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

Condition(s) studied

Investigational drug(s) / intervention(s)

Odronextamab: Administered per the protocol

Lenalidomide: Administered per the protocol

Rituximab: Administered per the protocol

Study summary

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

Eligibility

Primary outcome measure(s)

• Incidence of Dose Limiting Toxicities (DLTs) for odronextamab in combination with lenalidomide — Up to 35 days
  Part 1
• Incidence of Treatment Emergent Adverse Events (TEAEs) for odronextamab in combination with lenalidomide — Up to 2 years
  Part 1
• Severity of TEAEs for odronextamab in combination with lenalidomide — Up to 2 years
  Part 1
• Progression-Free Survival (PFS) as assessed by Independent Central Review (ICR) — Up to 5 years
  Part 2

Trial sites (171)

+ 131 more sites — see the full list on the official registry below.