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)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC

About this trial

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

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Zilovertamab vedotin
  • Rituximab
  • Cyclophosphamide
  • Doxorubicin
  • Rituximab Biosimilar
  • Prednisone
  • Prednisolone
  • Polatuzumab vedotin
  • Rescue Medication

Treatment groups

594 Participants
are divided into 2 treatment groups

Sponsors and collaborators