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)
Status: Recruiting
Location: See all (52) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ 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.
Locations
United States
Alabama
Infirmary Cancer Care ( Site 0157)
RECRUITING
Mobile
Arkansas
Genesis Cancer and Blood Institute ( Site 0193)
RECRUITING
Hot Springs
Arizona
Palo Verde Cancer Specialists ( Site 0105)
RECRUITING
Glendale
California
Bass Medical Group ( Site 0123)
RECRUITING
Walnut Creek
Florida
Mount Sinai Cancer Center ( Site 0140)
RECRUITING
Miami Beach
Mid Florida Hematology and Oncology Center ( Site 0152)
RECRUITING
Orange City
Iowa
University of Iowa-Holden Comprehensive Cancer Center ( Site 0139)
RECRUITING
Iowa City
Mission Blood & Cancer Care ( Site 0114)
RECRUITING
Waukee
Illinois
University of Chicago Medical Center ( Site 0126)
RECRUITING
Chicago
Kentucky
Saint Elizabeth Medical Center Edgewood ( Site 0141)
RECRUITING
Edgewood
Baptist Health Hardin ( Site 0154)
RECRUITING
Elizabethtown
Baptist Health Lexington ( Site 0127)
RECRUITING
Lexington
North Carolina
University of North Carolina Medical Center ( Site 0136)
RECRUITING
Chapel Hill
Nebraska
NHO Revive Research Institute, LLC ( Site 0121)
RECRUITING
Lincoln
University Of Nebraska Medical Center ( Site 0110)
RECRUITING
Omaha
New York
Erie County Medical Center ( Site 0175)
RECRUITING
Buffalo
Clinical Research Alliance ( Site 0122)
RECRUITING
Westbury
Texas
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0145)
RECRUITING
Tyler
Wisconsin
SSM Health Dean Medical Group ( Site 0106)
RECRUITING
Madison
Other Locations
Belgium
Cliniques Universitaires Saint-Luc ( Site 0302)
RECRUITING
Brussels
Hopital de Jolimont ( Site 0304)
RECRUITING
Haine-saint-paul
UZ Leuven ( Site 0301)
RECRUITING
Leuven
AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0306)
RECRUITING
Mechelen
Germany
Universitaetsklinikum Wuerzburg ( Site 0401)
RECRUITING
Würzburg
Israel
Rambam Health Care Campus ( Site 0604)
RECRUITING
Haifa
Edith Wolfson Medical Center ( Site 0602)
RECRUITING
Holon
Haddasah Medical Center ( Site 0601)
RECRUITING
Jerusalem
Sheba Medical Center ( Site 0603)
RECRUITING
Ramat Gan
ZIV Medical Center ( Site 0605)
RECRUITING
Safed
Italy
Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 0703)
RECRUITING
Alessandria
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori ( Site 0707)
RECRUITING
Meldola
Istituto Europeo di Oncologia ( Site 0701)
RECRUITING
Milan
Universita degli Studi di Napoli Federico II ( Site 0705)
RECRUITING
Napoli
Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO ( Site 0702)
RECRUITING
Palermo
Arcispedale Santa Maria Nuova ( Site 0706)
RECRUITING
Reggio Emilia
Istituto Clinico Humanitas ( Site 0704)
RECRUITING
Rozzano
Japan
Nippon Medical School Hospital ( Site 1001)
RECRUITING
Bunkyo
National Cancer Center Hospital ( Site 1009)
RECRUITING
Chūō
Kansai Medical University Hospital ( Site 1006)
RECRUITING
Hirakata
Shimane University Hospital ( Site 1002)
RECRUITING
Izumo
Nagasaki University Hospital ( Site 1008)
RECRUITING
Nagasaki
Aichi Cancer Center ( Site 1007)
RECRUITING
Nagoya
Hokkaido University Hospital ( Site 1004)
RECRUITING
Sapporo
National Hospital Organization Sendai Medical Center ( Site 1005)
RECRUITING
Sendai
Fujita Health University Hospital ( Site 1003)
RECRUITING
Toyoake
Poland
Pratia MCM Krakow ( Site 0804)
RECRUITING
Karkow
Pratia Onkologia Katowice ( Site 0801)
RECRUITING
Katowice
Szpital Specjalistyczny im. Jedrzeja Sniadeckiego w Nowym Saczu ( Site 0806)
RECRUITING
Nowy Sącz
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0803)
RECRUITING
Warsaw
United Kingdom
Stoke Mandeville Hospital ( Site 0917)
RECRUITING
Aylesbury
Bristol Haematology and Oncology Centre ( Site 0908)
RECRUITING
Bristol
University Hospitals Plymouth NHS Trust ( Site 0905)
RECRUITING
Plymouth
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2025-04-11
Estimated Completion Date: 2032-12-16
Participants
Target number of participants: 594
Treatments
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).
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).
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC