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)
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)
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:
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/ Exclusion criteria apply
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Indianapolis, Indiana 46202, United States
Indianapolis, Indiana 46260, United States
Baltimore, Maryland 21201, United States
Grand Rapids, Michigan 49503, United States
Ghent, Oost-Vlaanderen 9000, Belgium
Santiago, Santiago Metropolitan 7560907, Chile
Quimper, Brittany Region 29107, France
Marseille, 130005, France
Mainz, Rhineland-Palatinate 55131, Germany
Meldola, Forli-Cesena 47014, Italy
Turin, Piedmont 10137, Italy
Ampang, Selangor 68000, Malaysia
Gdansk, 80-952, Poland
Lublin, 20-954, Poland
Lodz, Łódź Voivodeship 93-510, Poland
Suwon, Gyeonggi-do 16247, South Korea
Santiago de Compostela, A Coruna 15706, Spain
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Valencia, 46026, Spain
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