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Diffuse Large B-Cell LymphomaPhase 2EPCORE DLBCL-3NCT05660967

Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell Lymphoma

A Phase 2 study testing Epcoritamab and Lenalidomide in people with Diffuse Large B-Cell Lymphoma, run by Genmab at 74 sites in 12 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of the study is to examine efficacy and safety of epcoritamab with and without lenalidomide in newly diagnosed elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL) who cannot tolerate anthracycline therapy. Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Diffuse Large B-Cell Lymphoma
What is being tested?
Epcoritamab and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
111 participants
Where
74 sitesin 12 countries
Study dates
6 Mar 2023to 10 Jun 2026
Phase
Phase 2
Are there results?
None posted in the registry

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 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Must have newly diagnosed CD20+ large cell lymphoma.
  • Is ineligible for anthracycline-based therapy/cytotoxic chemotherapy due to:
  • Being age ≥80 years; AND/OR
  • Being age ≥75 years and having important comorbid condition(s), which are likely to have a negative impact on tolerability of anthracycline-based therapy/cytotoxic chemotherapy.
  • Have Immune Effector Cell-Associated Encephalopathy (ICE) score of at least 8 out of 10.
  • Have Ann Arbor Stage II-IV disease.
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  • Have ECOG PS of 0, 1, or 2; (ECOG PS of 3 may be considered if impairment is attributed to current lymphoma/DLBCL and if pre-phase treatment during the screening phase results in an improvement of ECOG PS to ≤2 prior to enrollment).
  • Have measurable disease as per Lugano criteria.
  • Have acceptable organ function based on baseline bloodwork.
  • Must have fresh (preferred) or archival biopsy material at screening.

Who cannot join

  • Has known active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection at trial enrollment, including COVID-19 infection.
  • Has severe cardiovascular disease (other than those eligibility criteria that preclude the subject from receiving anthracycline-based therapy/cytotoxic chemotherapy),
  • Has been exposed to/received any of the following prior therapies, treatments, or procedures within the specified timeframes:
  • Major surgery within 4 weeks prior to the first dose of epcoritamab;
  • Non-investigational antineoplastic agents (except anti-CD20 monoclonal antibodies) or any investigational drug within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of epcoritamab;
  • Autologous hematopoietic stem cell transplantation (HSCT), CAR-T, allogeneic stem cell transplantation, or solid organ transplantation;
Show all 18Show fewer
  • Live, attenuated vaccines within 30 days prior to initiation of epcoritamab;
  • Investigational vaccines within 28 days before the planned first dose of epcoritamab (ie, experimental and/or non-authorized SARS-CoV-2 vaccinations and therapies are not allowed);
  • Invasive investigational medical device use within 28 days before the planned first dose of epcoritamab.
  • Has primary central nervous system (CNS) tumor or known CNS involvement or intracranial involvement as confirmed by mandatory brain magnetic resonance imaging/computed tomography (MRI/CT) scan at screening and, if clinically indicated, by lumbar puncture.
  • Has a seizure disorder requiring anti-epileptic therapy or experienced a seizure within 6 months of signing an informed consent form.
  • Has known past or current malignancy other than inclusion diagnosis, with exceptions as stated in protocol.
  • Has known or suspected allergies, hypersensitivity, or intolerance to either of the trial treatments or has known or suspected contraindication to the use of all locally available anti-cytokine therapies per local guidelines for management of cytokine release syndrome (CRS).
  • Has active hepatitis B virus (HBV) (DNA polymerase chain reaction [PCR]-positive) or hepatitis C virus (HCV) (RNA PCR-positive) infection, current alcohol abuse, or cirrhosis.
  • Has active cytomegalovirus (CMV) infection (DNA PCR-positive) requiring treatment.
  • Has suspected active or inadequately treated latent tuberculosis.
  • Has a known history of seropositivity for HIV. Note: HIV testing is required at screening only if required per local health authorities or institutional standards.
  • Note: Other protocol defined inclusion/exclusion criteria may apply.

Trial locations and contacts

74 sites in 12 countries.

74 sites in 12 countries

Italy11 sites

  • Clinica di Ematologia AOU Ospedali Riuniti di Ancona

    Ancona, Ancona

  • IRCCS Centro di Riferimento Oncologico

    Aviano

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

    Bologna

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

    Brescia

  • Fondazione del Piemonte per l'Oncologia IRCC Candiolo

    Candiolo

  • IRCCS Istituto Romagnolo Per Lo Studio Dei Tumori "Dino Amadori" - IRST

    Meldola

  • IEO Istituto Europeo di Oncologia Parent

    Milan

  • Ospedale San Raffaele

    Milan

  • Azienda Ospedaliera Vincenzo Cervello

    Palermo

  • AUSL Piacenza Ospedale Guglielmo da Saliceto

    Piacenza

  • Azienda sanitaria integrata università di Trieste

    Trieste

Other trials in Italy

Spain11 sites

  • ICO Badalona - Hospital Universitari Germans Trias i Pujol

    Badalona

  • Hospital Clinic de Barcelona

    Barcelona

  • ICO l'Hospitalet - Hospital Duran i Reynals

    Barcelona

  • Hospital San Pedro de Alcantara

    Cáceres

  • Hospital General Universitario Gregorio Marañon

    Madrid

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid

  • Hospital Universitario Ramon y Cajal

    Madrid

  • Hospital Universitario Nuestra Señora de Valme

    Seville

  • Hospital Universitario Puerta del Mar

    Seville

  • Hospital Universitario Virgen Macarena

    Seville

Other trials in Spain

France10 sites

  • CHU Angers - Hôpital Hôtel Dieu

    Angers

  • Hôpital Henri Mondor

    Créteil

  • Hopital Claude Huriez - CHRU Lille

    Lille

  • Hopital de la Conception - APHM

    Marseille

  • CHU de Nantes - Hotel Dieu

    Nantes

  • Hôpital Saint-Antoine

    Paris

  • Hôpital Saint-Louis

    Paris

  • CHU de Bordeaux - Hôpital Haut-Lévêque

    Pessac

  • CHU Amiens - Hopital Sud

    Salouël

  • CHU Tours - Hôpital Bretonneau

    Tours

Other trials in France

Japan9 sites

  • Kyushu University Hospital

    Fukuoka

  • Kagoshima University Hospital

    Kagoshima

  • Kanazawa University Hospital

    Kanazawa

  • National Cancer Center Hospital East

    Kashiwa

  • Cancer Institute Hospital of JFCR

    Kōtoku

  • Matsuyama Red Cross Hospital

    Matsuyama

  • NHO Nagoya Medical Center

    Nagoya

  • Kindai University Hospital

    Ōsaka-sayama

  • Yamagata University Hospital

    Yamagata

Other trials in Japan

Belgium7 sites

  • Institut Jules Bordet

    Anderlecht

  • ZNA

    Antwerp

  • UZ Brussels

    Jette

  • UZ Leuven

    Leuven

  • AZ Delta

    Roeselare

  • Vitaz

    Temse

  • AZ Turnhout - Campus Sint-Elisabeth

    Turnhout

Other trials in Belgium

South Korea6 sites

  • Keimyung University Dongsan Hospital

    Daegu

  • National Cancer Center

    Goyang-si

  • Jeonbuk National University Hospital

    Jeonju

  • Asan Medical Center

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

United Kingdom5 sites

  • Royal Marsden Hospital - Fulham

    London

  • Derriford Hospital

    Plymouth

  • Southampton General Hospital

    Southampton

  • Royal Marsden Hospital

    Sutton

  • Royal Cornwall Hospital NHS Trust

    Truro

Other trials in United Kingdom

Germany4 sites

  • Universitaetsklinikum Aachen AOeR

    Aachen

  • Vivantes Klinikum Neukoelln

    Berlin, State of Berlin

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg

  • Universitaetsklinikum Wuerzburg

    Würzburg

Other trials in Germany

Poland4 sites

  • Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej

    Biała Podlaska

  • Pratia MCM Krakow

    Krakow

  • Centrum Medyczne Pratia Poznan

    Skorzewo

  • MICS Centrum Medyczne Torun

    Torun

Other trials in Poland

Austria3 sites

  • Kepler Universitätsklinikum

    Linz

  • LKH - Universitätsklinikum der PMU Salzburg

    Salzburg

  • Klinikum Wels-Grieskirchen GmbH

    Wels

Other trials in Austria

Czechia3 sites

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové

  • Fakultni nemocnice v Motole

    Prague

  • Vseobecna fakultni nemocnice v Praze

    Prague

Other trials in Czechia

United States1 site

  • UW Cancer Center at ProHealth Care

    Waukesha, Wisconsin, 53188

Other trials in United States

About this study

Official title: Efficacy and Safety of Epcoritamab Monotherapy and in Combination With Lenalidomide as First-line Therapy for Anthracycline-ineligible Diffuse Large B-Cell Lymphoma Patients, an Open-label, Randomized, Multicenter, Global Phase 2 Trial

The purpose of the study is to examine efficacy and safety of epcoritamab with and without lenalidomide in newly diagnosed elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL) who cannot tolerate anthracycline therapy. Epcoritamab (also known as EPKINLY™, GEN3013 and DuoBody®-CD3xCD20) is an antibody that has already been tested in several clinical studies. All patients will receive active treatment. There is an equal chance of receiving epcoritamab or epcoritamab plus lenalidomide.

Read the detailed description

This is an open-label, multicenter, global phase-2 trial evaluating the efficacy and safety of epcoritamab monotherapy and epcoritamab plus lenalidomide in elderly patients who are deemed anthracycline ineligible.

The trial is designed in two stages:

  • Stage 1 which includes a safety run-in phase in each arm
  • Stage 2, an expansion of the selected treatment from Stage 1
Being tested
Epcoritamab, Lenalidomide
Keywords
Double-hit lymphoma, Triple-hit lymphoma, Follicular grade 3B, T-cell/histiocyte rich LBCL, DuoBody®, Anti-CD3, Anti-CD20, Subcutaneous, Bispecific antibody, EPCORE
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®-CD3×CD20, EPKINLY™

    Epcoritamab will be administered by subcutaneous (SC) injections in 28-day cycles for up to 12 cycles.

  • LenalidomideDrug

    Also called Revlimid®

    Lenalidomide will be administered orally (capsules; starting dose of 10 or 20 mg) once daily on Day 1 to Day 21 of each 28-day cycle for up to 12 cycles.

Study groups in NCT05660967
Study groupRoleWhat they receive
Epcoritamab monotherapyExperimentalNot described
Receives: Biological: Epcoritamab
Epcoritamab in combination with lenalidomideExperimentalNot described
Receives: Biological: Epcoritamab; Drug: Lenalidomide

What is being measured

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

  1. Complete Response (CR) rate

    Percentage of participants achieving CR. Assessed by the Investigator per Lugano criteria

    Measured: From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years

Secondary outcomes (12)

  1. Duration of response (DOR)

    Defined as the time between date of first response to the date of first documented tumor progression or death (due to any cause) whichever occurs first

    Measured: From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years

  2. Duration of complete response (DOCR)

    Defined as the time between the date of first CR to the date of the first documented tumor progression or death due to any cause, whichever comes first

    Measured: From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years

  3. Time to response (TTR)

    Defined as the time from first dose to first documentation of objective tumor response (CR or PR)

    Measured: From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 1 year

  4. Overall Response Rate (ORR)

    Defined as the percentage of patients who achieve best overall response of complete response (CR) or partial response (PR) determined by Lugano criteria

    Measured: From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years

  5. Progression-free survival (PFS)

    Defined as the time from first dose to date of PD or death (due to any cause) whichever occurs first

    Measured: From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years

  6. Time to next anti-lymphoma therapy (TTNT)

    Defined as the time from first dose to administration of subsequent anti-lymphoma therapy

    Measured: From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years

  7. Rate of minimal residual disease (MRD) negativity

    Percentage of participants with at least 1 post-screening MRD negative result

    Measured: From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years

  8. Overall survival (OS)

    Defined at the timeframe from first dose to death

    Measured: From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 3 years

  9. Incidence and severity of adverse events (AEs)

    An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment

    Measured: From screening until end of the safety follow-up period (60 days after last dose)

  10. Incidence of anti-drug antibodies (ADAs) to epcoritamab in plasma

    To evaluate immunogenicity

    Measured: From first dose until treatment discontinuation (assessed up to 12 months)

  11. Evaluate patient-reported outcomes (PROs) related to lymphoma symptoms

    Changes in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym). Scale from 0-168 obtained by summing individual subscale scores. Higher scores for the scales indicate better quality of life

    Measured: From cycle 1, day 1 until 90 days after last dose (each cycle is 28 days)

  12. Epcoritamab plasma concentrations over time

    Measured: From first dose and at multiple time points until treatment discontinuation (assessed up to 12 months)

Timeline

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

  1. First posted21 Dec 2022
  2. Study start6 Mar 2023
  3. Primary completion10 Jun 2026
  4. Study completion10 Jun 2026

Why it stopped: The study was terminated because sufficient data had been collected to meet the objectives of the development program. No new or unexpected safety findings were identified, and the decision to terminate was not related to participant safety.

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05660967
Sponsor's protocol ID
GCT3013-06
Other IDs
2021-005744-29, jRCT2021230015, 1006219, 2023-504832-16-00, 2023
Acronym
EPCORE DLBCL-3
Status last verified
Oct 2026
First submitted
29 Nov 2022
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No
Expanded access
Available

Publications

  • Vitolo U, Burgues JMB, Duell J, Kwiatek M, Belada D, Jurczak W, Maerevoet M, Sibon D, Greil R, Kumode T, Lopez-Jimenez J, Meert C, Cia JS, Thieblemont C, Alcaide SO, Kim WS, Cordoba R, Wielgos-Bonvallet M, Jiang T, Wang Y, McGoldrick S, Guo E, Morschhauser F, Woei-A-Jin FJSH. Epcoritamab monotherapy or epcoritamab with lenalidomide as first-line therapy for patients with diffuse large B-cell lymphoma (EPCORE DLBCL-3): primary analysis of an open-label, multicentre, randomised, phase 2 trial. Lancet Haematol. 2026 Jul;13(7):e435-e448. doi: 10.1016/S2352-3026(26)00112-2. Epub 2026 Jun 12.

    PubMed 42285113

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Epcoritamab and Lenalidomide in people with Diffuse Large B-Cell Lymphoma, run by Genmab at 74 sites in 12 countries.

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

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. 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: stopped early, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in Italy, Spain, France, Japan, Belgium and 7 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study was stopped early (reason given: The study was terminated because sufficient data had been collected to meet the objectives of the development program. No new or unexpected safety findings were identified, and the decision to terminate was not related to participant safety.). Results are not available in the source record.

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?

Complete Response (CR) rate (time frame: From randomization (for patients enrolled in stage 1) or from first dose (for patients enrolled in stage 2) and up to 2 years). 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 NCT05660967, which also lists 1 linked publication.

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 23 Oct 2026.

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