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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)


Description

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 when given alone. The aim of Part 2 of the study is to see how the study drug works compared to rituximab (called the "comparator drug") 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: * What side effects may happen from taking the study drug * 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

Trial Eligibility

Key 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 Key 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 NOTE: Other protocol defined inclusion/exclusion criteria apply

Study Info

Organization

Regeneron Pharmaceuticals


Primary Outcome

Incidence of dose-limiting toxicities (DLTs) for odronextamab


Outcome Timeframe Up to 35 days

NCTID NCT06091254

Phases PHASE3

Primary Purpose TREATMENT

Start Date 2023-12-12

Completion Date 2029-04-04

Enrollment Target 478

Interventions

DRUG Odronextamab

DRUG Rituximab

DRUG Cyclophosphamide

DRUG Doxorubicin

DRUG Vincristine

DRUG Prednisone/prednisolone

DRUG Bendamustine

Locations Recruiting

Arizona Health Sciences Center - The University of Arizona Cancer Center

United States, Arizona, Tucson


UCLA Clinical and Translational Research Center (CTRC)

United States, California, Los Angeles


University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center

United States, California, Orange


Investigative Clinical Research of Indiana, LLC

United States, Indiana, Noblesville


Beth Israel Deaconess Medical Center

United States, Massachusetts, Boston


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