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

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About the study

The purpose of this trial is to find out if epcoritamab, also known as EPKINLY™ and GEN3013, is safe and works well as treatment for patients with diffuse large B-cell lymphoma (DLBCL) that are not responding to treatment, have grown in size, or have come back following treatment with at least 1 prior systemic cancer therapy. All participants in this trial will be randomly assigned to receive either epcoritamab or a pre-specified investigator's choice (standard of care) chemotherapy (either rituximab + gemcitabine + oxaliplatin \[R-GemOx\], or bendamustine + rituximab \[BR\]). Participants must have failed or be ineligible to receive an autologous stem cell transplant (ASCT). Epcoritamab will be injected under the skin. Investigator's choice chemotherapy will be given intravenously. Trial details include: * The trial duration will be up to 5 years after last participant is randomized. * All trial participants have a 21-day screening period, a treatment period, and a follow-up period that continues until death. * The estimated trial duration for an individual subject depends upon the treatment arm assigned: * Participants who receive epcoritamab will have 28-day treatment cycles. Epcoritamab will be given once weekly for the first 3 months, then every other week for 6 months, then every 28 days until lymphoma progression or unacceptable adverse events. * Participants who receive investigator's choice (standard of care) chemotherapy will receive treatments either: * R-GemOx: On Day 1 (or Day 1 \& Day 2), and Day 15 (or Day 15 \& Day 16) every 28 days, for up to 4 months; or * BR: On Day 1 and Day 2 every 3 weeks for up to 4.5 months.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Main Inclusion Criteria:


  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:

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

EXCLUSION CRITERIA

Main Exclusion Criteria:


  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

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Study Locations

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How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details

Contition
Diffuse Large B-cell Lymphoma
Age (in years)
18+
Phase
PHASE3
Participants needed
552
Est. Completion Date
Apr 30, 2028
Treatment type
INTERVENTIONAL
Sponsor
Genmab
ClinicalTrials.gov identifier
NCT04628494
Study number
GCT3013-05

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