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)
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
Arms & interventions
- DrugOdronextamab
Administered per the protocol
- DrugLenalidomide
Administered per the protocol
- DrugRituximab
Administered per the protocol
Outcome measures
Primary
Incidence of Dose Limiting Toxicities (DLTs) for odronextamab in combination with lenalidomide
Part 1
Time frame: Up to 35 days
Incidence of Treatment Emergent Adverse Events (TEAEs) for odronextamab in combination with lenalidomide
Part 1
Time frame: Up to 2 years
Severity of TEAEs for odronextamab in combination with lenalidomide
Part 1
Time frame: Up to 2 years
Progression-Free Survival (PFS) as assessed by Independent Central Review (ICR) in participants with R/R FL and participants with indolent lymphoma
Part 2
Time frame: Up to 5 years
Secondary
Odronextamab concentrations in serum
Time frame: Up to 30 months
Incidence of Anti-drug Antibodies (ADA) to odronextamab
Time frame: Up to 30 months
Magnitude of ADAs to odronextamab
Time frame: Up to 30 months
Best Overall Response (BOR) as assessed by investigator review
Time frame: Up to 30 months
Duration of Response (DOR) as assessed by investigator review
Time frame: Up to 5 years
PFS as assessed by investigator review
Time frame: Up to 5 years
Complete Response (CR) as assessed by ICR
Time frame: Up to 30 months
BOR as assessed by ICR
Time frame: Up to 30 months
Overall Survival (OS)
Time frame: Up to 5 years
Event Free Survival (EFS) as assessed by ICR
Time frame: Up to 5 years
EFS as assessed by local investigator review
Time frame: Up to 5 years
DOR as assessed by ICR
Time frame: Up to 5 years
Time To Next anti-lymphoma Treatment (TTNT)
Time frame: Up to 5 years
Incidence of TEAEs for odronextamab in combination with lenalidomide versus R2
Time frame: Up to 2 years
Severity of TEAEs for odronextamab in combination with lenalidomide versus R2
Time frame: Up to 2 years
Overall change in patient reported outcomes (PROs) as measured by scores of European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQC30)
Time frame: Up to 5 years
Overall change in PROs as measured by scores of Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-LymS)
Time frame: Up to 5 years
Overall change in PROs as measured by scores of EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L)
Time frame: Up to 5 years
Change from first assessment in Patient Global Impression on Severity (PGIS)
Time frame: Up to 5 years
Change from first assessment in Patient Global Impression on Change (PGIC)
Time frame: Up to 5 years
Change from first assessment in the Global Population item 5 (GP5) items of the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire
Time frame: Up to 5 years
Eligibility criteria
Study locations (8)
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
Boca Raton Clinical Research (BRCR) Global
Plantation, Florida, 33322
Indiana University and Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401
Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Stony Brook University Hospital
Stony Brook, New York, 11794
Clinical Research Alliance Inc
Westbury, New York, 11590
Prohealth Care Inc
Waukesha, Wisconsin, 53188