A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in R/R DLBCL (EPCORE™DLBCL-1)

  • STATUS
    Recruiting
  • End date
    May 22, 2024
  • participants needed
    480
  • sponsor
    Genmab
Updated on 22 July 2022

Summary

The drug that will be investigated in the study is an antibody, epcoritamab, also known as GEN3013 . Since the safety and tolerability of epcoritamab has already been studied in previous studies in humans, the main purpose of this study is to evaluate efficacy. To evaluate this, half of the participants who are eligible will receive epcoritamab and the other half will receive a pre-specified investigator's choice of chemotherapy. Epcoritamab will be studied in R/R DLBCL participants who did not respond to a previous autologous stem cell transplant (ASCT) or do not meet the criteria for ASCT

Description

The trial is an open label, multi-center, global phase 3 randomized trial of Epcoritamab, GEN3013. The goal of this randomized trial is to evaluate the efficacy of epcoritamab (GEN3013 DuoBody®-CD3xCD20) compared to investigator's choice of chemotherapy, in patients with relapsed, refractory diffuse large B-Cell Lymphoma who have failed or are ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT). No change in chemotherapy is permitted for participants during the treatment phase of the trial.

Details
Condition Diffuse Large B-cell Lymphoma
Treatment Investigator's Choice Chemotherapy, Epcoritamab
Clinical Study IdentifierNCT04628494
SponsorGenmab
Last Modified on22 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Relapsed or refractory disease and previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since lymphoma diagnosis
One of the confirmed histologies below with CD20-positivity
DLBCL, NOS, including de novo or histologically transformed from FL
Double-hit" or "triple-hit" DLBCL (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations), including de novo or histologically transformed from FL
FL Grade 3B
ECOG PS score of 0-2
T-cell/histiocyte-rich large B-cell lymphoma
Failed previous HDT-ASCT or not eligible for HDT-ASCT at screening
Patients must have detectable disease by PET scan and measurable by CT scan or MRI
Acceptable renal and liver function
Life expectancy >2 months on SOC treatment

Exclusion Criteria

Any prior therapy with a bispecific antibody targeting CD3 and CD20
Primary Central Nervous System (CNS) tumor or known CNS involvement
Major surgery within 4 weeks prior to randomization
Chemotherapy and other non-investigational antineoplastic agents (except CD20 mAbs) within 4 weeks or 5 half-lives (whichever is shorter) prior to randomization
ASCT within 100 days of randomization
Any investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to randomization
Seizure disorder requiring anti-epileptic therapy
Treatment with CAR-T therapy within 100 days prior to randomization
Clinically significant cardiac disease
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