A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination with Rituximab and Lenalidomide (R2) compared to R2 in Subjects with Relapsed or Refractory Follicular Lymphoma (EPCORE™ FL-1)

Conditions

Relapsed and Refractory Follicular Lymphoma

Brief summary

Progression-Free Survival (PFS), Best overall response (BOR) of CR or PR, determined by Lugano criteria (Appendix F), as assessed by an Independent Review Committee (IRC)

Detailed description

Percentage of Participants Achieving Complete Response (CR), Overall Survival (OS), Percentage of Participants Achieving Minimal Residual Disease (MRD) Negativity, Changes from baseline in Functional Assessment of Cancer Therapy – Lymphoma (FACT-Lym)., PFS, BOR, and CR during the study, determined per Lugano criteria as assessed by investigator., Duration of response (DOR), duration of complete response (DOCR), time to progression (TTP), and CR at the end of treatment (12 cycles), time to response (TTR), time to complete response (TTCR), per Lugano criteria as assessed by an IRC and by the investigator, respectively., Event-Free Survival (EFS), defined as the duration from randomization to the date of any of the following (whichever occurs first): • Disease progression determined by Lugano criteria as assessed by the investigator • Initiation of any non-protocol-specified new anti lymphoma therapy for any reason • Death, Time to next anti-lymphoma treatment (TTNLT)., Changes from baseline in Patient-Reported Outcome Instruments (PROs; including Patient Global Impression of Severity [PGIS], Patient Global Impression of Change [PGIC], and EuroQol 5 dimension questionnaire, 5 level [EQ 5D 5L]).

Related papers

No related papers found yet.

Interventions

DRUGEpcoritamab (GEN3013)

DRUGRevlimid 5 mg hard capsules

DRUGRevlimid 20 mg hard capsules

DRUGTruxima 500 mg concentrate for solution for infusion

DRUGTruxima 100 mg concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-Free Survival (PFS), Best overall response (BOR) of CR or PR, determined by Lugano criteria (Appendix F), as assessed by an Independent Review Committee (IRC)	—

Secondary

Measure	Time frame
Percentage of Participants Achieving Complete Response (CR), Overall Survival (OS), Percentage of Participants Achieving Minimal Residual Disease (MRD) Negativity, Changes from baseline in Functional Assessment of Cancer Therapy – Lymphoma (FACT-Lym)., PFS, BOR, and CR during the study, determined per Lugano criteria as assessed by investigator., Duration of response (DOR), duration of complete response (DOCR), time to progression (TTP), and CR at the end of treatment (12 cycles), time to response (TTR), time to complete response (TTCR), per Lugano criteria as assessed by an IRC and by the investigator, respectively., Event-Free Survival (EFS), defined as the duration from randomization to the date of any of the following (whichever occurs first): • Disease progression determined by Lugano criteria as assessed by the investigator • Initiation of any non-protocol-specified new anti lymphoma therapy for any reason • Death, Time to next anti-lymphoma treatment (TTNLT)., Changes from basel	—

Measure

Time frame

Percentage of Participants Achieving Complete Response (CR), Overall Survival (OS), Percentage of Participants Achieving Minimal Residual Disease (MRD) Negativity, Changes from baseline in Functional Assessment of Cancer Therapy – Lymphoma (FACT-Lym)., PFS, BOR, and CR during the study, determined per Lugano criteria as assessed by investigator., Duration of response (DOR), duration of complete response (DOCR), time to progression (TTP), and CR at the end of treatment (12 cycles), time to response (TTR), time to complete response (TTCR), per Lugano criteria as assessed by an IRC and by the investigator, respectively., Event-Free Survival (EFS), defined as the duration from randomization to the date of any of the following (whichever occurs first): • Disease progression determined by Lugano criteria as assessed by the investigator • Initiation of any non-protocol-specified new anti lymphoma therapy for any reason • Death, Time to next anti-lymphoma treatment (TTNLT)., Changes from basel

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Countries

Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Slovakia, Spain, Sweden

Outcome results

None listed