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NCT06890884PHASE2Recruiting

A Clinical Study of Zilovertamab Vedotin (MK-2140) Plus Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Polatuzumab Vedotin Plus R-CHP in People With Diffuse Large B-cell Lymphoma (DLBCL) (MK-2140-011/waveLINE-011)

Merck Sharp & Dohme LLC

Start Date

4/11/2025

Completion Date

12/16/2032

Summary

Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing. The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically confirmed diagnosis of germinal center B-cell (GCB) subtype of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, according to the World Health Organization (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. * Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART). * Participants 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: The main exclusion criteria include but are not limited to the following: * 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. * 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 active HBV (defined as HBsAg positive and detectable HBV deoxyribonucleic acid (DNA)) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection. * Has history of stem cell/solid organ transplant.

Interventions

BIOLOGICAL

Zilovertamab vedotin

BIOLOGICAL

Rituximab

DRUG

Cyclophosphamide

DRUG

Doxorubicin

BIOLOGICAL

Rituximab Biosimilar

DRUG

Prednisone

DRUG

Prednisolone

BIOLOGICAL

Polatuzumab vedotin

DRUG

Rescue Medication

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Conditions

Lymphoma, Large B-Cell, Diffuse

Locations

Infirmary Cancer Care ( Site 0157)

Mobile, Alabama 36607

United States

Ironwood Cancer & Research Centers ( Site 0204)

Chandler, Arizona 85224

United States

Palo Verde Cancer Specialists ( Site 0105)

Glendale, Arizona 85304

United States

City of Hope - Phoenix ( Site 0202)

Goodyear, Arizona 85338

United States

Genesis Cancer and Blood Institute ( Site 0193)

Hot Springs, Arkansas 71913

United States

Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0135)

Burbank, California 91505

United States

City of Hope Comprehensive Cancer Center ( Site 0191)

Duarte, California 91010

United States

Bass Medical Group ( Site 0123)

Walnut Creek, California 94598

United States

Rocky Mountain Cancer Centers (RMCC) ( Site 8001)

Aurora, Colorado 80012

United States

Colorado West Healthcare System-Grand Valley Oncology ( Site 0165)

Grand Junction, Colorado 81505

United States

Medical Oncology Hematology Consultants (MOHC) ( Site 8007)

Newark, Delaware 19713

United States

Georgetown University Medical Center ( Site 0117)

Washington D.C., District of Columbia 20007

United States

Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0130)

Boca Raton, Florida 33486

United States

Baptist MD Anderson Cancer Center ( Site 0176)

Jacksonville, Florida 32207

United States

Mount Sinai Braman Comprehensive Cancer Center ( Site 0140)

Miami Beach, Florida 33140

United States

Mid Florida Hematology and Oncology Center ( Site 0152)

Orange City, Florida 32763

United States

Beacon Cancer Care ( Site 0142)

Post Falls, Idaho 83854

United States

University of Chicago Medical Center ( Site 0126)

Chicago, Illinois 60637

United States

Illinois Cancer Care ( Site 7005)

Peoria, Illinois 61615

United States

University of Iowa-Holden Comprehensive Cancer Center ( Site 0139)

Iowa City, Iowa 52242

United States

Mission Blood & Cancer Care ( Site 0114)

Waukee, Iowa 50263

United States

Saint Elizabeth Medical Center Edgewood ( Site 0141)

Edgewood, Kentucky 41017

United States

Baptist Health Hardin ( Site 0154)

Elizabethtown, Kentucky 42701

United States

Baptist Health Lexington ( Site 0127)

Lexington, Kentucky 40503

United States

Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0185)

Louisville, Kentucky 40207

United States

Our Lady of the Lake Physician Group-Medical Oncology ( Site 0180)

Baton Rouge, Louisiana 70808

United States

Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic ( Site 0209)

Monroe, Louisiana 71202

United States

Ochsner Clinic Foundation ( Site 0189)

New Orleans, Louisiana 70121

United States

Louisiana State University Health Sciences Shreveport ( Site 0195)

Shreveport, Louisiana 71103

United States

Beth Israel Deaconess Medical Center ( Site 0161)

Boston, Massachusetts 02215

United States

Dana Farber Cancer Institute ( Site 0111)

Boston, Massachusetts 02215

United States

Minnesota Oncology Hematology (MNO) ( Site 8004)

Burnsville, Minnesota 55337

United States

Bozeman Health Deaconess Hospital ( Site 0183)

Bozeman, Montana 59715

United States

NHO Revive Research Institute, LLC ( Site 0121)

Lincoln, Nebraska 68506

United States

University Of Nebraska Medical Center ( Site 0110)

Omaha, Nebraska 68198

United States

Atlantic Health Morristown Medical Center ( Site 0163)

Morristown, New Jersey 07960

United States

Valley Health Systems - Ridgewood Campus ( Site 0125)

Paramus, New Jersey 07652

United States

Erie County Medical Center ( Site 0175)

Buffalo, New York 14215

United States

Roswell Park Cancer Institute ( Site 0192)

Buffalo, New York 14263

United States

Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0208)

Mineola, New York 11501

United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0108)

New York, New York 10016

United States

SUNY Upstate Cancer Center ( Site 0178)

Syracuse, New York 13210

United States

Optum Medical Care, PC ( Site 0122)

Westbury, New York 11590

United States

University of North Carolina Medical Center ( Site 0136)

Chapel Hill, North Carolina 27514

United States

Novant Health Presbyterian Medical Center ( Site 0177)

Charlotte, North Carolina 28204

United States

Novant Health Forsyth Medical Center ( Site 0206)

Winston-Salem, North Carolina 27103

United States

University of Cincinnati Medical Center ( Site 0156)

Cincinnati, Ohio 45219

United States

University Hospitals of Cleveland ( Site 0155)

Cleveland, Ohio 44106

United States

Fairview Hospital-Moll Cancer Center ( Site 0198)

Cleveland, Ohio 44111

United States

Cleveland Clinic Main ( Site 0101)

Cleveland, Ohio 44195

United States

Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 0199)

Mayfield Heights, Ohio 44124

United States

Providence Portland Medical Center ( Site 0120)

Portland, Oregon 97213

United States

Providence Oncology and Hematology Clinic Westside ( Site 0179)

Portland, Oregon 97225

United States

Abramson Cancer Center and Perelman Center for Advanced Medicine ( Site 0131)

Philadelphia, Pennsylvania 19104

United States

Temple University Hospital ( Site 0133)

Philadelphia, Pennsylvania 19140

United States

Alliance Cancer Specialists (ACS) ( Site 8010)

Sellersville, Pennsylvania 18960

United States

Cancer Care Associates Of York ( Site 0174)

York, Pennsylvania 17403

United States

Medical University of South Carolina ( Site 0153)

Charleston, South Carolina 29425

United States

Tennessee Cancer Specialists ( Site 7004)

Knoxville, Tennessee 37909

United States

SCRI Oncology Partners ( Site 7002)

Nashville, Tennessee 37203

United States

Texas Oncology - West Texas ( Site 8008)

Amarillo, Texas 79124

United States

Texas Oncology - Central/South Texas ( Site 8006)

Austin, Texas 78705

United States

UT Southwestern Medical Center ( Site 0190)

Dallas, Texas 75390

United States

Texas Oncology - Northeast Texas ( Site 8002)

Palestine, Texas 75801

United States

Texas Oncology - San Antonio ( Site 8009)

San Antonio, Texas 78240

United States

The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0145)

Tyler, Texas 75701

United States

Intermountain Medical Center ( Site 0182)

Murray, Utah 84107

United States

Intermountain Healthcare - St. George ( Site 0203)

St. George, Utah 84790

United States

Virginia Cancer Specialists, PC ( Site 8003)

Manassas, Virginia 20110

United States

VCU Health Adult Outpatient Pavillion ( Site 0138)

Richmond, Virginia 23219

United States

Northwest Cancer Specialists (Compass Oncology) ( Site 8000)

Vancouver, Washington 98684

United States

SSM Health Dean Medical Group ( Site 0106)

Madison, Wisconsin 53715

United States

Medical College of Wisconsin ( Site 0103)

Milwaukee, Wisconsin 53226

United States

AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0306)

Mechelen, Antwerpen 2800

Belgium

CHU HELORA asbl ( Site 0304)

Mons, Brabant Wallon 7000

Belgium

Cliniques Universitaires Saint-Luc ( Site 0302)

Brussels, Bruxelles-Capitale, Region de 1200

Belgium

VITAZ ( Site 0307)

Sint-Niklaas, Oost-Vlaanderen 9100

Belgium

UZ Leuven ( Site 0301)

Leuven, Vlaams-Brabant 3000

Belgium

AZ Delta ( Site 0303)

Roeselare, West-Vlaanderen 8800

Belgium

Klinikum Stuttgart. Klinik fur Hamatologie. Onkologie. Palliativmedizin und Stammzelltransplantation ( Site 0419)

Stuttgart, Baden-Wurttemberg 70174

Germany

UniversitaetsklInikum Tuebingen ( Site 0410)

Tübingen, Baden-Wurttemberg 72076

Germany

Uniklinik Erlangen ( Site 0412)

Erlangen, Bavaria 91054

Germany

LMU Klinikum ( Site 0428)

Munich, Bavaria 81377

Germany

Universitaetsklinikum Wuerzburg ( Site 0401)

Würzburg, Bavaria 97080

Germany

Centrum für Hämatologie und Onkologie Bethanien ( Site 0417)

Frankfurt am Main, Hesse 60389

Germany

Klinikum Kassel GmbH ( Site 0434)

Kassel, Hesse 34125

Germany

KRH Klinikum Siloah ( Site 0441)

Hanover, Lower Saxony 30459

Germany

Dietrich Bonhoeffer Klinikum-Neubrandenburg ( Site 0439)

Neubrandenburg, Mecklenburg-Vorpommern 17036

Germany

Universitätsklinikum Aachen ( Site 0418)

Aachen, North Rhine-Westphalia 52074

Germany

HELIOS Klinikum Wuppertal ( Site 0435)

Wuppertal, North Rhine-Westphalia 42283

Germany

Klinikum Chemnitz gGmbH ( Site 0405)

Chemnitz, Saxony 09113

Germany

Otto-Von-Guericke-Universitaet Magdeburg ( Site 0411)

Magdeburg, Saxony-Anhalt 39120

Germany

Universitaetsklinikum Schleswig-Holstein - Campus Luebeck ( Site 0425)

Lübeck, Schleswig-Holstein 23562

Germany

Universitätsklinikum Jena ( Site 0438)

Jena, Thuringia 07747

Germany

St Vincent's University Hospital ( Site 0502)

Dublin, Dublin D04 T6F4

Ireland

Mater Misercordiae University Hospital ( Site 0501)

Dublin, D07 R2WY

Ireland

University Hospital Limerick ( Site 0503)

Limerick, V94 F858

Ireland

Soroka Medical Center ( Site 0606)

Beersheba, 8410101

Israel

Rambam Health Care Campus ( Site 0604)

Haifa, 3109601

Israel

Edith Wolfson Medical Center ( Site 0602)

Holon, 5810001

Israel

Haddasah Medical Center ( Site 0601)

Jerusalem, 9112001

Israel

Rabin Medical Center ( Site 0607)

Petah Tikva, 4941492

Israel

Sheba Medical Center ( Site 0603)

Ramat Gan, 5265601

Israel

ZIV Medical Center ( Site 0605)

Safed, 13100

Israel

Sourasky Medical Center ( Site 0608)

Tel Aviv, 6423906

Israel

IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0707)

Meldola, Forli-Cesena 47014

Italy

Istituto Clinico Humanitas ( Site 0704)

Rozzano, Milano 20089

Italy

Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO ( Site 0702)

Palermo, Sicily 90146

Italy

Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 0703)

Alessandria, 15121

Italy

Istituto Europeo di Oncologia ( Site 0701)

Milan, 20141

Italy

Universita degli Studi di Napoli Federico II ( Site 0705)

Naples, 80131

Italy

Arcispedale Santa Maria Nuova ( Site 0706)

Reggio Emilia, 42123

Italy

Aichi Cancer Center ( Site 1007)

Nagoya, Aichi-ken 464-8681

Japan

Fujita Health University Hospital ( Site 1003)

Toyoake, Aichi-ken 470-1192

Japan

Hokkaido University Hospital ( Site 1004)

Sapporo, Hokkaido 060-8648

Japan

National Hospital Organization Sendai Medical Center ( Site 1005)

Sendai, Miyagi 983-8520

Japan

Kansai Medical University Hospital ( Site 1006)

Hirakata, Osaka 573-1191

Japan

Shimane University Hospital ( Site 1002)

Izumo, Shimane 693-8501

Japan

Nippon Medical School Hospital ( Site 1001)

Bunkyo, Tokyo 113-8603

Japan

National Cancer Center Hospital ( Site 1009)

Chūō, Tokyo 104-0045

Japan

Nagasaki University Hospital ( Site 1008)

Nagasaki, 852-8501

Japan

Pratia MCM Krakow ( Site 0804)

Krakow, Lesser Poland Voivodeship 30-727

Poland

Szpital Specjalistyczny im. Jedrzeja Sniadeckiego w Nowym Saczu ( Site 0806)

Nowy Sącz, Lesser Poland Voivodeship 33-300

Poland

Specjalistyczny Szpital im. Dr Alfreda Sokolowskiego w Walbrzychu ( Site 0807)

Wałbrzych, Lower Silesian Voivodeship 58-309

Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0803)

Warsaw, Masovian Voivodeship 02-781

Poland

Uniwersyteckie Centrum Kliniczne ( Site 0802)

Gdansk, Pomeranian Voivodeship 80-214

Poland

Pratia Onkologia Katowice ( Site 0801)

Katowice, Silesian Voivodeship 40-519

Poland

Bristol Haematology and Oncology Centre ( Site 0908)

Bristol, Bristol, City of BS2 8ED

United Kingdom

Stoke Mandeville Hospital ( Site 0917)

Aylesbury, Buckinghamshire HP21 8AL

United Kingdom

Royal Devon & Exeter Hospital ( Site 0910)

Exeter, Devon EX2 5DW

United Kingdom

University Hospitals Plymouth NHS Trust ( Site 0905)

Plymouth, Devon PL68DH

United Kingdom

The James Cook University Hospital ( Site 0909)

Middlesbrough, England TS4 3BW

United Kingdom

Lincoln County Hospital ( Site 0906)

Lincoln, Lincolnshire LN2 5QY

United Kingdom

Guy s & St Thomas NHS Foundation Trust ( Site 0904)

London, London, City of SE1 9RT

United Kingdom

Hammersmith Hospital ( Site 0915)

London, London, City of W12 0 HS

United Kingdom

Churchill Hospital ( Site 0903)

Oxford, Oxfordshire OX3 7LJ

United Kingdom

Queen Elizabeth Hospital Birmingham ( Site 0912)

Birmingham, B15 2TH

United Kingdom

Clatterbridge Cancer Centre - Liverpool ( Site 0911)

Liverpool, L7 8YA

United Kingdom

Christie Hospital NHS Trust ( Site 0901)

Manchester, M20 4BX

United Kingdom