A Phase 3, Open Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Combination With Lenalidomide Versus Rituximab in Combination With Lenalidomide in Relapsed/Refractory Participants With Follicular Lymphoma and Marginal Zone Lymphoma (OLYMPIA-5)
A Phase 3, Open Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Combination With Lenalidomide Versus Rituximab in Combination With Lenalidomide in Relapsed/Refractory Participants With Follicular Lymphoma and Marginal Zone Lymphoma (OLYMPIA-5)
This study is researching an experimental drug called odronextamab (referred to as study drug), in combination with lenalidomide. The study is focused on participants who have one of two types of cancer: Follicular Lymphoma (FL) or Marginal Zone Lymphoma (MZL) that has come back after treatment (called "relapsed") or did not respond to treatment (called "refractory"). FL and MZL are subtypes of Non-Hodgkin 's Lymphoma (NHL).
This study will be made up of two parts (Part 1 not randomized, Part 2 randomized - controlled).
The aim of Part 1 of the study is to see how safe and tolerable the study drug is when used in combination with lenalidomide, in participants with FL or MZL, and to determine the dose of the study drug to be used in Part 2 of this study. This combination is considered "first-in-human" as it has not been tested as a combination treatment in humans before.
The aim of Part 2, of the study is to assess how well the combination of the study drug and lenalidomide works compared to the combination of rituximab (called "the comparator drug") and lenalidomide. The combination of comparator drug and lenalidomide is the current standard-of-care treatment for relapsed/refractory FL and/or MZL. 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:
Local histologic confirmation of FL grade 1-3a or MZL (nodal, splenic, or extra nodal MZL) as assessed by the investigator, as described in the protocol.
Must have refractory disease or relapsed after at least 1 prior line (with a duration of at least 2 cycles) of systemic chemo-immunotherapy or immunotherapy. Prior systemic therapy should have included at least one anti-Cluster of Differentiation 20 (CD20) monoclonal antibody, and participant should meet indication for treatment, as described in the protocol.
Have measurable disease on cross sectional imaging documented by diagnostic Computed Tomography [CT], or Magnetic Resonance Imaging [MRI] imaging, as described in the protocol.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Adequate hematologic and organ function, as described in the protocol.
All study participants must:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/Exclusion criteria apply
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Indianapolis, Indiana 46202, United States
Yvoir, Namur 5530, Belgium
Ghent, Oost-Vlaanderen 9000, Belgium
Tours, Centre-Val de Loire 37044, France
Mainz, Rhineland-Palatinate 55131, Germany
Meldola, Forli-Cesena 47014, Italy
Aviano, Pordenone 33081, Italy
Bologna, 40138, Italy
Kuala Lumpur, Negeri / Wilayah Persekutuan 50603, Malaysia
Ampang, Selangor 68000, Malaysia
Wałbrzych, Lower Silesian Voivodeship 58-309, Poland
Lublin, Lublin Voivodeship 20-090, Poland
Lodz, 93-513, 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
Great Yarmouth, NR31 6LA, United Kingdom
Romford, RM7 0AG, United Kingdom