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 vizsgálat adatai

Ki végzi

Merck Sharp & Dohme LLC

Azonosító

NCT06717347EU 2024-515566-13-00

A regiszteradat frissítve

2026. november 10.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

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)

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.

Bevonási feltételek: 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.

Kizáró feltételek: Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma; 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 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; 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 a history of transformation of indolent disease to DLBCL; 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; Known additional malignancy that is progressing or has required active treatment within the past 2 years; Has active autoimmune disease that has required systemic treatment in the past 2 years; Has active infection requiring systemic therapy; Has history of allogeneic tissue/solid organ transplant; Has Ann Arbor Stage I DLBCL; Has clinically significant pericardial or pleural effusion; Has ongoing Grade >1 peripheral neuropathy; Known active central nervous system (CNS) lymphoma.

ClinicalTrials.gov NCT06717347 · EU CTIS 2024-515566-13-00