OLYMPIA-1
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, Versus Investigator’s Choice in Previously Untreated Participants with Follicular Lymphoma (OLYMPIA-1)
IRAS ID
1007605
Contact name
Nishant Naik
Contact email
Sponsor organisation
Regeneron Pharmaceuticals
Research summary
The aim of this study is to investigate the use of an experimental drug; Odronextamab, in patients with previously untreated follicular lymphoma (a type of non-hodgkin lymphoma (NHL)). The study will look at several research questions such as "What side effects may happen from the use of Odronextamab?" and "What is the impact from the study drug on your quality of life and ability to complete routine daily activities?"
The study is made up of two parts. Part 1 aims to see how safe and tolerable Odronextamab is. Part 2 aims to assess how well Odronextamab works compared to the current treatment for NHL; Rituximab and Chemotherapy. Patients who are eligible to participate in the study, will be assigned to Part 1 or Part 2 of the study.
The study doctor will assess a patient's eligibility through a series of "screening assessments" which can take up to 28 days. If eligible, the study doctor will inform the patient if they are placed in Part 1 or Part 2 of the study. This is considered an "open-label" study, so the participant and the study doctor will know which part of the study they are in.
The experimental drug (also known as a study drug) will be administered using a needle. This is called intravenous infusion. It can last up to 4 hours, and then may be reduced to 1 hour.
The study will include NHS sites and the length of time a participant is enrolled in the study depends on the participant's response to treatment and what side effects they may have. Once the study treatment is completed, participants will continue to be followed up with the study team, until they have met the criteria to finish the follow up period of the study.REC name
North West - Haydock Research Ethics Committee
REC reference
23/NW/0141
Date of REC Opinion
6 Oct 2023
REC opinion
Further Information Favourable Opinion