OLYMPIA-3
Research type
Research Study
Full title
A Phase 3, Open label, Randomized Study Comparing the Efficacy and Safety of Odronextamab REGN1979, an anti-CD20 × anti-CD3 bispecific antibody, in Combination with CHOP (O-CHOP) versus Rituximab in combination with CHOP (R-CHOP) in Previously Untreated Participants with Diffuse Large B-cell Lymphoma (DLBCL) (OLYMPIA-3)
IRAS ID
1007491
Contact name
Nishant Naik
Contact email
Sponsor organisation
Regeneron Pharmaceuticals
ISRCTN Number
NA
Research summary
This study is researching the experimental drug; Odronextamab, when used in combination with chemotherapy, in patients with previously untreated diffuse large B-cell lymphoma. There are two parts of the study. Part 1 is to see how safe and tolerable the drug is with chemotherapy and to determine the dosage of the study drug, which should be taken during part 2. Part 2 is to compare the effectiveness of Odronextamab plus chemotherapy against Rituximab plus chemotherapy. Rituximab is currently approved for use in Non-Hodgkin’s Lymphoma.
There are specific conditions patients must meet to enter the study, which the study doctor will assess. If someone is eligible to join, they will be invited to participate in the trial. Only those 18 years and above can join the trial.
The length of time a participant successfully enrolled in the study will stay in the trial will depend on the response to the study drug/side effects they have from the drug.
In both parts of the study, the study doctor will determine participant's eligibility during the screening visit. This consists of reviewing the patient history, completing tests such as an ECG and Brain MRI or CT.
In part 1 of the study, participants will be given Odronextamab in combination with chemotherapy. The study doctor will administer the dosage depending on how well the study drug is tolerated. One the Odronextamab dosage is selected, the part 2 portion of the randomised study begins.
If participants are eligible for part 2 of the study, they will be randomly allocated to one of two groups 1) Odronextamab and chemotherapy or 2) Rituximab and chemotherapy. The maximum time a participant will spend on study treatment is 6 cycles (each cycle is made up of 21 days). Participants will continue to follow up until they meet one of the protocol criteria to withdraw.
Throughout the study, the study doctor will continue to collect information about the participant’s health.REC name
South West - Central Bristol Research Ethics Committee
REC reference
23/SW/0054
Date of REC Opinion
5 Sep 2023
REC opinion
Further Information Favourable Opinion