A Clinical Study of Zilovertamab Vedotin (MK-2140) Plus Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Polatuzumab Vedotin Plus R-CHP in People With Diffuse Large B-cell Lymphoma (DLBCL) (MK-2140-011/waveLINE-011)

Launched by MERCK SHARP & DOHME LLC · Mar 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different treatments for a type of fast-growing blood cancer called diffuse large B-cell lymphoma (DLBCL), specifically the germinal center B-cell-like subtype. The researchers want to see if a new treatment called zilovertamab vedotin, when combined with standard chemotherapy (R-CHP), is more effective at making the cancer go away compared to another treatment called polatuzumab vedotin with the same chemotherapy.

To be eligible for this study, participants must have a confirmed diagnosis of the germinal center subtype of DLBCL and have positive results on a specific imaging test (PET scan). They should not have received any prior treatment for their cancer. The trial is open to all genders and is looking for participants aged 65 to 74. If you or someone you know is interested in participating, it’s important to discuss this with a healthcare provider, as there are specific health conditions that may exclude someone from joining the study. Participants can expect to receive either of the two treatments being tested and will be closely monitored throughout the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• The main inclusion criteria include but are not limited to the following:
• • Has histologically confirmed diagnosis of germinal center B-cell (GCB) subtype of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, according to the World Health Organization (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.
• • Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART).
• • Participants 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:
• The main exclusion criteria include but are not limited to the following:
• • 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.
• • 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 active HBV (defined as HBsAg positive and detectable HBV deoxyribonucleic acid (DNA)) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection.
• • Has history of stem cell/solid organ transplant.