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NCT06717347

A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010)

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1046 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-27

Study Completion Date

2032-03-29

Brief Summary

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The purpose of this study is to evaluate if zilovertamab vedotin with standard treatment can help people live longer without the cancer growing or spreading than people who receive standard treatment alone.

Detailed Description

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Conditions

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Diffuse Large B-Cell Lymphoma

Keywords

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Lymphoma, Large B-Cell, Diffuse

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zilovertamab vedotin + Rituximab + Cyclophosphamide, Doxorubicin, Prednisone (R-CHP)

Participants receive a dose of zilovertamab vedotin (1.75 mg/kg) plus 750 mg/m\^2 cyclophosphamide, 50 mg/m\^2 doxorubicin, and 375 mg/m\^2 rituximab or rituximab biosimilar administered by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 6 cycles (up to approximately 4 months) plus 2 cycles of rituximab or biosimilar for participants with high risk DLBCL. Participants also receive 100 mg prednisone or prednisolone via oral tablet per day during Days 1-5 of each 21-day cycle for up to 6 cycles (up to approximately 4 months).

Group Type EXPERIMENTAL

Zilovertamab vedotin

Intervention Type BIOLOGICAL

IV infusion

Rituximab

Intervention Type BIOLOGICAL

IV infusion

Cyclophosphamide

Intervention Type DRUG

IV infusion

Doxorubicin

Intervention Type DRUG

IV infusion

Rituximab Biosimilar

Intervention Type BIOLOGICAL

IV infusion

Prednisone

Intervention Type DRUG

Per Approved Product Label

Prednisolone

Intervention Type DRUG

Oral administration

Rescue medication

Intervention Type DRUG

Participants receive rescue medication at the investigator's discretion, per approved product label. The recommended rescue medication is granulocyte colony-stimulating factor (G-CSF).

Rituximab + Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (R-CHOP)

Participants receive 750 mg/m\^2 cyclophosphamide, 50 mg/m\^2 doxorubicin, and 375 mg/m\^2 rituximab or rituximab biosimilar, 1.4 mg/m\^2 vincristine administered by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 6 cycles (up to approximately 4 months) plus 2 cycles of rituximab or biosimilar for participants with high risk DLBCL. Participants also receive 100 mg prednisone or prednisolone via oral tablet per day during Days 1-5 of each 21-day cycle for up to 6 cycles (up to approximately 4 months).

Group Type ACTIVE_COMPARATOR

Rituximab

Intervention Type BIOLOGICAL

IV infusion

Cyclophosphamide

Intervention Type DRUG

IV infusion

Doxorubicin

Intervention Type DRUG

IV infusion

Rituximab Biosimilar

Intervention Type BIOLOGICAL

IV infusion

Prednisone

Intervention Type DRUG

Per Approved Product Label

Prednisolone

Intervention Type DRUG

Oral administration

Vincristine

Intervention Type DRUG

IV infusion

Interventions

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Zilovertamab vedotin

IV infusion

Intervention Type BIOLOGICAL

Rituximab

IV infusion

Intervention Type BIOLOGICAL

Cyclophosphamide

IV infusion

Intervention Type DRUG

Doxorubicin

IV infusion

Intervention Type DRUG

Rituximab Biosimilar

IV infusion

Intervention Type BIOLOGICAL

Prednisone

Per Approved Product Label

Intervention Type DRUG

Prednisolone

Oral administration

Intervention Type DRUG

Vincristine

IV infusion

Intervention Type DRUG

Rescue medication

Participants receive rescue medication at the investigator's discretion, per approved product label. The recommended rescue medication is granulocyte colony-stimulating factor (G-CSF).

Intervention Type DRUG

Other Intervention Names

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MK-2140 VLS-101 RITUXAN® CYTOXAN® NEOSAR® ADRIAMYCIN® TRUXIMA® RUXIENCE® RIABNI®

Eligibility Criteria

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Inclusion Criteria

* Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, based on local testing according to the WHO classification of neoplasms of the hematopoietic and lymphoid tissues
* Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale
* Has received no prior treatment for their DLBCL
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization
* Has an ejection fraction ≥45% as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA)
* Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)
* Who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

Exclusion Criteria

* Has a history of transformation of indolent disease to DLBCL
* Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma
* Has Ann Arbor Stage I DLBCL
* Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\<6 months prior to enrollment), myocardial infarction (\<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication
* Has clinically significant pericardial or pleural effusion
* Has ongoing Grade \>1 peripheral neuropathy
* Has a demyelinating form of Charcot-Marie-Tooth disease
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Has ongoing corticosteroid therapy
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
* Known additional malignancy that is progressing or has required active treatment within the past 2 years
* Known active central nervous system (CNS) lymphoma
* Has active autoimmune disease that has required systemic treatment in the past 2 years
* Has active infection requiring systemic therapy
* Has concurrent active HBV (defined as HBsAg positive and detectable HBV DNA) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection
* Has history of allogeneic tissue/solid organ transplant

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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The University of Arizona Cancer Center - North Campus ( Site 0124)

Tucson, Arizona, United States

Site Status RECRUITING

Cancer Blood and Specialty Clinic ( Site 0109)

Los Alamitos, California, United States

Site Status RECRUITING

Cedars-Sinai Medical Center ( Site 0115)

Los Angeles, California, United States

Site Status RECRUITING

Pacific Hematology Oncology Associates ( Site 0131)

San Francisco, California, United States

Site Status RECRUITING

Bioresearch Partner ( Site 0157)

Hialeah, Florida, United States

Site Status RECRUITING

Cancer Care Specialists of Illinois ( Site 0152)

O'Fallon, Illinois, United States

Site Status RECRUITING

Fort Wayne Medical Oncology and Hematology ( Site 0149)

Fort Wayne, Indiana, United States

Site Status RECRUITING

Cotton O'Neil Cancer Center ( Site 0108)

Topeka, Kansas, United States

Site Status RECRUITING

University of Kentucky ( Site 0106)

Lexington, Kentucky, United States

Site Status RECRUITING

Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0163)

Louisville, Kentucky, United States

Site Status RECRUITING

Corewell Health ( Site 0130)

Grand Rapids, Michigan, United States

Site Status RECRUITING

Truman Medical Center ( Site 0122)

Kansas City, Missouri, United States

Site Status RECRUITING

OptumCare Cancer Care ( Site 0121)

Las Vegas, Nevada, United States

Site Status RECRUITING

Comprehensive Cancer Centers of Nevada ( Site 0113)

Las Vegas, Nevada, United States

Site Status RECRUITING

New York Oncology Hematology, P.C. ( Site 0129)

Albany, New York, United States

Site Status RECRUITING

Sanford Cancer Center ( Site 0143)

Sioux Falls, South Dakota, United States

Site Status RECRUITING

The University of Tennessee Medical Center ( Site 0142)

Knoxville, Tennessee, United States

Site Status RECRUITING

Center for Oncology and Blood Disorders ( Site 0153)

Houston, Texas, United States

Site Status RECRUITING

Houston Methodist Cancer Center ( Site 0154)

Houston, Texas, United States

Site Status RECRUITING

University of Virginia Cancer Center ( Site 0138)

Charlottesville, Virginia, United States

Site Status RECRUITING

Virginia Cancer Institute ( Site 0148)

Richmond, Virginia, United States

Site Status RECRUITING

Blue Ridge Cancer Care ( Site 0132)

Roanoke, Virginia, United States

Site Status RECRUITING

SSM Health Dean Medical Group ( Site 0140)

Madison, Wisconsin, United States

Site Status RECRUITING

Clinica Adventista Belgrano ( Site 0309)

Caba., Buenos Aires, Argentina

Site Status RECRUITING

Instituto de Investigaciones Clinicas Mar del Plata ( Site 0306)

Mar del Plata, Buenos Aires, Argentina

Site Status RECRUITING

Hospital Universitario Austral ( Site 0307)

Pilar, Buenos Aires, Argentina

Site Status RECRUITING

Hospital Aleman ( Site 0301)

Buenos Aites, Buenos Aires F.D., Argentina

Site Status RECRUITING

Fundacion Estudios Clinicos ( Site 0311)

Rosario, Santa Fe Province, Argentina

Site Status RECRUITING

C.I.C.E. 9 de Julio ( Site 0305)

San Miguel de Tucumán, Tucumán Province, Argentina

Site Status RECRUITING

Hospital Italiano de Buenos Aires ( Site 0304)

CABA, , Argentina

Site Status RECRUITING

Clinica EL Castaño ( Site 0312)

San Juan, , Argentina

Site Status RECRUITING

Townsville University Hospital ( Site 3006)

Douglas, Queensland, Australia

Site Status RECRUITING

Royal Adelaide Hospital ( Site 3001)

Adelaide, South Australia, Australia

Site Status RECRUITING

Grampians Health ( Site 3003)

Ballarat, Victoria, Australia

Site Status RECRUITING

Northern Hospital ( Site 3002)

Melbourne, Victoria, Australia

Site Status RECRUITING

Royal Perth Hospital-Haematology ( Site 3004)

Perth, Western Australia, Australia

Site Status RECRUITING

AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 1102)

Mechelen, Antwerpen, Belgium

Site Status RECRUITING

ASBL CHU Helora - Hôpital de Mons - Site Kennedy ( Site 1103)

Mons, Hainaut, Belgium

Site Status RECRUITING

CEONC ( Site 0412)

Cascavel, Paraná, Brazil

Site Status RECRUITING

Hospital Erasto Gaertner ( Site 0401)

Curitiba, Paraná, Brazil

Site Status RECRUITING

Liga Norte Riograndense Contra o Cancer ( Site 0407)

Natal, Rio Grande do Norte, Brazil

Site Status RECRUITING

CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0403)

Florianópolis, Santa Catarina, Brazil

Site Status RECRUITING

Hope ( Site 0413)

Ribeirão Preto, São Paulo, Brazil

Site Status RECRUITING

Clinica Advanze ( Site 0411)

São Carlos, São Paulo, Brazil

Site Status RECRUITING

F. F. R. M. São Jose do Rio Preto ( Site 0404)

SJRP, São Paulo, Brazil

Site Status RECRUITING

Hospital Paulistano ( Site 0406)

São Paulo, , Brazil

Site Status RECRUITING

Hospital das Clinicas FMUSP ( Site 0402)

São Paulo, , Brazil

Site Status RECRUITING

Lakeridge Health - The R.S. McLaughlin Durham Regional Cancer Centre (MDRCC) ( Site 0206)

Oshawa, Ontario, Canada

Site Status RECRUITING

IC La Serena Research ( Site 0504)

La Serena, Coquimbo Region, Chile

Site Status RECRUITING