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RECRUITING

NCT06717347

PHASE3

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)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1046

Start Date

2025-01-27

Completion Date

2032-03-29

Last Updated

2026-10-21

Healthy Volunteers

Conditions

Diffuse Large B-Cell Lymphoma

Interventions

BIOLOGICAL

Zilovertamab vedotin

IV infusion

BIOLOGICAL

Rituximab

IV infusion

DRUG

Cyclophosphamide

IV infusion

DRUG

Doxorubicin

IV infusion

BIOLOGICAL

Rituximab Biosimilar

IV infusion

DRUG

Prednisone

Per Approved Product Label

DRUG

Prednisolone

Oral administration

DRUG

Vincristine

IV infusion

DRUG

Rescue medication

Participants receive rescue medication per approved product label. The rescue medication is granulocyte colony-stimulating factor (G-CSF).

DRUG

Methylprednisolone

Per Approved Product Label

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

Locations (285)

USA Mitchell Cancer Institute ( Site 0173)

Mobile, Alabama, United States

Banner MD Anderson Cancer Center ( Site 0165)

Gilbert, Arizona, United States

Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0167)

Phoenix, Arizona, United States

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

Tucson, Arizona, United States

Providence Medical Foundation-Oncology ( Site 0168)

Fullerton, California, United States

MemorialCare Health System - Long Beach Medical Center ( Site 9559)

Long Beach, California, United States

Cancer Blood and Specialty Clinic ( Site 0109)

Los Alamitos, California, United States

Cedars-Sinai Medical Center ( Site 0115)

Los Angeles, California, United States

Pacific Hematology Oncology Associates ( Site 0131)

San Francisco, California, United States

Lutheran Hospital - Cancer Centers of Colorado ( Site 0180)

Golden, Colorado, United States

Clermont Oncology Center ( Site 0182)

Clermont, Florida, United States

Bioresearch Partner ( Site 0157)

Hialeah, Florida, United States

Orlando Health Cancer Institute ( Site 0169)

Ocoee, Florida, United States

Mid Florida Hematology and Oncology Center ( Site 0172)

Orange City, Florida, United States

Tampa General Hospital ( Site 0134)

Tampa, Florida, United States

University Cancer & Blood Center, LLC ( Site 0141)

Athens, Georgia, United States

Edward Cancer Center ( Site 0197)

Naperville, Illinois, United States

Cancer Care Specialists of Illinois ( Site 0152)

O'Fallon, Illinois, United States

Fort Wayne Medical Oncology and Hematology ( Site 0149)

Fort Wayne, Indiana, United States

Cotton O'Neil Cancer Center ( Site 0108)

Topeka, Kansas, United States

University of Kentucky ( Site 0106)

Lexington, Kentucky, United States

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

Louisville, Kentucky, United States

Owensboro Medical Health System ( Site 0195)

Owensboro, Kentucky, United States

CHRISTUS St. Frances Cabrini Hospital Center for Cancer Care ( Site 0184)

Alexandria, Louisiana, United States

American Oncology Partners, P.A. ( Site 0185)

Bethesda, Maryland, United States

Maryland Oncology Hematology (MOH) ( Site 8004)

Columbia, Maryland, United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor ( Site 9545)

Ann Arbor, Michigan, United States

Karmanos Cancer Institute ( Site 0174)

Detroit, Michigan, United States

Corewell Health ( Site 0130)

Grand Rapids, Michigan, United States

The University of Mississippi Medical Center ( Site 0161)

Jackson, Mississippi, United States

Circuit Clinical - SSM Health Cancer Care DePaul ( Site 0166)

Bridgeton, Missouri, United States

Truman Medical Center ( Site 0122)

Kansas City, Missouri, United States

Oncology and Hematology Associates ( Site 9546)

Springfield, Missouri, United States

Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0178)

Billings, Montana, United States

OptumCare Cancer Care ( Site 0121)

Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada ( Site 0113)

Las Vegas, Nevada, United States

Cancer Care Specialists ( Site 9582)

Reno, Nevada, United States

New Jersey Cancer Care ( Site 7002)

Belleville, New Jersey, United States

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

Albany, New York, United States

Icahn School of Medicine at Mount Sinai ( Site 0164)

New York, New York, United States

New York Cancer and Blood Specialists ( Site 9000)

Shirley, New York, United States

East Carolina University ( Site 0159)

Greenville, North Carolina, United States

Sanford Health Roger Maris Cancer Center ( Site 0189)

Fargo, North Dakota, United States

Oncology_Hematology Care Clinical Trials, LLC (OHC) ( Site 8002)

Cincinnati, Ohio, United States

Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8001)

Eugene, Oregon, United States

Kaiser Permanente Interstate Medical Office - Central ( Site 0181)

Portland, Oregon, United States

Prisma Health - Upstate ( Site 0158)

Greenville, South Carolina, United States

Sanford Cancer Center ( Site 0143)

Sioux Falls, South Dakota, United States

The University of Tennessee Medical Center ( Site 0142)

Knoxville, Tennessee, United States

SCRI Oncology Partners ( Site 7000)

Nashville, Tennessee, United States

Texas Oncology - DFW ( Site 8000)

Dallas, Texas, United States

Center for Oncology and Blood Disorders ( Site 0153)

Houston, Texas, United States

Houston Methodist Cancer Center ( Site 0154)

Houston, Texas, United States

Joe Arrington Cancer Research and Treatment Center ( Site 0183)

Lubbock, Texas, United States

Texas Oncology - Gulf Coast ( Site 8003)

The Woodlands, Texas, United States

University of Virginia Cancer Center ( Site 0138)

Charlottesville, Virginia, United States

Virginia Oncology Associates (VOA) ( Site 8005)

Hampton, Virginia, United States

Virginia Cancer Institute ( Site 0148)

Richmond, Virginia, United States

Blue Ridge Cancer Care ( Site 0132)

Roanoke, Virginia, United States

Vista Oncology ( Site 4201)

Olympia, Washington, United States

SSM Health Dean Medical Group ( Site 0140)

Madison, Wisconsin, United States

Clinica Adventista Belgrano ( Site 0309)

Caba., Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Mar del Plata ( Site 0306)

Mar del Plata, Buenos Aires, Argentina

Hospital Universitario Austral ( Site 0307)

Pilar, Buenos Aires, Argentina

Hospital Aleman ( Site 0301)

Buenos Aires, Buenos Aires F.D., Argentina

Fundacion Estudios Clinicos ( Site 0311)

Rosario, Santa Fe Province, Argentina

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

San Miguel de Tucumán, Tucumán Province, Argentina

Hospital Italiano de Buenos Aires ( Site 0304)

CABA, Argentina

Clinica EL Castaño ( Site 0312)

San Juan, Argentina

Townsville University Hospital ( Site 3006)

Townsville, Queensland, Australia

Royal Adelaide Hospital ( Site 3001)

Adelaide, South Australia, Australia

Grampians Health ( Site 3003)

Ballarat, Victoria, Australia

Northern Hospital ( Site 3002)

Melbourne, Victoria, Australia

Royal Perth Hospital-Haematology ( Site 3004)

Perth, Western Australia, Australia

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

Mechelen, Antwerpen, Belgium

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

Mons, Hainaut, Belgium

CEONC ( Site 0412)

Cascavel, Paraná, Brazil

Hospital Erasto Gaertner ( Site 0401)

Curitiba, Paraná, Brazil

Liga Norte Riograndense Contra o Cancer ( Site 0407)

Natal, Rio Grande do Norte, Brazil

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

Florianópolis, Santa Catarina, Brazil

Hope ( Site 0413)

Ribeirão Preto, São Paulo, Brazil

Clinica Advanze ( Site 0411)

São Carlos, São Paulo, Brazil

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

SJRP, São Paulo, Brazil

Hospital Paulistano ( Site 0406)

São Paulo, Brazil

Hospital das Clinicas FMUSP ( Site 0402)

São Paulo, Brazil

Cross Cancer Institute ( Site 0205)

Edmonton, Alberta, Canada

Queen Elizabeth II Health Sciences Centre ( Site 0207)

Halifax, Nova Scotia, Canada

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0208)

Hamilton, Ontario, Canada

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

Oshawa, Ontario, Canada

Sunnybrook Research Institute ( Site 0204)

Toronto, Ontario, Canada

Biocenter ( Site 0510)

Concepción, Biobio, Chile

IC La Serena Research ( Site 0504)

La Serena, Coquimbo Region, Chile

Oncocentro Valdivia ( Site 0506)

Valdivia, Los Ríos Region, Chile

Centro de Estudios Clínicos SAGA ( Site 0508)