Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-30 @ 11:12 AM
Study NCT ID:
NCT04628494
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2020-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)
Sponsor:
Genmab
Organization:
Study Overview
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)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT05733650
Has Expanded Access, NCT# Status:
APPROVED_FOR_MARKETING
Acronym:
EPCORE DLBCL-1
Brief 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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2023-504830-23-00 | CTIS | None | View | |
| 2020-003016-27 | EUDRACT_NUMBER | None | View | |
| jRCT2021220017 | REGISTRY | Japan Registry for Clinical Trials (jRCT) | View | |
| CTR20221558 | REGISTRY | ChinaDrugTrials.org.cn | View | |
| MOH_2021-01-18_009672 | REGISTRY | Clinical Research Site - mytrial | View | |
| NL75079.056.20 | REGISTRY | CCMO (the Netherlands) | View | |
| 286972 | OTHER | IRAS ID; UK Research Summaries Database | View |