A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in R/R DLBCL

Official Title

A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)

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

Trial Description

Primary Outcome:

  • Overall Survival (OS)
Secondary Outcome:
  • Progression Free Survival (PFS)
  • Overall Response Rate (ORR)
  • Complete Response (CR)
  • Duration of Response (DOR)
  • Time to Response (TTR)
  • Rate and duration of minimal residual disease (MRD) negative status
  • Time to next anti-lymphoma therapy (TTNT)
  • Incidence and severity of adverse events (AEs)
  • Incidence and severity of changes in laboratory values
  • Incidence of dose interruptions and delays
  • Anti-epcoritamab antibody response
  • Changes in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
The trial is an open label, multi-centre, 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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society