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A Trial to Find Out if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma

Study acronym: OLYMPIA-5
StatusRecruiting
PhasePhase 3
Started2023-12-28
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 27 months later Jan 23, 2029 → Apr 30, 2031
Primary endpoint reworded 1 of 4 changed
See other at-risk trials from Regeneron

Amendment history

2026-08-12
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v43
Primary endpoint(s) modified4 entries, revised
WasIncidence of Dose Limiting Toxicities (DLTs) for odronextamab in combination with lenalidomide, Incidence of Treatment Emergent Adverse Events (TEAEs) for odronextamab in combination with lenalidomide, Progression-Free Survival (PFS) as assessed by Independent Central Review (ICR) in participants with R/R FL and participants with indolent lymphoma, Severity of TEAEs for odronextamab in combination with lenalidomide
NowIncidence of Dose Limiting Toxicities (DLTs) for odronextamab in combination with lenalidomide, Incidence of Treatment Emergent Adverse Events (TEAEs) for odronextamab in combination with lenalidomide, Progression-Free Survival (PFS) as assessed by Independent Central Review (ICR), Severity of TEAEs for odronextamab in combination with lenalidomide
Enrollment increased: 470 → 580 participants
Primary completion pushed: 2029-01-23 → 2031-04-30
Completion pushed: 2029-01-23 → 2031-04-30
Study sites169→171
Eligibility criteria+1 characters
[...] nti-Cluster of Differentiation 20 (CD20) monoclonal antibody, and participant should meet indication for treatment, as de [...]
Secondary endpoints21 entries, revised
Incidence of Anti-drugDrug Antibodies (ADA) to odronextamab Overall change in patientPatient reportedReported outcomesOutcomes (PROs) as measured by scores of European Organisation for R [...]
2026-05-05
Study Status, Contacts/Locations v42
Study sitesdetails revised at 5 of 169 sites
2026-04-10
Study Status, Contacts/Locations v41
Study sitesdetails revised at 5 of 169 sites
2026-03-20
Study Status, Contacts/Locations v40
Study sites168→169
2026-03-05
Study Status, Contacts/Locations v39
Study sites167→168
Show 38 earlier versions
2026-02-04
Study Status, Contacts/Locations v38
Study sites166→167
2026-01-28
Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v37
Study sites165→166
Eligibility criteria+18 characters
[...] aging documented by diagnostic Computed Tomography [CT], or magneticMagnetic resonanceResonance imagingImaging [MRI] imaging, as described in the protocol. Eastern Cooper [...] ary CNS NHL, as described in the protocol. Participants with current or past histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma, or any histolo [...] y, as described in the protocol. A malignancy other than NHL (inclusion diagnosis) unless the participant is adequately and definitively treat [...]
Secondary endpoints22 to 21 entries
Incidence of antiAnti-drug antibodiesAntibodies (ADA) to odronextamab over the study duration TiterMagnitude of ADAs to odronextamab over the study duration Incidence of neutralizing antibodies (NAbs) to odronextamab over the study duration Best overallOverall responseResponse (BOR) as assessed by investigator review Duration of responseResponse (DOR) as assessed by investigator review Complete responseResponse (CR) as assessed by ICR Overall survivalSurvival (OS) Event freeFree survivalSurvival (EFS) as assessed by ICR Time toTo nextNext anti-lymphoma treatmentTreatment (TTNT) OverallChange c [...] [...]
Primary endpoints4 entries, revised
Incidence of doseDose limitingLimiting toxicitiesToxicities (DLTs) for odronextamab in combination with lenalidomide Incidence of treatmentTreatment emergentEmergent adverseAdverse eventsEvents (TEAEs) for odronextamab in combination with lenalidomide Progression-freeFree survivalSurvival (PFS) as assessed by independentIndependent centralCentral reviewReview (ICR) in participants with R/R FL and participants with indolent lymphoma
Study title+3 characters
A Trial to LearnFind Out if Odronextamab Combined With Lenalidomide is Safe and Work [...]
2026-01-08
Study Status, Contacts/Locations v36
Study sites163→165
2025-12-16
Study Status, Contacts/Locations v35
Study sites162→163
2025-11-19
Study Status, Contacts/Locations v34
Study sites160→162
2025-11-05
Study Status, Contacts/Locations v33
Study sites159→160
2025-10-23
Study Status, Contacts/Locations v32
Study sites158→159
2025-10-08
Study Status, Contacts/Locations v31
Study sites153→158
2025-09-17
Study Status, Contacts/Locations v30
Study sites152→153
2025-09-12
Study Status, Contacts/Locations v29
Study sites149→152
2025-08-20
Study Status, Contacts/Locations v28
Study sites148→149
2025-07-29
Study Status, Contacts/Locations v27
Study sites146→148
2025-07-18
Study Status, References v26
Re-verified, no change to tracked fields
2025-07-09
Study Status, Contacts/Locations v25
Study sites144→146
2025-06-24
Study Status, Contacts/Locations, References v24
Study sites143→144
2025-05-30
Study Status, Contacts/Locations v23
Study sites142→143
2025-05-12
Study Status, Contacts/Locations v22
Study sites141→142
2025-05-05
Study Status, Contacts/Locations v21
Study sites131→141
2025-03-11
Study Status, Contacts/Locations v20
Study sites130→131
2025-02-18
Study Status, Contacts/Locations v19
Study sites129→130
2025-02-04
Study Status, Contacts/Locations v18
Study sites128→129
2025-01-13
Study Status, Contacts/Locations v17
Study sites124→128
2024-12-18
Study Status, Contacts/Locations v16
Study sites122→124
2024-12-11
Study Status, Contacts/Locations v15
Study sites118→122
2024-11-05
Study Status, Contacts/Locations v14
Study sites113→118
2024-10-01
Study Status, Contacts/Locations v13
Study sites109→113
2024-09-06
Study Status, Contacts/Locations v12
Study sites99→109
2024-08-27
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v11
Primary completion date2029-10-04→2029-01-23
Completion date2029-10-04→2029-01-23
Study sites93→99
Eligibility criteria+589 characters
[...] splenic, or extra nodal MZL) as assessed by the investigator, as described in the protocol. Must have refractory disease or relapsed after at least 1 prior line (with a duration of at least 2 cycles) of prior systemic chemo-immunotherapy or immunotherapy. Prior systemic therapy should have included at least one anti-clusterCluster of differentiationDifferentiation 20 (CD20) monoclonal antibody and patientparticipant should meet indication for treatment, as described in the protocol. Have measurable disease on cross sectional imaging documented by diagnostic computedComputed tomographyTomograph [...] [...]
Secondary endpoints22 entries, revised
Incidence of anti-odronextamabdrug antibodies (ADA) to odronextamab over timethe study duration Titer of ADAs to odronextamab over timethe study duration Incidence of neutralizing antibodies (NAbs) to odronextamab over timethe study duration Overall change from baseline in patient reported outcomes (PROs) as measured by scores o [...] Quality-of-Life Questionnaire (EORTC QLQC30) Overall change from baseline in PROs as measured by scores of Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-LymS) Overall change from baseline in PROs as measured by scores of Patient Global Impression on S [...] [...]
Study title+6 characters
[...] d Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma
2024-07-08
Study Status, Contacts/Locations v10
Study sites81→93
2024-06-10
Study Status, Contacts/Locations v9
Study sites66→81
2024-05-28
Study Status, Contacts/Locations v8
Study sites61→66
2024-05-07
Study Status, Contacts/Locations v7
Study sites53→61
2024-04-09
Study Status, Contacts/Locations v6
Study sites34→53
2024-03-18
Study Status, Contacts/Locations v5
Study sites16→34
2024-02-20
Study Status, Contacts/Locations v4
Study sites8→16
2024-02-05
Study Status, Contacts/Locations v3
Study sites3→8
2024-01-05
Study Status, Contacts/Locations v2
Primary completion date2029-06-12→2029-10-04
Completion date2029-06-12→2029-10-04
Start dateestimated 2023-12-18→confirmed 2023-12-28
Study sites2→3
2023-12-14
Study Status, Contacts/Locations v1
Primary completion date2029-05-31→2029-06-12
Completion date2029-05-31→2029-06-12
Start date2023-12-04→2023-12-18
Study sites1→2
2023-11-20
Original filing
Regeneron
148 trials monitored
See 16 trials at risk
Follicular Lymphoma
313 trials monitored
See 21 trials at risk
This study is researching an experimental drug called odronextamab (referred to as study drug), in combination with lenalidomide. The study is focused on participants who have one of two types of cancer: Follicular Lymphoma (FL) or Marginal Zone Lymphoma (MZL) that has come back after treatment (called "relapsed") or did not respond to treatment (called "refractory"). FL and MZL are subtypes of Non-Hodgkin 's Lymphoma (NHL). This study will be made up of two parts (Part 1 not randomized, Part 2 randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is when used in combination with lenalidomide, in participants with FL or MZL, and to determine the dose of the study drug to be used in Part 2 of this study. This combination is considered "first-in-human" as it has not been tested as a combination treatment in humans before. The aim of Part 2, of the study is to assess how well the combination of the study drug and lenalidomide works compared to the combination of rituximab (called "the comparator drug") and lenalidomide. The combination of comparator drug and lenalidomide is the current standard-of-care treatment for relapsed/refractory FL and/or MZL. 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 in combination with lenalidomide * 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
Trial Details
NCT Number NCT06149286
Lead Sponsor Regeneron Pharmaceuticals
Conditions Relapsed/Refractory Follicular Lymphoma, Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL)
Enrollment 580 participants
Start Date 2023-12-28
Primary Completion 2031-04-30 (estimated)
Study Completion 2031-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-14