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A Phase 3, Open Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Combination with Lenalidomide Versus Rituximab in Combination with Lenalidomide in Relapsed/Refractory Participants with Follicular Lymphoma and Marginal Zone Lymphoma (OLYMPIA-5)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-503092-28-00
Acronym
R1979-ONC-22102
Enrollment
234
Registered
2023-09-25
Start date
2024-01-08
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed/Refractory Follicular Lymphoma, Relapsed/Refractory Marginal Zone Lymphoma (MZL)

Brief summary

Part 1: Incidence of dose limiting toxicities (DLTs) for odronextamab in combination with lenalidomide, Part 1: Incidence of treatment emergent adverse events (TEAEs) for odronextamab in combination with lenalidomide, Part 1: Severity of TEAEs for odronextamab in combination with lenalidomide, Part 2: Progression-free survival (PFS) as assessed by independent central review (ICR) in participants with R/R FL and participants with indolent lymphoma (FL and MZL)

Detailed description

Part 1 & 2: Odronextamab concentrations in serum, Part 1 & 2: Incidence of anti-drug antibodies (ADA) to odronextamab over the study duration, Part 1 & 2: Titer of ADAs to odronextamab over the study duration, Part 1 & 2: Incidence of neutralizing antibodies (NAbs) to odronextamab over the study duration, Part 1 & 2: Best overall response (BOR) as assessed by investigator review, Part 1 & 2: Duration of response (DOR) as assessed by investigator review, Part 1 & 2: PFS as assessed by investigator review, Part 2: Complete response (CR) as assessed by ICR, Part 2: BOR as assessed by ICR, Part 2: Overall survival (OS), Part 2: Event free survival (EFS) as assessed by ICR, Part 2: EFS as assessed by local investigator review, Part 2: DOR as assessed by ICR, Part 2: Time to next anti-lymphoma treatment (TTNT), Part 2: Incidence of TEAEs for odronextamab in combination with lenalidomide versus R2, Part 2: Severity of TEAEs for odronextamab in combination with lenalidomide versus R2, Part 2: Overall change in patient reported outcomes (PROs) as measured by scores of European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQC30), Part 2: Overall change in PROs as measured by scores of Functional Assessment of Cancer Therapy–Lymphoma Subscale (FACT-LymS), Part 2: Overall change in PROs as measured by scores of Patient Global Impression on Severity (PGIS), Part 2: Overall change in PROs as measured by scores of Patient Global Impression on Change (PGIC), Part 2: Overall change in PROs as measured by scores of EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L), Part 2: Overall change in score of the global population item 5 (GP5) items of the Functional Assessment of Cancer Therapy–General (FACT-G) questionnaire

Interventions

DRUGOdronextamab
DRUGLENALIDOMIDE
DRUGTruxima 500 mg concentrate for solution for infusion

Sponsors

Regeneron Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Part 1: Incidence of dose limiting toxicities (DLTs) for odronextamab in combination with lenalidomide, Part 1: Incidence of treatment emergent adverse events (TEAEs) for odronextamab in combination with lenalidomide, Part 1: Severity of TEAEs for odronextamab in combination with lenalidomide, Part 2: Progression-free survival (PFS) as assessed by independent central review (ICR) in participants with R/R FL and participants with indolent lymphoma (FL and MZL)

Secondary

MeasureTime frame
Part 1 & 2: Odronextamab concentrations in serum, Part 1 & 2: Incidence of anti-drug antibodies (ADA) to odronextamab over the study duration, Part 1 & 2: Titer of ADAs to odronextamab over the study duration, Part 1 & 2: Incidence of neutralizing antibodies (NAbs) to odronextamab over the study duration, Part 1 & 2: Best overall response (BOR) as assessed by investigator review, Part 1 & 2: Duration of response (DOR) as assessed by investigator review, Part 1 & 2: PFS as assessed by investigator review, Part 2: Complete response (CR) as assessed by ICR, Part 2: BOR as assessed by ICR, Part 2: Overall survival (OS), Part 2: Event free survival (EFS) as assessed by ICR, Part 2: EFS as assessed by local investigator review, Part 2: DOR as assessed by ICR, Part 2: Time to next anti-lymphoma treatment (TTNT), Part 2: Incidence of TEAEs for odronextamab in combination with lenalidomide versus R2, Part 2: Severity of TEAEs for odronextamab in combination with lenalidomide versus R2, Part 2:

Countries

Austria, Belgium, Czechia, France, Germany, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026