NCT06717347Recruiting
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)
Summary
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.
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
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Italy, United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Greece, Guatemala, Hong Kong, Hungary, Israel, Japan, Malaysia, Mexico, Netherlands, Peru, Poland, Portugal, Puerto Rico, Romania, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine
- Sponsor
- Merck Sharp & Dohme LLC(Industry)
- Protocol no.
- 2140-010
- Conditions
- Diffuse Large B-Cell Lymphoma
- Interventions
- Biological, Drug
Treatments studied
- Zilovertamab vedotin
- Rituximab
- Cyclophosphamide
- Doxorubicin
- Rituximab Biosimilar
- Prednisone
- Prednisolone
- Vincristine
- Rescue medication
- Methylprednisolone
Locations · 261
- Baden, SwitzerlandKantonspital Baden ( Site 2703)Recruiting at this site
- Sankt Gallen, SwitzerlandCantonal Hospital St.Gallen-Oncology & Hematology ( Site 2702)Recruiting at this site
- Bellinzona, SwitzerlandOspedale Regionale Bellinzona e Valli ( Site 2701)Recruiting at this site
- Lugano, SwitzerlandOspedale Italiano Lugano (OIL) ( Site 2705)Recruiting at this site
- Nice, FranceCentre Antoine-Lacassagne ( Site 1514)Recruiting at this site
- La Rochelle, FranceHopital Saint Louis, Centre Hospitalier de La Rochelle ( Site 1511)Recruiting at this site
- Dijon, FranceCHU Dijon Bourgogne ( Site 1516)Recruiting at this site
- La Tronche, FranceCHU GRENOBLE ALPES ( Site 1518)Recruiting at this site
- Limoges, FranceCentre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 1512)Recruiting at this site
- Metz, FranceCentre Hospitalier Régional Metz Thionville - Hôpital de Mercy ( Site 1515)Recruiting at this site
- Dunkirk, FranceCentre Hospitalier de Dunkerque ( Site 1513)Recruiting at this site
- Clermont-Ferrand, FranceCentre Hospitalier Universitaire Estaing ( Site 1508)Recruiting at this site
- Bayonne, FranceCentre Hospitalier de la Cote Basque ( Site 1509)Recruiting at this site
- Rouen, FranceCentre Henri Becquerel ( Site 1517)Recruiting at this site
- Toulon, FranceHIA Sainte Anne ( Site 1506)Recruiting at this site
- Avignon, FranceCentre Hospitalier d'Avignon ( Site 1505)Recruiting at this site
- La Roche-sur-Yon, FranceCHD Vendee ( Site 1502)Recruiting at this site
- Saint-Cloud, FranceInstitut Curie - site Saint-Cloud ( Site 1501)Recruiting at this site
- Monza, ItalyFondazione IRCCS San Gerardo dei Tintori ( Site 2008)Recruiting at this site
- Rionero in Vulture, ItalyIRCCS Crob ( Site 2002)Recruiting at this site
- Palermo, ItalyAz. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO ( Site 2005)Recruiting at this site
- Candiolo, ItalyINOC - Istituto Nazionale Oncologico Candiolo ( Site 2010)Recruiting at this site
- Brescia, ItalyAzienda Ospedaliera Spedali Civili di Brescia-Hemathology ( Site 2001)Recruiting at this site
- Milan, ItalyIRCCS Ospedale San Raffaele ( Site 2012)Recruiting at this site
- Milan, ItalyIEO Istituto Europeo di Oncologia ( Site 2009)Recruiting at this site
- Novara, ItalyAzienda Ospedaliero Universitaria Maggiore della Carità ( Site 2004)Recruiting at this site
- Ravenna, ItalyOspedale Santa Maria delle Croci ( Site 2006)Recruiting at this site
- Roma, ItalyFondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 2003)Recruiting at this site
- Mobile, United StatesUSA Mitchell Cancer Institute ( Site 0173)Recruiting at this site
- Gilbert, United StatesBanner MD Anderson Cancer Center ( Site 0165)Recruiting at this site
In total, worldwide, 261 of the 285 sites listed in the registry are recruiting; the other 24 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: October 21, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 231 more locations
Other identifiers
- MK-2140-010 · other identifier
- 2024-515566-13-00 · other registry
- U1111-1309-3971 · other registry
- jRCT2061240099 · other identifier
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.