Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Irvine, California and other locations
Dates
study started
estimated completion

Description

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

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)

Details

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.

Keywords

Diffuse Large B-cell Lymphoma, double-hit DLBCL, triple-hit DLBCL, follicular grade 3B, transformed DLBCL, T-cell histiocytes-rich large B cell lymphoma, Lymphoma, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Epcoritamab, Investigator's Choice Chemotherapy, Epcoritamab (GEN3013; DuoBody®CD3xCD20)

Eligibility

You can join if…

Open to people ages 18 years and up

  1. 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
  2. One of the confirmed histologies below with CD20-positivity:
  3. DLBCL, NOS, including de novo or histologically transformed from FL
  4. "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
  5. FL Grade 3B
  6. T-cell/histiocyte-rich large B-cell lymphoma
  7. ECOG PS score of 0-2
  8. Failed previous HDT-ASCT or not eligible for HDT-ASCT at screening
  9. Patients must have detectable disease by PET scan and measurable by CT scan or MRI
  10. Acceptable renal and liver function
  11. Life expectancy >2 months on SOC treatment

You CAN'T join if...

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

Locations

  • UC Irvine accepting new patients
    Irvine California 92697 United States
  • LDS Hospital accepting new patients
    Salt Lake City Utah 84143 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Genmab
ID
NCT04628494
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 480 study participants
Last Updated