Diffuse Large B-Cell Lymphoma (DLBCL): Epcoritamab in Combination with R-CHOP

• Research type

  Research Study

• 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)

• IRAS ID

  1006622

• Contact name

  Aleksandra Jankielewicz

• Contact email

  uk.reg.csm.cta@abbvie.com

• Sponsor organisation

  AbbVie Deutschland GmbH & Co. KG

• Eudract number

  2021-000168-31

• Research summary

  M20-621 study evaluates safety and efficacy of the study drug Epcoritamab in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL). The purpose of this study is to evaluate how well the study drug (epcoritamab) works and how safe it is when given in combination with standard of care therapies, R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) for DLBCL (cancer of B-lymphocytes).

  Epcoritamab is not chemotherapy. It is an antibody (a blood protein) designed to work by attaching to patients own lymphocytes (a type of white blood cell which fights infections), and to patients own cancer cells. By bringing the lymphocytes and cancer cells together, Epcoritamab then stimulates patients own lymphocytes to kill these tumour cells.
  
  Design: There are 2 arms included in this study. Investigational Arm: Patients will receive epcoritamab in combination with R-CHOP (6 cycles) followed by epcoritamab monotherapy (2 cycles), or Control Arm: Patients will receive R-CHOP (6 cycles) followed by rituximab monotherapy (2 cycles).

  Investigational Arm: Epcoritamab with R-CHOP
  R-CHOP will be administered on Day 1 every 3 weeks s for up to 6 cycles. The prednisone will be continued for another 4 days until Day 5 of each cycle. Epcoritamab will be administered once weekly during Cycle 1 to Cycle 4, then once every 3 weeks for up to a total of 8 cycles.

  Control Arm: R-CHOP alone
  R-CHOP will be administered on Day 1 every 3 weeks for up to 6 cycles. The prednisone will be continued for another 4 days starting until Day 5 of each cycle. After 6 cycles, rituximab will be administered once every 3 weeks for up to a total of 8 cycles.

  Duration: Treatment period is 8 cycles (1 cycle=21days). The follow up visits at week 36, 48 and then every 3 months through week 96 (approximately year 2 from first dose) then every 6 months until week 216 (approximately year 4), then 48weeks (approximately once a year) until the end of the study.

• REC name

  North of Scotland Research Ethics Committee 1

• REC reference

  23/NS/0091

• Date of REC Opinion

  27 Sep 2023

• REC opinion

  Further Information Favourable Opinion