M20-638 Relapsed Refractory Follicular Lymphoma Epcoritamab in Combination with R2

• Research type

  Research Study

• Full title

  A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination with Rituximab and Lenalidomide (R2) compared to R2 in Subjects with Relapsed or Refractory Follicular Lymphoma (EPCORE™ FL-1)

• IRAS ID

  1005988

• Contact name

  Aleksandra Jankielewicz

• Contact email

  global-clinical-trials@abbvie.com

• Sponsor organisation

  AbbVie Deutschland GmbH & Co. KG

• Eudract number

  2021-000169-34

• Research summary

  Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective
  epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed.

  Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Around 642 adult participants with R/R FL will be enrolled in approximately 300 sites across the world.

  Participants will receive R2 (intravenous infusion of rituximab up to 5 cycles and oral capsules of lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days).

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  23/NW/0076

• Date of REC Opinion

  21 Sep 2023

• REC opinion

  Further Information Favourable Opinion