NCT06091254

A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 822 (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. The study is focused on participants with previously untreated follicular lymphoma (a type of non-Hodgkin lymphoma or NHL). This study will be made up of two parts: Part 1 (non-randomized) and Part 2 (randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is when given alone. The aim of Part 2 of the study is to see how the study drug works compared to rituximab (called the "comparator drug") and chemotherapy (the current standard of care for NHL). 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 * 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) * How the study drug affects quality of life and ability to complete routine daily activities.

Conditions

• Follicular Lymphoma (FL)

Interventions

Type	Name	Description
DRUG	Odronextamab	Administered per the protocol
DRUG	Rituximab	Administered per the protocol
DRUG	Cyclophosphamide	Administered per the protocol as part of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) chemotherapy, or Cyclophosphamide, Vincristine, Prednisone (CVP) chemotherapy
DRUG	Doxorubicin	Administered per the protocol as part of CHOP chemotherapy
DRUG	Vincristine	Administered per the protocol as part of CHOP, and CVP chemotherapy
DRUG	Prednisone/prednisolone	Administered per the protocol as part of CVP chemotherapy
DRUG	Bendamustine	Administered per the protocol as part of chemotherapy (Rituximab-Bendamustine)

Timeline

• Start date: 2023-12-12
• Primary completion: 2028-02-07
• Completion: 2029-11-03
• First posted: 2023-10-19
• Last updated: 2026-03-11

Locations

190 sites across 19 countries: United States, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, France, Germany, Israel, Italy, Poland, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study