Not recruiting

Study of Zilovertamab Vedotin with Drug Combination for 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). The study is testing a new experimental drug called Zilovertamab Vedotin, also known by its code name MK-2140. This drug is being used in combination with a standard chemotherapy regimen known as R-CHP, which includes the medications Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone. The purpose of the study is to evaluate the safety and effectiveness of Zilovertamab Vedotin when used with R-CHP in patients with DLBCL.

Participants in the study will receive the treatment over a period of up to 24 months. The treatment involves administering the drugs through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor how well patients respond to the treatment and any side effects they may experience. The goal is to determine the best dose of Zilovertamab Vedotin that can be safely used with R-CHP and to see how effective this combination is in treating DLBCL.

This study is important for understanding how new treatments can help people with DLBCL. By participating, patients contribute to research that may improve future treatment options for this type of cancer. The study will collect data on the number of participants who experience side effects, how many achieve a complete response to the treatment, and the overall response rate according to specific criteria used by doctors to assess cancer treatment outcomes.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, you will have an initial visit where the medical team will confirm your diagnosis of diffuse large B-cell lymphoma (DLBCL). This will involve reviewing your medical history and conducting necessary tests.
You will also undergo a positron emission tomography (PET) scan to verify the disease status. This scan helps in assessing the activity of the lymphoma.
Step 2
Treatment plan discussion
The medical team will discuss the treatment plan with you. This includes the use of the experimental drug zilovertamab vedotin in combination with standard chemotherapy drugs.
The treatment aims to evaluate the safety and effectiveness of the drug combination.
Step 3
Treatment cycle 1
You will begin the first cycle of treatment. This includes receiving rituximab, cyclophosphamide, doxorubicin, and zilovertamab vedotin through an intravenous infusion.
You will also take prednisolone orally. The medical team will monitor you for any side effects or dose-limiting toxicities during this cycle.
Step 4
Subsequent treatment cycles
You will continue with additional treatment cycles as planned. The frequency and duration of these cycles will be explained by the medical team.
Regular monitoring will occur to assess your response to the treatment and to manage any side effects.
Step 5
Response assessment
After completing the treatment cycles, your response to the treatment will be evaluated using the Lugano response criteria. This involves imaging tests to determine the effectiveness of the treatment.
The medical team will discuss the results with you and plan any further necessary steps.
Step 6
Follow-up visits
You will have follow-up visits to monitor your health and any long-term effects of the treatment.
These visits are important to ensure your well-being and to address any concerns you may have.

Who can join the trial?

6 criteria

Must have a confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) through a previous biopsy.
Must have a positron emission tomography (PET)-positive disease, which means the disease shows up on a special type of scan. This must be verified by an independent review at the start of the study.
Must not have received any prior treatment for DLBCL.
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. This is a scale used to assess how well a person can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
Both male and female participants are eligible.
Participants from vulnerable populations are eligible.

Who cannot join the trial?

8 criteria

Patients with any other type of cancer besides Diffuse large B-cell lymphoma (DLBCL) cannot participate.
Patients who have had a different cancer treatment within the last 4 weeks are not eligible.
Patients with severe heart problems are excluded.
Patients with uncontrolled infections cannot join the study.
Pregnant or breastfeeding women are not allowed to participate.
Patients with a history of severe allergic reactions to similar drugs are excluded.
Patients with significant liver or kidney disease cannot take part in the trial.
Patients who are unable to follow the study procedures for any reason are not eligible.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria
Verified
Alexandria, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Responsive
Palermo, Italy
Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy

Trial locations

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Investigated drugs

Zilovertamab Vedotin (MK-2140)
is an experimental drug being tested in this clinical trial. It is designed to target and attach to specific cancer cells in the body. Once attached, it delivers a toxic substance directly to these cells, which may help to kill them or stop them from growing. This drug is being studied to see if it can be safely combined with other treatments to improve outcomes for patients with a type of cancer called DLBCL.
R-CHP
is a combination of medications used to treat certain types of cancer, including DLBCL. It includes three chemotherapy drugs and a monoclonal antibody. The chemotherapy drugs work by killing cancer cells or stopping them from dividing, while the monoclonal antibody helps the immune system recognize and attack cancer cells. This combination is being used in the trial to see if it works better when combined with Zilovertamab Vedotin.

What is already known about the treatment

Zilovertamab Vedotin – Zilovertamab Vedotin is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness and safety in treating diffuse large B-cell lymphoma (DLBCL), a type of blood cancer. The medication works by targeting specific proteins on cancer cells, delivering a toxic substance that helps kill these cells. It is classified as an antibody-drug conjugate, which combines an antibody with a drug to specifically target and destroy cancer cells.

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 responsible for producing antibodies. 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.