Study of Zilovertamab Vedotin with Drug Combination for Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called Diffuse Large B-Cell Lymphoma (DLBCL), which is a form of non-Hodgkin lymphoma. The study is investigating a treatment that combines a new medication, Zilovertamab Vedotin (also known by its code name MK-2140), with standard treatments for patients whose DLBCL has returned or has not responded to previous treatments. The standard treatments involved in this study include combinations of medications such as Rituximab, Gemcitabine, Oxaliplatin, and Bendamustine. These medications are typically used to help stimulate the immune system or directly target cancer cells.

The purpose of the study is to evaluate the safety and effectiveness of Zilovertamab Vedotin when used alongside these standard treatments. Participants in the study will receive these medications through an intravenous infusion, which means the medicine is given directly into a vein. The study will compare the outcomes of patients receiving the new combination treatment to those receiving the standard treatments alone. This will help determine if the new combination is more effective in controlling the disease.

Throughout the study, participants will be monitored for any side effects and how well the treatment is working. The study aims to find the best dose of Zilovertamab Vedotin that can be safely used with the other medications. The trial will also look at how long patients live without the disease getting worse and how long the response to the treatment lasts. The study is expected to continue until December 2029, providing valuable information on the potential benefits of this new treatment combination for patients with relapsed or refractory DLBCL.

1 joining the study

Upon joining the study, you will be assigned to one of the treatment groups. This assignment is random, meaning it is done by chance, like flipping a coin.

You will receive detailed information about the treatment plan, including the medications you will be taking and the schedule for your visits.

2 treatment initiation

The treatment involves receiving medications through an intravenous infusion, which means the medicine is given directly into your vein using a needle.

The main medication being studied is zilovertamab vedotin, which will be combined with other standard treatments for your condition.

3 medication administration

You may receive zilovertamab vedotin in combination with R-GemOx or BR. R-GemOx includes rituximab, gemcitabine, and oxaliplatin. BR includes bendamustine hydrochloride and rituximab.

The frequency and dosage of these medications will be explained to you by the study team. Typically, these medications are given in cycles, with each cycle lasting a few weeks.

4 monitoring and follow-up

Throughout the study, you will have regular visits to monitor your health and the effects of the treatment. This includes physical exams, blood tests, and possibly imaging tests like scans.

The study team will check for any side effects and adjust your treatment if necessary to ensure your safety.

5 completion of treatment

Once you have completed the treatment cycles, there will be a final evaluation to assess your response to the treatment.

You may be asked to return for follow-up visits to monitor your health after the treatment has ended.

Who Can Join the Study?

Has a confirmed diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL).
Has DLBCL that can be measured using imaging tests, as determined by the study doctor.
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, which is a scale used to assess how the disease affects daily living abilities, checked within 7 days before starting the study treatment.
Has adequate organ function, meaning the organs are working well enough to participate in the study.
Is able to provide a new or previously collected tumor tissue sample that has not been treated with radiation.
For the study groups involving Zilovertamab vedotin plus R-GemOx or R-GemOx:
- Has relapsed or refractory DLBCL and is not eligible for or has not succeeded with an autologous stem-cell transplant (ASCT), and has not succeeded with at least one previous treatment.
- Has not succeeded with chimeric antigen receptor T (CAR-T) cell therapy or is not eligible for it.
For the study groups involving Zilovertamab vedotin plus Bendamustine Rituximab (BR) or Bendamustine Rituximab:
- Has relapsed or refractory DLBCL and is not eligible for or has not succeeded with ASCT, and has not succeeded with at least two previous treatments.
- Has not succeeded with CAR-T cell therapy or is not eligible for it.
Is within the age range specified for the study.
Both male and female participants are eligible.

Who Cannot Join the Study?

Patients with any other type of cancer that is not Relapsed or Refractory Diffuse Large B-Cell Lymphoma.
Patients who have not recovered from the side effects of previous cancer treatments.
Patients with serious heart problems.
Patients with active infections that require treatment.
Patients who are pregnant or breastfeeding.
Patients with a history of severe allergic reactions to similar drugs.
Patients with uncontrolled high blood pressure.
Patients with severe liver or kidney disease.
Patients who have received another investigational drug within a certain period before the study.
Patients with any other medical condition that the study doctors think would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
IRCCS Humanitas Research Hospital	Rozzano	Italy

Other Sites

Site Name	City	Country
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.	Slupsk	Poland
Evangelismos S.A.	Athens	Greece
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego	Walbrzych	Poland
Pratia Hematologia Sp. z o.o.	Katowice	Poland
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy	Warsaw	Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Pratia S.A.	Skorzewo	Poland
University General Hospital Of Alexandroupoli	Alexandroupoli	Greece
Region Midtjylland	Aarhus	Denmark
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Centre Hospitalier Lyon Sud	Pierre Benite	France
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli	Lublin	Poland
Lzvqd Goqnjoy Huslcikf Oz Agtkuo	Athens	Greece
Sfkuocds Pyoptusaz Sgt z ovcu	Gdynia	Poland

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	24.06.2022
France	Recruiting	24.06.2022
Greece	Recruiting	24.06.2022
Italy	Recruiting	24.06.2022
Poland	Recruiting	24.06.2022

Trial locations

Investigated drugs:

Zilovertamab Vedotin (MK-2140) is a medication being studied for its potential to help treat a type of cancer called diffuse large B-cell lymphoma, especially in cases where the cancer has returned or has not responded to previous treatments. This medication is designed to target and attach to specific cancer cells, delivering a substance that can help kill these cells. It is being tested in combination with other standard cancer treatments to see if it can improve outcomes for patients.

R-GemOx is a combination of three different treatments used to fight cancer. It includes a medication called rituximab, which helps the immune system find and destroy cancer cells. The second part, gemcitabine, is a chemotherapy drug that stops cancer cells from growing and dividing. The third component, oxaliplatin, is another chemotherapy drug that damages the DNA of cancer cells, making it harder for them to survive. Together, these medications work to reduce the size of tumors and slow the progression of the disease.

BR stands for a combination of two medications: bendamustine and rituximab. Bendamustine is a chemotherapy drug that interferes with the growth of cancer cells, leading to their destruction. Rituximab, on the other hand, is an antibody that helps the immune system target and eliminate cancer cells. This combination is used to treat certain types of blood cancers, including diffuse large B-cell lymphoma, by attacking the cancer cells in different ways to improve the chances of treatment success.

Relapsed or Refractory Diffuse Large B-Cell Lymphoma – This is a type of non-Hodgkin lymphoma that affects B-lymphocytes, a kind of white blood cell. It is characterized by the rapid growth of large cancerous B-cells in the lymph nodes, spleen, liver, bone marrow, or other organs. The term “relapsed” refers to the return of the disease after treatment, while “refractory” indicates that the disease does not respond to treatment. The disease often presents with symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. As it progresses, it can spread to other parts of the body, affecting various organs and tissues. The progression can vary significantly among individuals, with some experiencing rapid advancement and others having a slower course.

Trial ID:

2022-502646-27-00

Protocol code:

MK-2140-003

NCT ID:

NCT05139017

Trial Phase:

Therapeutic use (Phase IV)

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Study of Zilovertamab Vedotin with Drug Combination for Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?