugs or their components.
  • Patients who are participating in another clinical trial.
  • Patients with a history of drug or alcohol abuse within the last 6 months.
  • Patients with any condition that, in the opinion of the study doctor, makes them unsuitable for the study.
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Investigated drugs

  • Zilovertamab Vedotin (MK-2140)

    is a medication being studied for its potential to treat a type of cancer called diffuse large B cell lymphoma (DLBCL). It is designed to target and attach to specific cancer cells, delivering a substance that can help kill these cells. This approach aims to reduce the number of cancer cells in the body and improve the patient's condition.

  • Polatuzumab Vedotin

    is another medication used in the study for treating DLBCL. Similar to zilovertamab vedotin, it targets specific cancer cells and delivers a toxic substance directly to them. This helps in destroying the cancer cells while trying to minimize damage to healthy cells, potentially leading to better outcomes for patients.

  • R-CHP

    is a combination of medications used in the treatment of DLBCL. It includes a mix of drugs that work together to attack cancer cells in different ways. This combination is often used to enhance the effectiveness of the treatment, aiming to reduce the cancer's ability to grow and spread.

What is already known about the treatment

Zilovertamab Vedotin – This medication is administered intravenously, meaning it is given through a vein, typically in a hospital or clinical setting. It is currently being studied in clinical trials for its effectiveness in treating a type of cancer called Diffuse Large B-Cell Lymphoma (DLBCL). The main purpose of this medication is to help the immune system target and destroy cancer cells. It works by attaching to a specific protein on the surface of cancer cells and delivering a toxic substance that kills these cells. Zilovertamab Vedotin is classified as an antibody-drug conjugate, which is a type of targeted cancer therapy.

Investigated diseases

Diffuse Large B-Cell Lymphoma (DLBCL) – This is a type of non-Hodgkin lymphoma that originates in the B-cells, which are a type of white blood cell. It is characterized by rapidly growing tumors in the lymph nodes, spleen, liver, bone marrow, or other organs. The disease often begins with a painless swelling in the neck, armpit, or groin due to enlarged lymph nodes. As it progresses, it can spread to other parts of the body, including the central nervous system. Symptoms may include fever, night sweats, and weight loss. The progression of the disease can vary, with some cases advancing quickly while others develop more slowly.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515526-89-00Protocol codeMK-2140-011Estimated enrolment586 patientsSponsorMerck Sharp & Dohme LLC

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