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Study on the Safety and Effectiveness of Zilovertamab Vedotin for Children and Young Adults with Blood Cancers or Solid Tumors

Verified siteInvestigationalNo 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 the effects of a treatment called zilovertamab vedotin in children and young adults who have certain types of cancers. These cancers include hematologic malignancies, which are cancers that start in blood-forming tissue, and solid tumors, which are abnormal masses of tissue. The specific types of cancers being studied are B-cell acute lymphoblastic leukemia (B-ALL), diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma, neuroblastoma, and Ewing sarcoma. The treatment, zilovertamab vedotin, is given as a solution through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.

The purpose of this study is to evaluate the safety and effectiveness of zilovertamab vedotin in treating these cancers. The study is divided into two parts. In the first part, the focus is on understanding how safe the treatment is and how well it is tolerated by participants aged 1 to under 18 years. The second part looks at the treatment's ability to reduce or eliminate the cancer in participants from birth to 25 years old. The study will monitor participants for any side effects and how their cancer responds to the treatment.

Participants in the study will receive either the treatment or a placebo. The study will track various outcomes, such as the number of participants who experience side effects, the number who need to stop the treatment due to side effects, and the number who need to change their dose. The study will also look at how the treatment affects the cancer, including whether it helps reduce the size of the tumors or leads to remission. The study is expected to continue until 2029, providing valuable information on the potential benefits and risks of using zilovertamab vedotin for these types of cancers in young patients.

The research process

The trial runs in 6 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, eligibility is confirmed based on specific criteria related to the type and stage of the disease.

    Participants must have a diagnosis of advanced, relapsed, or refractory disease that is not curable with standard treatments.

  2. Step 2

    Treatment initiation

    The treatment involves the administration of zilovertamab vedotin, a medication given as a solution for infusion.

    The medication is administered through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.

  3. Step 3

    Treatment schedule

    The frequency and duration of the treatment are determined by the study protocol and the participant's response to the medication.

    Regular monitoring is conducted to assess the safety and effectiveness of the treatment.

  4. Step 4

    Monitoring and assessments

    Participants undergo regular assessments to monitor for any side effects or adverse events.

    The study aims to evaluate the safety, tolerability, and preliminary antitumor activity of the medication.

  5. Step 5

    Completion of treatment

    The treatment continues until the study's end date or until the participant meets criteria for discontinuation.

    Participants may discontinue treatment due to adverse events or if the disease progresses.

  6. Step 6

    Follow-up

    After completing the treatment, participants may be required to attend follow-up visits to monitor their health and any long-term effects of the treatment.

    The study is estimated to conclude by March 31, 2029.

Who can join the trial?

11 criteria

  • The patient must have a type of cancer called **hematologic malignancies** or **solid tumors**. These are cancers that affect the blood, bone marrow, or other tissues.
  • The patient must be a **pediatric** (child) or **young adult**.
  • The patient must have a disease that is **advanced**, **relapsed**, or **refractory**. This means the disease is severe, has returned after treatment, or does not respond to treatment.
  • The disease must be **incurable**, meaning it cannot be completely cured, and previous treatments were not successful, or there are no standard treatments available that are known to help.
  • For blood-related cancers, the patient must have a confirmed diagnosis of **B-precursor B-cell acute lymphoblastic leukemia (ALL)** or **diffuse large B-cell lymphoma (DLBCL)/Burkitt lymphoma**. These are specific types of blood cancers.
  • The patient must be in their second or greater relapse, meaning the cancer has returned more than once, and it does not respond to treatment, or there are no other standard treatments available.
  • For solid tumors, the patient must have a confirmed diagnosis of **neuroblastoma** or **Ewing sarcoma**. These are specific types of solid tumors.
  • The solid tumor must not respond to initial treatment, or there are no other standard treatments available, or the cancer has returned at least once.
  • The patient must have **measurable disease**, which means the cancer can be measured in size and tracked over time to see if it is growing or shrinking.
  • For neuroblastoma, the disease must show positive results on specific scans called **MIBG** or **FDG** scans, which help to see the cancer in the body.
  • Both male and female patients are eligible to participate.

Who cannot join the trial?

10 criteria

  • Participants who have a different type of cancer than those specified in the study.
  • Participants who are not within the age range specified for the study.
  • Participants who have medical conditions that the study is not focusing on.
  • Participants who are unable to follow the study procedures or instructions.
  • Participants who have received certain treatments that might interfere with the study.
  • Participants who have other health issues that could affect their safety during the study.
  • Participants who are pregnant or breastfeeding.
  • Participants who have allergies to the study medication or its ingredients.
  • Participants who are currently participating in another clinical trial.
  • Participants who have a history of certain medical conditions that could affect the study results.
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Investigated drugs

Zilovertamab Vedotin is a medication being studied for its safety and effectiveness in treating young patients with certain types of cancers, including blood cancers and solid tumors. It is being tested in children and young adults to see how well it works against cancers like B-ALL, DLBCL/Burkitt lymphoma, neuroblastoma, and Ewing sarcoma. The study aims to understand how the medication can help in reducing or eliminating these cancers in young patients.

What is already known about the treatment

Zilovertamab Vedotin – This medication is administered intravenously and is currently being studied in clinical trials for its safety and effectiveness in treating hematologic malignancies or solid tumors in pediatric and young adult patients. It is in the investigational stage, with ongoing research to determine its potential benefits and risks. The main therapeutic indications include B-cell acute lymphoblastic leukemia (B-ALL), diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma, neuroblastoma, and Ewing sarcoma. 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

  • B-Cell Acute Lymphoblastic Leukemia (B-ALL)

    This is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of immature white blood cells called lymphoblasts. It progresses rapidly, leading to a decrease in the number of healthy blood cells, which can cause symptoms like fatigue, frequent infections, and easy bruising or bleeding. The disease primarily affects children but can also occur in adults.

  • Diffuse Large B-Cell Lymphoma (DLBCL)

    This is a common type of non-Hodgkin lymphoma that originates in the lymphatic system, specifically affecting B-cells. It typically presents as a rapidly growing mass, often in the lymph nodes, and can spread to other organs. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss.

  • Burkitt Lymphoma

    This is a highly aggressive form of non-Hodgkin lymphoma that often starts in the abdomen, but can also affect the jaw, central nervous system, and other organs. It is characterized by the rapid growth of tumors and is most commonly seen in children and young adults. Symptoms can include abdominal swelling, pain, and bowel obstruction.

  • Neuroblastoma

    This is a cancer that develops from immature nerve cells, most commonly affecting infants and young children. It usually begins in the adrenal glands but can also occur in the neck, chest, abdomen, or spine. Symptoms vary depending on the tumor's location and may include a lump in the abdomen, pain, or changes in bowel habits.

  • Ewing Sarcoma

    This is a rare type of cancer that occurs in bones or the soft tissue around the bones, primarily affecting children and young adults. It often presents as a painful mass in the arms, legs, pelvis, or chest. The disease can cause symptoms such as swelling, fever, and fatigue, and may spread to other parts of the body.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-507178-41-00Protocol codeMK-9999-01AEstimated enrolment113 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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