NCT06091865

A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Patients With Previously Untreated Diffuse Large B-cell Lymphoma

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 (ODRO-CHOP) Versus Rituximab in Combination With CHOP (R-CHOP) in Previously Untreated Participants With Diffuse Large B-cell Lymphoma (DLBCL) (OLYMPIA-3)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 904 (estimated)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is researching an experimental drug called odronextamab, referred to as study drug, when used in combination with chemotherapy. The study is focused on patients with Diffuse Large B-cell Lymphoma (DLBCL) that have not been treated before (called "previously untreated"). Patients with DLBCL that have come back after treatment (called "relapsed"), or have not responded to treatment (called "refractory"), can also participate in this study. This study will be made up of Part 1A, Part 1B, and Part 2.The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy in Part 2 of the study. The aim of Part 2 of the study is to see how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab (the comparator drug), and chemotherapy, the current standard of care treatment approved for DLBCL. Standard of care means the usual medication expected and used when receiving treatment for a condition. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug when combined with chemotherapy * How much study drug is in the 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 quality of life and ability to complete routine daily activities

Conditions

• Diffuse Large B-cell Lymphoma (DLBCL)

Interventions

Type	Name	Description
DRUG	Odronextamab	Odronextamab will be administered by intravenous (IV) infusion
DRUG	Rituximab	Rituximab will be administered IV, or subcutaneously (SC)
DRUG	Cyclophosphamide	Cyclophosphamide will be administered IV as part of chemotherapy
DRUG	Doxorubicin	Doxorubicin will be administered IV as part of chemotherapy
DRUG	Vincristine	Vincristine will be administered IV as part of chemotherapy
DRUG	Prednisone/Prednisolone	Prednisone or prednisolone will be administered orally (PO) as part of chemotherapy

Timeline

• Start date: 2023-12-13
• Primary completion: 2028-03-30
• Completion: 2029-09-02
• First posted: 2023-10-19
• Last updated: 2026-02-05

Locations

149 sites across 20 countries: United States, Australia, Austria, Belgium, Chile, Czechia, France, Germany, Ireland, Israel, Italy, Malaysia, Poland, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study