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Trial of the Safety and Efficacy of Epcoritamab in Japanese Subjects With Relapsed or Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (R/R B-NHL)

Study acronym: EPCORE™ NHL-3
StatusActive, Not Recruiting
PhasePhase 1/2
SponsorGenmab
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 33 words Secondary endpoints: details revised at 1 of 18 entries · Publications: details revised at 3 of 3 entries Show 2 more changesShow less
    • Secondary endpoints: details revised at 1 of 18 entries
    • Publications: details revised at 3 of 3 entries
  2. 12 versions Re-verified since Oct 7, 2025, no change to tracked fieldsv35-v46
  3. Study sites: 14 to 15v34
  4. 3 versions Re-verified since Jun 2, 2025, no change to tracked fieldsv31-v33
  5. Primary and study completion dates: Sep 2025 to Sep 2027 Primary endpoints revised (5) · Enrollment target: estimated 102 to confirmed 78 · Interventions: epcoritamab (Biological), epcoritamab (maintenance) (Biological), epcoritamab (monotherapy) (Biological), gemcitabine and oxaliplatin… to Epcoritamab (Biological), Epcoritamab (maintenance) (Biological), Epcoritamab (monotherapy) (Biological), Gemcitabine and oxaliplatin… · 5 morev30 Show 8 more changesShow less
    • Primary endpoints revised (5)
    • Enrollment target: estimated 102 to confirmed 78
    • Interventions: epcoritamab (Biological), epcoritamab (maintenance) (Biological), epcoritamab (monotherapy) (Biological), gemcitabine and oxaliplatin… to Epcoritamab (Biological), Epcoritamab (maintenance) (Biological), Epcoritamab (monotherapy) (Biological), Gemcitabine and oxaliplatin…
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: 19 to 18
    • Study description revised
    • Site details revised at 8 of 14 sites
    • Study title expanded, about 7 words

    See this version in full on ClinicalTrials.gov ↗

Show 28 earlier versionsHide 28 earlier versions
  1. 10 versions Re-verified since Jul 16, 2024, no change to tracked fieldsv20-v29
  2. Primary and study completion dates: Dec 30, 2024 to Sep 2025v19
  3. 3 versions Re-verified since May 6, 2024, no change to tracked fieldsv16-v18
  4. Study sites: 18 to 14v15
  5. 4 versions Re-verified since Aug 7, 2023, no change to tracked fieldsv11-v14
  6. Trial status: Recruiting to Active, Not Recruiting Study sites: 20 to 18v10 Show 1 more changeShow less
    • Study sites: 20 to 18
  7. Re-verified, no change to tracked fieldsv9
  8. Site details revised at 1 of 20 sitesv8
  9. Site details revised at 1 of 20 sitesv7
  10. Trial status: Active, Not Recruiting to Recruiting Primary endpoints: 3 to 5 · Enrollment target: 73 to 102 · Primary and study completion dates: Sep 30, 2024 to Dec 30, 2024 · 6 morev6 Show 9 more changesShow less
    • Primary endpoints: 3 to 5
    • Enrollment target: 73 to 102
    • Primary and study completion dates: Sep 30, 2024 to Dec 30, 2024
    • Interventions: epcoritamab (Biological) to epcoritamab (Biological), epcoritamab (maintenance) (Biological), epcoritamab (monotherapy) (Biological), gemcitabine and oxaliplatin…
    • Eligibility criteria expanded, about 265 words
    • Secondary endpoints: 9 to 19
    • Study description expanded, about 76 words
    • Study sites revised (20)
    • Study arms: 1 to 5

    See this version in full on ClinicalTrials.gov ↗

  11. Trial status: Recruiting to Active, Not Recruiting Site details revised at 20 of 20 sitesv5 Show 1 more changeShow less
    • Site details revised at 20 of 20 sites
  12. Site details revised at 2 of 20 sitesv4
  13. Study sites: 9 to 20v3
  14. Site details revised at 3 of 9 sites Eligibility criteria shortened, about 3 words · Collaborators expanded, about 1 wordv2 Show 2 more changesShow less
    • Eligibility criteria shortened, about 3 words
    • Collaborators expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  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
Chronic Lymphocytic Leukemia (CLL)
452 trials monitored
See 34 trials at risk
and 1 more disease
The trial is an open-label, multi-center safety and preliminary efficacy trial of epcoritamab (EPKINLY™) in Japanese participants with relapsed, progressive or refractory B-cell lymphomas and Japanese participants with B-cell lymphomas that have achieved partial response (PR) or complete response (CR) following prior standard of care (SOC). The trial consists of two parts: Part 1, dose escalation (phase 1), and Part 2, expansion (phase 2). The purpose of the dose-escalation part of the trial is to determine the maximum tolerated dose (MTD) and the recommended Phase-2 dose (RP2D), as well as to establish the safety profile of epcoritamab in Japanese participants with relapsed, progressive or refractory B-cell lymphoma and Japanese participants with B-cell lymphomas that have achieved PR or CR. In the expansion part, additional participants will be treated with epcoritamab, at the RP2D and the purpose is to further explore and determine the safety and efficacy of epcoritamab. Part 2 of the trial will be initiated once the RP2D has been determined in Part 1. In Part 2, epcoritamab is investigated as a monotherapy and in combination with other SOC agents.
Trial Details
NCT Number NCT04542824
Lead Sponsor Genmab
Collaborators: AbbVie
Conditions Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma, Primary Mediastinal Large B Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Small Lymphocytic Lymphoma
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov