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)

Last updated: May 1, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma

Treatment

Rituximab Biosimilar

Cyclophosphamide

Doxorubicin

Clinical Study ID

NCT06890884
2140-011
waveLINE-011
MK-2140-011
U1111-1309-2852
2024-515526-89
  • Ages > 18
  • All Genders

Study Summary

Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing.

The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.

Eligibility Criteria

Inclusion

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 ofdiffuse large B-cell lymphoma (DLBCL), by prior biopsy, according to the WorldHealth Organization (WHO) classification of neoplasms of the hematopoietic andlymphoid tissues.

  • Has positron emission tomography (PET) positive disease at screening, defined as 4to 5 on the Lugano 5-point scale.

  • Has received no prior treatment for their DLBCL.

  • Human immunodeficiency virus (HIV) infected participants must have well controlledHIV on antiretroviral therapy (ART).

  • Participants who are hepatitis B surface antigen (HBsAg) positive are eligible ifthey have received hepatitis B virus (HBV) antiviral therapy and have undetectableHBV viral load prior to randomization.

  • Participants with history of hepatitis C virus (HCV) infection are eligible if HCVviral load is undetectable at screening.

Exclusion

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 zonelymphoma.

  • Has Ann Arbor Stage I DLBCL.

  • Has clinically significant (i.e., active) cardiovascular disease: cerebral vascularaccident/stroke (<6 months prior to enrollment), myocardial infarction (<6 monthsprior to enrollment), unstable angina, congestive heart failure (New York HeartAssociation Classification Class ≥II), or serious cardiac arrhythmia requiringmedication.

  • 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 MulticentricCastleman's Disease.

  • Has ongoing corticosteroid therapy.

  • Known additional malignancy that is progressing or has required active treatmentwithin the past 2 years.

  • Known active central nervous system (CNS) lymphoma.

  • Has active autoimmune disease that has required systemic treatment in the past 2years.

  • 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 ribonucleicacid (RNA)) infection.

  • Has history of stem cell/solid organ transplant.

Study Design

Total Participants: 594
Treatment Group(s): 8
Primary Treatment: Rituximab Biosimilar
Phase: 2
Study Start date:
April 11, 2025
Estimated Completion Date:
December 16, 2032

Connect with a study center

  • Haddasah Medical Center ( Site 0601)

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Sheba Medical Center ( Site 0603)

    Ramat Gan, 5265601
    Israel

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.