Study Comparing Zilovertamab Vedotin with Drug Combination for Untreated Patients with 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), specifically the germinal center B-cell (GCB) subtype. The study is investigating the effectiveness and safety of a new treatment combination for people who have not received any prior treatment for this condition. The main treatment being tested is called Zilovertamab vedotin (also known by its code name MK-2140), which will be combined with a regimen known as R-CHP. This regimen includes the medications Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, and Prednisone. The study will compare this combination to another treatment that includes Polatuzumab vedotin with the same R-CHP regimen.

The purpose of the study is to see how well these treatments work in achieving a complete response, which means the disappearance of all signs of cancer in response to treatment. Participants will receive the treatments through intravenous infusions, which means the medication is given directly into a vein, and some medications will be taken orally. The study will monitor participants over a period to assess the effectiveness of the treatments and any side effects that may occur.

Throughout the study, participants will be closely observed to track their health and any changes in their condition. The study aims to provide valuable information on the potential benefits and risks of these treatment combinations for people with this specific type of lymphoma. The ultimate goal is to improve treatment options and outcomes for individuals diagnosed with Diffuse Large B-Cell Lymphoma.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two treatment groups. This means you will receive either zilovertamab vedotin plus R-CHP or polatuzumab vedotin plus R-CHP. The assignment is random, similar to flipping a coin, to ensure fairness and objectivity.

2 treatment administration

If you are in the zilovertamab vedotin group, you will receive this medication through an intravenous infusion. This means the medicine will be given directly into your vein using a needle.

You will also receive rituximab, doxorubicin hydrochloride, and cyclophosphamide through intravenous infusion. Additionally, you will take prednisolone orally, which means you will swallow it in pill form.

If you are in the polatuzumab vedotin group, you will receive this medication through an intravenous infusion, along with rituximab, doxorubicin hydrochloride, and cyclophosphamide. You will also take prednisolone orally.

3 treatment schedule

The treatment will be administered in cycles. Each cycle lasts for a specific period, during which you will receive the medications on certain days. The exact schedule will be provided to you by the study team.

The duration of the treatment will depend on your response to the medications and the overall study plan. Regular assessments will be conducted to monitor your progress.

4 monitoring and assessments

Throughout the study, you will undergo regular health assessments. These may include physical exams, blood tests, and imaging tests like PET scans to evaluate how the treatment is affecting your condition.

The study team will monitor for any side effects or adverse reactions to the medications. It is important to report any new symptoms or concerns to the study team promptly.

5 end of treatment evaluation

At the end of the treatment period, a comprehensive evaluation will be conducted to determine the effectiveness of the treatment. This will include assessing the response of your lymphoma to the medications.

The results will be compared to the criteria set by the study to determine the success of the treatment.

Who Can Join the Study?

Must have a confirmed diagnosis of the germinal center B-cell (GCB) subtype of Diffuse Large B-Cell Lymphoma (DLBCL) through a previous biopsy.
Must have a positive result on a positron emission tomography (PET) scan at screening, which is a type of imaging test that helps show how your tissues and organs are functioning. The result should be rated as 4 to 5 on the Lugano 5-point scale, a system used to assess lymphoma.
Must not have received any prior treatment for their DLBCL.
If infected with human immunodeficiency virus (HIV), the virus must be well controlled with antiretroviral therapy (ART), which is medication used to treat HIV.
If positive for hepatitis B surface antigen (HBsAg), must have received hepatitis B virus (HBV) antiviral therapy and have an undetectable HBV viral load before starting the study. This means the virus is not actively reproducing in the body.
If there is a history of hepatitis C virus (HCV) infection, the HCV viral load must be undetectable at screening, indicating the virus is not actively present in the body.
Both male and female participants are eligible.

Who Cannot Join the Study?

Patients with any other type of cancer that is not Diffuse Large B-Cell Lymphoma (DLBCL).
Patients who have previously received treatment with the drugs zilovertamab vedotin or polatuzumab vedotin.
Patients who are pregnant or breastfeeding.
Patients with severe uncontrolled illnesses, such as heart disease or infections.
Patients who have had a major surgery within the last 4 weeks.
Patients with known allergies to any of the study drugs or their components.
Patients who are participating in another clinical trial.
Patients with a history of drug or alcohol abuse within the last 6 months.
Patients with any condition that, in the opinion of the study doctor, makes them unsuitable for the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
IRCCS Humanitas Research Hospital	Rozzano	Italy
University Hospital Jena KöR	Jena	Germany
Universitaetsmedizin Goettingen	Goettingen	Germany
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Universitaetsklinikum Aachen AöR	Aachen	Germany
Vivantes Netzwerk fuer Gesundheit GmbH	Berlin	Germany
Klinikum Region Hannover GmbH	Hanover	Germany
Algemeen Ziekenhuis Delta	Roeselare	Belgium
University Hospital Limerick	Limerick	Ireland
Vitaz	Sint-Niklaas	Belgium
Diakonie Klinikum Dietrich Bonhoeffer GmbH	Neubrandenburg	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego	Walbrzych	Poland
Pratia Hematologia Sp. z o.o.	Katowice	Poland
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Klinikum Der Landeshauptstadt Stuttgart gKAöR	Stuttgart	Germany
Philipps-Universitaet Marburg	Marburg	Germany
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Helios Universitaetsklinikum Wuppertal	Wuppertal	Germany
Klinikum Kassel GmbH	Kassel	Germany
Pratia S.A.	Skorzewo	Poland
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach	Kielce	Poland
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Otto Von Guericke Universitaet Magdeburg	Magdeburg	Germany
Cyyyyfeyo Urzwcgmmphcfoj Sjqsqprhw	Woluwe-Saint-Lambert	Belgium
Ueacnwtxmsahayncbfuye Ewhen Ard	Essen	Germany
Enjrqzy	Mechelen	Belgium
Hwquosxvuyjxssbasgnhacv Zilyyhf glxpf	Zwickau	Germany
Gcqradgbhioscxdmajdoy Mbpuvepgngc gfmem	Koblenz	Germany
Acjrhgb Oiugmhcoyxw Oibgtmmw Rdkwmuf Vplfi Sjunw Czpwxqqo	Palermo	Italy
Sabibhv Scukjuyiawimkad Izw Jrekarix Sajrrauoytxe W Nmwxr Systc	Nowy Sacz	Poland
Cqlwrnt fuv Hhqmopuwhhd uay Oklkpvres au Bvotxkwxiadxynwidhlgj	Frankfurt	Germany
Hufrkau Jnsnyfxc	Haine-Saint-Paul	Belgium
Uhnpijdphh Hgwbysfz Cazpoeb	Cologne	Germany
Iywqlfol Rumigttek Pnb Lw Stsxex Dnr Tjzqdk Dwiw Anljzmb Iybu Ssljob	Meldola	Italy
Uhrlxjwcfunpoqgjebkmq Mzeaydcs Aug	Munster	Germany
Axiulhb Objtjkspaee Nmzmabuoe Sx Ailtkic E Buvbun E C Abwqfv Axmdcttoyhm	Alexandria	Italy
Njxktdkb Irlarybd Ozpjclckn Izn Mjpbv Sianfhumevtkymhfcmilqslyonlm Irvbkfbr Bdaywubf	Cracow	Poland
Ksdmrdne dlo Ujflejuevhug Mwbqnhfq Avx	Munich	Germany
Uumxjcmjoqmiciaddnmot Wkymacumb Axr	Wuerzburg	Germany
Afzfcuv Uwe Ihfhd Dv Rummxn Ejrlbc	Reggio Emilia	Italy
Utdntxwbuhgwts Ctglyiy Kzgmolgcx	Gdansk	Poland
Sh Vboovcgpmmpowhd Ucmljpqkiw Hnjruuxg	Dublin	Ireland
Jmfuperagw Gusj Jvpadufoqtncezhrwuadlh	Bonn	Germany

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	14.04.2025
Germany	Recruiting	14.04.2025
Ireland	Recruiting	14.04.2025
Italy	Recruiting	14.04.2025
Poland	Recruiting	14.04.2025

Trial locations

Investigated drugs:

Zilovertamab Vedotin (MK-2140) is a medication being studied for its potential to treat a type of cancer called diffuse large B cell lymphoma (DLBCL). It is designed to target and attach to specific cancer cells, delivering a substance that can help kill these cells. This approach aims to reduce the number of cancer cells in the body and improve the patient’s condition.

Polatuzumab Vedotin is another medication used in the study for treating DLBCL. Similar to zilovertamab vedotin, it targets specific cancer cells and delivers a toxic substance directly to them. This helps in destroying the cancer cells while trying to minimize damage to healthy cells, potentially leading to better outcomes for patients.

R-CHP is a combination of medications used in the treatment of DLBCL. It includes a mix of drugs that work together to attack cancer cells in different ways. This combination is often used to enhance the effectiveness of the treatment, aiming to reduce the cancer’s ability to grow and spread.

Investigated diseases:

Diffuse large B-cell lymphoma

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. 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.

Trial ID:

2024-515526-89-00

Protocol code:

MK-2140-011

Trial Phase:

Therapeutic exploratory (Phase II)

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Study Comparing Zilovertamab Vedotin with Drug Combination for Untreated Patients with Diffuse Large B-Cell Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?