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RECRUITING Phase 2 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT06890884

Registry updated: 2026-10-08
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Description

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.

Interventions

  • Zilovertamab vedotin (Biological)
    IV infusion
  • Rituximab (Biological)
    IV infusion
  • Cyclophosphamide (Drug)
    IV infusion
  • Doxorubicin (Drug)
    IV infusion
  • Rituximab Biosimilar (Biological)
    IV infusion
  • Prednisone (Drug)
    Oral administration or IV infusion
  • Prednisolone (Drug)
    Oral administration or IV infusion
  • Polatuzumab vedotin (Biological)
    IV infusion
  • Rescue Medication (Drug)
    Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF).

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.

Conditions

Lymphoma, Large B-Cell, Diffuse

Locations

  • Infirmary Cancer Care ( Site 0157) — Mobile, Alabama, United States
  • Ironwood Cancer & Research Centers ( Site 0204) — Chandler, Arizona, United States
  • Palo Verde Cancer Specialists ( Site 0105) — Glendale, Arizona, United States
  • City of Hope - Phoenix ( Site 0202) — Goodyear, 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
  • City of Hope Comprehensive Cancer Center ( Site 0191) — Duarte, 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 Braman Comprehensive 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
  • Beth Israel Deaconess Medical Center ( Site 0161) — Boston, Massachusetts, United States
  • Dana Farber Cancer Institute ( Site 0111) — Boston, Massachusetts, 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
  • Optum Medical Care, PC ( 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
  • Abramson Cancer Center and Perelman Center for Advanced Medicine ( Site 0131) — Philadelphia, Pennsylvania, United States
  • Temple University Hospital ( Site 0133) — Philadelphia, Pennsylvania, United States
  • Alliance Cancer Specialists (ACS) ( Site 8010) — Sellersville, Pennsylvania, United States
  • Cancer Care Associates Of York ( Site 0174) — York, Pennsylvania, United States
  • Medical University of South Carolina ( Site 0153) — Charleston, South Carolina, 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
  • UT Southwestern Medical Center ( Site 0190) — Dallas, 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
  • VITAZ ( Site 0307) — Sint-Niklaas, Oost-Vlaanderen, Belgium
  • UZ Leuven ( Site 0301) — Leuven, Vlaams-Brabant, Belgium
  • AZ Sint Jan Brugge-Oostende ( Site 0308) — Bruges, West-Vlaanderen, Belgium
  • AZ Delta ( Site 0303) — Roeselare, West-Vlaanderen, Belgium
  • Klinikum Stuttgart. Klinik fur Hamatologie. Onkologie. Palliativmedizin und Stammzelltransplantation ( Site 0419) — Stuttgart, Baden-Wurttemberg, Germany
  • UniversitaetsklInikum Tuebingen ( Site 0410) — Tübingen, Baden-Wurttemberg, Germany
  • Universitaetsklinikum Ulm. ( Site 0404) — Ulm, Baden-Wurttemberg, Germany
  • Uniklinik Erlangen ( Site 0412) — Erlangen, Bavaria, Germany
  • LMU Klinikum ( Site 0428) — Munich, Bavaria, Germany
  • Universitaetsklinikum Wuerzburg ( Site 0401) — Würzburg, Bavaria, Germany
  • Centrum für Hämatologie und Onkologie Bethanien ( Site 0417) — Frankfurt am Main, Hesse, Germany
  • Klinikum Kassel GmbH ( Site 0434) — Kassel, Hesse, Germany
  • KRH Klinikum Siloah ( Site 0441) — Hanover, Lower Saxony, Germany
  • Dietrich Bonhoeffer Klinikum-Neubrandenburg ( Site 0439) — Neubrandenburg, Mecklenburg-Vorpommern, Germany
  • Universitätsklinikum Aachen ( Site 0418) — Aachen, North Rhine-Westphalia, Germany
  • Johanniter Krankenhaus Bonn ( Site 0440) — Bonn, North Rhine-Westphalia, Germany
  • HELIOS Klinikum Wuppertal ( Site 0435) — Wuppertal, North Rhine-Westphalia, Germany
  • Gemeinschaftsklinikum Mittelrhein gGmbH Innere Medizin - Hamatologie/Onkologie.Palliativmedizin ( Site 0413) — Koblenz, Rhineland-Palatinate, Germany
  • Klinikum Chemnitz gGmbH ( Site 0405) — Chemnitz, Saxony, Germany
  • Otto-Von-Guericke-Universitaet Magdeburg ( Site 0411) — Magdeburg, Saxony-Anhalt, Germany
  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck ( Site 0425) — Lübeck, Schleswig-Holstein, Germany
  • Universitätsklinikum Jena ( Site 0438) — Jena, Thuringia, Germany
  • St Vincent's University Hospital ( Site 0502) — Dublin, Dublin, Ireland
  • Mater Misercordiae University Hospital ( Site 0501) — Dublin, Ireland
  • St. James's Hospital ( Site 0505) — Dublin, Ireland
  • Beaumont Hospital ( Site 0506) — Dublin, Ireland
  • University Hospital Limerick ( Site 0503) — Limerick, Ireland
  • University Hospital Waterford ( Site 0504) — Waterford, 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
  • Sourasky Medical Center ( Site 0608) — Tel Aviv, 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
  • Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO ( Site 0702) — Palermo, Sicily, 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
  • 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
  • AIDPORT Sp. z o.o. ( Site 0808) — Skórzewo, Greater Poland Voivodeship, Poland
  • Pratia MCM Krakow ( Site 0804) — Krakow, 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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