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)

Last updated: May 27, 2026
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma

Treatment

Cyclophosphamide

Doxorubicin

Rituximab

Clinical Study ID

NCT06890884
2140-011
waveLINE-011
MK-2140-011
U1111-1309-2852
2024-515526-89-00
jRCT2021250001
2024-515526-89
  • Ages > 18
  • All Genders

Study 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

Inclusion

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 ofdiffuse large B-cell lymphoma (DLBCL), by prior biopsy, according to the WorldHealth Organization (WHO) classification of neoplasms of the hematopoietic andlymphoid tissues.

  • Has positron emission tomography (PET) positive disease at screening, defined as 4to 5 on the Lugano 5-point scale.

  • Has received no prior treatment for their DLBCL.

  • Human immunodeficiency virus (HIV) infected participants must have well controlledHIV on antiretroviral therapy (ART).

  • Participants who are hepatitis B surface antigen (HBsAg) positive are eligible ifthey have received hepatitis B virus (HBV) antiviral therapy and have undetectableHBV viral load prior to randomization.

  • Participants with history of hepatitis C virus (HCV) infection are eligible if HCVviral load is undetectable at screening.

Exclusion

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 zonelymphoma.

  • Has Ann Arbor Stage I DLBCL.

  • Has clinically significant (i.e., active) cardiovascular disease: cerebral vascularaccident/stroke (<6 months prior to enrollment), myocardial infarction (<6 monthsprior to enrollment), unstable angina, congestive heart failure (New York HeartAssociation Classification Class ≥II), or serious cardiac arrhythmia requiringmedication.

  • 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 MulticentricCastleman's Disease.

  • Has ongoing corticosteroid therapy.

  • Known additional malignancy that is progressing or has required active treatmentwithin the past 2 years.

  • Known active central nervous system (CNS) lymphoma.

  • Has active autoimmune disease that has required systemic treatment in the past 2years.

  • 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 ribonucleicacid (RNA)) infection.

  • Has history of stem cell/solid organ transplant.

Study Design

Total Participants: 594
Treatment Group(s): 9
Primary Treatment: Cyclophosphamide
Phase: 2
Study Start date:
April 11, 2025
Estimated Completion Date:
December 16, 2032

Connect with a study center

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

    Mechelen, Antwerpen 2800
    Belgium

    Active - Recruiting

  • CHU HELORA asbl ( Site 0304)

    Mons, Brabant Wallon 7000
    Belgium

    Active - Recruiting

  • Cliniques Universitaires Saint-Luc ( Site 0302)

    Brussels, Bruxelles-Capitale, Region de 1200
    Belgium

    Active - Recruiting

  • UZ Leuven ( Site 0301)

    Leuven, Vlaams-Brabant 3000
    Belgium

    Active - Recruiting

  • AZ Delta ( Site 0303)

    Roeselare, West-Vlaanderen 8800
    Belgium

    Active - Recruiting

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

    Stuttgart, Baden-Wurttemberg 70174
    Germany

    Active - Recruiting

  • Uniklinik Erlangen ( Site 0412)

    Erlangen, Bavaria 91054
    Germany

    Active - Recruiting

  • Universitaetsklinikum Wuerzburg ( Site 0401)

    Würzburg, Bavaria 97080
    Germany

    Active - Recruiting

  • HELIOS Klinikum Wuppertal ( Site 0435)

    Wuppertal, North Rhine-Westphalia 42283
    Germany

    Active - Recruiting

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

    Magdeburg, Saxony-Anhalt 39120
    Germany

    Active - Recruiting

  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck ( Site 0425)

    Lübeck, Schleswig-Holstein 23562
    Germany

    Active - Recruiting

  • St Vincent's University Hospital ( Site 0502)

    Dublin, Dublin D04 T6F4
    Ireland

    Active - Recruiting

  • Mater Misercordiae University Hospital ( Site 0501)

    Dublin, D07 R2WY
    Ireland

    Active - Recruiting

  • Mater Misercordiae University Hospital ( Site 0501)

    Dublin 2964574, D07 R2WY
    Ireland

    Active - Recruiting

  • University Hospital Limerick ( Site 0503)

    Limerick, V94 F858
    Ireland

    Active - Recruiting

  • Soroka Medical Center ( Site 0606)

    Beersheba, 8410101
    Israel

    Active - Recruiting

  • Rambam Health Care Campus ( Site 0604)

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Edith Wolfson Medical Center ( Site 0602)

    Holon, 5810001
    Israel

    Active - Recruiting

  • Haddasah Medical Center ( Site 0601)

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Rabin Medical Center ( Site 0607)

    Petah Tikva, 4941492
    Israel

    Active - Recruiting

  • Sheba Medical Center ( Site 0603)

    Ramat Gan, 5265601
    Israel

    Active - Recruiting

  • ZIV Medical Center ( Site 0605)

    Safed, 13100
    Israel

    Active - Recruiting

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

    Alessandria 3183299, Ancona 15121
    Italy

    Active - Recruiting

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

    Meldola, Forli-Cesena 47014
    Italy

    Active - Recruiting

  • Istituto Clinico Humanitas ( Site 0704)

    Rozzano, Milano 20089
    Italy

    Active - Recruiting

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

    Alessandria, 15121
    Italy

    Active - Recruiting

  • Istituto Europeo di Oncologia ( Site 0701)

    Milan, 20141
    Italy

    Active - Recruiting

  • Universita degli Studi di Napoli Federico II ( Site 0705)

    Naples, 80131
    Italy

    Active - Recruiting

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

    Palermo, 90146
    Italy

    Active - Recruiting

  • Arcispedale Santa Maria Nuova ( Site 0706)

    Reggio Emilia, 42123
    Italy

    Active - Recruiting

  • Aichi Cancer Center ( Site 1007)

    Nagoya, Aichi-ken 464-8681
    Japan

    Active - Recruiting

  • Fujita Health University Hospital ( Site 1003)

    Toyoake, Aichi-ken 470-1192
    Japan

    Active - Recruiting

  • Hokkaido University Hospital ( Site 1004)

    Sapporo, Hokkaido 060-8648
    Japan

    Active - Recruiting

  • National Hospital Organization Sendai Medical Center ( Site 1005)

    Sendai, Miyagi 983-8520
    Japan

    Active - Recruiting

  • Kansai Medical University Hospital ( Site 1006)

    Hirakata, Osaka 573-1191
    Japan

    Active - Recruiting

  • Shimane University Hospital ( Site 1002)

    Izumo, Shimane 693-8501
    Japan

    Active - Recruiting

  • Nippon Medical School Hospital ( Site 1001)

    Bunkyo, Tokyo 113-8603
    Japan

    Active - Recruiting

  • National Cancer Center Hospital ( Site 1009)

    Chūō, Tokyo 104-0045
    Japan

    Active - Recruiting

  • Nagasaki University Hospital ( Site 1008)

    Nagasaki, 852-8501
    Japan

    Active - Recruiting

  • Pratia MCM Krakow ( Site 0804)

    Karkow, Lesser Poland Voivodeship 30-727
    Poland

    Active - Recruiting

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

    Nowy Sącz, Lesser Poland Voivodeship 33-300
    Poland

    Active - Recruiting

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

    Wałbrzych, Lower Silesian Voivodeship 58-309
    Poland

    Active - Recruiting

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

    Warsaw, Masovian Voivodeship 02-781
    Poland

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne ( Site 0802)

    Gdansk, Pomeranian Voivodeship 80-214
    Poland

    Active - Recruiting

  • Pratia Onkologia Katowice ( Site 0801)

    Katowice, Silesian Voivodeship 40-519
    Poland

    Active - Recruiting

  • Bristol Haematology and Oncology Centre ( Site 0908)

    Bristol, Bristol, City of BS2 8ED
    United Kingdom

    Active - Recruiting

  • Stoke Mandeville Hospital ( Site 0917)

    Aylesbury, Buckinghamshire HP21 8AL
    United Kingdom

    Active - Recruiting

  • Royal Devon & Exeter Hospital ( Site 0910)

    Exeter, Devon EX2 5DW
    United Kingdom

    Active - Recruiting

  • University Hospitals Plymouth NHS Trust ( Site 0905)

    Plymouth, Devon PL68DH
    United Kingdom

    Active - Recruiting

  • The James Cook University Hospital ( Site 0909)

    Middlesbrough, England TS4 3BW
    United Kingdom

    Active - Recruiting

  • Lincoln County Hospital ( Site 0906)

    Lincoln, Lincolnshire LN2 5QY
    United Kingdom

    Active - Recruiting

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

    London, London, City of SE1 9RT
    United Kingdom

    Active - Recruiting

  • Hammersmith Hospital ( Site 0915)

    London, London, City of W12 0 HS
    United Kingdom

    Active - Recruiting

  • Hammersmith Hospital ( Site 0915)

    London 2643743, London, City of W12 0 HS
    United Kingdom

    Active - Recruiting

  • Churchill Hospital ( Site 0903)

    Oxford, Oxfordshire OX3 7LJ
    United Kingdom

    Active - Recruiting

  • Queen Elizabeth Hospital Birmingham ( Site 0912)

    Birmingham, B15 2TH
    United Kingdom

    Active - Recruiting

  • Clatterbridge Cancer Centre - Liverpool ( Site 0911)

    Liverpool, L7 8YA
    United Kingdom

    Active - Recruiting

  • Christie Hospital NHS Trust ( Site 0901)

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

  • Infirmary Cancer Care ( Site 0157)

    Mobile, Alabama 36607
    United States

    Active - Recruiting

  • Ironwood Cancer & Research Centers ( Site 0204)

    Chandler, Arizona 85224
    United States

    Active - Recruiting

  • Palo Verde Cancer Specialists ( Site 0105)

    Glendale, Arizona 85304
    United States

    Active - Recruiting

  • City of Hope - Phoenix ( Site 0202)

    Goodyear, Arizona 85338
    United States

    Active - Recruiting

  • Genesis Cancer and Blood Institute ( Site 0193)

    Hot Springs, Arkansas 71913
    United States

    Active - Recruiting

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

    Burbank, California 91505
    United States

    Active - Recruiting

  • City of Hope Comprehensive Cancer Center ( Site 0191)

    Duarte, California 91010
    United States

    Active - Recruiting

  • Bass Medical Group ( Site 0123)

    Walnut Creek, California 94598
    United States

    Active - Recruiting

  • Rocky Mountain Cancer Centers (RMCC) ( Site 8001)

    Aurora, Colorado 80012
    United States

    Active - Recruiting

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

    Grand Junction, Colorado 81505
    United States

    Active - Recruiting

  • Medical Oncology Hematology Consultants (MOHC) ( Site 8007)

    Newark, Delaware 19713
    United States

    Active - Recruiting

  • Georgetown University Medical Center ( Site 0117)

    Washington D.C., District of Columbia 20007
    United States

    Active - Recruiting

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

    Boca Raton, Florida 33486
    United States

    Active - Recruiting

  • Baptist MD Anderson Cancer Center ( Site 0176)

    Jacksonville, Florida 32207
    United States

    Active - Recruiting

  • Mount Sinai Braman Comprehensive Cancer Center ( Site 0140)

    Miami Beach, Florida 33140
    United States

    Active - Recruiting

  • Mount Sinai Cancer Center ( Site 0140)

    Miami Beach, Florida 33140
    United States

    Active - Recruiting

  • Mid Florida Hematology and Oncology Center ( Site 0152)

    Orange City, Florida 32763
    United States

    Active - Recruiting

  • Beacon Cancer Care ( Site 0142)

    Post Falls, Idaho 83854
    United States

    Active - Recruiting

  • University of Chicago Medical Center ( Site 0126)

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Illinois Cancer Care ( Site 7005)

    Peoria, Illinois 61615
    United States

    Active - Recruiting

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

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Mission Blood & Cancer Care ( Site 0114)

    Waukee, Iowa 50263
    United States

    Active - Recruiting

  • Saint Elizabeth Medical Center Edgewood ( Site 0141)

    Edgewood, Kentucky 41017
    United States

    Active - Recruiting

  • Baptist Health Hardin ( Site 0154)

    Elizabethtown, Kentucky 42701
    United States

    Active - Recruiting

  • Baptist Health Lexington ( Site 0127)

    Lexington, Kentucky 40503
    United States

    Active - Recruiting

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

    Louisville, Kentucky 40207
    United States

    Active - Recruiting

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

    Baton Rouge, Louisiana 70808
    United States

    Active - Recruiting

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

    Monroe, Louisiana 71202
    United States

    Active - Recruiting

  • Ochsner Clinic Foundation ( Site 0189)

    New Orleans, Louisiana 70121
    United States

    Active - Recruiting

  • Louisiana State University Health Sciences Shreveport ( Site 0195)

    Shreveport, Louisiana 71103
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute ( Site 0111)

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Minnesota Oncology Hematology (MNO) ( Site 8004)

    Burnsville, Minnesota 55337
    United States

    Active - Recruiting

  • Bozeman Health Deaconess Hospital ( Site 0183)

    Bozeman, Montana 59715
    United States

    Active - Recruiting

  • NHO Revive Research Institute, LLC ( Site 0121)

    Lincoln, Nebraska 68506
    United States

    Active - Recruiting

  • University Of Nebraska Medical Center ( Site 0110)

    Omaha, Nebraska 68198
    United States

    Active - Recruiting

  • Atlantic Health Morristown Medical Center ( Site 0163)

    Morristown, New Jersey 07960
    United States

    Active - Recruiting

  • Valley Health Systems - Ridgewood Campus ( Site 0125)

    Paramus, New Jersey 07652
    United States

    Active - Recruiting

  • Erie County Medical Center ( Site 0175)

    Buffalo, New York 14215
    United States

    Active - Recruiting

  • Roswell Park Cancer Institute ( Site 0192)

    Buffalo, New York 14263
    United States

    Active - Recruiting

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

    Mineola, New York 11501
    United States

    Active - Recruiting

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

    New York, New York 10016
    United States

    Active - Recruiting

  • SUNY Upstate Cancer Center ( Site 0178)

    Syracuse, New York 13210
    United States

    Active - Recruiting

  • Clinical Research Alliance ( Site 0122)

    Westbury, New York 11590
    United States

    Active - Recruiting

  • Erie County Medical Center ( Site 0175)

    Buffalo 5110629, New York 5128638 14215
    United States

    Active - Recruiting

  • University of North Carolina Medical Center ( Site 0136)

    Chapel Hill, North Carolina 27514
    United States

    Active - Recruiting

  • Novant Health Presbyterian Medical Center ( Site 0177)

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Novant Health Forsyth Medical Center ( Site 0206)

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • University of Cincinnati Medical Center ( Site 0156)

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Cleveland Clinic Main ( Site 0101)

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Fairview Hospital-Moll Cancer Center ( Site 0198)

    Cleveland, Ohio 44111
    United States

    Active - Recruiting

  • University Hospitals of Cleveland ( Site 0155)

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

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

    Mayfield Heights, Ohio 44124
    United States

    Active - Recruiting

  • Cleveland Clinic Main ( Site 0101)

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Active - Recruiting

  • Fairview Hospital-Moll Cancer Center ( Site 0198)

    Cleveland 5150529, Ohio 5165418 44111
    United States

    Active - Recruiting

  • Providence Oncology and Hematology Clinic Westside ( Site 0179)

    Portland, Oregon 97225
    United States

    Active - Recruiting

  • Providence Portland Medical Center ( Site 0120)

    Portland, Oregon 97213
    United States

    Active - Recruiting

  • Providence Portland Medical Center ( Site 0120)

    Portland 5746545, Oregon 5744337 97213
    United States

    Active - Recruiting

  • Temple University Hospital ( Site 0133)

    Philadelphia, Pennsylvania 19140
    United States

    Active - Recruiting

  • Alliance Cancer Specialists (ACS) ( Site 8010)

    Sellersville, Pennsylvania 18960
    United States

    Active - Recruiting

  • Cancer Care Associates Of York ( Site 0174)

    York, Pennsylvania 17403
    United States

    Active - Recruiting

  • Medical University of South Carolina ( Site 0153)

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Tennessee Cancer Specialists ( Site 7004)

    Knoxville, Tennessee 37909
    United States

    Active - Recruiting

  • SCRI Oncology Partners ( Site 7002)

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Texas Oncology - West Texas ( Site 8008)

    Amarillo, Texas 79124
    United States

    Active - Recruiting

  • Texas Oncology - Central/South Texas ( Site 8006)

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Texas Oncology - Northeast Texas ( Site 8002)

    Palestine, Texas 75801
    United States

    Active - Recruiting

  • Texas Oncology - San Antonio ( Site 8009)

    San Antonio, Texas 78240
    United States

    Active - Recruiting

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

    Tyler, Texas 75701
    United States

    Completed

  • Intermountain Medical Center ( Site 0182)

    Murray, Utah 84107
    United States

    Active - Recruiting

  • Intermountain Healthcare - St. George ( Site 0203)

    St. George, Utah 84790
    United States

    Active - Recruiting

  • Virginia Cancer Specialists, PC ( Site 8003)

    Manassas, Virginia 20110
    United States

    Active - Recruiting

  • VCU Health Adult Outpatient Pavillion ( Site 0138)

    Richmond, Virginia 23219
    United States

    Active - Recruiting

  • Northwest Cancer Specialists (Compass Oncology) ( Site 8000)

    Vancouver, Washington 98684
    United States

    Active - Recruiting

  • SSM Health Dean Medical Group ( Site 0106)

    Madison, Wisconsin 53715
    United States

    Active - Recruiting

  • Medical College of Wisconsin ( Site 0103)

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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