A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)
Running, not enrolling · Phase 3
Conditions studied: Diffuse Large B-cell Lymphoma
In brief
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.
Key facts
- Study ID
- NCT04628494
- Run by
- Genmab
- People needed
- 483
- Starts
- 2021-01-13
- Expected to finish
- 2028-04-01
- Last updated by the study team
- 2026-05-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Community Health Network Cancer Center North — Indianapolis, Indiana, United States
- University of Kentucky Markey Cancer Center — Lexington, Kentucky, United States
- Henry Ford Health System — Jackson, Michigan, United States
- MMCORC Attn Delaney Anderson — Saint Louis Park, Minnesota, United States
- MD Anderson Cancer Center at Cooper — Camden, New Jersey, United States
- Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
- The Christ Hospital Cancer Center — Cincinnati, Ohio, United States
- TriHealth Cancer Institute- Good Samaritan Hospital — Cincinnati, Ohio, United States
- Brooke Army Medical Center — Fort Sam Houston, Texas, United States
- Community Cancer Trials of Utah — Ogden, Utah, United States
- LDS Hospital — Salt Lake City, Utah, United States
- Virginia Commonwealth University (VCU) Massey Cancer Center — Richmond, Virginia, United States
- North Star Lodge Cancer Center — Yakima, Washington, United States
- Waukesha Memorial Hospital — Waukesha, Wisconsin, United States
- Flinders Medical Centre — Bedford Park, Australia
- Concord Repatriation General Hospital — Concord, Australia
- Peninsula Private Hospital Clinical Trials Unit — Frankston, Australia
- Icon Cancer Centre Corporate Office — South Brisbane, Australia
- Calvary Mater Newcastle — Waratah, Australia
- Westmead Hospital — Westmead, Australia
- Ordensklinikum Linz Barmherzige Schwestern — Linz, Austria
- Ordensklinikum Linz GmbH Elisabethinen — Linz, Austria
- Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III der PMU — Salzburg, Austria
- ZNA Middelheim — Antwerp, Belgium
- Indiana Blood and Marrow Transplantation — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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