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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)
NCT04628494 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 484 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genmab, which has 59 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04628494 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, Indiana, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04628494?
The interventions under investigation include: Epcoritamab (BIOLOGICAL), Investigator's Choice Chemotherapy (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04628494?
This trial is sponsored by Genmab, which has 59 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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