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Evaluation of Safety and Efficacy of Zilovertamab Vedotin and Nemtabrutinib in Aggressive and Indolent B-cell Malignancies

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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 certain types of blood cancers known as B-cell malignancies. These include aggressive forms like mantle cell lymphoma and Richter's syndrome, as well as more slow-growing types such as chronic lymphocytic leukemia and follicular lymphoma. The study will test the safety and effectiveness of a medication called Zilovertamab Vedotin, both on its own and in combination with another drug named Nemtabrutinib.

The purpose of the study is to evaluate how well these treatments work and how safe they are for patients. Participants will receive either Zilovertamab Vedotin alone or together with Nemtabrutinib. Zilovertamab Vedotin is given as an injection into a vein, while Nemtabrutinib is taken as a tablet by mouth. Some participants may receive a placebo, which looks like the real medication but does not contain any active ingredients.

The study will take place over several weeks, during which participants will be closely monitored by healthcare professionals. They will undergo regular check-ups and tests to assess their response to the treatment and to ensure their safety. The study aims to provide valuable information that could lead to better treatment options for people with these types of blood cancers.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Administration of medications

    The treatment involves receiving zilovertamab vedotin, which is given through an intravenous infusion, meaning it is delivered directly into a vein.

    Depending on the assigned group, nemtabrutinib may also be taken as an oral medication in the form of a tablet or film-coated tablet.

  2. Step 2

    Monitoring and evaluation

    The safety and how well the body tolerates the medications will be monitored.

    The effectiveness of the treatments will be assessed to see how the b-cell malignancies, which are types of blood cancers, respond to the medication.

Who can join the trial?

8 criteria

  • You must have a confirmed diagnosis of B-cell malignancies, which are types of blood cancers, through a biopsy (a medical procedure where a small sample of tissue is removed for testing).
  • For mantle cell lymphoma (MCL) in the first group, your cancer must have returned or not responded to treatment (relapsed or refractory) after at least 2 previous treatments, including at least one BTK inhibitor (a type of medicine that blocks a specific protein to stop cancer cells from growing). You must also have already had or be unable to receive CAR-T cell therapy (a type of treatment where a patient's own immune cells are collected, changed in a lab to fight cancer, and put back into the body).
  • For mantle cell lymphoma (MCL) in the second group, your cancer must have returned or not responded to treatment after at least 1 previous treatment, and you must not have used a non-covalent BTK inhibitor (a specific type of medicine that binds to the target protein differently than other versions).
  • For Richter transformation lymphoma (RTL), your cancer must have returned or not responded to previous treatments.
  • For follicular lymphoma (FL) or chronic lymphocytic leukemia (CLL), your cancer must have returned or not responded to at least 2 previous treatments, and there must be no other available treatment options.
  • If you test positive for the hepatitis B surface antigen (HBsAg), which is a marker showing you have the hepatitis B virus, you may join if you have taken antiviral therapy (medicine that fights viruses) for at least 4 weeks and your viral load (the amount of virus in your blood) is undetectable (meaning the amount is so low it cannot be measured).
  • You must have an ECOG performance status of 0 to 2, which is a scale used by doctors to measure how well you can perform daily activities and your overall level of physical functioning.
  • The study is open to both males and females.

Who cannot join the trial?

16 criteria

  • You have ever received a solid organ transplant, which means an operation to replace a failing organ like a kidney or liver with a healthy one from another person.
  • You are currently taking corticosteroids, which are medicines used to reduce inflammation, at a dose higher than 30 mg of prednisone (a specific type of steroid medicine) every day.
  • You have received a live or live-attenuated vaccine, which is a type of vaccine that uses a weakened form of a germ, within 30 days before the first dose of the study medicine.
  • You have lymphoma, a type of cancer that starts in the immune system, that is currently active in your central nervous system (the brain and spinal cord).
  • You have an active infection that requires systemic therapy, which means an infection throughout the body that must be treated with medicine like antibiotics.
  • You have a history of human immunodeficiency virus (HIV) that is not well managed by antiretroviral therapy (ART), which is the daily medication used to treat HIV.
  • You have an active infection of HBV (Hepatitis B virus) or HCV (Hepatitis C virus), which are viruses that cause liver inflammation.
  • For those in Cohort C only, you have any important gastrointestinal abnormalities, which are issues in the stomach or intestines that could change how your body absorbs medicine.
  • You have active cardiovascular disease, which includes having had a stroke (interruption of blood flow to the brain), a myocardial infarction (heart attack), unstable angina (chest pain caused by reduced blood flow to the heart), congestive heart failure (a condition where the heart cannot pump blood well enough), or a serious cardiac arrhythmia (an irregular heartbeat) that requires medicine.
  • You have pericardial effusion (fluid buildup around the heart) or pleural effusion (fluid buildup around the lungs).
  • You have peripheral neuropathy of Grade >1, which is nerve damage in your hands or feet that causes symptoms like numbness or tingling, reaching a moderate level of severity.
  • You have a form of Charcot-Marie-Tooth disease that involves demyelinating, which means the protective coating around your nerves is being damaged.
  • You have a history of a second malignancy, which is a different type of cancer, unless you finished treatment for it and have had no signs of cancer for 2 years.
  • If you have follicular lymphoma (FL), you cannot participate if it has changed into a more aggressive and faster-growing type of lymphoma.
  • You have received previous systemic anticancer therapy, which includes experimental drugs, within a specific timeframe: 5 half-lives (the time it takes for half of a drug to leave your body), 4 weeks for monoclonal antibodies (targeted medicines), or 2 weeks for small molecules like kinase inhibitors (medicines that block specific proteins in cells).
  • You have received radiotherapy, which is the use of radiation to kill cancer cells, within 28 days of starting the study and have not fully recovered from any side effects caused by the radiation.
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Investigated drugs

  • Zilovertamab vedotin

    is an experimental treatment given through an intravenous infusion (a liquid medicine delivered directly into your vein) to see if it can effectively treat certain types of B-cell cancers.

  • Nemtabrutinib

    is an experimental medicine taken by mouth in tablet form. In this study, it is being tested both on its own and combined with another medication to see how well it works and how safe it is for people with specific blood cancers.

What is already known about the treatment

  • Nemtabrutinib

    This medication is taken as a tablet by mouth and is currently being studied for its ability to treat certain types of blood cancers, such as lymphoma and leukemia. It belongs to a class of drugs known as Bruton's tyrosine kinase (BTK) inhibitors, which work by blocking a specific protein inside immune cells that helps cancer cells grow and survive. By shutting down this protein signal, the drug aims to stop the progression of aggressive and slow-growing B-cell malignancies.

  • Zilovertamab vedotin

    This drug is administered as a liquid through an intravenous infusion into a vein and is under investigation for treating various B-cell cancers. It is classified as an antibody-drug conjugate, which means it uses a specialized protein to find and attach to specific markers on the surface of cancer cells to deliver a potent medicine directly to them. Once attached, the medication releases its toxic payload to kill the target cancer cells while attempting to minimize damage to healthy parts of the body.

Investigated diseases

  • Mantle cell lymphoma

    This is a type of blood cancer that starts in the B cells of the immune system. It typically develops in the lymph nodes and can spread to other parts of the body like the bone marrow or spleen. The disease can grow quickly or more slowly depending on the specific characteristics of the cells. It involves an abnormal accumulation of these cancerous cells within the lymphatic system.

  • Chronic lymphocytic leukemia

    This is a slow-growing cancer of the blood and bone marrow. It occurs when the body produces too many abnormal white blood cells called lymphocytes. These cells build up in the blood and lymphatic system over time. The condition often progresses gradually, sometimes remaining stable for long periods.

  • Follicular lymphoma

    This is a slow-growing type of non-Hodgkin lymphoma that originates in the lymph nodes. It is characterized by the formation of small groups of cells called follicles. The disease typically progresses at a very gradual pace. Over time, the cancerous cells can spread to different parts of the lymphatic system.

  • Richter’s syndrome

    This condition occurs when a previously existing slow-growing type of lymphoma, such as chronic lymphocytic leukemia, changes into a much more aggressive form. The disease shifts from a slow progression to a much faster and more rapid growth pattern. This transformation results in a significant change in how the cancer cells behave within the body.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501374-19-00Protocol codeMK-2140-006Estimated enrolment223 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).