RecruitingRecruiting
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)
NCT06890884 · Merck Sharp & Dohme LLC
In plain English
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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)
About this study
Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing.
The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.
Eligibility criteria
Inclusion 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 design
Enrollment target: 594 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-04-11
Estimated completion: 2032-12-16
Last updated: 2026-07-17
Interventions
Biological: Zilovertamab vedotinBiological: RituximabDrug: CyclophosphamideDrug: DoxorubicinBiological: Rituximab BiosimilarDrug: PrednisoneDrug: PrednisoloneBiological: Polatuzumab vedotinDrug: Rescue Medication
Primary outcomes
- • Complete Response Rate (CRR) at End of Treatment (EOT) per Lugano Response Criteria (Up to approximately 31 months)
Sponsor
Merck Sharp & Dohme LLC · industry
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (138)
Infirmary Cancer Care ( Site 0157)Recruiting
Mobile, Alabama, United States
Ironwood Cancer & Research Centers ( Site 0204)Recruiting
Chandler, Arizona, United States
Palo Verde Cancer Specialists ( Site 0105)Recruiting
Glendale, Arizona, United States
City of Hope - Phoenix ( Site 0202)Recruiting
Goodyear, Arizona, United States
Genesis Cancer and Blood Institute ( Site 0193)Recruiting
Hot Springs, Arkansas, United States
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0135)Recruiting
Burbank, California, United States
City of Hope Comprehensive Cancer Center ( Site 0191)Recruiting
Duarte, California, United States
Bass Medical Group ( Site 0123)Recruiting
Walnut Creek, California, United States
Rocky Mountain Cancer Centers (RMCC) ( Site 8001)Recruiting
Aurora, Colorado, United States
Colorado West Healthcare System-Grand Valley Oncology ( Site 0165)Recruiting
Grand Junction, Colorado, United States
Medical Oncology Hematology Consultants (MOHC) ( Site 8007)Recruiting
Newark, Delaware, United States
Georgetown University Medical Center ( Site 0117)Recruiting
Washington D.C., District of Columbia, United States
Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0130)Recruiting
Boca Raton, Florida, United States
Baptist MD Anderson Cancer Center ( Site 0176)Recruiting
Jacksonville, Florida, United States
Mount Sinai Braman Comprehensive Cancer Center ( Site 0140)Recruiting
Miami Beach, Florida, United States
Mid Florida Hematology and Oncology Center ( Site 0152)Recruiting
Orange City, Florida, United States
Beacon Cancer Care ( Site 0142)Recruiting
Post Falls, Idaho, United States
University of Chicago Medical Center ( Site 0126)Recruiting
Chicago, Illinois, United States
Illinois Cancer Care ( Site 7005)Recruiting
Peoria, Illinois, United States
University of Iowa-Holden Comprehensive Cancer Center ( Site 0139)Recruiting
Iowa City, Iowa, United States
Mission Blood & Cancer Care ( Site 0114)Recruiting
Waukee, Iowa, United States
Saint Elizabeth Medical Center Edgewood ( Site 0141)Recruiting
Edgewood, Kentucky, United States
Baptist Health Hardin ( Site 0154)Recruiting
Elizabethtown, Kentucky, United States
Baptist Health Lexington ( Site 0127)Recruiting
Lexington, Kentucky, United States
Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0185)Recruiting
Louisville, Kentucky, United States
Our Lady of the Lake Physician Group-Medical Oncology ( Site 0180)Recruiting
Baton Rouge, Louisiana, United States
Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic ( Site 0209)Recruiting
Monroe, Louisiana, United States
Ochsner Clinic Foundation ( Site 0189)Recruiting
New Orleans, Louisiana, United States
Louisiana State University Health Sciences Shreveport ( Site 0195)Recruiting
Shreveport, Louisiana, United States
Beth Israel Deaconess Medical Center ( Site 0161)Recruiting
Boston, Massachusetts, United States
Dana Farber Cancer Institute ( Site 0111)Recruiting
Boston, Massachusetts, United States
Minnesota Oncology Hematology (MNO) ( Site 8004)Recruiting
Burnsville, Minnesota, United States
Bozeman Health Deaconess Hospital ( Site 0183)Recruiting
Bozeman, Montana, United States
NHO Revive Research Institute, LLC ( Site 0121)Recruiting
Lincoln, Nebraska, United States
University Of Nebraska Medical Center ( Site 0110)Recruiting
Omaha, Nebraska, United States
Atlantic Health Morristown Medical Center ( Site 0163)Recruiting
Morristown, New Jersey, United States
Valley Health Systems - Ridgewood Campus ( Site 0125)Recruiting
Paramus, New Jersey, United States
Erie County Medical Center ( Site 0175)Completed
Buffalo, New York, United States
Roswell Park Cancer Institute ( Site 0192)Recruiting
Buffalo, New York, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0208)Recruiting
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0108)Recruiting
New York, New York, United States
SUNY Upstate Cancer Center ( Site 0178)Recruiting
Syracuse, New York, United States
Optum Medical Care, PC ( Site 0122)Recruiting
Westbury, New York, United States
University of North Carolina Medical Center ( Site 0136)Recruiting
Chapel Hill, North Carolina, United States
Novant Health Presbyterian Medical Center ( Site 0177)Recruiting
Charlotte, North Carolina, United States
Novant Health Forsyth Medical Center ( Site 0206)Recruiting
Winston-Salem, North Carolina, United States
University of Cincinnati Medical Center ( Site 0156)Recruiting
Cincinnati, Ohio, United States
University Hospitals of Cleveland ( Site 0155)Recruiting
Cleveland, Ohio, United States
Fairview Hospital-Moll Cancer Center ( Site 0198)Recruiting
Cleveland, Ohio, United States
Cleveland Clinic Main ( Site 0101)Recruiting
Cleveland, Ohio, United States
Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 0199)Recruiting
Mayfield Heights, Ohio, United States
Providence Portland Medical Center ( Site 0120)Recruiting
Portland, Oregon, United States
Providence Oncology and Hematology Clinic Westside ( Site 0179)Recruiting
Portland, Oregon, United States
Abramson Cancer Center and Perelman Center for Advanced Medicine ( Site 0131)Recruiting
Philadelphia, Pennsylvania, United States
Temple University Hospital ( Site 0133)Recruiting
Philadelphia, Pennsylvania, United States
Alliance Cancer Specialists (ACS) ( Site 8010)Recruiting
Sellersville, Pennsylvania, United States
Cancer Care Associates Of York ( Site 0174)Recruiting
York, Pennsylvania, United States
Medical University of South Carolina ( Site 0153)Recruiting
Charleston, South Carolina, United States
Tennessee Cancer Specialists ( Site 7004)Recruiting
Knoxville, Tennessee, United States
SCRI Oncology Partners ( Site 7002)Recruiting
Nashville, Tennessee, United States
Texas Oncology - West Texas ( Site 8008)Recruiting
Amarillo, Texas, United States
Texas Oncology - Central/South Texas ( Site 8006)Recruiting
Austin, Texas, United States
UT Southwestern Medical Center ( Site 0190)Recruiting
Dallas, Texas, United States
Texas Oncology - Northeast Texas ( Site 8002)Recruiting
Palestine, Texas, United States
Texas Oncology - San Antonio ( Site 8009)Recruiting
San Antonio, Texas, United States
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0145)Completed
Tyler, Texas, United States
Intermountain Medical Center ( Site 0182)Recruiting
Murray, Utah, United States
Intermountain Healthcare - St. George ( Site 0203)Recruiting
St. George, Utah, United States
Virginia Cancer Specialists, PC ( Site 8003)Recruiting
Manassas, Virginia, United States
VCU Health Adult Outpatient Pavillion ( Site 0138)Recruiting
Richmond, Virginia, United States
Northwest Cancer Specialists (Compass Oncology) ( Site 8000)Recruiting
Vancouver, Washington, United States
SSM Health Dean Medical Group ( Site 0106)Recruiting
Madison, Wisconsin, United States
Medical College of Wisconsin ( Site 0103)Recruiting
Milwaukee, Wisconsin, United States
AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0306)Recruiting
Mechelen, Antwerpen, Belgium
CHU HELORA asbl ( Site 0304)Recruiting
Mons, Brabant Wallon, Belgium
Cliniques Universitaires Saint-Luc ( Site 0302)Recruiting
Brussels, Bruxelles-Capitale, Region de, Belgium
VITAZ ( Site 0307)Recruiting
Sint-Niklaas, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 0301)Recruiting
Leuven, Vlaams-Brabant, Belgium
AZ Delta ( Site 0303)Recruiting
Roeselare, West-Vlaanderen, Belgium
Klinikum Stuttgart. Klinik fur Hamatologie. Onkologie. Palliativmedizin und Stammzelltransplantation ( Site 0419)Recruiting
Stuttgart, Baden-Wurttemberg, Germany
UniversitaetsklInikum Tuebingen ( Site 0410)Recruiting
Tübingen, Baden-Wurttemberg, Germany
Uniklinik Erlangen ( Site 0412)Recruiting
Erlangen, Bavaria, Germany
LMU Klinikum ( Site 0428)Recruiting
Munich, Bavaria, Germany
Universitaetsklinikum Wuerzburg ( Site 0401)Recruiting
Würzburg, Bavaria, Germany
Centrum für Hämatologie und Onkologie Bethanien ( Site 0417)Recruiting
Frankfurt am Main, Hesse, Germany
KRH Klinikum Siloah ( Site 0441)Recruiting
Hanover, Lower Saxony, Germany
Dietrich Bonhoeffer Klinikum-Neubrandenburg ( Site 0439)Recruiting
Neubrandenburg, Mecklenburg-Vorpommern, Germany
Universitätsklinikum Aachen ( Site 0418)Recruiting
Aachen, North Rhine-Westphalia, Germany
HELIOS Klinikum Wuppertal ( Site 0435)Recruiting
Wuppertal, North Rhine-Westphalia, Germany
Klinikum Chemnitz gGmbH ( Site 0405)Recruiting
Chemnitz, Saxony, Germany
Otto-Von-Guericke-Universitaet Magdeburg ( Site 0411)Recruiting
Magdeburg, Saxony-Anhalt, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck ( Site 0425)Recruiting
Lübeck, Schleswig-Holstein, Germany
Universitätsklinikum Jena ( Site 0438)Recruiting
Jena, Thuringia, Germany
St Vincent's University Hospital ( Site 0502)Recruiting
Dublin, Dublin, Ireland
Mater Misercordiae University Hospital ( Site 0501)Recruiting
Dublin, Ireland
University Hospital Limerick ( Site 0503)Recruiting
Limerick, Ireland
Soroka Medical Center ( Site 0606)Recruiting
Beersheba, Israel
Rambam Health Care Campus ( Site 0604)Recruiting
Haifa, Israel
Edith Wolfson Medical Center ( Site 0602)Recruiting
Holon, Israel
Haddasah Medical Center ( Site 0601)Recruiting
Jerusalem, Israel
Rabin Medical Center ( Site 0607)Recruiting
Petah Tikva, Israel
Sheba Medical Center ( Site 0603)Recruiting
Ramat Gan, Israel
ZIV Medical Center ( Site 0605)Recruiting
Safed, Israel
Sourasky Medical Center ( Site 0608)Recruiting
Tel Aviv, Israel
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0707)Recruiting
Meldola, Forli-Cesena, Italy
Istituto Clinico Humanitas ( Site 0704)Recruiting
Rozzano, Milano, Italy
Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 0703)Recruiting
Alessandria, Italy
Istituto Europeo di Oncologia ( Site 0701)Recruiting
Milan, Italy
Universita degli Studi di Napoli Federico II ( Site 0705)Recruiting
Naples, Italy
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO ( Site 0702)Recruiting
Palermo, Italy
Arcispedale Santa Maria Nuova ( Site 0706)Recruiting
Reggio Emilia, Italy
Aichi Cancer Center ( Site 1007)Recruiting
Nagoya, Aichi-ken, Japan
Fujita Health University Hospital ( Site 1003)Recruiting
Toyoake, Aichi-ken, Japan
Hokkaido University Hospital ( Site 1004)Recruiting
Sapporo, Hokkaido, Japan
National Hospital Organization Sendai Medical Center ( Site 1005)Recruiting
Sendai, Miyagi, Japan
Kansai Medical University Hospital ( Site 1006)Recruiting
Hirakata, Osaka, Japan
Shimane University Hospital ( Site 1002)Recruiting
Izumo, Shimane, Japan
Nippon Medical School Hospital ( Site 1001)Recruiting
Bunkyo, Tokyo, Japan
National Cancer Center Hospital ( Site 1009)Recruiting
Chūō, Tokyo, Japan
Nagasaki University Hospital ( Site 1008)Recruiting
Nagasaki, Japan
Pratia MCM Krakow ( Site 0804)Recruiting
Krakow, Lesser Poland Voivodeship, Poland
Szpital Specjalistyczny im. Jedrzeja Sniadeckiego w Nowym Saczu ( Site 0806)Recruiting
Nowy Sącz, Lesser Poland Voivodeship, Poland
Specjalistyczny Szpital im. Dr Alfreda Sokolowskiego w Walbrzychu ( Site 0807)Recruiting
Wałbrzych, Lower Silesian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0803)Recruiting
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne ( Site 0802)Recruiting
Gdansk, Pomeranian Voivodeship, Poland
Pratia Onkologia Katowice ( Site 0801)Recruiting
Katowice, Silesian Voivodeship, Poland
Bristol Haematology and Oncology Centre ( Site 0908)Recruiting
Bristol, Bristol, City of, United Kingdom
Stoke Mandeville Hospital ( Site 0917)Recruiting
Aylesbury, Buckinghamshire, United Kingdom
Royal Devon & Exeter Hospital ( Site 0910)Recruiting
Exeter, Devon, United Kingdom
University Hospitals Plymouth NHS Trust ( Site 0905)Recruiting
Plymouth, Devon, United Kingdom
The James Cook University Hospital ( Site 0909)Recruiting
Middlesbrough, England, United Kingdom
Lincoln County Hospital ( Site 0906)Recruiting
Lincoln, Lincolnshire, United Kingdom
Guy s & St Thomas NHS Foundation Trust ( Site 0904)Recruiting
London, London, City of, United Kingdom
Hammersmith Hospital ( Site 0915)Recruiting
London, London, City of, United Kingdom
Churchill Hospital ( Site 0903)Recruiting
Oxford, Oxfordshire, United Kingdom
Queen Elizabeth Hospital Birmingham ( Site 0912)Recruiting
Birmingham, United Kingdom
Clatterbridge Cancer Centre - Liverpool ( Site 0911)Recruiting
Liverpool, United Kingdom
Christie Hospital NHS Trust ( Site 0901)Recruiting
Manchester, United Kingdom