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NCT04628494 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)
A Phase 3 study of Diffuse Large B Cell Lymphoma, sponsored by Genmab.
- Active
- Registry status
- Phase 3
- Development phase
- 484
- Enrollment target
- 20
- Study locations
NCT04628494 is a Phase 3 study of Diffuse Large B Cell Lymphoma that is active but no longer recruiting, run by Genmab. The registered enrollment target is 484 participants, above the 214-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (126% higher). The trial reports 20 study locations across 13 states.
The verdict
NCT04628494, a Phase 3 study of Diffuse Large B Cell Lymphoma, is active but no longer recruiting, sponsored by Genmab.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 484 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL Epcoritamab
- DRUG Investigator's Choice Chemotherapy
Study Locations (20)
Other
- Flinders Medical Centre - Bedford Park
- Concord Repatriation General Hospital - Concord
- Peninsula Private Hospital Clinical Trials Unit - Frankston
- Icon Cancer Centre Corporate Office - South Brisbane
- Calvary Mater Newcastle - Waratah
Indiana
- Indiana Blood and Marrow Transplantation - Indianapolis
- Community Health Network Cancer Center North - Indianapolis
Ohio
- The Christ Hospital Cancer Center - Cincinnati
- TriHealth Cancer Institute- Good Samaritan Hospital - Cincinnati
Utah
- Community Cancer Trials of Utah - Ogden
- LDS Hospital - Salt Lake City
Kentucky
- University of Kentucky Markey Cancer Center - Lexington
Michigan
- Henry Ford Health System - Jackson
Minnesota
- MMCORC Attn Delaney Anderson - Saint Louis Park
New Jersey
- MD Anderson Cancer Center at Cooper - Camden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 484 participants |
| Start Date | 2021-01-13 |
| Est. Completion | 2028-04 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04628494
The ClinicalTrials.gov registry entry for NCT04628494 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 484 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 214-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (126% higher). The listed sponsor is Genmab, which has 45 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Epcoritamab is the first listed.
NCT04628494 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, Indiana, Ohio.
Frequently Asked Questions
What is clinical trial NCT04628494 about?
NCT04628494 is a clinical study titled "A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)". 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. ...
What is the current status of trial NCT04628494?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 484 participants. The study started on 2021-01-13. Estimated completion is 2028-04.
What conditions does trial NCT04628494 study?
This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma.
What interventions are being tested in trial NCT04628494?
The interventions under investigation include: Epcoritamab (BIOLOGICAL), Investigator's Choice Chemotherapy (DRUG).
Who is sponsoring clinical trial NCT04628494?
This trial is sponsored by Genmab, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04628494 being conducted?
This trial has 20 study locations across Indiana, Kentucky, Michigan, Minnesota, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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