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)

Recruiting now · Phase 3

Conditions studied: Diffuse Large B-Cell Lymphoma

In brief

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.

Key facts

Study ID: NCT06717347
Run by: Merck Sharp & Dohme LLC
People needed: 1046
Starts: 2025-01-27
Expected to finish: 2032-03-29
Last updated by the study team: 2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Banner MD Anderson Cancer Center ( Site 0165) — Gilbert, Arizona, United States (enrolling)
Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0167) — Phoenix, Arizona, United States (enrolling)
The University of Arizona Cancer Center - North Campus ( Site 0124) — Tucson, Arizona, United States (enrolling)
Providence Medical Foundation-Oncology ( Site 0168) — Fullerton, California, United States (enrolling)
MemorialCare Health System - Long Beach Medical Center ( Site 9559) — Long Beach, California, United States (enrolling)
Cancer Blood and Specialty Clinic ( Site 0109) — Los Alamitos, California, United States (enrolling)
Cedars-Sinai Medical Center ( Site 0115) — Los Angeles, California, United States (enrolling)
Pacific Hematology Oncology Associates ( Site 0131) — San Francisco, California, United States (enrolling)
Lutheran Hospital - Cancer Centers of Colorado ( Site 0180) — Golden, Colorado, United States (enrolling)
Clermont Oncology Center ( Site 0182) — Clermont, Florida, United States (enrolling)
Bioresearch Partner ( Site 0157) — Hialeah, Florida, United States (enrolling)
Orlando Health Cancer Institute ( Site 0169) — Ocoee, Florida, United States (enrolling)
Mid Florida Hematology and Oncology Center ( Site 0172) — Orange City, Florida, United States (enrolling)
Cancer Care Specialists of Illinois ( Site 0152) — O'Fallon, Illinois, United States (enrolling)
Fort Wayne Medical Oncology and Hematology ( Site 0149) — Fort Wayne, Indiana, United States (enrolling)
Cotton O'Neil Cancer Center ( Site 0108) — Topeka, Kansas, United States (enrolling)
University of Kentucky ( Site 0106) — Lexington, Kentucky, United States (enrolling)
Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0163) — Louisville, Kentucky, United States (enrolling)
Owensboro Medical Health System ( Site 0195) — Owensboro, Kentucky, United States (enrolling)
CHRISTUS St. Frances Cabrini Hospital Center for Cancer Care ( Site 0184) — Alexandria, Louisiana, United States (enrolling)
American Oncology Partners, P.A. ( Site 0185) — Bethesda, Maryland, United States (enrolling)
Karmanos Cancer Institute ( Site 0174) — Detroit, Michigan, United States (enrolling)
Corewell Health ( Site 0130) — Grand Rapids, Michigan, United States (enrolling)
The University of Mississippi Medical Center ( Site 0161) — Jackson, Mississippi, United States (enrolling)
USA Mitchell Cancer Institute ( Site 0173) — Mobile, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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