NCT06230224: OLYMPIA-4

A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma

Recruiting now Phase 3 Last updated 8 April 2026

What this trial tests

Phase 3 trial testing Odronextamab in B-Cell Non-Hodgkin Lymphoma (B-NHL) in 216 participants. Currently enrolling.

Timeline

15 February 2024

Primary endpoint
14 May 2027

14 May 2027

Quick facts

Lead sponsor	Regeneron Pharmaceuticals
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	216
Start date	15 February 2024
Primary completion	14 May 2027
Estimated completion	14 May 2027
Sites	101 locations across Italy, Colombia, Netherlands, Malaysia, Chile, Taiwan, Hungary, South Korea

Drugs / interventions tested

• Odronextamab
• Ifosfamide
• Carboplatin (Carboplatin) — full drug profile →
• Etoposide
• Rituximab
• Dexamethasone (dexamethasone) — full drug profile →
• Cisplatin (cisplatin) — full drug profile →
• Cytarabine — full drug profile →
• Gemcitabine (gemcitabine) — full drug profile →

Conditions studied

• B-Cell Non-Hodgkin Lymphoma (B-NHL) — all drugs for B-Cell Non-Hodgkin Lymphoma (B-NHL) →

Sponsor

Regeneron Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with B-Cell Non-Hodgkin Lymphoma (B-NHL). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on patients with previously treated aggressive B-cell non-Hodgkin lymphoma whose cancer has stopped responding to treatment (also known as 'refractory') or has returned (also known as 'relapsed'). The aim of the study is to see how safe, tolerable and effective the study drug is when given alone.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug versus Standard of Care (SOC)
* 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)
* Comparing the impact from the study drug versus SOC on quality-of-life and ability to complete routine daily activities

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Bispecific Antibodies for Lymphoid Malignancy Treatment.
   Bisio M, Legato L, Fasano F, Benevolo Savelli C, et al · · 2024 · cited 4× · PMID 39796723 · DOI 10.3390/cancers17010094
2. Early clearance of circulating tumor DNA and association with odronextamab response in relapsed/refractory FL and DLBCL.
   Arnason JE, Matasar M, Luminari S, Tucker D, et al · · 2025 · cited 1× · PMID 40902079 · DOI 10.1182/bloodadvances.2025016332
3. Dynamics of complete responses (CRs) in patients with relapsed or refractory follicular lymphoma (R/R FL) treated with odronextamab in the ELM-2 study.
   Luminari S, Jiménez-Ubieto A, Chong G, Tucker D, et al · · 2026 · PMID 42007452 · DOI 10.1002/hem3.70300