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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)
Sponsor: Merck Sharp & Dohme LLC
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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
594
Start Date
2025-04-11
Completion Date
2032-12-16
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
Zilovertamab vedotin
IV infusion
Rituximab
IV infusion
Cyclophosphamide
IV infusion
Doxorubicin
IV infusion
Rituximab Biosimilar
IV infusion
Prednisone
Oral administration or IV infusion
Prednisolone
Oral administration or IV infusion
Polatuzumab vedotin
IV infusion
Rescue Medication
Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF).
Locations (117)
Infirmary Cancer Care ( Site 0157)
Mobile, Alabama, United States
Palo Verde Cancer Specialists ( Site 0105)
Glendale, Arizona, United States
Genesis Cancer and Blood Institute ( Site 0193)
Hot Springs, Arkansas, United States
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0135)
Burbank, California, United States
Bass Medical Group ( Site 0123)
Walnut Creek, California, United States
Rocky Mountain Cancer Centers (RMCC) ( Site 8001)
Aurora, Colorado, United States
Colorado West Healthcare System-Grand Valley Oncology ( Site 0165)
Grand Junction, Colorado, United States
Medical Oncology Hematology Consultants (MOHC) ( Site 8007)
Newark, Delaware, United States
Georgetown University Medical Center ( Site 0117)
Washington D.C., District of Columbia, United States
Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0130)
Boca Raton, Florida, United States
Baptist MD Anderson Cancer Center ( Site 0176)
Jacksonville, Florida, United States
Mount Sinai Cancer Center ( Site 0140)
Miami Beach, Florida, United States
Mid Florida Hematology and Oncology Center ( Site 0152)
Orange City, Florida, United States
Beacon Cancer Care ( Site 0142)
Post Falls, Idaho, United States
University of Chicago Medical Center ( Site 0126)
Chicago, Illinois, United States
Illinois Cancer Care ( Site 7005)
Peoria, Illinois, United States
University of Iowa-Holden Comprehensive Cancer Center ( Site 0139)
Iowa City, Iowa, United States
Mission Blood & Cancer Care ( Site 0114)
Waukee, Iowa, United States
Saint Elizabeth Medical Center Edgewood ( Site 0141)
Edgewood, Kentucky, United States
Baptist Health Hardin ( Site 0154)
Elizabethtown, Kentucky, United States
Baptist Health Lexington ( Site 0127)
Lexington, Kentucky, United States
Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0185)
Louisville, Kentucky, United States
Our Lady of the Lake Physician Group-Medical Oncology ( Site 0180)
Baton Rouge, Louisiana, United States
Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic ( Site 0209)
Monroe, Louisiana, United States
Ochsner Clinic Foundation ( Site 0189)
New Orleans, Louisiana, United States
Louisiana State University Health Sciences Shreveport ( Site 0195)
Shreveport, Louisiana, United States
Minnesota Oncology Hematology (MNO) ( Site 8004)
Burnsville, Minnesota, United States
Bozeman Health Deaconess Hospital ( Site 0183)
Bozeman, Montana, United States
NHO Revive Research Institute, LLC ( Site 0121)
Lincoln, Nebraska, United States
University Of Nebraska Medical Center ( Site 0110)
Omaha, Nebraska, United States
Atlantic Health Morristown Medical Center ( Site 0163)
Morristown, New Jersey, United States
Valley Health Systems - Ridgewood Campus ( Site 0125)
Paramus, New Jersey, United States
Erie County Medical Center ( Site 0175)
Buffalo, New York, United States
Roswell Park Cancer Institute ( Site 0192)
Buffalo, New York, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0208)
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0108)
New York, New York, United States
SUNY Upstate Cancer Center ( Site 0178)
Syracuse, New York, United States
Clinical Research Alliance ( Site 0122)
Westbury, New York, United States
University of North Carolina Medical Center ( Site 0136)
Chapel Hill, North Carolina, United States
Novant Health Presbyterian Medical Center ( Site 0177)
Charlotte, North Carolina, United States
Novant Health Forsyth Medical Center ( Site 0206)
Winston-Salem, North Carolina, United States
University of Cincinnati Medical Center ( Site 0156)
Cincinnati, Ohio, United States
University Hospitals of Cleveland ( Site 0155)
Cleveland, Ohio, United States
Fairview Hospital-Moll Cancer Center ( Site 0198)
Cleveland, Ohio, United States
Cleveland Clinic Main ( Site 0101)
Cleveland, Ohio, United States
Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 0199)
Mayfield Heights, Ohio, United States
Providence Portland Medical Center ( Site 0120)
Portland, Oregon, United States
Providence Oncology and Hematology Clinic Westside ( Site 0179)
Portland, Oregon, United States
Alliance Cancer Specialists (ACS) ( Site 8010)
Horsham, Pennsylvania, United States
Cancer Care Associates Of York ( Site 0174)
York, Pennsylvania, United States
Tennessee Cancer Specialists ( Site 7004)
Knoxville, Tennessee, United States
SCRI Oncology Partners ( Site 7002)
Nashville, Tennessee, United States
Texas Oncology - West Texas ( Site 8008)
Amarillo, Texas, United States
Texas Oncology - Central/South Texas ( Site 8006)
Austin, Texas, United States
Texas Oncology - Northeast Texas ( Site 8002)
Palestine, Texas, United States
Texas Oncology - San Antonio ( Site 8009)
San Antonio, Texas, United States
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0145)
Tyler, Texas, United States
Intermountain Medical Center ( Site 0182)
Murray, Utah, United States
Intermountain Healthcare - St. George ( Site 0203)
St. George, Utah, United States
Virginia Cancer Specialists, PC ( Site 8003)
Manassas, Virginia, United States
VCU Health Adult Outpatient Pavillion ( Site 0138)
Richmond, Virginia, United States
Northwest Cancer Specialists (Compass Oncology) ( Site 8000)
Vancouver, Washington, United States
SSM Health Dean Medical Group ( Site 0106)
Madison, Wisconsin, United States
Medical College of Wisconsin ( Site 0103)
Milwaukee, Wisconsin, United States
AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0306)
Mechelen, Antwerpen, Belgium
Cliniques Universitaires Saint-Luc ( Site 0302)
Brussels, Bruxelles-Capitale, Region de, Belgium
Hopital de Jolimont ( Site 0304)
Haine-Saint-Paul, Hainaut, Belgium
UZ Leuven ( Site 0301)
Leuven, Vlaams-Brabant, Belgium
AZ Delta ( Site 0303)
Roeselare, West-Vlaanderen, Belgium
Uniklinik Erlangen ( Site 0412)
Erlangen, Bavaria, Germany
Universitaetsklinikum Wuerzburg ( Site 0401)
Würzburg, Bavaria, Germany
HELIOS Klinikum Wuppertal ( Site 0435)
Wuppertal, North Rhine-Westphalia, Germany
Otto-Von-Guericke-Universitaet Magdeburg ( Site 0411)
Magdeburg, Saxony-Anhalt, Germany
St Vincent's University Hospital ( Site 0502)
Dublin, Dublin, Ireland
Mater Misercordiae University Hospital ( Site 0501)
Dublin, Ireland
University Hospital Limerick ( Site 0503)
Limerick, Ireland
Soroka Medical Center ( Site 0606)
Beersheba, Israel
Rambam Health Care Campus ( Site 0604)
Haifa, Israel
Edith Wolfson Medical Center ( Site 0602)
Holon, Israel
Haddasah Medical Center ( Site 0601)
Jerusalem, Israel
Rabin Medical Center ( Site 0607)
Petah Tikva, Israel
Sheba Medical Center ( Site 0603)
Ramat Gan, Israel
ZIV Medical Center ( Site 0605)
Safed, Israel
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0707)
Meldola, Forli-Cesena, Italy
Istituto Clinico Humanitas ( Site 0704)
Rozzano, Milano, Italy
Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 0703)
Alessandria, Italy
Istituto Europeo di Oncologia ( Site 0701)
Milan, Italy
Universita degli Studi di Napoli Federico II ( Site 0705)
Naples, Italy
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO ( Site 0702)
Palermo, Italy
Arcispedale Santa Maria Nuova ( Site 0706)
Reggio Emilia, Italy
Aichi Cancer Center ( Site 1007)
Nagoya, Aichi-ken, Japan
Fujita Health University Hospital ( Site 1003)
Toyoake, Aichi-ken, Japan
Hokkaido University Hospital ( Site 1004)
Sapporo, Hokkaido, Japan
National Hospital Organization Sendai Medical Center ( Site 1005)
Sendai, Miyagi, Japan
Kansai Medical University Hospital ( Site 1006)
Hirakata, Osaka, Japan
Shimane University Hospital ( Site 1002)
Izumo, Shimane, Japan
Nippon Medical School Hospital ( Site 1001)
Bunkyo, Tokyo, Japan
National Cancer Center Hospital ( Site 1009)
Chūō, Tokyo, Japan
Nagasaki University Hospital ( Site 1008)
Nagasaki, Japan
Pratia MCM Krakow ( Site 0804)
Karkow, Lesser Poland Voivodeship, Poland
Szpital Specjalistyczny im. Jedrzeja Sniadeckiego w Nowym Saczu ( Site 0806)
Nowy Sącz, Lesser Poland Voivodeship, Poland
Specjalistyczny Szpital im. Dr Alfreda Sokolowskiego w Walbrzychu ( Site 0807)
Wałbrzych, Lower Silesian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0803)
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne ( Site 0802)
Gdansk, Pomeranian Voivodeship, Poland
Pratia Onkologia Katowice ( Site 0801)
Katowice, Silesian Voivodeship, Poland
Bristol Haematology and Oncology Centre ( Site 0908)
Bristol, Bristol, City of, United Kingdom
Stoke Mandeville Hospital ( Site 0917)
Aylesbury, Buckinghamshire, United Kingdom
Royal Devon & Exeter Hospital ( Site 0910)
Exeter, Devon, United Kingdom
University Hospitals Plymouth NHS Trust ( Site 0905)
Plymouth, Devon, United Kingdom
The James Cook University Hospital ( Site 0909)
Middlesbrough, England, United Kingdom
Lincoln County Hospital ( Site 0906)
Lincoln, Lincolnshire, United Kingdom
Guy s & St Thomas NHS Foundation Trust ( Site 0904)
London, London, City of, United Kingdom
Hammersmith Hospital ( Site 0915)
London, London, City of, United Kingdom
Churchill Hospital ( Site 0903)
Oxford, Oxfordshire, United Kingdom
Queen Elizabeth Hospital Birmingham ( Site 0912)
Birmingham, United Kingdom
Clatterbridge Cancer Centre - Liverpool ( Site 0911)
Liverpool, United Kingdom
Christie Hospital NHS Trust ( Site 0901)
Manchester, United Kingdom