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RecruitingInterventionalPhase 3

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)

NCT ID: NCT06091254Sponsor: Regeneron PharmaceuticalsLast updated: 2026-05-19

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 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.

Arms & interventions

  • DrugOdronextamab

    Administered per the protocol

  • DrugRituximab

    Administered per the protocol

  • DrugCyclophosphamide

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

  • DrugDoxorubicin

    Administered per the protocol as part of CHOP chemotherapy

  • DrugVincristine

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

  • DrugPrednisone/prednisolone

    Administered per the protocol as part of CVP chemotherapy

  • DrugBendamustine

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

Outcome measures

Primary

  • Incidence of Dose-Limiting Toxicities (DLTs) for odronextamab

    Part 1

    Time frame: Up to 35 days

  • Incidence of Treatment-Emergent Adverse Events (TEAEs) of odronextamab

    Part 1

    Time frame: Up to 2 years

  • Severity of TEAEs of odronextamab

    Part 1

    Time frame: Up to 2 years

  • Complete Response at 30 months (CR30) as assessed by independent central review

    Part 2

    Time frame: Up to 30 months

Secondary

  • Concentrations of odronextamab in serum

    Time frame: Up to 30 months

  • Occurrence of Anti-Drug Antibodies (ADAs) to odronextamab

    Time frame: Up to 30 months

  • Magnitude of ADAs to odronextamab

    Time frame: Up to 30 months

  • Objective response as assessed by the investigator

    Time frame: Up to 30 months

  • Progression-Free Survival (PFS) as assessed by independent central review

    Time frame: Up to 5 years

  • Event-Free Survival (EFS) as assessed by independent central review

    Time frame: Up to 5 years

  • Overall Survival (OS)

    Time frame: Up to 5 years

  • Overall mean change in physical function [European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC-QLQ-C30)]

    Time frame: Up to 5 years

  • CR30 as assessed by local investigator

    Time frame: Up to 30 months

  • PFS as assessed by the local investigator

    Time frame: Up to 5 years

  • EFS as assessed by the local investigator

    Time frame: Up to 5 years

  • Objective response assessed by local investigator

    Time frame: Up to 30 months

  • Objective response assessed by independent central review

    Time frame: Up to 30 months

  • Duration Of Response (DOR) assessed by independent central review

    Time frame: Up to 5 years

  • DOR assessed by local investigator

    Time frame: Up to 5 years

  • Time To Next anti-lymphoma Treatment (TTNT)

    Time frame: Up to 5 years

  • Incidence of TEAEs

    Time frame: Up to 2 years

  • Severity of TEAEs

    Time frame: Up to 2 years

  • Odronextamab concentrations in serum during the induction period

    Time frame: Up to 30 months

  • Odronextamab concentrations in serum during the maintenance period

    Time frame: Up to 30 months

  • Occurrence of ADAs to odronextamab

    Time frame: Up to 30 months

  • Magnitude of ADAs to odronextamab

    Time frame: Up to 30 months

  • Overall mean changes in scores of patient reported outcomes (PROs), as measured by the validated instruments EORTCQLQ- C30

    Time frame: Up to 5 years

  • Overall mean changes in scores of PROs, as measured by the validated instruments Functional Assessment of Cancer Therapy-Lymphoma (FACT-LymS)

    Time frame: Up to 5 years

  • Overall mean changes in scores of PROs, as measured by the validated instruments EuroQol-5 Dimension-5 Level Scale (EQ-5D- 5L)

    Time frame: Up to 5 years

  • Change in Patient Global Impression of Severity (PGIS)

    Time frame: Up to 5 years

  • Change in Patient Global Impression of Change (PGIC)

    Time frame: Up to 5 years

  • Change in score of the GP5 item in the participant population

    Time frame: Up to 5 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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

Study locations (20)

University of Arizona Cancer Center

Tucson, Arizona, 85724

Recruiting

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095

Recruiting

UC Irvine Health

Orange, California, 92868

Withdrawn

Investigative Clinical Research of Indiana

Noblesville, Indiana, 46062

Recruiting

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

Recruiting

Karmanos Cancer Institute

Detroit, Michigan, 48201

Recruiting

Hattiesburg Clinic

Hattiesburg, Mississippi, 39401

Completed

Icahn School of Medicine at Mt Sinai

New York, New York, 10029

Recruiting

Stony Brook University Hospital

Stony Brook, New York, 11794

Recruiting

Clinical Research Alliance Inc

Westbury, New York, 11590

Withdrawn

University of North Carolina

Chapel Hill, North Carolina, 27514

Recruiting

Levine Cancer Institute

Charlotte, North Carolina, 28207

Recruiting

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

Recruiting

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

Recruiting

Center for Oncology and Blood Disorders

Houston, Texas, 77030

Recruiting

HOPE Cancer Center of East Texas

Tyler, Texas, 75701

Withdrawn

Huntsman Cancer Institute - Oncology Division

Salt Lake City, Utah, 84112

Recruiting

University of Virginia

Charlottesville, Virginia, 22908

Recruiting

Virginia Commonwealth University

Richmond, Virginia, 23219

Withdrawn

Prohealth Care Inc

Waukesha, Wisconsin, 53188

Withdrawn