A Phase 3 Study of Epcoritamab and R-CHOP Versus R-CHOP Alone in People With Newly Diagnosed Lymphoma

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Full Title

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)

Purpose

Researchers want to see if adding epcoritamab to standard treatment is better than standard treatment alone for lymphoma. The people in this study have diffuse large B cell lymphoma (DLBCL) that has not yet been treated.

Epcoritamab boosts the immune system’s ability to fight cancer cells. In this study, it will be given with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP).  Adding epcoritamab to R-CHOP may prevent lymphoma from coming back after treatment.

If you join this study, you will be randomly assigned to get one of these treatments:

  • Epcoritamab with R-CHOP (6 cycles of treatment) and then epcoritamab alone (2 cycles)
  • R-CHOP (6 cycles) and then rituximab alone (2 cycles)

Epcoritamab is given as an injection under the skin. Rituximab, cyclophosphamide, doxorubicin, and vincristine are given intravenously (by vein). Prednisone is taken orally (by mouth).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have newly diagnosed DLBCL.
  • Have DLBCL that makes a protein called CD20.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18-79.

Contact

For more information and to see if you can join this study, please call Dr. Gilles Salles’ office at 646-608-4153.

Protocol

23-384

Phase

Phase III (phase 3)

Disease Status

Newly Diagnosed

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05578976