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)

Study of Investigational Medication with Standard Treatment for a Type of Lymphoma

Recruiting
18 years or above
All
Phase 3
1046 participants needed
5 Locations

Study Overview

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.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Diffuse Large B-Cell Lymphoma
  • Age: 18 years or above
  • Gender: All

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.

Updated on 28 Jan 2025. Study ID: NCT06717347

This study investigates the effectiveness of an investigational medication when used with standard treatment for people with diffuse large B-cell lymphoma (DLBCL). DLBCL is a type of cancer that affects the lymphatic system, which is part of the body's immune system. The study aims to determine if this combination can prevent the cancer from growing or spreading longer than standard treatment alone.

Participants in the study will be randomly assigned to one of two study arms. One group will receive the investigational medication along with standard treatment, while the other group will receive only the standard treatment. The study will involve regular assessments to monitor the progress of the disease and the participants' health. Participants will undergo imaging tests like PET scans, which help in visualizing the cancer's activity in the body.

  • Who can participate: Adults with untreated diffuse large B-cell lymphoma, PET-positive disease, and a performance status allowing daily activities are eligible. Exclusions include significant heart disease or active infections.
  • Study details: Participants will receive either the investigational medication with standard treatment or standard treatment alone. A placebo is not used in this study.

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