Study on the Safety and Effectiveness of Zilovertamab Vedotin 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, which is a form of non-Hodgkin’s lymphoma. This study is specifically for patients whose cancer has returned or has not responded to previous treatments. The treatment being tested in this study is a medication called Zilovertamab vedotin, also known by its code name MK-2140. This medication is given as a solution through an intravenous infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of this study is to evaluate the safety and effectiveness of Zilovertamab vedotin in treating patients with this type of lymphoma. Participants in the study will receive the medication and will be monitored to see how their cancer responds to the treatment. The study will also look at how long any positive effects last and whether there are any side effects. Some participants may receive a placebo, which is a substance with no active medication, to compare the results.

The study will take place over a period of time, during which participants will have regular check-ups and assessments to track their progress. The goal is to gather information that could help improve treatment options for people with Diffuse Large B Cell Lymphoma in the future. Participants and healthcare providers will be aware of the treatment being given, as this is an open-label study, meaning there is no blinding or concealment of the treatment from those involved.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes reviewing medical history and conducting necessary tests to ensure the diagnosis of diffuse large B-cell lymphoma (DLBCL) is accurate.

The assessment will also evaluate previous treatments and determine if the condition has progressed after at least two lines of prior therapy, including a multiagent regimen with an alkylating agent, anthracycline, and anti-CD20 monoclonal antibody.

2 treatment plan discussion

A healthcare provider will discuss the treatment plan, which involves the administration of zilovertamab vedotin.

The treatment will be given as an intravenous infusion, which means the medication will be delivered directly into the bloodstream through a vein.

3 treatment administration

The medication, zilovertamab vedotin, will be administered as a solution for infusion. The specific dosage and frequency will be determined by the healthcare provider based on individual health needs.

The duration of the treatment will be outlined by the healthcare provider, and regular monitoring will be conducted to assess the response to the treatment.

4 regular monitoring

Throughout the trial, regular monitoring will be conducted to evaluate the effectiveness of the treatment and to check for any side effects.

This includes assessments based on the Lugano Response Criteria, which is a set of guidelines used to measure the response of lymphoma to treatment.

5 follow-up assessments

Follow-up assessments will be scheduled to determine the objective response rate and the duration of response to the treatment.

The healthcare provider will also monitor for any adverse events and determine if any adjustments to the treatment plan are necessary.

Who Can Join the Study?

Must have Diffuse Large B-Cell Lymphoma (DLBCL) that has come back or did not respond to previous treatments.
Must have tried at least two different treatments before, including a stem cell transplant or be unable to have one.
Must have received a treatment plan that included an alkylating agent (a type of chemotherapy), anthracycline (another type of chemotherapy), and an anti-CD20 monoclonal antibody (a medicine that targets specific cells).
Must have a confirmed diagnosis of DLBCL through a tissue sample.
Must have DLBCL that can be measured by scans according to specific criteria.
Should have either not responded to CAR-T cell therapy (a type of treatment that uses modified immune cells) or be unable to receive it for any reason.
Must have a life expectancy of at least 3 months.
Must have a performance status score between 0 to 2, which means being fully active or having some limitations but able to care for oneself.
Must have organs that are working well enough to participate in the study.
Both men and women can participate.

Who Cannot Join the Study?

Patients who have not failed prior therapies for Diffuse Large B Cell Lymphoma (a type of non-Hodgkin’s lymphoma) cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not part of the specified clinical trial groups cannot participate.
Patients who are not male or female cannot participate.
Patients who are not considered part of a vulnerable population cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
IRCCS Humanitas Research Hospital	Rozzano	Italy
Hospital Universitario De Salamanca	Salamanca	Spain
Osrodek Badan Klinicznych Przy Szpitalu Specjalistycznym Im. Ludwika Rydygiera W Krakowie Sp. z o.o.	Cracow	Poland

Other Sites

Site Name	City	Country
Evangelismos S.A.	Athens	Greece
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Fakultni Nemocnice Brno	Brno	Czechia
Karolinska University Hospital	Solna	Sweden
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Centre Hospitalier De La Cote Basque	Bayonne	France
Oslo University Hospital HF	Oslo	Norway
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
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
North Estonia Medical Centre Foundation	Tallin	Estonia
Hqxkc Bpohhp Ha	Bergen	Norway
Ljwjt Gzpnzml Heahxpzx Ob Amktfj	Athens	Greece
Ajnwozt Uymjq Srszpolfu Ljefbz Dj Bhsjwpq	Bologna	Italy
Ieptpnrw Cxvdmz Djujfmeyjzgfxnbot	L'hospitalet De Llobregat	Spain
Sryjlztd Prdtflygh Soh z ockl	Gdynia	Poland
Habndacb Vngq dxprifsj	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	23.02.2022
Estonia	Not recruiting	23.02.2022
France	Not recruiting	23.02.2022
Greece	Not recruiting	23.02.2022
Italy	Not recruiting	23.02.2022
Norway	Not recruiting	23.02.2022
Poland	Not recruiting	23.02.2022
Spain	Not recruiting	23.02.2022
Sweden	Not recruiting	23.02.2022

Trial locations

Investigated drugs:

Zilovertamab Vedotin

Zilovertamab Vedotin (MK-2140) is a medication being studied for its potential to treat a type of cancer called diffuse large B-cell lymphoma, which is a form of non-Hodgkin lymphoma. This medication is designed to target and attach to specific proteins found on the surface of cancer cells. Once attached, it delivers a toxic substance directly into the cancer cells, which may help to kill them or stop them from growing. The goal of using this medication in the trial is to see how well it works in shrinking the tumors and to assess its safety for patients who have not responded to other treatments or whose cancer has returned.

Diffuse Large B Cell Lymphoma – Diffuse Large B Cell Lymphoma is a type of non-Hodgkin’s lymphoma characterized by the rapid growth of large B cells in the lymphatic system. It typically begins in the lymph nodes but can also affect other organs. The disease progresses quickly, with the abnormal B cells spreading throughout the body. As the lymphoma advances, it can cause swelling of the lymph nodes, fatigue, fever, and weight loss. The rapid proliferation of these cells can lead to the formation of tumors in various parts of the body. The progression of the disease can vary, with some cases advancing more rapidly than others.

Trial ID:

2022-501243-33-00

Protocol code:

MK2140-004

NCT ID:

NCT05144841

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effectiveness of Zilovertamab Vedotin 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?