OLYMPIA-3 R1979-ONC-2105
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 (O-CHOP) Versus Rituximab in Combination With CHOP (R-CHOP) in Previously Untreated Participants With Diffuse Large B-cell Lymphoma (DLBCL) (OLYMPIA-3)
Trial summary:
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”), have come back after treatment (called “relapsed”), or have not responded to treatment (called “refractory”).
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 and chemotherapy, the current standard of care treatment approved for Non-Hodgkin’s lymphoma (NHL). Standard of care means the usual medication expected and used when receiving treatment for a condition.
Receptor status / problem studied:
Inclusion criteria
1) Previously untreated participants for lymphoma with documented cluster of differentiation 20+ (CD20+) DLBCL, as described in the protocol OR relapsed or refractory DLBCL (Part 1A only).
2) Measurable disease with at least one nodal lesion or at least one extranodal lesion, as described in the protocol.
3) Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
4) Life expectancy ≥ 12 months.
5) International Prognostic Index (IPI) of 3 to 5 (part 1 only) and ≥2 (part 2) for untreated DLBCL only.
6) Adequate hematologic and organ function, as defined in the protocol.
Exclusion criteria
1) Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS NHL and history or current relevant CNS pathology.
2) Another active malignancy, significant active disease or medical condition, as described in the protocol.
3) Peripheral neuropathy Grade ≥3.
4) Treatment with any systemic anti-lymphoma therapy.
5) Any investigational therapy within 28 days or 5 half-lives of the drug, whichever is shorter, prior to the start of study treatment.
6) Recent major surgery, prior organ transplantation, or standard radiotherapy, as described in the protocol.
7) Allergy/hypersensitivity to study drugs, as described in the protocol.
8) Infections such as any active infection (bacterial, viral, fungal, mycobacterial, parasitic or other), active Coronavirus disease (COVID-19) infection, uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV), Cytomegalovirus (CMV) infection, as described in the protocol.
Trial Title
OLYMPIA-3 / R1979-ONC-2105
Diagnosis
Lymphoma – B-cell Non Hodgkin’s
Type of trial
Pharmaceutical
Type of treatement
Haematology
Phase
III