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Relapsed/Refractory Follicular LymphomaFirst-in-humanCancerDrugPhase 3

What this study is

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

What's being tested

  • Odronextamab

    Intervention · DRUG

  • Lenalidomide

    Intervention · DRUG

  • Rituximab

    Intervention · DRUG

All interventions

Administered per the protocol

Study details

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 in Relapsed/Refractory Participants With Follicular Lymphoma and Marginal Zone Lymphoma (OLYMPIA-5)
Sponsor
Regeneron Pharmaceuticals
Conditions
Relapsed/Refractory Follicular Lymphoma · Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL)
Enrolling
580 people
Starts
2023-12-28
Est. completion
2031-04-30
Design
Open-label, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗