M22-003 Epcoritamab Combined with R2 Compared to Chemo in Previously Untreated Follicular Lymphoma

• Research type

  Research Study

• Full title

  A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE™FL-2)

• IRAS ID

  1008979

• Contact name

  Aleksandra Jankielewicz

• Contact email

  global-clinical-trials@abbvie.com

• Sponsor organisation

  AbbVie Deutschland GmbH & Co. KG

• Eudract number

  2023-506906-38

• Clinicaltrials.gov Identifier

  NCT06191744

• 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 previously untreated 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 4 groups, called treatment arms. Each group receives a different treatment. Around 900 adult participants with previously untreated FL will be enrolled in approximately 250 sites across the world.
  Participants will receive R2 (intravenous [IV] infusion of rituximab (R) and oral capsules of lenalidomide) alone or in combination with subcutaneous injections of epcoritamab. Participants may also receive investigator's choice chemoimmunotherapy (CIT): IV infusion of obinutuzumab (G) and IV injections of cyclophosphamide, IV injections of doxorubicin, IV injections of vincristine, oral tablets of prednisone (CHOP) [G-CHOP]/ R-CHOP or G and IV infusion of bendamustine (Benda) [G-Benda]/R-Benda. The total study duration will be 120 weeks.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  24/SC/0098

• Date of REC Opinion

  26 Apr 2024

• REC opinion

  Further Information Favourable Opinion