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Protocol NumberR1979-ONC-2105
Active

2023-06-01 - 2028-11-27

Phase III

Recruiting9

A Phase 3, Open label, Randomized Study Comparing the Efficacy and Safety of Odronex tamab (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 Bcell Lymphoma (DLBCL) (OLYMPIA-3)

  • Trial Applicant

    ICON Clinical Research Pte Ltd

  • Sponsor

    Regeneron Pharmaceuticals, Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator WEI-LI MA Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 謝耀宇 Division of Hematology & Oncology
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 黃慈恩 Division of Hematology & Oncology
Chiayi Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳宇欽 Division of Hematology & Oncology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 邱玲榕 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hung Chang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 王全正 Division of Hematology & Oncology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shih-Feng Cho Division of Hematology & Oncology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tzeon-jye Chiou
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Previously Untreated Participants with Diffuse Large Bcell Lymphoma (DLBCL)

Objectives

To assess the safety, tolerability and dose limiting toxicities (DLTs) of odronextamab in combination with CHOP (Odro-CHOP) in participants previously untreated for Diffuse Large B-Cell Lymphoma (DLBCL) with high-risk features, or participants with relapsed or refractory DLBCL (Part 1A), and to determine the dose of odronextamab to combine with CHOP in Part 2.

Test Drug

injection

Active Ingredient

REGN1979
Rituximab

Dosage Form

401
270

Dosage

2 mg/mL
100mg/10ml

Endpoints

• Incidence of DLTs during the DLT
observation period
• Incidence and severity of treatment emergent
adverse events (TEAEs)

Inclution Criteria

1. Previously untreated participants for lymphoma with *documented CD20+ DLBCL
including one of the following diagnoses as per 2016 WHO classification of lymphoid
neoplasms:
a. **DLBCL, not otherwise specified (NOS) including germinal center B-cell type,
activated B-cell type.
b. High grade B-cell neoplasm, with MYC, bcl-2 and/or bcl-6 rearrangements
For Part 1 only:
• Participants with untreated DLBCL will need to have at least one of the high-risk
features to be eligible. High-risk features include, but are not limited to, IPI score 3 to
5, cell of origin (non-GCB type), double-hit or triple-hit lymphoma (classified as
high-grade B-cell neoplasm, with MYC, bcl-2 and/or bcl-6 rearrangements according
to 2016 WHO classification of lymphoid neoplasms), TP53 mutations, CDKN2A
loss, etc (Sehn, 2021),
OR
• Participants with 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).

Exclusion Criteria

1. Primary central nervous system (CNS) lymphoma or known involvement by non-primary
CNS NHL.
2. History of or current relevant CNS pathology, such as:
i. epilepsy, seizure, paresis, aphasia, apoplexy, severe brain injury, cerebellar disease,
organic brain syndrome, psychosis, or
ii. evidence for presence of inflammatory lesions and/or vasculitis on cerebral MRI
3. Peripheral neuropathy Grade ≥3.
4. Another active malignancy (aside from B-cell NHL) in the past 5 years, with the
following exceptions: non-melanoma skin cancer that has undergone potentially curative
therapy, in situ cervical carcinoma, or any other tumor that has been deemed to be
effectively treated with definitive local control and with curative intent.
5. Any other significant active disease or medical condition that could interfere with the
conduct of the study or put the participant at significant risk, including but not limited to
significant cardiovascular disease (eg, New York Heart Association Class III or IV
cardiac disease, myocardial infarction within the previous 6 months, unstable
arrhythmias, or unstable angina) or significant pulmonary disease (eg, obstructive
pulmonary disease and history of symptomatic bronchospasm).
6. Treatment with any systemic anti-lymphoma therapy, except for participants with R/R
DLBCL and participants with DLBCL transformed from an indolent follicular lymphoma
after treatment with systemic anti-lymphoma therapy.
7. 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.
8. Recent major surgery (within 4 weeks prior to the start of study treatment).
9. Standard radiotherapy within 14 days of first administration of study treatment.

The Estimated Number of Participants

  • Taiwan

    40 participants

  • Global

    904 participants

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