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

Study acronym: EPCORE DLBCL-1
StatusActive, Not Recruiting
PhasePhase 3
SponsorGenmab
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 58 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Enrollment target: 484 to 483v58
  2. 6 versions Re-verified since Dec 1, 2025, no change to tracked fieldsv52-v57
  3. Study description expanded, about 9 wordsv51 See this version in full on ClinicalTrials.gov ↗
  4. Enrollment target: 556 to 484 Study sites: 208 to 186v50 Show 1 more changeShow less
    • Study sites: 208 to 186
  5. Enrollment target: estimated 552 to confirmed 556 Primary completion date changed from estimate of Dec 2025 to Oct 13, 2025v49 Show 1 more changeShow less
    • Primary completion date changed from estimate of Dec 2025 to Oct 13, 2025
Show 40 earlier versionsHide 40 earlier versions
  1. 2 versions Re-verified since Sep 1, 2025, no change to tracked fieldsv47-v48
  2. Eligibility criteria expanded, about 43 words Secondary endpoints revised (12) · Study description expanded, about 45 words · Study title expanded, about 5 wordsv46 Show 3 more changesShow less
    • Secondary endpoints revised (12)
    • Study description expanded, about 45 words
    • Study title expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  3. 5 versions Re-verified since Mar 3, 2025, no change to tracked fieldsv41-v45
  4. Study sites: 200 to 208v40
  5. Primary completion date: Dec 2024 to Dec 2025v39
  6. 2 versions Re-verified since Oct 7, 2024, no change to tracked fieldsv37-v38
  7. Study sites: 196 to 200v36
  8. 3 versions Re-verified since Jul 1, 2024, no change to tracked fieldsv33-v35
  9. Study description shortened, about 5 wordsv32 See this version in full on ClinicalTrials.gov ↗
  10. 2 versions Re-verified since Apr 3, 2024, no change to tracked fieldsv30-v31
  11. Study sites: 186 to 196v29
  12. 2 versions Re-verified since Jan 2, 2024, no change to tracked fieldsv27-v28
  13. Primary completion date: Apr 2028 to Dec 2024v26
  14. Study sites: 264 to 186v25
  15. Primary and study completion dates: Jun 2024 to Apr 2028 Trial status: Recruiting to Active, Not Recruiting · Secondary endpoints: details revised at 12 of 12 entries · Site details revised at 264 of 264 sitesv24 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Secondary endpoints: details revised at 12 of 12 entries
    • Site details revised at 264 of 264 sites
  16. 2 versions Re-verified since May 24, 2023, no change to tracked fieldsv22-v23
  17. Primary completion date: Jun 2023 to Jun 2024 Enrollment target: 480 to 552 · Study sites: 265 to 264 · Completion date: May 2024 to Jun 2024v21 Show 3 more changesShow less
    • Enrollment target: 480 to 552
    • Study sites: 265 to 264
    • Completion date: May 2024 to Jun 2024
  18. Study sites: 261 to 265v20
  19. Study sites: 260 to 261v19
  20. Re-verified, no change to tracked fieldsv18
  21. Study sites: 254 to 260v17
  22. Study sites: 253 to 254 Study description revisedv16 Show 1 more changeShow less
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  23. Re-verified, no change to tracked fieldsv15
  24. Study sites: 248 to 253v14
  25. Study sites: 236 to 248v13
  26. Study sites: 233 to 236v12
  27. Study sites: 232 to 233v11
  28. Study sites: 219 to 232v10
  29. Study sites: 212 to 219v9
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Genmab
45 trials monitored
See 3 trials at risk
Non-Hodgkin Lymphoma
1,517 trials monitored
See 84 trials at risk
DLBCL
650 trials monitored
See 38 trials at risk
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 participants with 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 participant 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.
Trial Details
NCT Number NCT04628494
Lead Sponsor Genmab
Collaborators: AbbVie
Conditions Diffuse Large B-cell Lymphoma
Enrollment 483 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov