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Study of Zilovertamab Vedotin and Drug Combination for Untreated Diffuse Large B-Cell Lymphoma Patients

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). The study is testing a new treatment called zilovertamab vedotin, also known by its code name MK-2140. This treatment will be combined with other medications, including rituximab, cyclophosphamide, doxorubicin, and prednisone. These medications are part of a standard treatment regimen known as R-CHP. The study will compare this new combination to the standard treatment regimen called R-CHOP, which includes the same medications plus an additional drug called vincristine.

The purpose of the study is to see if the new combination of treatments can help people with DLBCL live longer without their disease getting worse. Participants in the study will receive either the new treatment combination or the standard treatment. The study will last for up to 18 months, during which participants will receive their assigned treatment and be monitored regularly. The study will also look at how the treatments affect participants' quality of life and any side effects they may experience.

Throughout the study, participants will have regular check-ups and tests to monitor their health and the progress of their disease. These tests may include imaging scans and blood tests. The study aims to provide valuable information about the effectiveness and safety of the new treatment combination for people with DLBCL.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of diffuse large B-cell lymphoma (DLBCL) through a prior biopsy and ensuring no previous treatment for DLBCL has been received.

    A positron emission tomography (PET) scan is performed to confirm disease presence, and an evaluation of general health status is conducted, including heart function tests.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two treatment groups. One group receives zilovertamab vedotin in combination with R-CHP, while the other group receives R-CHOP.

  3. Step 3

    Treatment administration

    Treatment involves a combination of medications administered over a series of cycles. The medications include rituximab, cyclophosphamide, doxorubicin hydrochloride, prednisolone, and vincristine, all given intravenously, except for prednisolone, which is taken orally.

    The specific dosage and frequency of each medication are determined by the study protocol and are administered under medical supervision.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment and any side effects. This includes imaging tests and health assessments.

    Participants are evaluated for progression-free survival and overall survival, as well as any adverse events experienced during the study.

  5. Step 5

    End of treatment evaluation

    At the end of the treatment period, a comprehensive evaluation is conducted to determine the complete response to treatment.

    Health-related quality of life is assessed using specific questionnaires to evaluate physical and emotional well-being.

Who can join the trial?

9 criteria

  • The patient must have a confirmed diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL), which is a type of cancer, based on a previous biopsy.
  • The patient must have a positive result on a positron emission tomography (PET) scan at the start of the study. This means the scan shows a score of 4 to 5 on a specific scale used to measure disease activity.
  • The patient must not have received any previous treatment for their DLBCL.
  • The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 2 being able to do some activities but not work.
  • The patient must have a heart ejection fraction of 45% or higher. This is a measure of how well the heart is pumping blood, determined by tests like an echocardiogram (ECHO) or a multigated acquisition (MUGA) scan.
  • If the patient is infected with human immunodeficiency virus (HIV), their HIV must be well controlled with medication.
  • If the patient has a positive test for hepatitis B surface antigen (HBsAg), they can participate if they have been treated for hepatitis B and have no detectable virus in their blood before starting the study.
  • If the patient has a history of hepatitis C virus (HCV) infection, they can participate if there is no detectable virus in their blood at the start of the study.
  • Both male and female patients are eligible to participate.

Who cannot join the trial?

4 criteria

  • Patients with medical conditions other than Diffuse Large B-Cell Lymphoma (DLBCL) cannot participate. DLBCL is a type of cancer that affects the lymphatic system, which is part of the body's immune system.
  • Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study and may include specific age groups.
  • Patients who are part of a vulnerable population, such as those who may not be able to give informed consent, cannot participate. This is to ensure the safety and well-being of all participants.
  • Patients who do not meet other specific criteria set by the study, which may include health status, previous treatments, or other medical conditions, cannot participate.
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Investigated drugs

  • Zilovertamab Vedotin (MK-2140)

    is an experimental medication being tested in this clinical trial. It is designed to target and destroy cancer cells in patients with diffuse large B-cell lymphoma (DLBCL). The medication works by attaching to specific proteins on the surface of cancer cells, delivering a toxic substance directly to them, which helps to kill the cancer cells while minimizing damage to normal cells.

  • R-CHP

    is a combination of medications used to treat diffuse large B-cell lymphoma. It includes three chemotherapy drugs and a monoclonal antibody. The chemotherapy drugs work by stopping the growth of cancer cells, while the monoclonal antibody helps the immune system recognize and attack the cancer cells.

  • R-CHOP

    is another combination of medications used as a standard treatment for diffuse large B-cell lymphoma. It includes the same components as R-CHP, with the addition of a fourth chemotherapy drug. This combination works to kill cancer cells and support the immune system in fighting the cancer.

What is already known about the treatment

Zilovertamab Vedotin – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating Diffuse Large B-Cell Lymphoma (DLBCL). It is in the experimental phase and not yet widely available in medical practice. The main therapeutic indication is for patients with previously untreated DLBCL. Zilovertamab Vedotin works by targeting specific proteins on cancer cells, delivering a toxic agent directly to these cells to inhibit their growth. It is classified as an antibody-drug conjugate, combining a monoclonal antibody with a cytotoxic drug to enhance its cancer-fighting capabilities.

Investigated diseases

Diffuse Large B-Cell Lymphoma (DLBCL) – This is a type of non-Hodgkin lymphoma, which is a cancer that starts in white blood cells called lymphocytes. It is characterized by rapidly growing tumors in the lymph nodes, spleen, liver, bone marrow, or other organs. DLBCL can occur in any part of the body and often presents with symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The disease progresses quickly, and without intervention, it can spread to other parts of the body. It is the most common type of non-Hodgkin lymphoma in adults. The progression of DLBCL can vary, with some cases responding well to treatment while others may be more aggressive.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515566-13-00Protocol codeMK-2140-010Estimated enrolment1 071 patientsSponsorMerck Sharp & Dohme LLC

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