Clinical trial • Phase II • Oncology

Epcoritamab for Diffuse large B-cell lymphoma

Phase II trial of Epcoritamab for Diffuse large B-cell lymphoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Diffuse large B-cell lymphoma
Trial Stage
Phase II
Drug Modality
Bispecific antibody | Small molecule
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
06-12-2023
First CTIS Authorization Date
18-01-2024

Trial design

Randomised, open-label, arm 1: epcoritamab monotherapy (subcutaneous formulation, product listing shows maximum daily dose amount 48 mg). arm 2: epcoritamab plus lenalidomide (oral lenalidomide listed with max daily dose amount 20 mg).-controlled Phase II trial in Austria, Belgium, Czechia and others.

Randomised
Yes
Open Label
Yes
Comparator
Arm 1: Epcoritamab monotherapy (subcutaneous formulation, product listing shows maximum daily dose amount 48 mg). Arm 2: Epcoritamab plus Lenalidomide (oral lenalidomide listed with max daily dose amount 20 mg).
Target Sample Size
38

Eligibility

Recruits 38 Vulnerable population not selected (isVulnerablePopulationSelected=false). Informed consent is obtained from adult participants via provided subject information and informed consent forms (multiple ICF versions present); eConsent/remote consent materials are available. Additional ICFs for pregnant partners and baby data collection are present in the document list..

Vulnerable Population
Vulnerable population not selected (isVulnerablePopulationSelected=false). Informed consent is obtained from adult participants via provided subject information and informed consent forms (multiple ICF versions present); eConsent/remote consent materials are available. Additional ICFs for pregnant partners and baby data collection are present in the document list.

Inclusion criteria

  • {"criterion_text":"- Must have newly diagnosed CD20+ large cell lymphoma."}
  • {"criterion_text":"- Is ineligible for anthracycline-based therapy/cytotoxic chemotherapy due to: oBeing age ≥80 years; AND/OR oBeing 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."}
  • {"criterion_text":"- Have Ann Arbor Stage II-IV disease."}
  • {"criterion_text":"- 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.)"}
  • {"criterion_text":"- Have measurable disease as per Lugano criteria."}
  • {"criterion_text":"- Have acceptable organ function based on baseline bloodwork."}
  • {"criterion_text":"- Must have fresh (preferred) or archival biopsy material at screening."}

Exclusion criteria

  • {"criterion_text":"- Has known active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection at trial enrollment, including COVID-19 infection."}
  • {"criterion_text":"- Has suspected active or inadequately treated latent tuberculosis."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Has severe cardiovascular disease (other than those eligibility criteria that preclude the subject from receiving anthracycline-based therapy/cytotoxic chemotherapy)."}
  • {"criterion_text":"- Has been exposed to/received any of the following prior therapies, treatments, or procedures within the specified timeframes: oMajor surgery within 4 weeks prior to the first dose of epcoritamab; oNon-investigational antineoplastic agents or any investigational drug within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of epcoritamab; oAutologous hematopoietic stem cell transplantation (HSCT), CAR-T, allogeneic stem cell transplantation, or solid organ transplantation; oLive, attenuated vaccines within 30 days prior to initiation of epcoritamab; oInvestigational 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); oInvasive investigational medical device use within 28 days before the planned first dose of epcoritamab."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Has a seizure disorder requiring anti-epileptic therapy or experienced a seizure within 6 months of signing an informed consent form."}
  • {"criterion_text":"- Has known past or current malignancy other than inclusion diagnosis, with exceptions as stated in protocol."}
  • {"criterion_text":"- 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)."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Has active cytomegalovirus (CMV) infection (DNA PCR-positive) requiring treatment."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Complete response (CR) rate determined by Lugano criteria","definition_or_measurement_approach":"Determined by Lugano criteria"}

Secondary endpoints

  • {"endpoint_text":"- Duration of response (DOR) determined by Lugano criteria","definition_or_measurement_approach":"Determined by Lugano criteria"}
  • {"endpoint_text":"- Duration of complete response (DOCR) determined by Lugano criteria","definition_or_measurement_approach":"Determined by Lugano criteria"}
  • {"endpoint_text":"- Time to response (TTR) determined by Lugano criteria","definition_or_measurement_approach":"Determined by Lugano criteria"}
  • {"endpoint_text":"- Overall response rate (ORR) determined by Lugano criteria","definition_or_measurement_approach":"Determined by Lugano criteria"}
  • {"endpoint_text":"- Progression-free survival (PFS) determined by Lugano criteria","definition_or_measurement_approach":"Determined by Lugano criteria"}
  • {"endpoint_text":"- Time to next (anti-lymphoma) therapy (TTNT).","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Rate and duration of minimal residual disease (MRD) negative status","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Incidence of dose-limiting toxicities (DLTs)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Incidence and severity of adverse events (AEs)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Incidence and severity of changes in laboratory values","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Incidence of antidrug antibodies (ADAs) to epcoritamab","definition_or_measurement_approach":""}
  • {"endpoint_text":"- PK parameters (clearance, volume of distribution, area under-the- concentration-time curve [AUC0-last and AUC0-∞], maximum concentration [Cmax], time of Cmax [Tmax], predose values, and halflife [t½])","definition_or_measurement_approach":"Standard PK parameter assessment (AUC0-last, AUC0-∞, Cmax, Tmax, clearance, volume of distribution, predose values, t½)"}
  • {"endpoint_text":"- Changes in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy – Lymphoma (FACT-Lym)","definition_or_measurement_approach":"Patient-reported outcomes measured using FACT-Lym instrument"}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
38
Recruitment Window Months
57
Consent Approach
Informed consent obtained from adult participants via provided subject information sheets and formal informed consent forms (multiple ICF versions listed). eConsent/remote consent platform is available (eConsent submission letter, video storyboard, system email screenshots, remote consent screenshots). Additional documents include Pregnant Partner and Baby data collection ICFs. Consent materials available in multiple languages as indicated by document filenames (EN, FR, PL, DE, ES, IT, CZ, NL).

Methods

  • Physician referral letters (documents titled 'Referral letter' and 'Physician Referral Letter' present) — targets referring physicians and clinical sites.
  • Site website / patient-facing landing pages (documents titled 'Site ... Website information' and 'Patient facing landing page') — targets potential patients searching site-specific information.
  • Social media scripts (document 'Social Media Script') — digital outreach to potential patients.
  • eConsent / remote consent procedures (documents: eConsent Submission Letter, eConsent Video Storyboard, eConsent System Email Screenshots, Remote Consent Screenshots) — remote/digital consenting for participants.
  • Patient-facing recruitment materials (patient ID cards, information leaflets, Lenalidomide information sheets) — direct-to-patient informational materials at sites.

Geography

Total Number Of Sites
41
Total Number Of Participants
102

Austria

Earliest CTIS Part Ii Submission Date
21-12-2023
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
827
Number Of Sites
2
Number Of Participants
7

Sites

Site Name
Klinikum Wels-Grieskirchen GmbH
Department Name
Abteilung für Innere Medizin IV
Contact Person Name
Sonja Heibl
Contact Person Email
sonja.heibl@klinikum-wegr.at
Site Name
SCRI CCCIT Ges.m.b.H.
Department Name
Universitätsklinik für Innere Medizin III der PMU
Contact Person Name
Thomas Melchardt
Contact Person Email
t.melchardt@salk.at

Belgium

Earliest CTIS Part Ii Submission Date
21-12-2023
Latest Decision Or Authorization Date
25-03-2026
Processing Time Days
825
Number Of Sites
5
Number Of Participants
17

Sites

Site Name
Ziekenhuis Aan De Stroom
Department Name
Hematology
Contact Person Name
Ka Lung Wu
Contact Person Email
kalung.wu@zna.be
Site Name
UZ Brussel
Department Name
Hematology
Contact Person Name
Veerle Beckers
Contact Person Email
veerle.beckers@uzbrussel.be
Site Name
UZ Leuven
Department Name
General Medical Oncology
Contact Person Name
Sherida Woei-A-Jin
Contact Person Email
sherida.woei-a-jin@uzleuven.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
Hematology
Contact Person Name
Caressa Meert
Contact Person Email
caressa.meert@azdelta.be
Site Name
Institut Jules Bordet
Department Name
Clinical Hematology
Contact Person Name
Fulvio Massaro
Contact Person Email
fulvio.massaro@hubruxelles.be

Czechia

Earliest CTIS Part Ii Submission Date
21-12-2023
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
827
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
IV. interní hematologická klinika
Contact Person Name
David Belada
Contact Person Email
david.belada@fnhk.cz

France

Earliest CTIS Part Ii Submission Date
21-12-2023
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
830
Number Of Sites
11
Number Of Participants
24

Sites

Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Hématologie
Contact Person Name
Pierre MOREL
Contact Person Email
morel.pierre@chu-amiens.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Hématologie
Contact Person Name
Emmanuel Gyan
Contact Person Email
emmanuel.gyan@univ-tours.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Onco-hématologie
Contact Person Name
Catherine Thieblemont
Contact Person Email
catherine.thieblemont@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hématologie
Contact Person Name
Nicolas Stocker
Contact Person Email
nicolas.stocker@aphp.fr
Site Name
Assistance Publique Hopitaux De Marseille
Department Name
Hématologie
Contact Person Name
Régis Costello
Contact Person Email
regis.costello@ap-hm.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Hématologie
Contact Person Name
Jérôme Paillassa
Contact Person Email
jerome.paillassa@chu-angers.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Hématologie
Contact Person Name
Thomas Gastinne
Contact Person Email
thomas.gastinne@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Hématologie
Contact Person Name
Franck Morschhauser
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hématologie
Contact Person Name
David Sibon
Contact Person Email
david.sibon@aphp.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Hématologie
Contact Person Name
François-Xavier Gros
Site Name
Centre Hospitalier Universitaire De Pessac (Bordeaux region)
Department Name
Hématologie

Germany

Earliest CTIS Part Ii Submission Date
21-12-2023
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
830
Number Of Sites
6
Number Of Participants
7

Sites

Site Name
Universitaetsklinikum Augsburg
Department Name
II. Medizinische Klinik
Contact Person Name
Mathias Lutz
Contact Person Email
mathias.lutz@uk-augsburg.de
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Med. Klinik und Poliklinik II, Zentrum für Innere Medizin
Contact Person Name
Johannes Düll
Contact Person Email
Duell_J@ukw.de
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
Fachbereich Hämatologie, Onkologie und Palliativmedizin
Contact Person Name
Maike de Wit
Contact Person Email
maike.dewit@vivantes.de
Site Name
Klinikum Chemnitz gGmbH
Department Name
Zentrum für klinische Studien
Contact Person Name
Mathias Hänel
Contact Person Email
m.haenel@skc.de
Site Name
Medical Center - University Of Freiburg
Department Name
Innere Medizin I - Hämatologie und Onkologie
Contact Person Name
Reinhard Marks
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Medizinische Klinik IV Onkologie, Haematologie
Contact Person Name
Mareike Tometten
Contact Person Email
mtometten@ukaachen.de

Italy

Earliest CTIS Part Ii Submission Date
21-12-2023
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
830
Number Of Sites
5
Number Of Participants
16

Sites

Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
UO Ematologia
Contact Person Name
Alessandra Tucci
Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Department Name
Oncologia Medica
Contact Person Name
Umberto Vitolo
Contact Person Email
umberto.vitolo@ircc.it
Site Name
European Institute Of Oncology S.r.l.
Department Name
Divisione di Oncoematologia e Trapianto di cellule staminali
Contact Person Name
Enrico Derenzini
Contact Person Email
enrico.derenzini@ieo.it
Site Name
Azienda Sanitaria Universitaria Giuliano Isontina
Department Name
SC Ematologia
Contact Person Name
Francesco Zaja
Site Name
Azienda Unita Sanitaria Locale Di Piacenza
Department Name
Ematologia
Contact Person Name
Annalisa Arcari
Contact Person Email
a.arcari@ausl.pc.it

Spain

Earliest CTIS Part Ii Submission Date
21-12-2023
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
827
Number Of Sites
9
Number Of Participants
21

Sites

Site Name
Hospital San Pedro De Alcantara
Department Name
Haematology
Contact Person Name
Juan Miguel Bergua Burgues
Contact Person Email
jmberguaburg@gmail.com
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Contact Person Name
Juan Manuel Sancho Cia
Contact Person Email
jsancho@iconcologia.net
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Haematology
Contact Person Name
Sergio Ramos Cillan
Contact Person Email
sergio.ramosc@quironsalud.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Haematology
Contact Person Name
Mariana Bastos Oreiro
Contact Person Email
bastosmariana@yahoo.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Haematology
Contact Person Name
Javier Lopez Jimenez
Contact Person Email
jljimenez@salud.madrid.org
Site Name
Hospital Clinic De Barcelona
Department Name
Haematology
Contact Person Name
Eva Giné Soca
Contact Person Email
EGINE@clinic.cat
Site Name
Hospital Universitario Virgen De Valme
Department Name
Haematology
Contact Person Name
Eduardo Rios Herranz
Site Name
Institut Catala D'oncologia (L'hospitalet De Llobregat)
Department Name
Haematology
Contact Person Name
Anna Sureda Balari
Contact Person Email
asureda@iconcologia.net
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Hematology
Contact Person Name
Sergio Ortegon Alcaide
Contact Person Email
sortegonalcaide@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
21-12-2023
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
827
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Pratia S.A.
Department Name
Pratia MCM Krakow
Contact Person Name
Wojciech Jurczak
Contact Person Email
wojciech.jurczak@pratia.com
Site Name
Aidport Sp. z o.o.
Contact Person Name
Michał Kwiatek
Contact Person Email
michal.kwiatek@aidport.pl

Sponsor

Primary sponsor

Full Name
Genmab A/S
Organisation Type
Pharmaceutical company
Country Of Registered Address
Denmark

Contract research organisations

Name
Fortrea Development Limited
Name
Tigermed-Bdm Inc.
Responsibilities
Programming/Biostatistics
Name
Icon Laboratory Services Inc.
Responsibilities
Pharmacokinetics and antidrug antibody analysis. Central Repository and Review of local lab reports
Name
Clinipace Inc.
Name
Q Squared Solutions Limited
Name
Endpoint Clinical Inc.
Name
CellCarta
Responsibilities
Immunohistochemistry
Name
Adaptive Biotechnologies Corp.
Responsibilities
MRD analysis.
Name
Eresearchtechnology Inc.
Responsibilities
ePROs and ECG analysis
Name
Perceptive Eclinical Limited
Responsibilities
Medical image analysis.
Name
IQVIA Limited
Responsibilities
Project management, expedited and aggregate safety reporting to investigators, and ECs. DNA sequencing.

Third parties

  • {"country":"United Kingdom","full_name":"Fortrea Development Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Tigermed-Bdm Inc.","duties_or_roles":"Programming/Biostatistics","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"Pharmacokinetics and antidrug antibody analysis. Central Repository and Review of local lab reports","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Clinipace Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"Immunohistochemistry","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"MRD analysis.","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ePROs and ECG analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Genmab US Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Perceptive Eclinical Limited","duties_or_roles":"Medical image analysis.","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Project management, expedited and aggregate safety reporting to investigators, and ECs. DNA sequencing.","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Epcoritamab
Active Substance
Epcoritamab
Modality
Bispecific antibody
Routes Of Administration
Subcutaneous
Route
Subcutaneous
Orphan Designation
Yes
Maximum Dose
48 mg
Investigational Product Name
Lenalidomide
Active Substance
Lenalidomide
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Maximum Dose
20 mg
Combination Treatment
Yes

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