RecruitingLymphoma, Large B-Cell, Diffuse

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)

Eligible age

18+ yrs

Accepts

All genders

Locations

30 states

Healthy volunteers

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About this study

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.

Sponsor: Merck Sharp & Dohme LLC

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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.