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Diffuse Large B-cell LymphomaPhase 3EPCORE DLBCL-1NCT04628494

A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)

A Phase 3 study testing Epcoritamab and Investigator's Choice Chemotherapy in people with Diffuse Large B-cell Lymphoma, run by Genmab at 186 sites in 24 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Large B-cell Lymphoma
What is being tested?
Epcoritamab and Investigator's Choice Chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
483 participants
Where
186 sitesin 24 countries
Study dates
13 Jan 2021to Apr 2028
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Main Inclusion Criteria:

  1. 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
  2. One of the confirmed histologies below with CD20-positivity:
  3. DLBCL, not otherwise specified (NOS), including de novo or histologically transformed from follicular lymphoma (FL)
  4. "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
  5. FL Grade 3B
  6. T-cell/histiocyte-rich large B-cell lymphoma
  7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2
  8. Failed previous HDT-ASCT or not eligible for high-dose therapy autologous stem cell transplant (HDT-ASCT) at screening
  9. Participants must have detectable disease by positron emission tomography (PET) scan and measurable by computed tomography (CT) scan or magnetic resonance imaging (MRI)
  10. Acceptable renal and liver function
  11. Life expectancy >2 months on standard of care treatment

Main Exclusion Criteria:

  1. Primary Central Nervous System (CNS) tumor or known CNS involvement
  2. Any prior therapy with a bispecific antibody targeting CD3 and CD20
  3. Major surgery within 4 weeks prior to randomization
  4. Chemotherapy and other non-investigational antineoplastic agents (except CD20 mAbs) within 4 weeks or 5 half-lives (whichever is shorter) prior to randomization
  5. Any investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to randomization
  6. Autologous stem cell transplant (ASCT) within 100 days of randomization
  7. Treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 100 days prior to randomization
  8. Seizure disorder requiring anti-epileptic therapy
  9. Clinically significant cardiac disease

Trial locations and contacts

186 sites in 24 countries.

186 sites in 24 countries

France19 sites

  • Audrey ALEME

    Amiens

  • Centre Hospitalier de la Côte Basque

    Bayonne

  • CHRU de Brest - Hospital Morvan

    Brest

  • CHU Caen - IHBN

    Caen

  • Groupe Hospitalier de La Rochelle

    La Rochelle

  • CHU de LIMOGES

    Limoges

  • Centre Léon Bérard

    Lyon

  • Hopital de la Conception APHM

    Marseille

  • CHU de Nantes - Hôtel Dieu

    Nantes

  • Centre Antoine Lacassagne

    Nice

  • Clinique Victor Hugo

    Paris

  • Hôpital Saint-Louis

    Paris

  • CHU de Bordeaux Hôpital Haut-Lévêque

    Pessac

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite

  • CHU de Poitiers - Hôpital la Milétrie

    Poitiers

  • Centre Hospitalier Rene Dubos

    Pontoise

  • Ch Cornouaille

    Quimper

  • Centre Henri Becquerel

    Rouen

  • CHRU Tours Hôpital Bretonneau

    Tours

Other trials in France

Japan18 sites

  • Kyushu University Hospital

    Fukuoka

  • Fukushima Medical University Hospital

    Fukushima

  • Chugoku Central Hospital

    Fukuyama

  • Hokkaido University Hospital

    Hokkaido

  • National Cancer Center Hospital East

    Kashiwa

  • Kyoto University Medical Hospital

    Kyoto

  • Matsuyama Red Cross Hospital

    Matsuyama

  • Mie University Hospital

    Mie

  • Japanese Red Cross Nagoya Daini Hospital

    Nagoya

  • NHO Nagoya Medical Center

    Nagoya

  • Okayama University Hospital

    Okayama

  • Kindai University Hospital

    Ōsaka-sayama

  • Tohoku University Hospital

    Sendai

  • Keio University Hospital

    Tokyo

  • National Cancer Center Hospital

    Tokyo

  • Tokai University Hospital

    Tokyo

  • Fujita Health University Hospital

    Toyoake

  • Yamagata University Hospital

    Yamagata

Other trials in Japan

United States15 sites

  • MD Anderson Cancer Center at Cooper

    Camden, New Jersey, 08103

  • The Christ Hospital Cancer Center

    Cincinnati, Ohio, 45229

  • TriHealth Cancer Institute- Good Samaritan Hospital

    Cincinnati, Ohio, 45247

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Indiana Blood and Marrow Transplantation

    Indianapolis, Indiana, 46237

  • Community Health Network Cancer Center North

    Indianapolis, Indiana, 46250

  • Henry Ford Health System

    Jackson, Michigan, 49201

  • University of Kentucky Markey Cancer Center

    Lexington, Kentucky, 40536

  • Community Cancer Trials of Utah

    Ogden, Utah, 84405

  • Virginia Commonwealth University (VCU) Massey Cancer Center

    Richmond, Virginia, 23298

  • MMCORC Attn Delaney Anderson

    Saint Louis Park, Minnesota, 55416

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

  • North Star Lodge Cancer Center

    Yakima, Washington, 98902

Other trials in United States

Spain15 sites

  • ICO Badalona - Hospital Universitari Germans Trias i Pujol

    Badalona

  • ICO l'Hospitalet - Hospital Duran i Reynals

    Barcelona

  • Hospital San Pedro de Alcántara

    Cáceres

  • Hospita Universitario Puerta Del Mar

    Cadiz

  • Hospital Universitario Reina Sofía

    Córdoba

  • Hospital Arnau de Vilanova

    Lleida

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid

  • Hospital Universitario Ramon y Cajal

    Madrid

  • Md Anderson Cancer Center

    Madrid

  • Hospital Universitario de Salamanca

    Salamanca

  • Hospital Universitario Marqués de Valdecilla

    Santander

  • Hospital Universitario Virgen De Valme

    Seville

  • Hospital Universitario Virgen del Rocío

    Seville

  • Hospital Universitario Virgen Macarena

    Seville

Other trials in Spain

Italy13 sites

  • IRCCS Istituto Tumori Giovanni Paolo II Bari

    Bari

  • Azienda Socio Sanitaria Territoriale Sette Laghi (Presidio Ospedale di Circolo e Fondazione Macchi)

    Bergamo

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

    Brescia

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)

    Meldola

  • Istituto Oncologico Europeo

    Milan

  • San Raffaele Hospital

    Milan

  • Azienda Ospedaliero - Universitaria Maggiore delle Carita SCDU Ematologia building C

    Novara

  • Fondazione IRCCS Policlinico San matteo

    Pavia

  • Ospedale Santa Maria delle Croci

    Ravenna

  • Azienda Ospedaliera Universitaria Policlinico Umberto I Università di Roma La Sapienza, Dip Med Tra

    Rome

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo

  • Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) Ospedale Maggiore di Trieste

    Trieste

  • SC di Ematologia - AON SS Antonio e Biagio e Cesare Arrigo

    Venezia

Other trials in Italy

South Korea12 sites

  • Dong-A University Hospital

    Busan

  • Pusan National University Hospital

    Busan

  • Pusan National University Hosptial

    Busan

  • Keimyung University Dongsan Hospital

    Daegu

  • Chonbuk National University Hospital

    Geumam

  • Asan Medical Center

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul National University Bundang Hospital

    Seoul

  • Seoul National University Hospital

    Seoul

  • Severance Hospital, Yonsei University Health System

    Seoul

  • The Catholic University of Korea Seoul St. Marys Hospital

    Seoul

  • Ulsan University Hospital

    Ulsan

Other trials in South Korea

Turkey (Türkiye)11 sites

  • Ankara University Medical Faculty

    Ankara

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

    Ankara

  • Gazi University Medical Faculty

    Ankara

  • Amerikan Hospital

    Istanbul

  • Iqvia Tibbi Istatistik

    Istanbul

  • Istanbul University Cerrahpasa - Cerrahpasa Tip Fakultesi

    Istanbul

  • Istanbul University Medical Faculty

    Istanbul

  • Dokuz Eylul University Medical Faculty

    Izmir

  • Ege University Medical Faculty

    Izmir

  • Tekirdag Namik Kemal University

    Tekirdağ

  • Karadeniz Technical University

    Trabzon

Other trials in Turkey (Türkiye)

Belgium9 sites

  • ZNA Middelheim

    Antwerp

  • AZ Sint-Jan

    Bruges

  • Institut Jules Bordet

    Brussels

  • Universitair Ziekenhuis Gent

    Ghent

  • UZ Brussel

    Jette

  • Hôpital de Jolimont

    La Louvière

  • Universitair Ziekenhuis gasthuisberg Leuven

    Leuven

  • AZ Nikolaas- Verenigde Ziekenhuizen van Waas en Durme

    Sint-Niklaas

  • AZ Turnhout, Campus Sint-Elisabeth

    Turnhout

Other trials in Belgium

Hungary9 sites

  • National Institute of Oncology

    Budapest

  • Semmelweis Egyetem Belgyógyászati és Onkológiai Klinika

    Budapest

  • Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Hematologia

    Debrecen

  • Belgyógyászati osztály Markhot Ferenc Kórház

    Eger

  • Petz Aladar Egyetemi Oktato Korhaz

    Győr

  • Josa Andras Teaching Hospital, Hematology Dept

    Nyíregyháza

  • University of Pecs 1st. Internal medicine Clinic Dept. Hematology

    Pécs

  • Szegedi Tudományegyetem II. sz. Belgyogyaszat, Hematologia

    Szeged

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár

Other trials in Hungary

United Kingdom9 sites

  • Haematology - University Hospitals Birmingham NHS Foundation Trust

    Birmingham

  • Guys and St Thomas NHS Foundation Trust

    London

  • Hammersmith Hospital

    London

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    Norwich

  • Nottingham University Hospitals NHS Trust

    Nottingham

  • Derriford Hospital

    Plymouth

  • University Hospital Southampton

    Southampton

  • Royal Marsden NHS Foundation Trust (Sutton)

    Sutton

  • Royal Cornwall Hospital

    Truro

Other trials in United Kingdom

Netherlands7 sites

  • Rijnstate Arnhem

    Arnhem

  • Amphia Ziekenhuis, Interne Geneeskunde, Oncologie. Route 43

    Breda

  • Albert Schweitzer Ziekenhuis

    Dordrecht

  • Admiraal de Ruyter Ziekenhuis

    Goes

  • Bravis Ziekenhuis

    Roosendaal

  • Erasmus MC

    Rotterdam

  • Franciscus Gasthuis And Vlietland

    Rotterdam

Other trials in Netherlands

Poland7 sites

  • Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii

    Gdansk

  • Pratia Onkologia Katowice

    Katowice

  • Pratia MCM Kraków

    Krakow

  • Instytut Centrum Zdrowia Matki Polki

    Lodz

  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii

    Lodz

  • Centrum Medyczne Pratia Poznan

    Skorzewo

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

    Wroclaw

Other trials in Poland

Australia6 sites

  • Flinders Medical Centre

    Bedford Park

  • Concord Repatriation General Hospital

    Concord

  • Peninsula Private Hospital Clinical Trials Unit

    Frankston

  • Icon Cancer Centre Corporate Office

    South Brisbane

  • Calvary Mater Newcastle

    Waratah

  • Westmead Hospital

    Westmead

Other trials in Australia

Russia6 sites

  • State Autonomous Institution of Healthcare Republican Clinical Oncological Dispensary of the Ministr

    Kazan'

  • Federal State Budgetary Institution of Science

    Moscow

  • Federal State Budgetary Institution

    Moscow

  • State Budgetary Institution of Healthcare of Nizhniy Novgorod region, 1st inpatient facility, 5th fl

    Nizhny Novgorod

  • Federal State Budgetary Institution V.A. Almazov National Medical Research Center of the Ministry of

    Saint Petersburg

  • State Budgetary Institution of Healthcare Leningrad Regional Clinical Hospital

    Saint Petersburg

Other trials in Russia

Israel5 sites

  • Bnai Zion Medical Center

    Haifa

  • Rambam Health Care Center

    Haifa

  • Hadassah University Hospital

    Jerusalem

  • Shaare Zedek Medical Center

    Jerusalem

  • Sourasky Medical Center

    Tel Aviv

Other trials in Israel

Taiwan5 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City

  • National Cheng Kung University Hospital

    Tainan

  • National Taiwan University Hospital

    Taipei

  • Taipei Veterans General Hospital

    Taipei

  • Tri-Service General Hospital

    Taipei

Other trials in Taiwan

Denmark4 sites

  • Aalborg Universitetshospital

    Aalborg

  • Aarhus University Hospital, Department of Hematology, Clinical Research Unit C116

    Aarhus

  • Clinical Research Unit, Roskilde Sygehus

    Roskilde

  • Vejle Hospital

    Vejle

Other trials in Denmark

Germany4 sites

  • Uniklinik Köln, Klinik I für Innere Medizin, CIO Gebäude 70, 5.094

    Cologne

  • Universitaetsklinikum Essen

    Essen

  • Universitätsklinikum Schleswig-Holstein Medizinische Klinik II Hämatologie und Onkologie

    Kiel

  • Universitätsklinikum Würzburg

    Würzburg

Other trials in Germany

Austria3 sites

  • Ordensklinikum Linz Barmherzige Schwestern

    Linz

  • Ordensklinikum Linz GmbH Elisabethinen

    Linz

  • Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III der PMU

    Salzburg

Other trials in Austria

Singapore3 sites

  • National University Hospital

    Kent Ridge

  • Clinical Trials and Research Centre

    Singapore

  • National Cancer Centre Singapore

    Singapore

Other trials in Singapore

Finland2 sites

  • HUS Cancer Center/ Clinical Trial Unit

    Helsinki

  • Oulu university hospital, Department of hematology

    Oulu

Other trials in Finland

Norway2 sites

  • Oslo University Hospital location Radium hospital

    Oslo

  • St. Olavs Hospital HF

    Trondheim

Other trials in Norway

Canada1 site

  • CHU de Quebec-Universite Laval

    Québec

Other trials in Canada

Sweden1 site

  • Karolinska university Hospital

    Stockholm

Other trials in Sweden

About this study

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)

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.

Read more

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.
Read the 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.

Being tested
Epcoritamab, Investigator's Choice Chemotherapy
Keywords
double-hit DLBCL, triple-hit DLBCL, follicular grade 3B, transformed DLBCL, T-cell histiocytes-rich large B cell lymphoma
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EpcoritamabBiological

    Also called GEN3013, DuoBody®-CD3xCD20, EPKINLY™

    Following mandatory pre-medication, participants will be administered epcoritamab as a subcutaneous injection.

  • Investigator's Choice ChemotherapyDrug

    Also called BR or R-GemOx

    Following mandatory pre-medication, participants will be administered intravenously either BR or R-GemOx.

Study groups in NCT04628494
Study groupRoleWhat they receive
Epcoritamab (GEN3013; DuoBody®CD3xCD20)ExperimentalEpcoritamab will be administered in Cycles of 28 days until any of the discontinuation criteria is met
Receives: Biological: Epcoritamab
Investigator's choice of chemotherapyActive 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
Receives: Drug: Investigator's Choice Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    OS was defined as the time from the date of randomization to date of death due to any cause. Participants who were still alive at the clinical cut-off date for the analysis were censored at the last date known to be alive.

    Measured: Up to approximately 4 years, 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2020
  2. Study start13 Jan 2021
  3. Primary completion13 Oct 2025
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
483 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04628494
Sponsor's protocol ID
GCT3013-05
Other IDs
2023-504830-23-00, 2020-003016-27, jRCT2021220017, CTR20221558, MOH_2021-01-18_009672, NL75079.056.20, 286972, 2023
Acronym
EPCORE DLBCL-1
Status last verified
Oct 2026
First submitted
9 Nov 2020
Last updated
3 Nov 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Epcoritamab and Investigator's Choice Chemotherapy in people with Diffuse Large B-cell Lymphoma, run by Genmab at 186 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 186 sites in France, Japan, United States, Spain, Italy and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to approximately 4 years, 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04628494.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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