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)

June 5, 2026 updated by: Merck Sharp & Dohme LLC

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

594

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Antwerpen
      • Mechelen, Antwerpen, Belgium, 2800
        • Recruiting
        • AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0306)
        • Contact:
          • Study Coordinator
          • Phone Number: +3215891669
    • Brabant Wallon
      • Mons, Brabant Wallon, Belgium, 7000
        • Recruiting
        • CHU HELORA asbl ( Site 0304)
        • Contact:
          • Study Coordinator
          • Phone Number: +3264231726
    • Bruxelles-Capitale, Region de
      • Brussels, Bruxelles-Capitale, Region de, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Saint-Luc ( Site 0302)
        • Contact:
          • Study Coordinator
          • Phone Number: +3227641810
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • UZ Leuven ( Site 0301)
        • Contact:
          • Study Coordinator
          • Phone Number: +3216340938
    • West-Vlaanderen
      • Roeselare, West-Vlaanderen, Belgium, 8800
        • Recruiting
        • AZ Delta ( Site 0303)
        • Contact:
          • Study Coordinator
          • Phone Number: +32(0)51237447
  • Germany
    • Baden-Wurttemberg
      • Stuttgart, Baden-Wurttemberg, Germany, 70174
        • Recruiting
        • Klinikum Stuttgart. Klinik fur Hamatologie. Onkologie. Palliativmedizin und Stammzelltransplantation ( Site 0419)
        • Contact:
          • Study Coordinator
          • Phone Number: +4971127830410
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Recruiting
        • Uniklinik Erlangen ( Site 0412)
        • Contact:
          • Study Coordinator
          • Phone Number: +4991318535954
      • Würzburg, Bavaria, Germany, 97080
        • Recruiting
        • Universitaetsklinikum Wuerzburg ( Site 0401)
        • Contact:
          • Study Coordinator
          • Phone Number: +4993120140013
    • Mecklenburg-Vorpommern
      • Neubrandenburg, Mecklenburg-Vorpommern, Germany, 17036
        • Recruiting
        • Dietrich Bonhoeffer Klinikum-Neubrandenburg ( Site 0439)
        • Contact:
          • Study Coordinator
          • Phone Number: +493957750
    • North Rhine-Westphalia
      • Wuppertal, North Rhine-Westphalia, Germany, 42283
        • Recruiting
        • HELIOS Klinikum Wuppertal ( Site 0435)
        • Contact:
          • Study Coordinator
          • Phone Number: +492028960
    • Saxony-Anhalt
      • Magdeburg, Saxony-Anhalt, Germany, 39120
        • Recruiting
        • Otto-Von-Guericke-Universitaet Magdeburg ( Site 0411)
        • Contact:
          • Study Coordinator
          • Phone Number: 01732988725
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23562
        • Recruiting
        • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck ( Site 0425)
        • Contact:
          • Study Coordinator
          • Phone Number: +4945150044777
  • Ireland
      • Dublin, Ireland, D07 R2WY
        • Recruiting
        • Mater Misercordiae University Hospital ( Site 0501)
        • Contact:
          • Study Coordinator
          • Phone Number: +353 1 8034831
      • Limerick, Ireland, V94 F858
        • Recruiting
        • University Hospital Limerick ( Site 0503)
        • Contact:
          • Study Coordinator
          • Phone Number: +4461301111
    • Dublin
      • Dublin, Dublin, Ireland, D04 T6F4
        • Recruiting
        • St Vincent's University Hospital ( Site 0502)
        • Contact:
          • Study Coordinator
          • Phone Number: +35312214000
  • Israel
      • Beersheba, Israel, 8410101
        • Recruiting
        • Soroka Medical Center ( Site 0606)
        • Contact:
          • Study Coordinator
          • Phone Number: +97286400111
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus ( Site 0604)
        • Contact:
          • Study Coordinator
          • Phone Number: +972-47771514
      • Holon, Israel, 5810001
        • Recruiting
        • Edith Wolfson Medical Center ( Site 0602)
        • Contact:
          • Study Coordinator
          • Phone Number: +972-508805538
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Haddasah Medical Center ( Site 0601)
        • Contact:
          • Study Coordinator
          • Phone Number: +97239377377
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center ( Site 0607)
        • Contact:
          • Study Coordinator
          • Phone Number: +97239377377
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center ( Site 0603)
        • Contact:
          • Study Coordinator
          • Phone Number: +972-35302127
      • Safed, Israel, 13100
        • Recruiting
        • ZIV Medical Center ( Site 0605)
        • Contact:
          • Study Coordinator
          • Phone Number: +972-46828132
  • Italy
      • Alessandria, Italy, 15121
        • Recruiting
        • Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 0703)
        • Contact:
          • Study Coordinator
          • Phone Number: +390131206262
      • Milan, Italy, 20141
        • Recruiting
        • Istituto Europeo di Oncologia ( Site 0701)
        • Contact:
          • Study Coordinator
          • Phone Number: 0390257489403
      • Naples, Italy, 80131
        • Recruiting
        • Universita degli Studi di Napoli Federico II ( Site 0705)
        • Contact:
          • Study Coordinator
          • Phone Number: +390817462037
      • Palermo, Italy, 90146
        • Recruiting
        • Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO ( Site 0702)
        • Contact:
          • Study Coordinator
          • Phone Number: +390917802047
      • Reggio Emilia, Italy, 42123
        • Recruiting
        • Arcispedale Santa Maria Nuova ( Site 0706)
        • Contact:
          • Study Coordinator
          • Phone Number: +39 0522295654
    • Forli-Cesena
      • Meldola, Forli-Cesena, Italy, 47014
        • Recruiting
        • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0707)
        • Contact:
          • Study Coordinator
          • Phone Number: +390543739266
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Recruiting
        • Istituto Clinico Humanitas ( Site 0704)
        • Contact:
          • Study Coordinator
          • Phone Number: +390282244540
  • Japan
      • Nagasaki, Japan, 852-8501
        • Recruiting
        • Nagasaki University Hospital ( Site 1008)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-95-819-7256
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Recruiting
        • Aichi Cancer Center ( Site 1007)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-52-762-6111
      • Toyoake, Aichi-ken, Japan, 470-1192
        • Recruiting
        • Fujita Health University Hospital ( Site 1003)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-562-93-2111
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital ( Site 1004)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-11-716-1161
    • Miyagi
      • Sendai, Miyagi, Japan, 983-8520
        • Recruiting
        • National Hospital Organization Sendai Medical Center ( Site 1005)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-22-293-1111
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Recruiting
        • Kansai Medical University Hospital ( Site 1006)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-72-804-2808
    • Shimane
      • Izumo, Shimane, Japan, 693-8501
        • Recruiting
        • Shimane University Hospital ( Site 1002)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-853-20-2492
    • Tokyo
      • Bunkyo, Tokyo, Japan, 113-8603
        • Recruiting
        • Nippon Medical School Hospital ( Site 1001)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3822-2131
      • Chūō, Tokyo, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital ( Site 1009)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3542-2511
  • Poland
    • Lesser Poland Voivodeship
      • Karkow, Lesser Poland Voivodeship, Poland, 30-727
        • Recruiting
        • Pratia MCM Krakow ( Site 0804)
        • Contact:
          • Study Coordinator
          • Phone Number: +48 12 295 81 60
      • Nowy Sącz, Lesser Poland Voivodeship, Poland, 33-300
        • Recruiting
        • Szpital Specjalistyczny im. Jedrzeja Sniadeckiego w Nowym Saczu ( Site 0806)
        • Contact:
          • Study Coordinator
          • Phone Number: +48 18 443 88 77
    • Lower Silesian Voivodeship
      • Wałbrzych, Lower Silesian Voivodeship, Poland, 58-309
        • Recruiting
        • Specjalistyczny Szpital im. Dr Alfreda Sokolowskiego w Walbrzychu ( Site 0807)
        • Contact:
          • Study Coordinator
          • Phone Number: +48746489742
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0803)
        • Contact:
          • Study Coordinator
          • Phone Number: 225462223
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-214
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne ( Site 0802)
        • Contact:
          • Study Coordinator
          • Phone Number: +48 58 584 43 57
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-519
        • Recruiting
        • Pratia Onkologia Katowice ( Site 0801)
        • Contact:
          • Study Coordinator
          • Phone Number: +48 501 714 019
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Recruiting
        • Queen Elizabeth Hospital Birmingham ( Site 0912)
        • Contact:
          • Study Coordinator
          • Phone Number: +441213717842
      • Liverpool, United Kingdom, L7 8YA
        • Recruiting
        • Clatterbridge Cancer Centre - Liverpool ( Site 0911)
        • Contact:
          • Study Coordinator
          • Phone Number: +441515565000
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • Christie Hospital NHS Trust ( Site 0901)
        • Contact:
          • Study Coordinator
          • Phone Number: +441619187222
    • Bristol, City of
      • Bristol, Bristol, City of, United Kingdom, BS2 8ED
        • Recruiting
        • Bristol Haematology and Oncology Centre ( Site 0908)
        • Contact:
          • Study Coordinator
          • Phone Number: +441179230000
    • Buckinghamshire
      • Aylesbury, Buckinghamshire, United Kingdom, HP21 8AL
        • Recruiting
        • Stoke Mandeville Hospital ( Site 0917)
        • Contact:
          • Study Coordinator
          • Phone Number: +441296315000
    • Devon
      • Exeter, Devon, United Kingdom, EX2 5DW
        • Recruiting
        • Royal Devon & Exeter Hospital ( Site 0910)
        • Contact:
          • Study Coordinator
          • Phone Number: 01392402850
      • Plymouth, Devon, United Kingdom, PL68DH
        • Recruiting
        • University Hospitals Plymouth NHS Trust ( Site 0905)
        • Contact:
          • Study Coordinator
          • Phone Number: +441752431043
    • England
      • Middlesbrough, England, United Kingdom, TS4 3BW
        • Recruiting
        • The James Cook University Hospital ( Site 0909)
        • Contact:
          • Study Coordinator
          • Phone Number: +441642850850
    • Lincolnshire
      • Lincoln, Lincolnshire, United Kingdom, LN2 5QY
        • Recruiting
        • Lincoln County Hospital ( Site 0906)
        • Contact:
          • Study Coordinator
          • Phone Number: +441522573557
    • London, City of
      • London, London, City of, United Kingdom, W12 0 HS
        • Recruiting
        • Hammersmith Hospital ( Site 0915)
        • Contact:
          • Study Coordinator
          • Phone Number: +442033134594
      • London, London, City of, United Kingdom, SE1 9RT
        • Recruiting
        • Guy s & St Thomas NHS Foundation Trust ( Site 0904)
        • Contact:
          • Study Coordinator
          • Phone Number: +442071887188
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LJ
        • Recruiting
        • Churchill Hospital ( Site 0903)
        • Contact:
          • Study Coordinator
          • Phone Number: +441865227063
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36607
        • Recruiting
        • Infirmary Cancer Care ( Site 0157)
        • Contact:
          • Study Coordinator
          • Phone Number: 251-435-2273
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Recruiting
        • Ironwood Cancer & Research Centers ( Site 0204)
        • Contact:
          • Study Coordinator
          • Phone Number: 480-314-6670
      • Glendale, Arizona, United States, 85304
        • Recruiting
        • Palo Verde Cancer Specialists ( Site 0105)
        • Contact:
          • Study Coordinator
          • Phone Number: 602-978-6255
      • Goodyear, Arizona, United States, 85338
        • Recruiting
        • City of Hope - Phoenix ( Site 0202)
        • Contact:
          • Study Coordinator
          • Phone Number: 602-883-1537
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Recruiting
        • Genesis Cancer and Blood Institute ( Site 0193)
        • Contact:
          • Study Coordinator
          • Phone Number: 501-624-7700
    • California
      • Burbank, California, United States, 91505
        • Recruiting
        • Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0135)
        • Contact:
          • Study Coordinator
          • Phone Number: 818-840-0921
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Comprehensive Cancer Center ( Site 0191)
        • Contact:
          • Study Coordinator
          • Phone Number: 626-218-2405
      • Walnut Creek, California, United States, 94598
        • Recruiting
        • Bass Medical Group ( Site 0123)
        • Contact:
          • Study Coordinator
          • Phone Number: 925-433-8786
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Recruiting
        • Rocky Mountain Cancer Centers (RMCC) ( Site 8001)
        • Contact:
          • Study Coordinator
          • Phone Number: 303-925-0700
      • Grand Junction, Colorado, United States, 81505
        • Recruiting
        • Colorado West Healthcare System-Grand Valley Oncology ( Site 0165)
        • Contact:
          • Study Coordinator
          • Phone Number: 970-644-4460
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Medical Oncology Hematology Consultants (MOHC) ( Site 8007)
        • Contact:
          • Study Coordinator
          • Phone Number: 302-366-1200
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Recruiting
        • Georgetown University Medical Center ( Site 0117)
        • Contact:
          • Study Coordinator
          • Phone Number: 202-444-2223
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Recruiting
        • Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0130)
        • Contact:
          • Study Coordinator
          • Phone Number: 561-955-4800
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist MD Anderson Cancer Center ( Site 0176)
        • Contact:
          • Study Coordinator
          • Phone Number: 904-202-7300
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Braman Comprehensive Cancer Center ( Site 0140)
        • Contact:
          • Study Coordinator
          • Phone Number: 305-674-2625
      • Orange City, Florida, United States, 32763
        • Recruiting
        • Mid Florida Hematology and Oncology Center ( Site 0152)
        • Contact:
          • Study Coordinator
          • Phone Number: 386-774-1223
    • Idaho
      • Post Falls, Idaho, United States, 83854
        • Recruiting
        • Beacon Cancer Care ( Site 0142)
        • Contact:
          • Study Coordinator
          • Phone Number: 208-755-2804
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medical Center ( Site 0126)
        • Contact:
          • Study Coordinator
          • Phone Number: 773-702-5550
      • Peoria, Illinois, United States, 61615
        • Recruiting
        • Illinois Cancer Care ( Site 7005)
        • Contact:
          • Study Coordinator
          • Phone Number: 309-240-6040
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa-Holden Comprehensive Cancer Center ( Site 0139)
        • Contact:
          • Study Coordinator
          • Phone Number: 319-356-4200
      • Waukee, Iowa, United States, 50263
        • Recruiting
        • Mission Blood & Cancer Care ( Site 0114)
        • Contact:
          • Study Coordinator
          • Phone Number: 515-282-2921
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Recruiting
        • Saint Elizabeth Medical Center Edgewood ( Site 0141)
        • Contact:
          • Study Coordinator
          • Phone Number: 859-301-2000
      • Elizabethtown, Kentucky, United States, 42701
        • Recruiting
        • Baptist Health Hardin ( Site 0154)
        • Contact:
          • Study Coordinator
          • Phone Number: 270-706-5065
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • Baptist Health Lexington ( Site 0127)
        • Contact:
          • Study Coordinator
          • Phone Number: 859-260-6100
      • Louisville, Kentucky, United States, 40207
        • Recruiting
        • Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0185)
        • Contact:
          • Study Coordinator
          • Phone Number: 502-899-3366
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Recruiting
        • Our Lady of the Lake Physician Group-Medical Oncology ( Site 0180)
        • Contact:
          • Study Coordinator
          • Phone Number: 225-374-0320
      • Monroe, Louisiana, United States, 71202
        • Recruiting
        • Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic ( Site 0209)
        • Contact:
          • Study Coordinator
          • Phone Number: 318-330-0000
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Clinic Foundation ( Site 0189)
        • Contact:
          • Study Coordinator
          • Phone Number: 504-703-1340
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • Louisiana State University Health Sciences Shreveport ( Site 0195)
        • Contact:
          • Study Coordinator
          • Phone Number: 318-813-1057
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute ( Site 0111)
        • Contact:
          • Study Coordinator
          • Phone Number: 877-442-3324
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Recruiting
        • Minnesota Oncology Hematology (MNO) ( Site 8004)
        • Contact:
          • Study Coordinator
          • Phone Number: 952-892-7190
    • Montana
      • Bozeman, Montana, United States, 59715
        • Recruiting
        • Bozeman Health Deaconess Hospital ( Site 0183)
        • Contact:
          • Study Coordinator
          • Phone Number: 406-414-3749
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Recruiting
        • NHO Revive Research Institute, LLC ( Site 0121)
        • Contact:
          • Study Coordinator
          • Phone Number: 402-484-4900
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University Of Nebraska Medical Center ( Site 0110)
        • Contact:
          • Study Coordinator
          • Phone Number: 402-559-5600
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Atlantic Health Morristown Medical Center ( Site 0163)
        • Contact:
          • Study Coordinator
          • Phone Number: 973-971-6608
      • Paramus, New Jersey, United States, 07652
        • Recruiting
        • Valley Health Systems - Ridgewood Campus ( Site 0125)
        • Contact:
          • Study Coordinator
          • Phone Number: 201-447-8000
    • New York
      • Buffalo, New York, United States, 14215
        • Recruiting
        • Erie County Medical Center ( Site 0175)
        • Contact:
          • Study Coordinator
          • Phone Number: 716-898-1880
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute ( Site 0192)
        • Contact:
          • Study Coordinator
          • Phone Number: 716-845-2300
      • Mineola, New York, United States, 11501
        • Recruiting
        • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0208)
        • Contact:
          • Study Coordinator
          • Phone Number: 516-663-2988
      • New York, New York, United States, 10016
        • Recruiting
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0108)
        • Contact:
          • Study Coordinator
          • Phone Number: 212-731-6000
      • Syracuse, New York, United States, 13210
        • Recruiting
        • SUNY Upstate Cancer Center ( Site 0178)
        • Contact:
          • Study Coordinator
          • Phone Number: 315-464-8200
      • Westbury, New York, United States, 11590
        • Recruiting
        • Clinical Research Alliance ( Site 0122)
        • Contact:
          • Study Coordinator
          • Phone Number: 646-872-8630
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • University of North Carolina Medical Center ( Site 0136)
        • Contact:
          • Study Coordinator
          • Phone Number: 984-974-1000
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Novant Health Presbyterian Medical Center ( Site 0177)
        • Contact:
          • Study Coordinator
          • Phone Number: 704-384-4000
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Novant Health Forsyth Medical Center ( Site 0206)
        • Contact:
          • Study Coordinator
          • Phone Number: 336-718-5000
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Medical Center ( Site 0156)
        • Contact:
          • Study Coordinator
          • Phone Number: 513-584-1000
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Main ( Site 0101)
        • Contact:
          • Study Coordinator
          • Phone Number: 216-444-6833
      • Cleveland, Ohio, United States, 44111
        • Recruiting
        • Fairview Hospital-Moll Cancer Center ( Site 0198)
        • Contact:
          • Study Coordinator
          • Phone Number: 216-444-6833
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals of Cleveland ( Site 0155)
        • Contact:
          • Study Coordinator
          • Phone Number: 216-286-3867
      • Mayfield Heights, Ohio, United States, 44124
        • Recruiting
        • Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 0199)
        • Contact:
          • Study Coordinator
          • Phone Number: 216-444-6833
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center ( Site 0120)
        • Contact:
          • Study Coordinator
          • Phone Number: 503-216-6300
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Oncology and Hematology Clinic Westside ( Site 0179)
        • Contact:
          • Study Coordinator
          • Phone Number: 503-216-6300
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Temple University Hospital ( Site 0133)
        • Contact:
          • Study Coordinator
          • Phone Number: 215-707-8712
      • Sellersville, Pennsylvania, United States, 18960
        • Recruiting
        • Alliance Cancer Specialists (ACS) ( Site 8010)
        • Contact:
          • Study Coordinator
          • Phone Number: 215-706-2034
      • York, Pennsylvania, United States, 17403
        • Recruiting
        • Cancer Care Associates Of York ( Site 0174)
        • Contact:
          • Study Coordinator
          • Phone Number: 484-371-5102
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina ( Site 0153)
        • Contact:
          • Study Coordinator
          • Phone Number: 843-792-2529
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Recruiting
        • Tennessee Cancer Specialists ( Site 7004)
        • Contact:
          • Study Coordinator
          • Phone Number: 865-862-0998
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners ( Site 7002)
        • Contact:
          • Study Coordinator
          • Phone Number: 615-329-7274
    • Texas
      • Amarillo, Texas, United States, 79124
        • Recruiting
        • Texas Oncology - West Texas ( Site 8008)
        • Contact:
          • Study Coordinator
          • Phone Number: 806-358-8654
      • Austin, Texas, United States, 78705
        • Recruiting
        • Texas Oncology - Central/South Texas ( Site 8006)
        • Contact:
          • Study Coordinator
          • Phone Number: 512-427-9400
      • Palestine, Texas, United States, 75801
        • Recruiting
        • Texas Oncology - Northeast Texas ( Site 8002)
        • Contact:
          • Study Coordinator
          • Phone Number: 903-727-2200
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Texas Oncology - San Antonio ( Site 8009)
        • Contact:
          • Study Coordinator
          • Phone Number: 210-595-5300
      • Tyler, Texas, United States, 75701
        • Completed
        • The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0145)
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain Medical Center ( Site 0182)
        • Contact:
          • Study Coordinator
          • Phone Number: 801-507-3630
      • St. George, Utah, United States, 84790
        • Recruiting
        • Intermountain Healthcare - St. George ( Site 0203)
        • Contact:
          • Study Coordinator
          • Phone Number: 801-507-3630
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Recruiting
        • Virginia Cancer Specialists, PC ( Site 8003)
        • Contact:
          • Study Coordinator
          • Phone Number: 703-554-6800
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • VCU Health Adult Outpatient Pavillion ( Site 0138)
        • Contact:
          • Study Coordinator
          • Phone Number: 315-383-8748
    • Washington
      • Vancouver, Washington, United States, 98684
        • Recruiting
        • Northwest Cancer Specialists (Compass Oncology) ( Site 8000)
        • Contact:
          • Study Coordinator
          • Phone Number: 360-944-9889
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Recruiting
        • SSM Health Dean Medical Group ( Site 0106)
        • Contact:
          • Study Coordinator
          • Phone Number: 608-252-8000
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin ( Site 0103)
        • Contact:
          • Study Coordinator
          • Phone Number: 414-805-6700

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zilovertamab vedotin + Rituximab + Cyclophosphamide, Doxorubicin, Prednisone (R-CHP)
Participants 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).
Biological: Zilovertamab vedotin
IV infusion
Other Names:
  • MK-2140
  • VLS-101
Biological: Rituximab
IV infusion
Other Names:
  • RITUXAN®
Drug: Cyclophosphamide
IV infusion
Other Names:
  • CYTOXAN®
  • NEOSAR®
Drug: Doxorubicin
IV infusion
Other Names:
  • ADRIAMYCIN®
Biological: Rituximab Biosimilar
IV infusion
Other Names:
  • TRUXIMA®
  • RUXIENCE®
  • RIABNI®
Drug: Prednisone
Oral administration or IV infusion
Drug: Prednisolone
Oral administration or IV infusion
Drug: Rescue Medication
Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF).
Active Comparator: Polatuzumab vedotin + R-CHP
Participants 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).
Biological: Rituximab
IV infusion
Other Names:
  • RITUXAN®
Drug: Cyclophosphamide
IV infusion
Other Names:
  • CYTOXAN®
  • NEOSAR®
Drug: Doxorubicin
IV infusion
Other Names:
  • ADRIAMYCIN®
Biological: Rituximab Biosimilar
IV infusion
Other Names:
  • TRUXIMA®
  • RUXIENCE®
  • RIABNI®
Drug: Prednisone
Oral administration or IV infusion
Drug: Prednisolone
Oral administration or IV infusion
Biological: Polatuzumab vedotin
IV infusion
Drug: Rescue Medication
Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response Rate (CRR) at End of Treatment (EOT) per Lugano Response Criteria
Time Frame: Up to approximately 31 months
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.
Up to approximately 31 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS) per Lugano Response Criteria
Time Frame: Up to approximately 51 months
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.
Up to approximately 51 months
Overall Survival (OS)
Time Frame: Up to approximately 87 months
OS is defined as the time from randomization to death due to any cause.
Up to approximately 87 months
Event-free Survival (EFS) per Lugano Response Criteria
Time Frame: Up to approximately 51 months
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.
Up to approximately 51 months
Duration of CR
Time Frame: Up to approximately 51 months
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.
Up to approximately 51 months
Number of participants who experience one or more adverse events (AEs)
Time Frame: Up to approximately 9 months
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.
Up to approximately 9 months
Number of participants who discontinue study intervention due to an AE
Time Frame: Up to approximately 6 months
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.
Up to approximately 6 months
Change From Baseline in Health-Related Quality Of Life (HRQoL) on Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Trial Outcome Index (TOI)
Time Frame: Baseline and up to Week 25
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.
Baseline and up to Week 25
Change From Baseline in HRQoL on FACT-Lym Total Score
Time Frame: Baseline and up to Week 25
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.
Baseline and up to Week 25
Change From Baseline in HRQoL on FACT-Lym Physical Well-being (PWB) (Items General Physical [GP]1 through GP7)
Time Frame: Baseline and up to Week 25
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.
Baseline and up to Week 25
Change From Baseline in HRQoL on Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Neurotoxicity Subscale Score
Time Frame: Baseline and up to Week 25
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.
Baseline and up to Week 25

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2025

Primary Completion (Estimated)

December 13, 2027

Study Completion (Estimated)

December 16, 2032

Study Registration Dates

First Submitted

March 20, 2025

First Submitted That Met QC Criteria

March 20, 2025

First Posted (Actual)

March 24, 2025

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2140-011
  • U1111-1309-2852 (Registry Identifier: UTN)
  • MK-2140-011 (Other Identifier: MSD)
  • waveLINE-011 (Other Identifier: MSD)
  • 2024-515526-89-00 (Registry Identifier: EU CT)
  • jRCT2021250001 (Registry Identifier: Japan Registry of Clinical Trials (jRCT))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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