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A Phase 3 Trial of Epcoritamab in R / R DLBCL

Trial Status: Active

This is an open-label, randomized (1:1), multi-center trial of epcoritamab (GEN3013; DuoBody®-CD3xCD20) versus prespecified investigator's choice of chemotherapy in patients with relapsed, refractory diffuse large B-Cell Lymphoma

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
  • 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

  • Primary CNS tumor or known CNS involvement
  • Any prior therapy with a bispecific antibody targeting CD3 and CD20
  • 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
  • Any investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to randomization
  • ASCT within 100 days of randomization
  • Treatment with CAR-T therapy within 100 days prior to randomization
  • Seizure disorder requiring anti-epileptic therapy
  • Clinically significant cardiac disease,

North Carolina

Winston-Salem
Wake Forest University Health Sciences
Status: IN_REVIEW

The purpose of this 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

HDT-ASCT.

Eligible patients will be randomized (1:1) to either epcoritamab or investigator's choice of

chemotherapy: R-GemOx (rituximab, gemcitabine and oxaliplatin) or BR (bendamustine and

rituximab).

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Genmab

  • Primary ID GCT3013-05
  • Secondary IDs NCI-2021-05626
  • Clinicaltrials.gov ID NCT04628494