A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)
Public ClinicalTrials.gov record NCT04628494. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04628494
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 483 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 12, 2021
- Primary completion
- Oct 12, 2025
- Completion
- Mar 31, 2028
- Last update posted
- May 21, 2026
2021 – 2028
United States locations
- U.S. sites
- 15
- U.S. states
- 12
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Indiana Blood and Marrow Transplantation | Indianapolis | Indiana | 46237 | — |
| Community Health Network Cancer Center North | Indianapolis | Indiana | 46250 | — |
| University of Kentucky Markey Cancer Center | Lexington | Kentucky | 40536 | — |
| Henry Ford Health System | Jackson | Michigan | 49201 | — |
| MMCORC Attn Delaney Anderson | Saint Louis Park | Minnesota | 55416 | — |
| MD Anderson Cancer Center at Cooper | Camden | New Jersey | 08103 | — |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | — |
| The Christ Hospital Cancer Center | Cincinnati | Ohio | 45229 | — |
| TriHealth Cancer Institute- Good Samaritan Hospital | Cincinnati | Ohio | 45247 | — |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | — |
| Community Cancer Trials of Utah | Ogden | Utah | 84405 | — |
| LDS Hospital | Salt Lake City | Utah | 84143 | — |
| Virginia Commonwealth University (VCU) Massey Cancer Center | Richmond | Virginia | 23298 | — |
| North Star Lodge Cancer Center | Yakima | Washington | 98902 | — |
| Waukesha Memorial Hospital | Waukesha | Wisconsin | 53188 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 171 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04628494, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 21, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04628494 live on ClinicalTrials.gov.