A Phase 3, Open-Label, Randomized Study to Compare the Efficacy and Safety of an Anti-CD20 X Anti-CD3 BiSpecific Antibody, Versus Investigator’s Choice in Previously Untreated Participants with Follicular Lymphoma (OLYMPIA-1)

UVA Tracking #
HSR230281
Principal Investigator
Emily Ayers
Contact
Contact Phone
Official Trial Title
A PHASE 3, OPEN-LABEL, RANDOMIZED STUDY TO COMPARE THE
EFFICACY AND SAFETY OF ODRONEXTAMAB (REGN1979), AN ANTICD20
X ANTI-CD3 BISPECIFIC ANTIBODY, VERSUS INVESTIGATOR’S
CHOICE IN PREVIOUSLY UNTREATED PARTICIPANTS WITH
FOLLICULAR LYMPHOMA (OLYMPIA-1)
Study Description

The University of Virginia is conducting a clinical research study for adults ages 18 and over with previously untreated follicular lymphoma (a type of non-Hodgkin lymphoma or NHL). The study is researching a study drug. Please note that this clinical trial will use an investigational drug product, the safety and efficacy of which has not been fully evaluated by Regulatory Authorities and which has not received marketing authorization in any country. This study will be made up of two parts: Part 1 and Part 2. The aim of Part 1 of the study is to see how tolerable the study drug is. The aim of Part 2 of the study is to assess how study drug works compared to rituximab and chemotherapy (the current standard of care for NHL). The study doctor will tell you which part of the study you are joining. In part 1 of the study, you will come into the clinic to receive infusions of study drug . In part 2 of the study, you will be randomly (by chance, like flipping a coin) assigned to receive one of the following treatments. You will have an equal (50%) chance of receiving either of these:
• Arm A: Study drug induction treatment followed by study drug maintenance treatment
• Arm B: Rituximab and chemotherapy (R-CHOP, R-CVP, or BR) induction treatment selected by the study doctor followed by rituximab maintenance treatment
The length of your participation in this study will vary depending on how your body reacts to the study drugYou will receive the study drug via an IV infusion.
Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.

Additional information can be found here: https://classic.clinicaltrials.gov/ct2/show/NCT06091254

uvacancertrials@hscmail.mcc.virginia.edu

Compensation

No Compensation