What is the Purpose of this Study?
The purpose of this study is to evaluate the safety and effectiveness of the combination of an experimental drug called zilovertamab vedotin (MK-2140) plus a series of cancer drugs (R-CHP) in treating people with diffuse large B-cell lymphoma (DLBCL). R-CHP includes rituximab, cyclophosphamide, doxorubicin, and prednisone/prednisolone. The FDA has approved the R-CHP drugs and their combination for the treatment of DLBCL; however, R-CHP in combination with zilovertamab vedotin is considered experimental for treating DLBCL. Researchers will compare zilovertamab vedotin plus R-CHP to a standard treatment for DLBCL called R-CHOP. R-CHOP includes the same drugs as R-CHP, as well as a cancer drug called vincristine sulfate. R-CHOP is the standard-of-care treatment for patients diagnosed with DLBCL. The FDA has approved the use of R-CHOP as it is being used in this study. Participants will randomly be assigned to 1 of 2 drug treatment courses (either the standard-of-care drug treatment course or experimental drug treatment course).
Eligibility
- * 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
Where can I participate?
- CS Cancer at Beverly Hills
- CS Cancer at Cedars-Sinai Medical Center
More about this Clinical Trial
What is the full name of this clinical trial?
MK2140-010: A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma