Study of Zilovertamab Vedotin and Drug Combination for Untreated Diffuse Large B-Cell Lymphoma Patients

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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). The study is testing a new treatment called zilovertamab vedotin, also known by its code name MK-2140. This treatment will be combined with other medications, including rituximab, cyclophosphamide, doxorubicin, and prednisone. These medications are part of a standard treatment regimen known as R-CHP. The study will compare this new combination to the standard treatment regimen called R-CHOP, which includes the same medications plus an additional drug called vincristine.

The purpose of the study is to see if the new combination of treatments can help people with DLBCL live longer without their disease getting worse. Participants in the study will receive either the new treatment combination or the standard treatment. The study will last for up to 18 months, during which participants will receive their assigned treatment and be monitored regularly. The study will also look at how the treatments affect participants’ quality of life and any side effects they may experience.

Throughout the study, participants will have regular check-ups and tests to monitor their health and the progress of their disease. These tests may include imaging scans and blood tests. The study aims to provide valuable information about the effectiveness and safety of the new treatment combination for people with DLBCL.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of diffuse large B-cell lymphoma (DLBCL) through a prior biopsy and ensuring no previous treatment for DLBCL has been received.

A positron emission tomography (PET) scan is performed to confirm disease presence, and an evaluation of general health status is conducted, including heart function tests.

2 randomization

Participants are randomly assigned to one of two treatment groups. One group receives zilovertamab vedotin in combination with R-CHP, while the other group receives R-CHOP.

3 treatment administration

Treatment involves a combination of medications administered over a series of cycles. The medications include rituximab, cyclophosphamide, doxorubicin hydrochloride, prednisolone, and vincristine, all given intravenously, except for prednisolone, which is taken orally.

The specific dosage and frequency of each medication are determined by the study protocol and are administered under medical supervision.

4 monitoring and follow-up

Regular monitoring is conducted to assess the response to treatment and any side effects. This includes imaging tests and health assessments.

Participants are evaluated for progression-free survival and overall survival, as well as any adverse events experienced during the study.

5 end of treatment evaluation

At the end of the treatment period, a comprehensive evaluation is conducted to determine the complete response to treatment.

Health-related quality of life is assessed using specific questionnaires to evaluate physical and emotional well-being.

Who Can Join the Study?

The patient must have a confirmed diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL), which is a type of cancer, based on a previous biopsy.
The patient must have a positive result on a positron emission tomography (PET) scan at the start of the study. This means the scan shows a score of 4 to 5 on a specific scale used to measure disease activity.
The patient must not have received any previous treatment for their DLBCL.
The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 2 being able to do some activities but not work.
The patient must have a heart ejection fraction of 45% or higher. This is a measure of how well the heart is pumping blood, determined by tests like an echocardiogram (ECHO) or a multigated acquisition (MUGA) scan.
If the patient is infected with human immunodeficiency virus (HIV), their HIV must be well controlled with medication.
If the patient has a positive test for hepatitis B surface antigen (HBsAg), they can participate if they have been treated for hepatitis B and have no detectable virus in their blood before starting the study.
If the patient has a history of hepatitis C virus (HCV) infection, they can participate if there is no detectable virus in their blood at the start of the study.
Both male and female patients are eligible to participate.

Who Cannot Join the Study?

Patients with medical conditions other than Diffuse Large B-Cell Lymphoma (DLBCL) cannot participate. DLBCL is a type of cancer that affects the lymphatic system, which is part of the body’s immune system.
Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study and may include specific age groups.
Patients who are part of a vulnerable population, such as those who may not be able to give informed consent, cannot participate. This is to ensure the safety and well-being of all participants.
Patients who do not meet other specific criteria set by the study, which may include health status, previous treatments, or other medical conditions, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
CHU Grenoble Alpes	La Tronche	France
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Orszagos Onkologiai Intezet	Budapest	Hungary
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
CCAB Centro Clinico Academico Braga Associacao	Braga	Portugal
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis	La Rochelle	France
Albert Schweitzer Ziekenhuis	Dordrecht	The Netherlands
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie	Olsztyn	Poland
Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria	Spain
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.	Slupsk	Poland
Centre Hospitalier D Avignon	Avignon	France
Evangelismos S.A.	Athens	Greece
Centre Henri Becquerel	Rouen	France
Pratia Hematologia Sp. z o.o.	Katowice	Poland
HIA Sainte Anne	Toulon	France
Tolna Vármegyei Balassa János Kórház	Szekszard	Hungary
University Of Debrecen	Debrecen	Hungary
Spitalul Clinic Coltea	Bucharest	Romania
Spitalul Clinic Colentina Bucuresti	Bucharest	Romania
Institutul Regional De Oncologie Iasi	Iasi	Romania
Odense University Hospital	Odense	Denmark
Ospedale San Raffaele S.r.l.	Milan	Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Semmelweis University	Budapest	Hungary
Hospital Universitario De Cruces	Barakaldo	Spain
Meander Medical Center	Amersfoort	The Netherlands
Universita’ Politecnica Delle Marche	Ancona	Italy
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz	Nyiregyhaza	Hungary
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Aalborg University Hospital	Aalborg	Denmark
Centre Hospitalier De La Cote Basque	Bayonne	France
Pratia S.A.	Skorzewo	Poland
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie	Lublin	Poland
University General Hospital Of Alexandroupoli	Alexandroupoli	Greece
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Spitalul Clinic Judetean De Urgenta Sibiu	Sibiu	Romania
Region Midtjylland	Aarhus	Denmark
Onco Card S.R.L.	Brasov	Romania
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
CHU Helora	La Louviere	Belgium
Universita Degli Studi Di Brescia	Brescia	Italy
L’Hopital Alexandra Lepeve	Dunkirk	France
IRCCS CROB	Rionero In Vulture	Italy
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Centre Hospital Region Metz Thionville	Metz	France
Ivibvbdd Czedhs Dovudpgrtzasbltct	L'hospitalet De Llobregat	Spain
Evyhmbe	Mechelen	Belgium
Lntlw Giiyska Heprcefn Os Agqhxy	Athens	Greece
Aquzjye Opnstvhmpts Ovbdqknl Rvrnoxt Vqrzc Sfwnv Cdzhzfll	Palermo	Italy
Ckzynq Haezizeivxl Er Utwxgdoxqvlux Dl Ljyxxkv	Limoges	France
Ctlfwj Hdwldwcdpjt Uyzglabtdvvxr Dc Dotvv	Dijon	France
Niyacvbd Iwiarpzx Orpurxmwm Iui Mvhue Simvorylduwmqusnlplzawptwzcz Ihxdqqyv Bsnnukwx	Cracow	Poland
Fufshqqkk Plbt Ly Iuzdyatpslggg Bpjfmqyoy Det Hxmbanwd Ucqfpoaltgkuu Ly Pmj	Madrid	Spain
Uivxsrudmk Gucujzv Hooatekq Autqnao	Athens	Greece
Iglcjgpk Ctliw	Paris	France

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	28.03.2025
Denmark	Recruiting	28.03.2025
France	Recruiting	28.03.2025
Greece	Recruiting	28.03.2025
Hungary	Recruiting	28.03.2025
Italy	Recruiting	28.03.2025
Poland	Recruiting	28.03.2025
Portugal	Recruiting	28.03.2025
Romania	Recruiting	28.03.2025
Spain	Recruiting	28.03.2025
The Netherlands	Recruiting	28.03.2025

Trial locations

Investigated drugs:

Zilovertamab Vedotin (MK-2140) is an experimental medication being tested in this clinical trial. It is designed to target and destroy cancer cells in patients with diffuse large B-cell lymphoma (DLBCL). The medication works by attaching to specific proteins on the surface of cancer cells, delivering a toxic substance directly to them, which helps to kill the cancer cells while minimizing damage to normal cells.

R-CHP is a combination of medications used to treat diffuse large B-cell lymphoma. It includes three chemotherapy drugs and a monoclonal antibody. The chemotherapy drugs work by stopping the growth of cancer cells, while the monoclonal antibody helps the immune system recognize and attack the cancer cells.

R-CHOP is another combination of medications used as a standard treatment for diffuse large B-cell lymphoma. It includes the same components as R-CHP, with the addition of a fourth chemotherapy drug. This combination works to kill cancer cells and support the immune system in fighting the cancer.

Investigated diseases:

Diffuse large B-cell lymphoma

Diffuse Large B-Cell Lymphoma (DLBCL) – This is a type of non-Hodgkin lymphoma, which is a cancer that starts in white blood cells called lymphocytes. It is characterized by rapidly growing tumors in the lymph nodes, spleen, liver, bone marrow, or other organs. DLBCL can occur in any part of the body and often presents with symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The disease progresses quickly, and without intervention, it can spread to other parts of the body. It is the most common type of non-Hodgkin lymphoma in adults. The progression of DLBCL can vary, with some cases responding well to treatment while others may be more aggressive.

Trial ID:

2024-515566-13-00

Protocol code:

MK-2140-010

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Zilovertamab Vedotin and Drug Combination for Untreated Diffuse Large B-Cell Lymphoma Patients

What is this study about?

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