A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)
EPCORE DLBCL-1
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)
8 other identifiers
interventional
484
23 countries
180
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2021
Longer than P75 for phase_3
180 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2020
CompletedFirst Posted
Study publicly available on registry
November 13, 2020
CompletedStudy Start
First participant enrolled
January 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
ExpectedMay 5, 2026
May 1, 2026
4.8 years
November 9, 2020
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
Up to approximately 5 years
Secondary Outcomes (12)
Progression Free Survival (PFS)
Up to approximately 5 years
Overall Response Rate (ORR)
Up to approximately 5 years
Complete Response (CR) Rate
Up to approximately 5 years
Duration of Response (DOR)
Up to approximately 5 years
Time to Response (TTR)
Up to approximately 5 years
- +7 more secondary outcomes
Study Arms (2)
Epcoritamab (GEN3013; DuoBody®CD3xCD20)
EXPERIMENTALEpcoritamab will be administered in Cycles of 28 days until any of the discontinuation criteria is met
Investigator's choice of chemotherapy
ACTIVE COMPARATORR-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
Interventions
Following mandatory pre-medication, participants will be administered epcoritamab as a subcutaneous injection.
Following mandatory pre-medication, participants will be administered intravenously either BR or R-GemOx.
Eligibility Criteria
You may qualify if:
- Relapsed or refractory disease and previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 monoclonal antibody (mAb)-containing combination chemotherapy since lymphoma diagnosis
- One of the confirmed histologies below with CD20-positivity:
- DLBCL, not otherwise specified (NOS), including de novo or histologically transformed from follicular lymphoma (FL)
- "Double-hit" or "triple-hit" DLBCL (technically classified in World Health Organization (WHO) 2016 as high-grade B-cell lymphoma (HGBCL), with MYC and BCL2 and/or BCL6 translocations), including de novo or histologically transformed from FL
- FL Grade 3B
- T-cell/histiocyte-rich large B-cell lymphoma
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2
- Failed previous HDT-ASCT or not eligible for high-dose therapy autologous stem cell transplant (HDT-ASCT) at screening
- Participants must have detectable disease by positron emission tomography (PET) scan and measurable by computed tomography (CT) scan or magnetic resonance imaging (MRI)
- Acceptable renal and liver function
- Life expectancy \>2 months on standard of care treatment
You may not qualify if:
- Primary Central Nervous System (CNS) tumor or known CNS involvement
- Any prior therapy with a bispecific antibody targeting CD3 and CD20
- Major surgery within 4 weeks prior to randomization
- Chemotherapy and other non-investigational antineoplastic agents (except CD20 mAbs) within 4 weeks or 5 half-lives (whichever is shorter) prior to randomization
- Any investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to randomization
- Autologous stem cell transplant (ASCT) within 100 days of randomization
- Treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 100 days prior to randomization
- Seizure disorder requiring anti-epileptic therapy
- Clinically significant cardiac disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (186)
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, 46237, United States
Community Health Network Cancer Center North
Indianapolis, Indiana, 46250, United States
University of Kentucky Markey Cancer Center
Lexington, Kentucky, 40536, United States
Henry Ford Health System
Jackson, Michigan, 49201, United States
MMCORC Attn Delaney Anderson
Saint Louis Park, Minnesota, 55416, United States
MD Anderson Cancer Center at Cooper
Camden, New Jersey, 08103, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
The Christ Hospital Cancer Center
Cincinnati, Ohio, 45229, United States
TriHealth Cancer Institute- Good Samaritan Hospital
Cincinnati, Ohio, 45247, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
Community Cancer Trials of Utah
Ogden, Utah, 84405, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Virginia Commonwealth University (VCU) Massey Cancer Center
Richmond, Virginia, 23298, United States
North Star Lodge Cancer Center
Yakima, Washington, 98902, United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, 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
Okayama University Hospital
Okayama, Japan
Kindai University Hospital
Ōsaka-sayama, Japan
Tohoku University Hospital
Sendai, Japan
Keio University Hospital
Tokyo, Japan
National Cancer Center Hospital
Tokyo, Japan
Tokai University Hospital
Tokyo, Japan
Fujita Health University Hospital
Toyoake, Japan
Yamagata University Hospital
Yamagata, Japan
Rijnstate Arnhem
Arnhem, Netherlands
Amphia Ziekenhuis, Interne Geneeskunde, Oncologie. Route 43
Breda, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, Netherlands
Admiraal de Ruyter Ziekenhuis
Goes, Netherlands
Bravis Ziekenhuis
Roosendaal, Netherlands
Erasmus MC
Rotterdam, Netherlands
Franciscus Gasthuis And Vlietland
Rotterdam, Netherlands
Oslo University Hospital location Radium hospital
Oslo, Norway
St. Olavs Hospital HF
Trondheim, Norway
Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii
Gdansk, Poland
Pratia Onkologia Katowice
Katowice, Poland
Pratia MCM Kraków
Krakow, Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii
Lodz, Poland
Centrum Medyczne Pratia Poznan
Skorzewo, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, Poland
State Autonomous Institution of Healthcare Republican Clinical Oncological Dispensary of the Ministr
Kazan', Russia
Federal State Budgetary Institution of Science
Moscow, Russia
Federal State Budgetary Institution
Moscow, Russia
State Budgetary Institution of Healthcare of Nizhniy Novgorod region, 1st inpatient facility, 5th fl
Nizhny Novgorod, Russia
Federal State Budgetary Institution V.A. Almazov National Medical Research Center of the Ministry of
Saint Petersburg, Russia
State Budgetary Institution of Healthcare Leningrad Regional Clinical Hospital
Saint Petersburg, Russia
National University Hospital
Kent Ridge, Singapore
Clinical Trials and Research Centre
Singapore, Singapore
National Cancer Centre Singapore
Singapore, Singapore
Dong-A University Hospital
Busan, South Korea
Pusan National University Hospital
Busan, South Korea
Pusan National University Hosptial
Busan, South Korea
Keimyung University Dongsan Hospital
Daegu, South Korea
Chonbuk National University Hospital
Geumam, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Bundang Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
The Catholic University of Korea Seoul St. Marys Hospital
Seoul, South Korea
Ulsan University Hospital
Ulsan, South Korea
ICO Badalona - Hospital Universitari Germans Trias i Pujol
Badalona, Spain
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, Spain
Hospita Universitario Puerta Del Mar
Cadiz, Spain
Hospital San Pedro de Alcántara
Cáceres, Spain
Hospital Universitario Reina Sofía
Córdoba, Spain
Hospital Arnau de Vilanova
Lleida, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Md Anderson Cancer Center
Madrid, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Hospital Universitario Virgen De Valme
Seville, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Karolinska university Hospital
Stockholm, Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Ankara University Medical Faculty
Ankara, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
Ankara, Turkey (Türkiye)
Gazi University Medical Faculty
Ankara, Turkey (Türkiye)
Amerikan Hospital
Istanbul, Turkey (Türkiye)
Iqvia Tibbi Istatistik
Istanbul, Turkey (Türkiye)
Istanbul University Cerrahpasa - Cerrahpasa Tip Fakultesi
Istanbul, Turkey (Türkiye)
Istanbul University Medical Faculty
Istanbul, Turkey (Türkiye)
Dokuz Eylul University Medical Faculty
Izmir, Turkey (Türkiye)
Ege University Medical Faculty
Izmir, Turkey (Türkiye)
Tekirdag Namik Kemal University
Tekirdağ, Turkey (Türkiye)
Karadeniz Technical University
Trabzon, Turkey (Türkiye)
Haematology - University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Guys and St Thomas NHS Foundation Trust
London, United Kingdom
Hammersmith Hospital
London, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
University Hospital Southampton
Southampton, United Kingdom
Royal Marsden NHS Foundation Trust (Sutton)
Sutton, United Kingdom
Royal Cornwall Hospital
Truro, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
November 9, 2020
First Posted
November 13, 2020
Study Start
January 13, 2021
Primary Completion
October 13, 2025
Study Completion (Estimated)
April 1, 2028
Last Updated
May 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share