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A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010)

NCT06717347

RecruitingPhase 3

Sponsor: Merck Sharp & Dohme LLC

Conditions: Diffuse Large B-Cell Lymphoma

Interventions: Zilovertamab vedotin, Rituximab, Cyclophosphamide, Doxorubicin, Rituximab Biosimilar

Countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China

The purpose of this study is to evaluate if zilovertamab vedotin with standard treatment can help people live longer without the cancer growing or spreading than people who receive standard treatment alone.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, based on local testing according to the 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
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization
* Has an ejection fraction ≥45% as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA)
* Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)
* 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:

* 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
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
* 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 concurrent active HBV (defined as HBsAg positive and detectable HBV DNA) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection
* Has history of allogeneic tissue/solid organ transplant

Locations (268)

Mobile, Alabama, United States
Gilbert, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Fullerton, California, United States
Long Beach, California, United States
Los Alamitos, California, United States
Los Angeles, California, United States
San Francisco, California, United States
Golden, Colorado, United States
Clermont, Florida, United States
Hialeah, Florida, United States
Ocoee, Florida, United States
Orange City, Florida, United States
O'Fallon, Illinois, United States
Fort Wayne, Indiana, United States
Topeka, Kansas, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Owensboro, Kentucky, United States
Alexandria, Louisiana, United States
Bethesda, Maryland, United States
Detroit, Michigan, United States
Grand Rapids, Michigan, United States
Jackson, Mississippi, United States
Bridgeton, Missouri, United States
Kansas City, Missouri, United States
Billings, Montana, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
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