A Trial to Learn if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Participants With Follicular Lymphoma and Marginal Zone Lymphoma — OLYMPIA-5

Marginal Zone Lymphoma (MZL) Clinical Trial

Official title:
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 Therapy in Relapsed/Refractory Participants With Follicular Lymphoma and Marginal Zone Lymphoma (OLYMPIA-5)

Status Recruiting

Clinical Trial Summary

This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on patients 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 the combination of odronextamab and lenalidomide works compared to the combination of rituximab and lenalidomide, (the current standard-of-care treatment for 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 your 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 your quality-of-life and ability to complete routine daily activities

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06149286
Study type	Interventional
Source	Regeneron Pharmaceuticals
Contact	Clinical Trials Administrator
Phone	844-734-6643
Email	clinicaltrials@regeneron.com
Status	Recruiting
Phase	Phase 3
Start date	December 28, 2023
Completion date	October 4, 2029

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.