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RECRUITINGPhase 3INTERVENTIONAL

A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 could lead to side effects) * How the study drug affects quality of life and ability to complete routine daily activities.

Who May Be Eligible (Plain English)

Key Who May Qualify: 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, as described in the protocol Key Who Should NOT Join This Trial: 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, as described in the protocol NOTE: Other protocol defined inclusion/exclusion criteria apply Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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, as described in the protocol 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, as described in the protocol NOTE: Other protocol defined inclusion/exclusion criteria apply

Treatments Being Tested

DRUG

Odronextamab

Administered per the protocol

DRUG

Rituximab

Administered per the protocol

DRUG

Cyclophosphamide

Administered per the protocol as part of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) chemotherapy, or Cyclophosphamide, Vincristine, Prednisone (CVP) chemotherapy

DRUG

Doxorubicin

Administered per the protocol as part of CHOP chemotherapy

DRUG

Vincristine

Administered per the protocol as part of CHOP, and CVP chemotherapy

DRUG

Prednisone/prednisolone

Administered per the protocol as part of CVP chemotherapy

DRUG

Bendamustine

Administered per the protocol as part of chemotherapy (Rituximab-Bendamustine)

Locations (20)

University of Arizona Cancer Center
Tucson, Arizona, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
UC Irvine Health
Orange, California, United States
Investigative Clinical Research of Indiana
Noblesville, Indiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Icahn School of Medicine at Mt Sinai
New York, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Clinical Research Alliance Inc
Westbury, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Center for Oncology and Blood Disorders
Houston, Texas, United States
HOPE Cancer Center of East Texas
Tyler, Texas, United States
Huntsman Cancer Institute - Oncology Division
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Prohealth Care Inc
Waukesha, Wisconsin, United States