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)

Launched by MERCK SHARP & DOHME LLC · Dec 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with diffuse large B-cell lymphoma (DLBCL), a type of cancer that affects the lymphatic system. Researchers want to see if adding a drug called zilovertamab vedotin to the standard treatment regimen (which includes rituximab, cyclophosphamide, doxorubicin, and prednisone, known as R-CHP) can help patients live longer without their cancer getting worse compared to those who receive the standard treatment alone (R-CHOP).

To participate in the trial, patients need to be between the ages of 65 and 74 and have recently been diagnosed with DLBCL, confirmed by a biopsy. They should not have received any previous treatment for their cancer and must have certain health conditions under control. Participants can expect to receive either the new combination treatment or the standard treatment and will be closely monitored throughout the study. This trial is currently recruiting participants, and it's an important step in finding better treatment options for DLBCL.

Gender

ALL

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