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RecruitingInterventionalPhase 3

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 (ODRO-CHOP) Versus Rituximab in Combination With CHOP (R-CHOP) in Previously Untreated Participants With Diffuse Large B-cell Lymphoma (DLBCL) (OLYMPIA-3)

NCT ID: NCT06091865Sponsor: Regeneron PharmaceuticalsLast updated: 2026-06-15

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"). Patients with DLBCL that have come back after treatment (called "relapsed"), or have not responded to treatment (called "refractory"), can also participate in this study. 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 (the comparator drug), and chemotherapy, the current standard of care treatment approved for DLBCL. 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 when combined with chemotherapy * 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) * The impact from the study drug on quality of life and ability to complete routine daily activities

Arms & interventions

  • DrugOdronextamab

    Odronextamab will be administered by intravenous (IV) infusion

  • DrugRituximab

    Rituximab will be administered IV, or subcutaneously (SC)

  • DrugCyclophosphamide

    Cyclophosphamide will be administered IV as part of chemotherapy

  • DrugDoxorubicin

    Doxorubicin will be administered IV as part of chemotherapy

  • DrugVincristine

    Vincristine will be administered IV as part of chemotherapy

  • DrugPrednisone/Prednisolone

    Prednisone or prednisolone will be administered orally (PO) as part of chemotherapy

Outcome measures

Primary

  • Incidence of Dose Limiting Toxicities (DLTs)

    Part 1A

    Time frame: Up to 35 days

  • Incidence of Treatment Emergent Adverse Events (TEAEs)

    Part 1

    Time frame: Up to 2 years

  • Severity of TEAEs

    Part 1

    Time frame: Up to 2 years

  • Progression Free Survival (PFS), assessed by Independent Central Review (ICR)

    Part 2

    Time frame: Up to 5 years

Secondary

  • Event-Free Survival (EFS) assessed by ICR

    Time frame: Up to 5 years

  • Complete Response (CR) assessed by ICR

    Time frame: Up to 22 weeks

  • Overall Survival (OS)

    Time frame: Up to 5 years

  • Best Overall Response (BOR) as assessed by local investigators

    Time frame: Up to 22 weeks

  • CR as assessed by local investigators

    Time frame: Up to 22 weeks

  • Duration of Response (DOR) as assessed by local investigators

    Time frame: Up to 5 years

  • Odronextamab concentrations in serum when administered with CHOP

    Time frame: Up to 22 weeks

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

    Time frame: Up to 22 weeks

  • Magnitude of ADA to odronextamab

    Time frame: Up to 22 weeks

  • PFS assessed by local investigator review

    Time frame: Up to 5 years

  • EFS assessed by local investigator review

    Time frame: Up to 5 years

  • BOR assessed by ICR

    Time frame: Up to 22 weeks

  • DOR assessed by ICR

    Time frame: Up to 5 years

  • Incidence of TEAEs

    Time frame: Up to 2 years

  • Severity of TEAEs

    Time frame: Up to 2 years

  • Minimal Residual Disease (MRD) status

    Time frame: Up to 22 weeks

  • Change in physical functioning as measured by European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C) 30

    Time frame: Up to 5 years

  • Change in patient reported outcomes, as measured by EORTC QLQ-C30

    Time frame: Up to 5 years

  • Change in patient reported outcomes, as measured by Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS)

    Time frame: Up to 5 years

  • Change in patient reported outcomes, as measured by Patient Global Impression of Severity (PGIS)

    Time frame: Up to 5 years

  • Change in patient reported outcomes, as measured by Patient Global Impression of Change (PGIC)

    Time frame: Up to 5 years

  • Change in patient reported outcomes, as measured by EuroQol-5 Dimension-5 Level Scale (EQ-5D-5L)

    Time frame: Up to 5 years

  • Change in score of the Functional Assessment of Cancer Therapy-General (FACT-G ) GP5 item

    Time frame: Up to 5 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Key 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, for whom next available standard of care therapy is not available or deemed ineligible according to the investigator (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. Key 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, except for participants with Relapsed/Refractory (R/R) DLBCL and participants with DLBCL transformed from an indolent lymphoma after treatment with systemic anti-lymphoma therapy. 5. Any other therapy or investigational treatment 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. Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Study locations (20)

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095

Recruiting

University of California Irvine Medical Center

Orange, California, 92868

Recruiting

University of California (UC) Davis

Sacramento, California, 95817

Recruiting

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202

Recruiting

St Vincent Ascension at Peyton Manning Childrens Hospital

Indianapolis, Indiana, 46260

Recruiting

Investigative Clinical Research of Indiana

Noblesville, Indiana, 46062

Recruiting

University of Kentucky

Lexington, Kentucky, 40536

Recruiting

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201

Recruiting

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

Recruiting

Henry Ford Health System

Detroit, Michigan, 48202

Recruiting

Cancer and Hematology Centers of Western Michigan

Grand Rapids, Michigan, 49503

Recruiting

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901

Recruiting

Stony Brook University Hospital

Stony Brook, New York, 11794

Recruiting

Clinical Research Alliance Inc

Westbury, New York, 11590

Withdrawn

Duke University Medical Center

Durham, North Carolina, 27710

Recruiting

East Carolina University

Greenville, North Carolina, 27834

Recruiting

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

Recruiting

Center for Oncology and Blood Disorders

Houston, Texas, 77030

Withdrawn

Community Cancer Trials of Utah

Ogden, Utah, 84405

Recruiting

Prohealth Care Inc

Waukesha, Wisconsin, 53188

Withdrawn