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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)
Sponsor: Genmab
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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
483
Start Date
2021-01-13
Completion Date
2028-04
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
Epcoritamab
Following mandatory pre-medication, participants will be administered epcoritamab as a subcutaneous injection.
Investigator's Choice Chemotherapy
Following mandatory pre-medication, participants will be administered intravenously either BR or R-GemOx.
Locations (186)
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, United States
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
AZ Sint-Jan
Bruges, Belgium
Institut Jules Bordet
Brussels, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
UZ Brussel
Jette, Belgium
Hôpital de Jolimont
La Louvière, Belgium
Universitair Ziekenhuis gasthuisberg Leuven
Leuven, Belgium
AZ Nikolaas- Verenigde Ziekenhuizen van Waas en Durme
Sint-Niklaas, Belgium
AZ Turnhout, Campus Sint-Elisabeth
Turnhout, Belgium
CHU de Quebec-Universite Laval
Québec, Canada
Aalborg Universitetshospital
Aalborg, Denmark
Aarhus University Hospital, Department of Hematology, Clinical Research Unit C116
Aarhus, Denmark
Clinical Research Unit, Roskilde Sygehus
Roskilde, Denmark
Vejle Hospital
Vejle, Denmark
HUS Cancer Center/ Clinical Trial Unit
Helsinki, Finland
Oulu university hospital, Department of hematology
Oulu, Finland
Audrey ALEME
Amiens, France
Centre Hospitalier de la Côte Basque
Bayonne, France
CHRU de Brest - Hospital Morvan
Brest, France
CHU Caen - IHBN
Caen, France
Groupe Hospitalier de La Rochelle
La Rochelle, France
CHU de LIMOGES
Limoges, France
Centre Léon Bérard
Lyon, France
Hopital de la Conception APHM
Marseille, France
CHU de Nantes - Hôtel Dieu
Nantes, France
Centre Antoine Lacassagne
Nice, France
Clinique Victor Hugo
Paris, France
Hôpital Saint-Louis
Paris, France
CHU de Bordeaux Hôpital Haut-Lévêque
Pessac, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
CHU de Poitiers - Hôpital la Milétrie
Poitiers, France
Centre Hospitalier Rene Dubos
Pontoise, France
Ch Cornouaille
Quimper, France
Centre Henri Becquerel
Rouen, France
CHRU Tours Hôpital Bretonneau
Tours, France
Uniklinik Köln, Klinik I für Innere Medizin, CIO Gebäude 70, 5.094
Cologne, Germany
Universitaetsklinikum Essen
Essen, Germany
Universitätsklinikum Schleswig-Holstein Medizinische Klinik II Hämatologie und Onkologie
Kiel, Germany
Universitätsklinikum Würzburg
Würzburg, Germany
National Institute of Oncology
Budapest, Hungary
Semmelweis Egyetem Belgyógyászati és Onkológiai Klinika
Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Hematologia
Debrecen, Hungary
Belgyógyászati osztály Markhot Ferenc Kórház
Eger, Hungary
Petz Aladar Egyetemi Oktato Korhaz
Győr, Hungary
Josa Andras Teaching Hospital, Hematology Dept
Nyíregyháza, Hungary
University of Pecs 1st. Internal medicine Clinic Dept. Hematology
Pécs, Hungary
Szegedi Tudományegyetem II. sz. Belgyogyaszat, Hematologia
Szeged, Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, Hungary
Bnai Zion Medical Center
Haifa, Israel
Rambam Health Care Center
Haifa, Israel
Hadassah University Hospital
Jerusalem, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Sourasky Medical Center
Tel Aviv, Israel
IRCCS Istituto Tumori Giovanni Paolo II Bari
Bari, Italy
Azienda Socio Sanitaria Territoriale Sette Laghi (Presidio Ospedale di Circolo e Fondazione Macchi)
Bergamo, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
Meldola, Italy
Istituto Oncologico Europeo
Milan, Italy
San Raffaele Hospital
Milan, Italy
Azienda Ospedaliero - Universitaria Maggiore delle Carita SCDU Ematologia building C
Novara, Italy
Fondazione IRCCS Policlinico San matteo
Pavia, Italy
Ospedale Santa Maria delle Croci
Ravenna, Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I Università di Roma La Sapienza, Dip Med Tra
Rome, Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) Ospedale Maggiore di Trieste
Trieste, Italy
SC di Ematologia - AON SS Antonio e Biagio e Cesare Arrigo
Venezia, Italy
Kyushu University Hospital
Fukuoka, Japan
Fukushima Medical University Hospital
Fukushima, Japan
Chugoku Central Hospital
Fukuyama, Japan
Hokkaido University Hospital
Hokkaido, Japan
National Cancer Center Hospital East
Kashiwa, Japan
Kyoto University Medical Hospital
Kyoto, Japan
Matsuyama Red Cross Hospital
Matsuyama, Japan
Mie University Hospital
Mie, Japan
Japanese Red Cross Nagoya Daini Hospital
Nagoya, Japan
NHO Nagoya Medical Center
Nagoya, Japan