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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)

RecruitingPhase 3

A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010)

Who can join

Ages 18 and older · All sexes

Full 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

About the study

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.

What is being tested

Sponsor: Merck Sharp & Dohme LLC · Participants: 1,046 · Started: Jan 27, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06717347

Locations in the U.S.

AlabamaUSA Mitchell Cancer Institute ( Site 0173), Mobile
ArizonaBanner MD Anderson Cancer Center ( Site 0165), Gilbert
Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0167), Phoenix
The University of Arizona Cancer Center - North Campus ( Site 0124), Tucson
CaliforniaProvidence Medical Foundation-Oncology ( Site 0168), Fullerton
MemorialCare Health System - Long Beach Medical Center ( Site 9559), Long Beach
Cancer Blood and Specialty Clinic ( Site 0109), Los Alamitos
Cedars-Sinai Medical Center ( Site 0115), Los Angeles
Pacific Hematology Oncology Associates ( Site 0131), San Francisco
ColoradoLutheran Hospital - Cancer Centers of Colorado ( Site 0180), Golden
FloridaClermont Oncology Center ( Site 0182), Clermont
Bioresearch Partner ( Site 0157), Hialeah
Orlando Health Cancer Institute ( Site 0169), Ocoee
Mid Florida Hematology and Oncology Center ( Site 0172), Orange City
GeorgiaUniversity Cancer & Blood Center, LLC ( Site 0141), Athens
IllinoisEdward Cancer Center ( Site 0197), Naperville
Cancer Care Specialists of Illinois ( Site 0152), O'Fallon
IndianaFort Wayne Medical Oncology and Hematology ( Site 0149), Fort Wayne
KansasCotton O'Neil Cancer Center ( Site 0108), Topeka
KentuckyUniversity of Kentucky ( Site 0106), Lexington
Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0163), Louisville
Owensboro Medical Health System ( Site 0195), Owensboro
LouisianaCHRISTUS St. Frances Cabrini Hospital Center for Cancer Care ( Site 0184), Alexandria
MarylandAmerican Oncology Partners, P.A. ( Site 0185), Bethesda
MichiganTrinity Health Saint Joseph Mercy Hospital Ann Arbor ( Site 9545), Ann Arbor
Karmanos Cancer Institute ( Site 0174), Detroit
Corewell Health ( Site 0130), Grand Rapids
MississippiThe University of Mississippi Medical Center ( Site 0161), Jackson
MissouriCircuit Clinical - SSM Health Cancer Care DePaul ( Site 0166), Bridgeton
Truman Medical Center ( Site 0122), Kansas City
MontanaIntermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0178), Billings
NevadaComprehensive Cancer Centers of Nevada ( Site 0113), Las Vegas
OptumCare Cancer Care ( Site 0121), Las Vegas
Cancer Care Specialists ( Site 9582), Reno
New YorkNew York Oncology Hematology, P.C. ( Site 0129), Albany
Icahn School of Medicine at Mount Sinai ( Site 0164), New York
New York Cancer and Blood Specialists ( Site 9000), Shirley
North CarolinaEast Carolina University ( Site 0159), Greenville
North DakotaSanford Health Roger Maris Cancer Center ( Site 0189), Fargo
OhioOncology_Hematology Care Clinical Trials, LLC (OHC) ( Site 8002), Cincinnati
OregonKaiser Permanente Interstate Medical Office - Central ( Site 0181), Portland
South CarolinaPrisma Health - Upstate ( Site 0158), Greenville
South DakotaSanford Cancer Center ( Site 0143), Sioux Falls
TennesseeThe University of Tennessee Medical Center ( Site 0142), Knoxville
TexasTexas Oncology - DFW ( Site 8000), Dallas
Houston Methodist Cancer Center ( Site 0154), Houston
Joe Arrington Cancer Research and Treatment Center ( Site 0183), Lubbock
Texas Oncology - Gulf Coast ( Site 8003), The Woodlands
VirginiaUniversity of Virginia Cancer Center ( Site 0138), Charlottesville
Virginia Cancer Institute ( Site 0148), Richmond
Blue Ridge Cancer Care ( Site 0132), Roanoke
WashingtonVista Oncology ( Site 4201), Olympia
WisconsinSSM Health Dean Medical Group ( Site 0140), Madison

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.