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:
* What side effects may happen from taking the study drug when combined with chemotherapy * 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) * The impact from the study drug on quality of life and ability to complete routine daily activities
Previously untreated participants for lymphoma with documented Cluster of Differentiation 20+ (CD20+) DLBCL, as described in the protocol OR relapsed or refractory DLBCL, for whom next available standard of care therapy is not available or deemed ineligible according to the investigator (Part 1A only)
Measurable disease with at least one nodal lesion or at least one extranodal lesion, as described in the protocol
Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Life expectancy ≥ 12 months
Primary Central Nervous System (CNS) lymphoma or known involvement by non-primary CNS NHL and history or current relevant CNS pathology
Another active malignancy, significant active disease or medical condition, as described in the protocol
Peripheral neuropathy Grade ≥3
Treatment with any systemic anti-lymphoma therapy, except for participants with Relapsed/Refractory (R/R) DLBCL and participants with DLBCL transformed from an indolent lymphoma after treatment with systemic anti-lymphoma therapy.
Parallel
Odronextamab
DrugOdronextamab will be administered by intravenous (IV) infusion
Rituximab
DrugRituximab will be administered IV, or subcutaneously (SC)
Cyclophosphamide
DrugCyclophosphamide will be administered IV as part of chemotherapy
Doxorubicin
DrugDoxorubicin will be administered IV as part of chemotherapy
Vincristine
DrugVincristine will be administered IV as part of chemotherapy
Prednisone/Prednisolone
DrugPrednisone or prednisolone will be administered orally (PO) as part of chemotherapy
Incidence of Dose Limiting Toxicities (DLTs)
Part 1A
Incidence of Treatment Emergent Adverse Events (TEAEs)
Part 1
Severity of TEAEs
Part 1
Progression Free Survival (PFS), assessed by Independent Central Review (ICR)
Part 2
Event-Free Survival (EFS) assessed by ICR
Part 2
Complete Response (CR) assessed by ICR
Part 2
Overall Survival (OS)
Part 2
Best Overall Response (BOR) as assessed by local investigators
Part 1 and Part 2
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