Last updated 7 days ago
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)
1046 patients around the world
Available in Puerto Rico, Guatemala, Argentina
Merck Sharp & Dohme LLC
9Research sites
1046Patients around the world
This study is for people with
Non-Hodgkin Lymphoma
Diffuse large B-cell lymphoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Instituto de Investigaciones Clínicas Mar del Plata
Recruiting
Clínica Adventista Belgrano - CABA - Buenos Aires
Recruiting
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Recruiting
Clínica El Castaño
Recruiting
Sanatorio 9 de Julio - Tucumán
Recruiting
Hospital Universitario Austral - Pilar
Recruiting
Hospital Alemán
Recruiting
Medi-K Cayala
Recruiting
Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN
Recruiting
StudywaveLINE-010
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Diffuse large B-cell lymphoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06717347
