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NCT06717347From ClinicalTrials.govRecruiting

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)

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)

  • Diffuse Large B-Cell Lymphoma

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
1,046
Started
27 January 2025
Main results due
2 July 2029
Study sites
278
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(278)

  • USA Mitchell Cancer Institute ( Site 0173)

    Mobile, Alabama, United States

    Recruiting

  • Banner MD Anderson Cancer Center ( Site 0165)

    Gilbert, Arizona, United States

    Recruiting

  • Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0167)

    Phoenix, Arizona, United States

    Recruiting

  • The University of Arizona Cancer Center - North Campus ( Site 0124)

    Tucson, Arizona, United States

    Recruiting

  • Providence Medical Foundation-Oncology ( Site 0168)

    Fullerton, California, United States

    Recruiting

  • MemorialCare Health System - Long Beach Medical Center ( Site 9559)

    Long Beach, California, United States

    Recruiting

  • Cancer Blood and Specialty Clinic ( Site 0109)

    Los Alamitos, California, United States

    Recruiting

  • Cedars-Sinai Medical Center ( Site 0115)

    Los Angeles, California, United States

    Recruiting

  • Pacific Hematology Oncology Associates ( Site 0131)

    San Francisco, California, United States

    Recruiting

  • Lutheran Hospital - Cancer Centers of Colorado ( Site 0180)

    Golden, Colorado, United States

    Recruiting

  • Clermont Oncology Center ( Site 0182)

    Clermont, Florida, United States

    Recruiting

  • Bioresearch Partner ( Site 0157)

    Hialeah, Florida, United States

    Recruiting

  • Orlando Health Cancer Institute ( Site 0169)

    Ocoee, Florida, United States

    Recruiting

  • Mid Florida Hematology and Oncology Center ( Site 0172)

    Orange City, Florida, United States

    Recruiting

  • University Cancer & Blood Center, LLC ( Site 0141)

    Athens, Georgia, United States

    Recruiting

  • Edward Cancer Center ( Site 0197)

    Naperville, Illinois, United States

    Recruiting

  • Cancer Care Specialists of Illinois ( Site 0152)

    O'Fallon, Illinois, United States

    Recruiting

  • Fort Wayne Medical Oncology and Hematology ( Site 0149)

    Fort Wayne, Indiana, United States

    Recruiting

  • Cotton O'Neil Cancer Center ( Site 0108)

    Topeka, Kansas, United States

    Recruiting

  • University of Kentucky ( Site 0106)

    Lexington, Kentucky, United States

    Recruiting

  • Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0163)

    Louisville, Kentucky, United States

    Recruiting

  • Owensboro Medical Health System ( Site 0195)

    Owensboro, Kentucky, United States

    Recruiting

  • CHRISTUS St. Frances Cabrini Hospital Center for Cancer Care ( Site 0184)

    Alexandria, Louisiana, United States

    Recruiting

  • American Oncology Partners, P.A. ( Site 0185)

    Bethesda, Maryland, United States

    Recruiting

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor ( Site 9545)

    Ann Arbor, Michigan, United States

    Recruiting

  • Karmanos Cancer Institute ( Site 0174)

    Detroit, Michigan, United States

    Recruiting

  • Corewell Health ( Site 0130)

    Grand Rapids, Michigan, United States

    Recruiting

  • The University of Mississippi Medical Center ( Site 0161)

    Jackson, Mississippi, United States

    Recruiting

  • Circuit Clinical - SSM Health Cancer Care DePaul ( Site 0166)

    Bridgeton, Missouri, United States

    Recruiting

  • Truman Medical Center ( Site 0122)

    Kansas City, Missouri, United States

    Recruiting

  • Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0178)

    Billings, Montana, United States

    Recruiting

  • OptumCare Cancer Care ( Site 0121)

    Las Vegas, Nevada, United States

    Recruiting

  • Comprehensive Cancer Centers of Nevada ( Site 0113)

    Las Vegas, Nevada, United States

    Recruiting

  • Cancer Care Specialists ( Site 9582)

    Reno, Nevada, United States

    Recruiting

  • New York Oncology Hematology, P.C. ( Site 0129)

    Albany, New York, United States

    Recruiting

  • Icahn School of Medicine at Mount Sinai ( Site 0164)

    New York, New York, United States

    Recruiting

  • New York Cancer and Blood Specialists ( Site 9000)

    Shirley, New York, United States

    Recruiting

  • East Carolina University ( Site 0159)

    Greenville, North Carolina, United States

    Recruiting

  • Sanford Health Roger Maris Cancer Center ( Site 0189)

    Fargo, North Dakota, United States

    Recruiting

  • Oncology_Hematology Care Clinical Trials, LLC (OHC) ( Site 8002)

    Cincinnati, Ohio, United States

    Recruiting

  • Kaiser Permanente Interstate Medical Office - Central ( Site 0181)

    Portland, Oregon, United States

    Recruiting

  • Prisma Health - Upstate ( Site 0158)

    Greenville, South Carolina, United States

    Recruiting

  • Sanford Cancer Center ( Site 0143)

    Sioux Falls, South Dakota, United States

    Recruiting

  • The University of Tennessee Medical Center ( Site 0142)

    Knoxville, Tennessee, United States

    Recruiting

  • Texas Oncology - DFW ( Site 8000)

    Dallas, Texas, United States

    Recruiting

  • Center for Oncology and Blood Disorders ( Site 0153)

    Houston, Texas, United States

    Completed

  • Houston Methodist Cancer Center ( Site 0154)

    Houston, Texas, United States

    Recruiting

  • Joe Arrington Cancer Research and Treatment Center ( Site 0183)

    Lubbock, Texas, United States

    Recruiting

  • Texas Oncology - Gulf Coast ( Site 8003)

    The Woodlands, Texas, United States

    Recruiting

  • University of Virginia Cancer Center ( Site 0138)

    Charlottesville, Virginia, United States

    Recruiting

  • Virginia Cancer Institute ( Site 0148)

    Richmond, Virginia, United States

    Recruiting

  • Blue Ridge Cancer Care ( Site 0132)

    Roanoke, Virginia, United States

    Recruiting

  • Vista Oncology ( Site 4201)

    Olympia, Washington, United States

    Recruiting

  • SSM Health Dean Medical Group ( Site 0140)

    Madison, Wisconsin, United States

    Recruiting

  • Clinica Adventista Belgrano ( Site 0309)

    Caba., Buenos Aires, Argentina

    Recruiting

  • Instituto de Investigaciones Clinicas Mar del Plata ( Site 0306)

    Mar del Plata, Buenos Aires, Argentina

    Recruiting

  • Hospital Universitario Austral ( Site 0307)

    Pilar, Buenos Aires, Argentina

    Recruiting

  • Hospital Aleman ( Site 0301)

    Buenos Aires, Buenos Aires F.D., Argentina

    Recruiting

  • Fundacion Estudios Clinicos ( Site 0311)

    Rosario, Santa Fe Province, Argentina

    Recruiting

  • C.I.C.E. 9 de Julio ( Site 0305)

    San Miguel de Tucumán, Tucumán Province, Argentina

    Completed

Showing 60 of 278 sites — filter to narrow it down. 257 of the 278 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06717347. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubic | Trialion