AzTrials
AzTrials

Lymphoma, Large B-Cell, DiffusePhase 2NCT06890884

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)

A Phase 2 study testing Zilovertamab vedotin, Rituximab and Cyclophosphamide in people with Lymphoma, Large B-Cell, Diffuse, run by Merck Sharp & Dohme LLC at 147 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Large B-Cell, Diffuse
What is being tested?
Zilovertamab vedotin, Rituximab and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
594 participants
Where
147 sitesin 9 countries
Study dates
11 Apr 2025to 16 Dec 2032
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

147 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

147 sites in 9 countries

United States73 sites, 71 recruiting

  • Texas Oncology - West Texas ( Site 8008)

    Amarillo, Texas, 79124

    Study Coordinator, 806-358-8654

    Recruiting

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

    Aurora, Colorado, 80012

    Study Coordinator, 303-925-0700

    Recruiting

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

    Austin, Texas, 78705

    Study Coordinator, 512-427-9400

    Recruiting

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

    Baton Rouge, Louisiana, 70808

    Study Coordinator, 225-374-0320

    Recruiting

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

    Boca Raton, Florida, 33486

    Study Coordinator, 561-955-4800

    Recruiting

  • Beth Israel Deaconess Medical Center ( Site 0161)

    Boston, Massachusetts, 02215

    Study Coordinator, 617-667-2100

    Recruiting

  • Dana Farber Cancer Institute ( Site 0111)

    Boston, Massachusetts, 02215

    Study Coordinator, 877-442-3324

    Recruiting

  • Bozeman Health Deaconess Hospital ( Site 0183)

    Bozeman, Montana, 59715

    Study Coordinator, 406-414-3749

    Recruiting

  • Erie County Medical Center ( Site 0175)

    Buffalo, New York, 14215

    Completed

  • Roswell Park Cancer Institute ( Site 0192)

    Buffalo, New York, 14263

    Study Coordinator, 716-845-2300

    Recruiting

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

    Burbank, California, 91505

    Study Coordinator, 818-840-0921

    Recruiting

  • Minnesota Oncology Hematology (MNO) ( Site 8004)

    Burnsville, Minnesota, 55337

    Study Coordinator, 952-892-7190

    Recruiting

  • Ironwood Cancer & Research Centers ( Site 0204)

    Chandler, Arizona, 85224

    Study Coordinator, 480-314-6670

    Recruiting

  • University of North Carolina Medical Center ( Site 0136)

    Chapel Hill, North Carolina, 27514

    Study Coordinator, 984-974-1000

    Recruiting

  • Medical University of South Carolina ( Site 0153)

    Charleston, South Carolina, 29425

    Study Coordinator, 843-792-2529

    Recruiting

  • Novant Health Presbyterian Medical Center ( Site 0177)

    Charlotte, North Carolina, 28204

    Study Coordinator, 704-384-4000

    Recruiting

  • University of Chicago Medical Center ( Site 0126)

    Chicago, Illinois, 60637

    Study Coordinator, 773-702-5550

    Recruiting

  • University of Cincinnati Medical Center ( Site 0156)

    Cincinnati, Ohio, 45219

    Study Coordinator, 513-584-1000

    Recruiting

  • University Hospitals of Cleveland ( Site 0155)

    Cleveland, Ohio, 44106

    Study Coordinator, 216-286-3867

    Recruiting

  • Fairview Hospital-Moll Cancer Center ( Site 0198)

    Cleveland, Ohio, 44111

    Study Coordinator, 216-444-6833

    Recruiting

  • Cleveland Clinic Main ( Site 0101)

    Cleveland, Ohio, 44195

    Study Coordinator, 216-444-6833

    Recruiting

  • UT Southwestern Medical Center ( Site 0190)

    Dallas, Texas, 75390

    Study Coordinator, 214-648-3111

    Recruiting

  • City of Hope Comprehensive Cancer Center ( Site 0191)

    Duarte, California, 91010

    Study Coordinator, 626-218-2405

    Recruiting

  • Saint Elizabeth Medical Center Edgewood ( Site 0141)

    Edgewood, Kentucky, 41017

    Study Coordinator, 859-301-2000

    Recruiting

  • Baptist Health Hardin ( Site 0154)

    Elizabethtown, Kentucky, 42701

    Study Coordinator, 270-706-5065

    Recruiting

  • Palo Verde Cancer Specialists ( Site 0105)

    Glendale, Arizona, 85304

    Study Coordinator, 602-978-6255

    Recruiting

  • City of Hope - Phoenix ( Site 0202)

    Goodyear, Arizona, 85338

    Study Coordinator, 602-883-1537

    Recruiting

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

    Grand Junction, Colorado, 81505

    Study Coordinator, 970-644-4460

    Recruiting

  • Genesis Cancer and Blood Institute ( Site 0193)

    Hot Springs, Arkansas, 71913

    Study Coordinator, 501-624-7700

    Recruiting

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

    Iowa City, Iowa, 52242

    Study Coordinator, 319-356-4200

    Recruiting

  • Baptist MD Anderson Cancer Center ( Site 0176)

    Jacksonville, Florida, 32207

    Study Coordinator, 904-202-7300

    Recruiting

  • Tennessee Cancer Specialists ( Site 7004)

    Knoxville, Tennessee, 37909

    Study Coordinator, 865-862-0998

    Recruiting

  • Baptist Health Lexington ( Site 0127)

    Lexington, Kentucky, 40503

    Study Coordinator, 859-260-6100

    Recruiting

  • NHO Revive Research Institute, LLC ( Site 0121)

    Lincoln, Nebraska, 68506

    Study Coordinator, 402-484-4900

    Recruiting

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

    Louisville, Kentucky, 40207

    Study Coordinator, 502-899-3366

    Recruiting

  • SSM Health Dean Medical Group ( Site 0106)

    Madison, Wisconsin, 53715

    Study Coordinator, 608-252-8000

    Recruiting

  • Virginia Cancer Specialists, PC ( Site 8003)

    Manassas, Virginia, 20110

    Study Coordinator, 703-554-6800

    Recruiting

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

    Mayfield Heights, Ohio, 44124

    Study Coordinator, 216-444-6833

    Recruiting

  • Mount Sinai Braman Comprehensive Cancer Center ( Site 0140)

    Miami Beach, Florida, 33140

    Study Coordinator, 305-674-2625

    Recruiting

  • Medical College of Wisconsin ( Site 0103)

    Milwaukee, Wisconsin, 53226

    Study Coordinator, 414-805-6700

    Recruiting

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

    Mineola, New York, 11501

    Study Coordinator, 516-663-2988

    Recruiting

  • Infirmary Cancer Care ( Site 0157)

    Mobile, Alabama, 36607

    Study Coordinator, 251-435-2273

    Recruiting

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

    Monroe, Louisiana, 71202

    Study Coordinator, 318-330-0000

    Recruiting

  • Atlantic Health Morristown Medical Center ( Site 0163)

    Morristown, New Jersey, 07960

    Study Coordinator, 973-971-6608

    Recruiting

  • Intermountain Medical Center ( Site 0182)

    Murray, Utah, 84107

    Study Coordinator, 801-507-3630

    Recruiting

  • SCRI Oncology Partners ( Site 7002)

    Nashville, Tennessee, 37203

    Study Coordinator, 615-329-7274

    Recruiting

  • Ochsner Clinic Foundation ( Site 0189)

    New Orleans, Louisiana, 70121

    Study Coordinator, 504-703-1340

    Recruiting

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

    New York, New York, 10016

    Study Coordinator, 212-731-6000

    Recruiting

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

    Newark, Delaware, 19713

    Study Coordinator, 302-366-1200

    Recruiting

  • University Of Nebraska Medical Center ( Site 0110)

    Omaha, Nebraska, 68198

    Study Coordinator, 402-559-5600

    Recruiting

  • Mid Florida Hematology and Oncology Center ( Site 0152)

    Orange City, Florida, 32763

    Study Coordinator, 386-774-1223

    Recruiting

  • Texas Oncology - Northeast Texas ( Site 8002)

    Palestine, Texas, 75801

    Study Coordinator, 903-727-2200

    Recruiting

  • Valley Health Systems - Ridgewood Campus ( Site 0125)

    Paramus, New Jersey, 07652

    Study Coordinator, 201-447-8000

    Recruiting

  • Illinois Cancer Care ( Site 7005)

    Peoria, Illinois, 61615

    Study Coordinator, 309-240-6040

    Recruiting

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

    Philadelphia, Pennsylvania, 19104

    Study Coordinator, 215-662-2867

    Recruiting

  • Temple University Hospital ( Site 0133)

    Philadelphia, Pennsylvania, 19140

    Study Coordinator, 215-707-8712

    Recruiting

  • Providence Portland Medical Center ( Site 0120)

    Portland, Oregon, 97213

    Study Coordinator, 503-216-6300

    Recruiting

  • Providence Oncology and Hematology Clinic Westside ( Site 0179)

    Portland, Oregon, 97225

    Study Coordinator, 503-216-6300

    Recruiting

  • Beacon Cancer Care ( Site 0142)

    Post Falls, Idaho, 83854

    Study Coordinator, 208-755-2804

    Recruiting

  • VCU Health Adult Outpatient Pavillion ( Site 0138)

    Richmond, Virginia, 23219

    Study Coordinator, 315-383-8748

    Recruiting

  • Texas Oncology - San Antonio ( Site 8009)

    San Antonio, Texas, 78240

    Study Coordinator, 210-595-5300

    Recruiting

  • Alliance Cancer Specialists (ACS) ( Site 8010)

    Sellersville, Pennsylvania, 18960

    Study Coordinator, 215-706-2034

    Recruiting

  • Louisiana State University Health Sciences Shreveport ( Site 0195)

    Shreveport, Louisiana, 71103

    Study Coordinator, 318-813-1057

    Recruiting

  • Intermountain Healthcare - St. George ( Site 0203)

    St. George, Utah, 84790

    Study Coordinator, 801-507-3630

    Recruiting

  • SUNY Upstate Cancer Center ( Site 0178)

    Syracuse, New York, 13210

    Study Coordinator, 315-464-8200

    Recruiting

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

    Tyler, Texas, 75701

    Completed

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

    Vancouver, Washington, 98684

    Study Coordinator, 360-944-9889

    Recruiting

  • Bass Medical Group ( Site 0123)

    Walnut Creek, California, 94598

    Study Coordinator, 925-433-8786

    Recruiting

  • Georgetown University Medical Center ( Site 0117)

    Washington D.C., District of Columbia, 20007

    Study Coordinator, 202-444-2223

    Recruiting

  • Mission Blood & Cancer Care ( Site 0114)

    Waukee, Iowa, 50263

    Study Coordinator, 515-282-2921

    Recruiting

  • Optum Medical Care, PC ( Site 0122)

    Westbury, New York, 11590

    Study Coordinator, 646-872-8630

    Recruiting

  • Novant Health Forsyth Medical Center ( Site 0206)

    Winston-Salem, North Carolina, 27103

    Study Coordinator, 336-718-5000

    Recruiting

  • Cancer Care Associates Of York ( Site 0174)

    York, Pennsylvania, 17403

    Study Coordinator, 484-371-5102

    Recruiting

Other trials in United States

Germany18 sites, 18 recruiting

  • Universitätsklinikum Aachen ( Site 0418)

    Aachen, North Rhine-Westphalia, 52074

    Study Coordinator, 0241 800

    Recruiting

  • Johanniter Krankenhaus Bonn ( Site 0440)

    Bonn, North Rhine-Westphalia, 53113

    Study Coordinator, +492285433691

    Recruiting

  • Klinikum Chemnitz gGmbH ( Site 0405)

    Chemnitz, Saxony, 09113

    Study Coordinator, 01732988725

    Recruiting

  • Uniklinik Erlangen ( Site 0412)

    Erlangen, Bavaria, 91054

    Study Coordinator, +4991318535954

    Recruiting

  • Centrum für Hämatologie und Onkologie Bethanien ( Site 0417)

    Frankfurt am Main, Hesse, 60389

    Study Coordinator, +4969451080

    Recruiting

  • KRH Klinikum Siloah ( Site 0441)

    Hanover, Lower Saxony, 30459

    Study Coordinator, +4905119270

    Recruiting

  • Universitätsklinikum Jena ( Site 0438)

    Jena, Thuringia, 07747

    Study Coordinator, +493641 9327113

    Recruiting

  • Klinikum Kassel GmbH ( Site 0434)

    Kassel, Hesse, 34125

    Study Coordinator, +495619803046

    Recruiting

  • Gemeinschaftsklinikum Mittelrhein gGmbH Innere Medizin - Hamatologie/Onkologie.Palliativmedizin ( Site 0413)

    Koblenz, Rhineland-Palatinate, 56073

    Study Coordinator, 06772 8040

    Recruiting

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

    Lübeck, Schleswig-Holstein, 23562

    Study Coordinator, +4945150044777

    Recruiting

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

    Magdeburg, Saxony-Anhalt, 39120

    Study Coordinator, 01732988725

    Recruiting

  • LMU Klinikum ( Site 0428)

    Munich, Bavaria, 81377

    Study Coordinator, 089440075212

    Recruiting

  • Dietrich Bonhoeffer Klinikum-Neubrandenburg ( Site 0439)

    Neubrandenburg, Mecklenburg-Vorpommern, 17036

    Study Coordinator, +493957750

    Recruiting

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

    Stuttgart, Baden-Wurttemberg, 70174

    Study Coordinator, +4971127830410

    Recruiting

  • UniversitaetsklInikum Tuebingen ( Site 0410)

    Tübingen, Baden-Wurttemberg, 72076

    Study Coordinator, +4970712986018

    Recruiting

  • Universitaetsklinikum Ulm. ( Site 0404)

    Ulm, Baden-Wurttemberg, 89081

    Study Coordinator, +49 731500 45 953

    Recruiting

  • HELIOS Klinikum Wuppertal ( Site 0435)

    Wuppertal, North Rhine-Westphalia, 42283

    Study Coordinator, +492028960

    Recruiting

  • Universitaetsklinikum Wuerzburg ( Site 0401)

    Würzburg, Bavaria, 97080

    Study Coordinator, +4993120140013

    Recruiting

Other trials in Germany

United Kingdom12 sites, 12 recruiting

  • Stoke Mandeville Hospital ( Site 0917)

    Aylesbury, Buckinghamshire, HP21 8AL

    Study Coordinator, +441296315000

    Recruiting

  • Queen Elizabeth Hospital Birmingham ( Site 0912)

    Birmingham, B15 2TH

    Study Coordinator, +441213717842

    Recruiting

  • Bristol Haematology and Oncology Centre ( Site 0908)

    Bristol, Bristol, City of, BS2 8ED

    Study Coordinator, +441179230000

    Recruiting

  • Royal Devon & Exeter Hospital ( Site 0910)

    Exeter, Devon, EX2 5DW

    Study Coordinator, 01392402850

    Recruiting

  • Lincoln County Hospital ( Site 0906)

    Lincoln, Lincolnshire, LN2 5QY

    Study Coordinator, +441522573557

    Recruiting

  • Clatterbridge Cancer Centre - Liverpool ( Site 0911)

    Liverpool, L7 8YA

    Study Coordinator, +441515565000

    Recruiting

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

    London, London, City of, SE1 9RT

    Study Coordinator, +442071887188

    Recruiting

  • Hammersmith Hospital ( Site 0915)

    London, London, City of, W12 0 HS

    Study Coordinator, +442033134594

    Recruiting

  • Christie Hospital NHS Trust ( Site 0901)

    Manchester, M20 4BX

    Study Coordinator, +441619187222

    Recruiting

  • The James Cook University Hospital ( Site 0909)

    Middlesbrough, England, TS4 3BW

    Study Coordinator, +441642850850

    Recruiting

  • Churchill Hospital ( Site 0903)

    Oxford, Oxfordshire, OX3 7LJ

    Study Coordinator, +441865227063

    Recruiting

  • University Hospitals Plymouth NHS Trust ( Site 0905)

    Plymouth, Devon, PL68DH

    Study Coordinator, +441752431043

    Recruiting

Other trials in United Kingdom

Japan9 sites, 9 recruiting

  • Nippon Medical School Hospital ( Site 1001)

    Bunkyo, Tokyo, 113-8603

    Study Coordinator, +81-3-3822-2131

    Recruiting

  • National Cancer Center Hospital ( Site 1009)

    Chūō, Tokyo, 104-0045

    Study Coordinator, +81-3-3542-2511

    Recruiting

  • Kansai Medical University Hospital ( Site 1006)

    Hirakata, Osaka, 573-1191

    Study Coordinator, +81-72-804-2808

    Recruiting

  • Shimane University Hospital ( Site 1002)

    Izumo, Shimane, 693-8501

    Study Coordinator, +81-853-20-2492

    Recruiting

  • Nagasaki University Hospital ( Site 1008)

    Nagasaki, 852-8501

    Study Coordinator, +81-95-819-7256

    Recruiting

  • Aichi Cancer Center ( Site 1007)

    Nagoya, Aichi-ken, 464-8681

    Study Coordinator, +81-52-762-6111

    Recruiting

  • Hokkaido University Hospital ( Site 1004)

    Sapporo, Hokkaido, 060-8648

    Study Coordinator, +81-11-716-1161

    Recruiting

  • National Hospital Organization Sendai Medical Center ( Site 1005)

    Sendai, Miyagi, 983-8520

    Study Coordinator, +81-22-293-1111

    Recruiting

  • Fujita Health University Hospital ( Site 1003)

    Toyoake, Aichi-ken, 470-1192

    Study Coordinator, +81-562-93-2111

    Recruiting

Other trials in Japan

Israel8 sites, 8 recruiting

  • Soroka Medical Center ( Site 0606)

    Beersheba, 8410101

    Study Coordinator, +97286400111

    Recruiting

  • Rambam Health Care Campus ( Site 0604)

    Haifa, 3109601

    Study Coordinator, +972-47771514

    Recruiting

  • Edith Wolfson Medical Center ( Site 0602)

    Holon, 5810001

    Study Coordinator, +972-508805538

    Recruiting

  • Haddasah Medical Center ( Site 0601)

    Jerusalem, 9112001

    Study Coordinator, +97239377377

    Recruiting

  • Rabin Medical Center ( Site 0607)

    Petah Tikva, 4941492

    Study Coordinator, +97239377377

    Recruiting

  • Sheba Medical Center ( Site 0603)

    Ramat Gan, 5265601

    Study Coordinator, +972-35302127

    Recruiting

  • ZIV Medical Center ( Site 0605)

    Safed, 13100

    Study Coordinator, +972-46828132

    Recruiting

  • Sourasky Medical Center ( Site 0608)

    Tel Aviv, 6423906

    Study Coordinator, 972-3-6973576

    Recruiting

Other trials in Israel

Belgium7 sites, 7 recruiting

  • AZ Sint Jan Brugge-Oostende ( Site 0308)

    Bruges, West-Vlaanderen, 8000

    Study Coordinator, +3250452328

    Recruiting

  • Cliniques Universitaires Saint-Luc ( Site 0302)

    Brussels, Bruxelles-Capitale, Region de, 1200

    Study Coordinator, +3227641810

    Recruiting

  • Hopital de Jolimont ( Site 0304)

    Haine-Saint-Paul, Hainaut, 7100

    Study Coordinator, +3264231726

    Recruiting

  • UZ Leuven ( Site 0301)

    Leuven, Vlaams-Brabant, 3000

    Study Coordinator, +3216340938

    Recruiting

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

    Mechelen, Antwerpen, 2800

    Study Coordinator, +3215891669

    Recruiting

  • AZ Delta ( Site 0303)

    Roeselare, West-Vlaanderen, 8800

    Study Coordinator, +32(0)51237447

    Recruiting

  • VITAZ ( Site 0307)

    Sint-Niklaas, Oost-Vlaanderen, 9100

    Study Coordinator, 3237602327

    Recruiting

Other trials in Belgium

Italy7 sites, 7 recruiting

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

    Alessandria, 15121

    Study Coordinator, +390131206262

    Recruiting

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

    Meldola, Forli-Cesena, 47014

    Study Coordinator, +390543739266

    Recruiting

  • Istituto Europeo di Oncologia ( Site 0701)

    Milan, 20141

    Study Coordinator, 0390257489403

    Recruiting

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

    Naples, 80131

    Study Coordinator, +390817462037

    Recruiting

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

    Palermo, Sicily, 90146

    Study Coordinator, +390917802047

    Recruiting

  • Arcispedale Santa Maria Nuova ( Site 0706)

    Reggio Emilia, 42123

    Study Coordinator, +39 0522295654

    Recruiting

  • Istituto Clinico Humanitas ( Site 0704)

    Rozzano, Milano, 20089

    Study Coordinator, +390282244540

    Recruiting

Other trials in Italy

Poland7 sites, 7 recruiting

  • Uniwersyteckie Centrum Kliniczne ( Site 0802)

    Gdansk, Pomeranian Voivodeship, 80-214

    Study Coordinator, +48 58 584 43 57

    Recruiting

  • Pratia Onkologia Katowice ( Site 0801)

    Katowice, Silesian Voivodeship, 40-519

    Study Coordinator, +48 501 714 019

    Recruiting

  • Pratia MCM Krakow ( Site 0804)

    Krakow, Lesser Poland Voivodeship, 30-727

    Study Coordinator, +48 12 295 81 60

    Recruiting

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

    Nowy Sącz, Lesser Poland Voivodeship, 33-300

    Study Coordinator, +48 18 443 88 77

    Recruiting

  • AIDPORT Sp. z o.o. ( Site 0808)

    Skórzewo, Greater Poland Voivodeship, 60-185

    Study Coordinator, +48570783100

    Recruiting

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

    Wałbrzych, Lower Silesian Voivodeship, 58-309

    Study Coordinator, +48746489742

    Recruiting

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

    Warsaw, Masovian Voivodeship, 02-781

    Study Coordinator, 225462223

    Recruiting

Other trials in Poland

Ireland6 sites, 6 recruiting

  • St Vincent's University Hospital ( Site 0502)

    Dublin, Dublin, D04 T6F4

    Study Coordinator, +35312214000

    Recruiting

  • Mater Misercordiae University Hospital ( Site 0501)

    Dublin, D07 R2WY

    Study Coordinator, +353 1 8034831

    Recruiting

  • St. James's Hospital ( Site 0505)

    Dublin, D08 E9P6

    Study Coordinator, 014284934

    Recruiting

  • Beaumont Hospital ( Site 0506)

    Dublin, D09 V2N0

    Study Coordinator, 018092010

    Recruiting

  • University Hospital Limerick ( Site 0503)

    Limerick, V94 F858

    Study Coordinator, +4461301111

    Recruiting

  • University Hospital Waterford ( Site 0504)

    Waterford, X91 ER8E

    Study Coordinator, +35351848000

    Recruiting

Other trials in Ireland

About this study

Official title: A Randomized, Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) Plus R-CHP Versus Polatuzumab Vedotin Plus R-CHP in Treatment-naïve Participants With GCB Subtype of Diffuse Large B-cell Lymphoma (DLBCL)

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.

Being tested
Zilovertamab vedotin, Rituximab, Cyclophosphamide, Doxorubicin, Rituximab Biosimilar
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zilovertamab vedotinBiological

    Also called MK-2140, VLS-101

    IV infusion

  • RituximabBiological

    Also called RITUXAN®

    IV infusion

  • CyclophosphamideDrug

    Also called CYTOXAN®, NEOSAR®

    IV infusion

  • DoxorubicinDrug

    Also called ADRIAMYCIN®

    IV infusion

  • Rituximab BiosimilarBiological

    Also called TRUXIMA®, RUXIENCE®, RIABNI®

    IV infusion

  • PrednisoneDrug

    Oral administration or IV infusion

  • PrednisoloneDrug

    Oral administration or IV infusion

  • Polatuzumab vedotinBiological

    IV infusion

  • Rescue MedicationDrug

    Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF).

Study groups in NCT06890884
Study groupRoleWhat they receive
Zilovertamab vedotin + Rituximab + Cyclophosphamide, Doxorubicin, Prednisone (R-CHP)ExperimentalParticipants will 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 3-week cycle for up to 6 cycles (up to approximately 4 months) plus 2 additional cycles of rituximab or biosimilar for participants with high risk DLBCL. Participants will also receive 100 mg prednisone or prednisolone via oral tablet per day during Days 1-5 of each 3-week cycle for up to 6 cycles (up to approximately 4 months).
Receives: Biological: Zilovertamab vedotin; Biological: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Biological: Rituximab Biosimilar; Drug: Prednisone; Drug: Prednisolone; Drug: Rescue Medication
Polatuzumab vedotin + R-CHPActive comparatorParticipants will receive a dose of polatuzumab vedotin (1.8 mg/kg) plus 750 mg/m^2 cyclophosphamide, 50 mg/m^2 doxorubicin, and 375 mg/m^2 rituximab or rituximab biosimilar administered by IV infusion on Day 1 of each 3-week cycle for up to 6 cycles (up to approximately 4 months) plus 2 additional cycles of rituximab or biosimilar for participants with high risk DLBCL. Participants will also receive 100 mg prednisone or prednisolone via oral tablet per day during Days 1-5 of each 3-week cycle for up to 6 cycles (up to approximately 4 months).
Receives: Biological: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Biological: Rituximab Biosimilar; Drug: Prednisone; Drug: Prednisolone; Biological: Polatuzumab vedotin; Drug: Rescue Medication

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Response Rate (CRR) at End of Treatment (EOT) per Lugano Response Criteria

    CRR at EOT is defined as the percentage of participants who experience complete response (CR) per Lugano response criteria as assessed by blinded independent central review (BICR) at end of treatment. CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. Participants with missing data or who discontinue treatment or study prior to reaching EOT will be considered non-responders and included in the total number of participants.

    Measured: Up to approximately 31 months

Secondary outcomes (10)

  1. Progression-free Survival (PFS) per Lugano Response Criteria

    PFS is defined as the time from randomization to the first documented disease progression per Lugano response criteria by BICR or death due to any cause, whichever occurs first.

    Measured: Up to approximately 51 months

  2. Overall Survival (OS)

    OS is defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 87 months

  3. Event-free Survival (EFS) per Lugano Response Criteria

    EFS is defined as the time from randomization to any of the following events: progressive disease per Lugano response criteria by BICR, death due to any cause, initiation of a new anti-caner therapy, or a positive biopsy for residual disease. The EFS for all participants will be presented.

    Measured: Up to approximately 51 months

  4. Duration of CR

    For participants who demonstrate CR at EOT per Lugano response criteria by BICR, duration of complete response is defined as the time from the first documented evidence of CR at or before EOT until disease progression or death due to any cause, whichever occurs first.

    Measured: Up to approximately 51 months

  5. Number of participants who experience one or more adverse events (AEs)

    An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented.

    Measured: Up to approximately 9 months

  6. Number of participants who discontinue study intervention due to an AE

    An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented.

    Measured: Up to approximately 6 months

  7. Change From Baseline in Health-Related Quality Of Life (HRQoL) on Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Trial Outcome Index (TOI)

    The FACT-Lym is a 42-item questionnaire designed to measure HRQoL and cancer-specific symptoms in non-Hodgkin lymphoma patients. Subscales include FACT-General (FACT-G), FACT-Trial Outcome Index (FACT-TOI), FACT-Lym total score (FACT-Lym TS), and the Lymphoma subscale (Lym S). The Lym S has a single domain consisting of 15 items specific to lymphoma burden with a score ranging from 0 to 60. FACT-G has 4 well-being domains, physical (7 items), social/family (7), emotional (6), and functional (7), with scores ranging from 0 to 108. FACT-TOI combines FACT-G's physical and functional domains with Lym S, with scores ranging from 0 to 116. FACT-Lym TS combines FACT-G with Lym S, with scores ranging from 0 to 168. The scoring of FACT-Lym is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. The higher the score the better the quality of life.

    Measured: Baseline and up to Week 25

  8. Change From Baseline in HRQoL on FACT-Lym Total Score

    The FACT-Lym is a 42-item questionnaire designed to measure HRQoL and cancer-specific symptoms in non-Hodgkin lymphoma patients. Subscales include FACT-General (FACT-G), FACT-Trial Outcome Index (FACT-TOI), FACT-Lym total score (FACT-Lym TS), and the Lymphoma subscale (Lym S). The Lym S has a single domain consisting of 15 items specific to lymphoma burden with a score ranging from 0 to 60. FACT-G has 4 well-being domains, physical (7 items), social/family (7), emotional (6), and functional (7), with scores ranging from 0 to 108. FACT-TOI combines FACT-G's physical and functional domains with Lym S, with scores ranging from 0 to 116. FACT-Lym TS combines FACT-G with Lym S, with scores ranging from 0 to 168. The scoring of FACT-Lym is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. The higher the score the better the quality of life.

    Measured: Baseline and up to Week 25

  9. Change From Baseline in HRQoL on FACT-Lym Physical Well-being (PWB) (Items General Physical [GP]1 through GP7)

    The FACT-Lym is a 42-item questionnaire designed to measure HRQoL and cancer-specific symptoms in non-Hodgkin lymphoma patients. Subscales include FACT-General (FACT-G), FACT-Trial Outcome Index (FACT-TOI), FACT-Lym total score (FACT-Lym TS), and the Lymphoma subscale (Lym S). The Lym S has a single domain consisting of 15 items specific to lymphoma burden with a score ranging from 0 to 60. FACT-G has 4 well-being domains, physical (7 items), social/family (7), emotional (6), and functional (7), with scores ranging from 0 to 108. FACT-TOI combines FACT-G's physical and functional domains with Lym S, with scores ranging from 0 to 116. FACT-Lym TS combines FACT-G with Lym S, with scores ranging from 0 to 168. The scoring of FACT-Lym is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. The higher the score the better the quality of life.

    Measured: Baseline and up to Week 25

  10. Change From Baseline in HRQoL on Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Neurotoxicity Subscale Score

    The FACT/GOG-NTX provides a targeted assessment of symptoms of peripheral neuropathy, including sensory, motor, and auditory problems and cold sensitivity. It is an 11-item questionnaire designed to measure the neurotoxicity subscale. The scoring of FACT/GOG-NTX is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. To produce a Neurotoxicity Subscale score (range 0-44), the sum of the item scores are multiplied by the number of items in the subscale, then divided by the number of items answered.

    Measured: Baseline and up to Week 25

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2025
  2. Study start11 Apr 2025
  3. Primary completion13 Dec 2027 (estimated)
  4. Study completion16 Dec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
594 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06890884
Sponsor's protocol ID
2140-011
Other IDs
2024-515526-89-00, U1111-1309-2852, MK-2140-011, waveLINE-011, jRCT2021250001
Status last verified
Oct 2026
First submitted
20 Mar 2025
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

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