RecruitingDiffuse Large B-Cell Lymphoma

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)

Eligible age

18+ yrs

Accepts

All genders

Locations

27 states

Healthy volunteers

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About this study

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.

Sponsor: Merck Sharp & Dohme LLC

You may qualify if…

✓ 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

You may not qualify if…

✕ 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