A Phase 3 interventional study of Epcoritamab and Investigator's Choice Chemotherapy in Diffuse Large B-cell Lymphoma, sponsored by Genmab. Active, not recruiting at 186 sites in 24 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Genmab · Phase 3, Interventional, and Treatment
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 estimated trial duration for an individual participant depends upon the treatment arm assigned:
Participants who receive investigator's choice (standard of care) chemotherapy will receive treatments either:
The trial is an open label, multi-center, global phase-3 randomized trial of epcoritamab. The goal of this randomized trial is to evaluate the efficacy of epcoritamab (GEN3013, DuoBody®-CD3xCD20) compared to investigator's choice of chemotherapy, in participants with relapsed, refractory DLBCL who have failed or are ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT). No change in chemotherapy is permitted for participants during the treatment phase of the trial.
Overall Survival (OS) is the primary endpoint in USA and in China, with the analysis population including all randomized participants. OS/Progression Free Survival (PFS) are dual-primary endpoints for rest of the world (outside US and China), with the analysis population also including all participants randomized.
The China sub-study of GCT3013-05 is registered under NCT07226752.
1,390 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 350 are open to participants now.
This study's enrollment of 483 is above the median of 47 across 1,185 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.
Browse Lymphoma, Large B-Cell, Diffuse studies →Genmab is the lead sponsor of 67 studies on the registry; 14 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 12 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
One of the confirmed histologies below with CD20-positivity:
Main Exclusion Criteria:
Epcoritamab will be administered in Cycles of 28 days until any of the discontinuation criteria is met
Biological: Epcoritamab
R-GemOx will be administrated in Cycles of 28 days until maximum cycles completion or any of the discontinuation criteria is met BR will be administrated in Cycles of 21 days until maximum cycles completion or any of the discontinuation criteria is met
Drug: Investigator's Choice Chemotherapy
Following mandatory pre-medication, participants will be administered epcoritamab as a subcutaneous injection.
Also known as: GEN3013, DuoBody®-CD3xCD20, EPKINLY™
Following mandatory pre-medication, participants will be administered intravenously either BR or R-GemOx.
Also known as: BR or R-GemOx
Overall Survival (OS)
Time frame: Up to approximately 5 years
Progression Free Survival (PFS)
Time frame: Up to approximately 5 years
Overall Response Rate (ORR)
Time frame: Up to approximately 5 years
Complete Response (CR) Rate
Time frame: Up to approximately 5 years
Duration of Response (DOR)
Time frame: Up to approximately 5 years
Time to Response (TTR)
Time frame: Up to approximately 5 years
Duration of Minimal Residual Disease (MRD) Negative Status
Time frame: Up to approximately 5 years
Rate of MRD Negative Status
Time frame: Up to approximately 5 years
Time to Next Anti-lymphoma Therapy (TTNT)
Time frame: Up to approximately 5 years
Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 5 years
Number of Participants with Dose Interruptions and Delays
Time frame: Up to approximately 5 years
Number of Participants with an Anti-epcoritamab Antibody Response
Time frame: Up to approximately 5 years
Changes from Baseline in Lymphoma Symptoms as Measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
Time frame: Baseline up to approximately 5 years
Showing the first 100 of 186 sites across 24 countries.
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Lymphoma, Large B-Cell, Diffuse→
Genmab