Olympia 5
Research type
Research Study
Full title
A Phase 3, Open Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Combination with Lenalidomide Versus Rituximab in Combination with Lenalidomide in Relapsed/Refractory Participants with Follicular Lymphoma and Marginal Zone Lymphoma (OLYMPIA-5)
IRAS ID
1007959
Contact name
Nishant Naik
Contact email
Sponsor organisation
Regeneron Pharmaceuticals
Eudract number
2022-503092-28
Research summary
The study is researching an experimental drug called odronextamab. The study is focused on patients who have one of two types of cancer: follicular lymphoma (FL) or marginal zone lymphoma (MZL) that is at a stage called “relapsed/refractory”. Follicular lymphoma and marginal zone lymphoma are subtypes of Non-Hodgkin lymphoma. This study will be made up of two parts. In Part 1, the aim is to see how safe and tolerable the study drug is when used in combination with lenalidomide, in participants with FL, and to determine the dose of the study drug to be used in Part 2 of this study. This combination is considered “first-in-human” as it has not been tested as a combination treatment in humans.
In Part 2, the aim is to assess how the combination of odronextamab and lenalidomide work compared to current treatment (rituximab and lenalidomide), in participants with FL and/or MZL. The study is looking at several other research questions, including: •What side effects may happen from taking the study drug in combination with lenalidomide
•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 activitiesREC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
23/YH/0124
Date of REC Opinion
6 Sep 2023
REC opinion
Further Information Favourable Opinion