A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination with R-CHOP Compared to R-CHOP in Subjects with Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) (EPCORE DLBCL-2)

The University of Virginia seeks patients ages 18 and over with Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) for a research study.

The purpose of the study is test the safety and effectiveness of an investigational treatment called Epcoritamab in combination with standard of care therapies, specifically R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). This study will assess change in disease activity of Epcoritamab when combined with intravenous and oral R-Chop, or R-Chop alone in adult participants with Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL). This is a randomized study. Study doctors will use a computer program to randomly put subjects into 1 of 2 different groups. We will call these groups “arms”. You will take the study drugs below depending on which arm you are in. Your study doctor will communicate to you the study treatment you will receive:

• Arm 1; Participants will receive subcutaneous (injection under the skin) Epcoritamab combined R-CHOP followed by subcutaneous Epcoritamab in 21-day cycles.
• Arm 2; Participants will receive R-CHOP followed by intravenous rituximab in 21-day cycles.

The length of your participation in this study will vary depending on how your body reacts to the study treatment. Your participation in this study could be up to approximately 6.5 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/ct2/show/NCT05578976