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 (O-CHOP) versus Rituximab in Combination with CHOP (R-CHOP) in Previously Untreated Participants with Diffuse Large B-cell Lymphoma (DLBCL) (OLYMPIA-3).
Part 1 (safety run-in):
Primary objective:
To assess the safety, tolerability and dose limiting toxicities (DLTs) of odronextamab in combination with CHOP (O-CHOP) in participants previously untreated for Diffuse Large B-Cell Lymphoma (DLBCL) with high-risk features and determine the dose of odronextamab
to combine with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) in Part 2.
Secondary objectives:
a. To evaluate the preliminary anti-tumor activity of O-CHOP in participants with previously untreated DLBCL with high-risk features
b. To evaluate the pharmacokinetics (PK) of odronextamab when administered in combination with CHOP
c. To assess the immunogenicity of odronextamab when administered in combination with CHOP
Part 2 (randomized portion):
Primary objective: To compare the efficacy of O-CHOP with that of R-CHOP in participants with previously untreated DLBCL with an (International Prognostic Index) IPI score ≥3, and subsequently in all participants with an IPI score ≥2
Key secondary objective:
To compare therapeutic benefit with O-CHOP versus that with R-CHOP assessed by event-free survival (EFS), complete response (CR) and overall survival (OS)
Secondary objectives:
a. To compare supplemental measures of efficacy for O-CHOP versus R-CHOP
b. To compare safety and tolerability of O-CHOP with that of R-CHOP
c. To evaluate the PK of odronextamab when administered in combination with CHOP
d. To assess the immunogenicity of odronextamab
when administered in combination with CHOP
e. To compare measurable residual disease (MRD) with O-CHOP versus R-CHOP
f. To compare the treatment effects on patient reported physical function between O-CHOP and R-CHOP
g. To compare the treatment effects of O-CHOP versus R-CHOP on patient reported outcomes (PROs) including health-related quality of life, functioning and disease-related symptoms, as measured by EORTC QLQ-C30, FACT-LymS, EQ-5D-5L, two global anchors Patient Global Impression of Severity (PGIS) and Patient Global Impression of Change (PGIC), collected during study visits
h. To evaluate the overall impact of treatment toxicity based upon the single item GP5 of the validated FACT-G questionnaire ( I am bothered by side effects of treatment )
Odronextamab(REGN1979)
- Rutgers Cancer Institute of New Jersey
- Principal Investigator
- Matthew Matasar
- Principal Investigator
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 (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
5. Any investigational therapy 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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.