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Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)

Study acronym: EPCORE™ NHL-2
StatusActive, Not Recruiting
PhasePhase 1/2
SponsorGenmab
Started
View on ClinicalTrials.gov ↗

Record History

  1. Interventions: Epcoritamab (Biological), Epcoritamab (Biological), Epcoritamab (Biological), Epcoritamab (Biological), Epcoritamab (Biological)… to Epcoritamab (Biological), Epcoritamab (Biological), Epcoritamab (Biological), Epcoritamab (Biological), Epcoritamab (Biological)… Eligibility criteria expanded, about 43 words · Secondary endpoints: details revised at 2 of 24 entries · Study description expanded, about 10 words · 2 more Show 5 more changesShow less
    • Eligibility criteria expanded, about 43 words
    • Secondary endpoints: details revised at 2 of 24 entries
    • Study description expanded, about 10 words
    • Site details revised at 3 of 57 sites
    • Publications: 4 to 5
  2. 8 versions Re-verified since Feb 2, 2026, no change to tracked fieldsv39-v46
  3. Primary and study completion dates: Sep 30, 2028 to Sep 30, 2027v38
  4. 3 versions Re-verified since Nov 3, 2025, no change to tracked fieldsv35-v37
  5. Study sites revised (57)v34 See this version in full on ClinicalTrials.gov ↗
Show 32 earlier versionsHide 32 earlier versions
  1. Study sites: 58 to 57v33
  2. Re-verified, no change to tracked fieldsv32
  3. Primary endpoints revised (3) Secondary endpoints revised (24)v31 Show 1 more changeShow less
    • Secondary endpoints revised (24)

    See this version in full on ClinicalTrials.gov ↗

  4. 4 versions Re-verified since Mar 3, 2025, no change to tracked fieldsv27-v30
  5. Primary and study completion dates: Mar 31, 2029 to Sep 30, 2028 Interventions: Epcoritamab (Biological), Epcoritamab (Biological), Epcoritamab (Biological), Epcoritamab (Biological), Epcoritamab (Biological)… to Epcoritamab (Biological), Epcoritamab (Biological), Epcoritamab (Biological), Epcoritamab (Biological), Epcoritamab (Biological)… · Eligibility criteria expanded, about 7 words · Secondary endpoints: 26 to 24 · 1 morev26 Show 4 more changesShow less
    • Interventions: Epcoritamab (Biological), Epcoritamab (Biological), Epcoritamab (Biological), Epcoritamab (Biological), Epcoritamab (Biological)… to Epcoritamab (Biological), Epcoritamab (Biological), Epcoritamab (Biological), Epcoritamab (Biological), Epcoritamab (Biological)…
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: 26 to 24
    • Study description expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  6. Re-verified, no change to tracked fieldsv25
  7. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 662 to confirmed 543 · Study sites: 64 to 58 · Study description expanded, about 2 wordsv24 Show 3 more changesShow less
    • Enrollment target: estimated 662 to confirmed 543
    • Study sites: 64 to 58
    • Study description expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  8. 4 versions Re-verified since Sep 2, 2024, no change to tracked fieldsv20-v23
  9. Site details revised at 5 of 64 sitesv19
  10. Re-verified, no change to tracked fieldsv18
  11. Eligibility criteria expanded, about 6 words Study description expanded, about 35 wordsv17 Show 1 more changeShow less
    • Study description expanded, about 35 words

    See this version in full on ClinicalTrials.gov ↗

  12. Re-verified, no change to tracked fieldsv16
  13. Study description shortened, about 2 wordsv15 See this version in full on ClinicalTrials.gov ↗
  14. Re-verified, no change to tracked fieldsv14
  15. Site details revised at 1 of 64 sitesv13
  16. 3 versions Re-verified since May 24, 2023, no change to tracked fieldsv10-v12
  17. Enrollment target: 396 to 662 Primary completion date: Apr 30, 2023 to Mar 31, 2029 · Primary endpoints: 6 to 3 · Completion date: Nov 30, 2024 to Mar 31, 2029 · 7 morev9 Show 10 more changesShow less
    • Primary completion date: Apr 30, 2023 to Mar 31, 2029
    • Primary endpoints: 6 to 3
    • Completion date: Nov 30, 2024 to Mar 31, 2029
    • Start date: Nov 16, 2020 to Nov 3, 2020
    • Interventions: Epcoritamab (Biological), Epcoritamab Maintenance (Biological), gemcitabine and oxaliplatin (Drug), rituximab and bendamustine (Drug)… to Epcoritamab (Biological), Epcoritamab (Biological), Epcoritamab (Biological), Epcoritamab (Biological), Epcoritamab (Biological)…
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: 16 to 26
    • Study description expanded, about 48 words
    • Site details revised at 2 of 64 sites
    • Study arms: 8 to 10

    See this version in full on ClinicalTrials.gov ↗

  18. Re-verified, no change to tracked fieldsv8
  19. Study sites: 62 to 64v7
  20. Study sites: 61 to 62v6
  21. Primary endpoints: 3 to 6 Enrollment target: 270 to 396 · Study sites: 57 to 61 · Interventions: Epcoritamab (Biological), Epcoritamab Maintenance (Biological), gemcitabine and oxaliplatin (Drug), rituximab and bendamustine (Drug)… to Epcoritamab (Biological), Epcoritamab Maintenance (Biological), gemcitabine and oxaliplatin (Drug), rituximab and bendamustine (Drug)… · 5 morev5 Show 8 more changesShow less
    • Enrollment target: 270 to 396
    • Study sites: 57 to 61
    • Interventions: Epcoritamab (Biological), Epcoritamab Maintenance (Biological), gemcitabine and oxaliplatin (Drug), rituximab and bendamustine (Drug)… to Epcoritamab (Biological), Epcoritamab Maintenance (Biological), gemcitabine and oxaliplatin (Drug), rituximab and bendamustine (Drug)…
    • Eligibility criteria expanded, about 60 words
    • Secondary endpoints: 20 to 16
    • Study description expanded, about 142 words
    • Study arms: 7 to 8
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  22. Primary completion date: Jan 30, 2022 to Apr 30, 2023 Study sites: 50 to 57 · Completion date: Sep 30, 2024 to Nov 30, 2024v4 Show 2 more changesShow less
    • Study sites: 50 to 57
    • Completion date: Sep 30, 2024 to Nov 30, 2024
  23. Enrollment target: 130 to 270 Study sites: 36 to 50 · Interventions: Epcoritamab (Biological), gemcitabine and oxaliplatin (Drug), rituximab and bendamustine (Drug), rituximab and lenalidomide (Drug)… to Epcoritamab (Biological), Epcoritamab Maintenance (Biological), gemcitabine and oxaliplatin (Drug), rituximab and bendamustine (Drug)… · Eligibility criteria expanded, about 45 words · 2 morev3 Show 5 more changesShow less
    • Study sites: 36 to 50
    • Interventions: Epcoritamab (Biological), gemcitabine and oxaliplatin (Drug), rituximab and bendamustine (Drug), rituximab and lenalidomide (Drug)… to Epcoritamab (Biological), Epcoritamab Maintenance (Biological), gemcitabine and oxaliplatin (Drug), rituximab and bendamustine (Drug)…
    • Eligibility criteria expanded, about 45 words
    • Study description expanded, about 6 words
    • Study arms: 5 to 7

    See this version in full on ClinicalTrials.gov ↗

  24. Study sites: 5 to 36v2
  1. Study First Submitted
  • 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
Follicular Lymphoma
313 trials monitored
See 26 trials at risk
The purpose of this trial is to measure the safety and effectiveness of epcoritamab (EPKINLY™), either by itself or together with other therapies, when treating participants with B-cell non-Hodgkin Lymphoma (B-NHL). The aim of the first part of the trial is to identify the most appropriate dose of epcoritamab, and the aim of the second part of the trial is to assess the selected epcoritamab dose in a larger group of participants with B-NHL. All participants in this trial will receive either epcoritamab alone, or epcoritamab combined with another standard treatment regimen, with a total of 10 different treatment arms being studied. Trial details include: * The treatment duration for each participant depends upon which arm of treatment they are assigned to. * The visit frequency for each participant depends upon which arm of treatment they are assigned to, but will be weekly to start for all participants, then will decrease to either: every 2 weeks, or every 3 weeks, or every 4 weeks, or every 8 weeks. * All participants will receive active drug; no one will be given placebo. Participants who receive treatment with epcoritamab will have it injected right under the skin. Participants will receive a different regimen of epcoritamab depending upon which arm of treatment they are assigned. Participants who receive standard treatments will have intravenous (IV) infusions and/or oral administration of those treatments. Participants will receive a different standard treatment regimen depending upon which arm of treatment they are assigned.
Trial Details
NCT Number NCT04663347
Lead Sponsor Genmab
Collaborators: AbbVie
Conditions Diffuse Large B-Cell Lymphoma, Follicular Lymphoma
Enrollment 543 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov