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Testing a new drug combination for relapsed or refractory follicular and marginal zone lymphoma

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)

Phase 3 Interventional Regeneron Pharmaceuticals · NCT06149286

This study is testing a new combination of drugs to see if it can help adults with relapsed or hard-to-treat follicular or marginal zone lymphoma feel better compared to standard treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment470 (estimated)
Ages18 Years and up
SexAll
SponsorRegeneron Pharmaceuticals Industry-sponsored
Drugs / interventionsimmunotherapy, odronextamab, rituximab
Locations169 sites (Los Angeles, California and 168 other locations)
Trial IDNCT06149286 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of an experimental drug called odronextamab combined with lenalidomide in adults with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL). The study consists of two parts: the first part assesses the safety and tolerability of the drug combination, while the second part compares its effectiveness against a standard treatment of rituximab combined with lenalidomide. Participants must have measurable disease and a history of prior treatment with anti-CD20 monoclonal antibodies. This combination treatment is considered first-in-human as it has not been previously tested together in humans.

Who should consider this trial

Good fit: Ideal candidates are adults with relapsed or refractory follicular lymphoma or marginal zone lymphoma who have received at least one prior line of systemic therapy.

Not a fit: Patients who have not been previously treated with anti-CD20 monoclonal antibodies or those with other types of lymphoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with difficult-to-treat lymphoma types.

How similar studies have performed: Other studies have shown success with similar drug combinations in treating lymphomas, but this specific combination is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

1. Local histologic confirmation of FL grade 1-3a or MZL (nodal, splenic, or extra nodal MZL) as assessed by the investigator, as described in the protocol.
2. Must have refractory disease or relapsed after at least 1 prior line (with a duration of at least 2 cycles) of systemic chemo-immunotherapy or immunotherapy. Prior systemic therapy should have included at least one anti-Cluster of Differentiation 20 (CD20) monoclonal antibody and participant should meet indication for treatment, as described in the protocol.
3. Have measurable disease on cross sectional imaging documented by diagnostic Computed Tomography \[CT\], or Magnetic Resonance Imaging \[MRI\] imaging, as described in the protocol.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
5. Adequate hematologic and organ function, as described in the protocol.
6. All study participants must:

   1. Have an understanding that lenalidomide could have a potential teratogenic risk.
   2. Agree to abstain from donating blood while taking study drug therapy and for 28 days after discontinuation of lenalidomide.
   3. Agree not to share study medication with another person.
   4. Agree to be counseled about pregnancy precautions and risk of fetal exposure associated with lenalidomide.

Key Exclusion Criteria:

1. Primary Central Nervous System (CNS) lymphoma or known involvement (either current or prior history of CNS involvement) by non-primary CNS NHL, as described in the protocol.
2. Participants with current or past histological evidence of high-grade or diffuse large B-cell lymphoma, or any histology other than FL grade 1-3a or MZL.
3. History of or current relevant CNS pathology, as described in the protocol.
4. A malignancy other than NHL (inclusion diagnosis) unless the participant is adequately and definitively treated and is cancer free for at least 3 years, with the exception of localized prostate cancer treated with hormone therapy or local radiotherapy (ie, pellets), cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that was definitively treated.
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, as described in the protocol.
6. Allergy/hypersensitivity to study drugs or excipients. as described in the protocol.
7. Active infection as defined in the protocol.

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Where this trial is running

Los Angeles, California and 168 other locations

+119 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Relapsed/Refractory Follicular LymphomaRelapsed/Refractory Marginal Zone LymphomaNon-Hodgkin lymphomasIndolent lymphomasOdronextamab
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.