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Clinical Trials | A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010)

A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010)

The University of Virginia is conducting a clinical research study for adults ages 18 and over who have untreated Diffuse Large B-Cell Lymphoma. The purpose of this trial is to test zilovertamab vedotin (MK-2140) plus a combination of cancer drugs called R CHP in people with diffuse large B-cell lymphoma (DLBCL). Zilovertamab vedotin is an experimental drug (“trial drug”). It has not been approved to treat people with DLBCL or any other type of cancer by the U.S. Food and Drug Administration. R-CHP includes rituximab, cyclophosphamide, doxorubicin, and prednisone or prednisolone. Getting R-CHP with zilovertamab vedotin is experimental for treating DLBCL. The trial 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 and is approved by the FDA for the treatment of DLBCL. The drug you get will depend on which group you are placed in. The trial has 2 groups: • Group 1 will get zilovertamab vedotin plus R-CHP • Group 2 will get R-CHOP A computer will decide which group you are put in. You have an equal chance of being put in either group. You, your trial doctor, and trial staff will what treatment you are receiving. You will receive treatment once every three weeks. The treatment will be given by IV infusion. You are expected to be in this research study for about 5 years. Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance. Additional information can be found here: https://clinicaltrials.gov/study/NCT06717347 [email protected]