OLYMPIA-1 R1979-HM-2298
A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 X Anti-CD3 Bispecific Antibody Versus Investigator’s Choice in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-1)
Trial summary:
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 (a type of non-Hodgkin lymphoma or NHL).
This study will be made up of two parts: Part 1 (non-randomized) and Part 2 (randomized – controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is. The aim of Part 2 of the study is to see how the study drug works compared to 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.
Receptor status / problem studied:
Inclusion criteria
1) Diagnosis of cluster of differentiation 20^+ (CD20^+) FL Grade 1-3a, stage II bulky or stage III / IV.
2) Need for treatment as described in the protocol.
3) Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed tomography (CT) or Magnetic resonance imaging (MRI).
4) Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
5) Adequate bone marrow function and hepatic function.
Exclusion criteria
1) Central nervous system (CNS) lymphoma or leptomeningeal lymphoma.
2) Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma.
3) Waldenström macroglobulinemia (WM, lymphoplasmacytic lymphoma), Grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma.
4) Treatment with any systemic anti-lymphoma therapy.
5) Infections and allergy/hypersensitivity to study drug or excipient.
Trial Title
OLYMPIA-1 / R1979-HM-2298
Diagnosis
Lymphoma – B-cell Non Hodgkin’s
Type of trial
Pharmaceutical
Type of treatement
Haematology
Phase
III