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)

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40

ClinicalTrials ID:NCT06890884

This study evaluates the efficacy of zilovertamab vedotin plus R-CHP versus polatuzumab vedotin plus R-CHP in treating GCB DLBCL. Eligible participants must have confirmed GCB DLBCL, PET-positive disease, and no prior DLBCL treatment. Interventions include IV infusions of biologicals and drugs, with rescue medication as needed.

Patient Parameters

Program Overview

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 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.

Locations

FACILITYZIPCITYSTATE
Infirmary Cancer Care ( Site 0157)36607MobileAlabama
Palo Verde Cancer Specialists ( Site 0105)85304GlendaleArizona
Genesis Cancer and Blood Institute ( Site 0193)71913Hot SpringsArkansas
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0135)91505BurbankCalifornia
Medical Oncology Hematology Consultants (MOHC) ( Site 8007)19713NewarkDelaware
Georgetown University Medical Center ( Site 0117)20007Washington D.C.District of Columbia
Mount Sinai Cancer Center ( Site 0140)33140Miami BeachFlorida
Mid Florida Hematology and Oncology Center ( Site 0152)32763Orange CityFlorida
University of Chicago Medical Center ( Site 0126)60637ChicagoIllinois
University of Iowa-Holden Comprehensive Cancer Center ( Site 0139)52242Iowa CityIowa

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