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)
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)
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:
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined inclusion/exclusion criteria apply
clinicaltrials@regeneron.com844-734-6643
Salzburg, 5020, Austria
Ghent, Oost-Vlaanderen 9000, Belgium
Salvador, Estado de Bahia 41950640, Brazil
Belo Horizonte, Minas Gerais 30380-420, Brazil
Passo Fundo, Rio Grande do Sul 99010-080, Brazil
Ribeirão Preto, São Paulo 14048-900, Brazil
Greenfield Park, Quebec J4V 2H1, Canada
Sherbrooke, Quebec J1H 5N4, Canada
Santiago, Santiago Metropolitan 7560907, Chile
Tours, Centre-Val de Loire 37044, France
Mainz, Rhineland-Palatinate 55131, Germany
Ascoli Piceno, 63100, Italy
Wałbrzych, Lower Silesian Voivodeship 58-309, Poland
Lublin, 20-954, Poland
Warsaw, 02781, Poland
Suwon, Gyeonggi-do 16247, South Korea
Santiago de Compostela, A Coruna 15706, Spain
Yenimahalle, Ankara 06200, Turkey (Türkiye)
Truro, Cornwall TR1 3LJ, United Kingdom