OLYMPIA-2

• Research type

  Research Study

• Full title

  A Phase 3, Open-Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20x Anti-CD3 Bispecific Antibody, Combined with Chemotherapy Versus Rituximab Combined with Chemotherapy in Previously Untreated Participants with Follicular Lymphoma (OLYMPIA-2)

• IRAS ID

  1007851

• Contact name

  xiaonan pugh

• Contact email

  xiaonan.pugh@regeneron.com

• Sponsor organisation

  Regeneron Pharmaceuticals Inc.

• Eudract number

  2022-502113-28

• Research summary

  The study is researching an experimental drug called odronextamab.

  The study is focused on participants with previously untreated follicular lymphoma (a type of non-Hodgkin lymphoma or NHL).

  This study will be made up of two parts: Part 1 (unrandomised) and Part 2 (randomised). The aim of Part 1 of the study is to see how safe and tolerable the study drug in combination with chemotherapy is.

  The aim of Part 2 of the study is to assess how odronextamab and chemotherapy work compared to rituximab and chemotherapy (the current standard of care for NHL).

  The study is looking at several other research questions, including:
  • What side effects may happen from taking the study drug
  • How much study drug is in your blood at different times
  • Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
  • The impact from the study drug on your quality-of-life and ability to complete routine daily activities

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  23/LO/0442

• Date of REC Opinion

  25 Sep 2023

• REC opinion

  Further Information Favourable Opinion