A Phase 3, Open-Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20x Anti-CD3 Bispecific Antibody, Combined With Chemotherapy Versus Rituximab Combined With Chemotherapy in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-2)
A Phase 3, Open-Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20x Anti-CD3 Bispecific Antibody, Combined With Chemotherapy Versus Rituximab Combined With Chemotherapy in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-2)
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. Follicular lymphoma is a type of non-Hodgkin lymphoma or NHL. Participants with follicular lymphoma that has come back after treatment (called "relapsed") or did not respond to treatment (called "refractory") are eligible to take part only in Part 1A of the study.
This study is made up of 3 parts: Part 1A (non-randomized), Part 1B and Part 2 (randomized - controlled).
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 to be used in Part 2 of the study.
The aim of Part 2 of the study is to assess how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab 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:
Have diagnosis of cluster of differentiation 20 positive (CD20+) FL grade 1-3a, stage II bulky or stage III / IV
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 0-2
Adequate bone marrow and hepatic function.
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/Exclusion criteria apply
Salvador, Estado de Bahia 40050-410, Brazil
Passo Fundo, Rio Grande do Sul 99010-080, Brazil
Ribeirão Preto, São Paulo 14048-900, Brazil
Pessac, 33600, France
Turin, Piedmont 10137, Italy
Gdansk, 80-952, Poland
Lodz, 93-513, Poland
Lublin, 20-954, Poland
Warsaw, 02781, Poland
Yenimahalle, Ankara 06200, Turkey (Türkiye)
Birmingham, West Midlands B15 2SY, United Kingdom