Clinical Trials Register

Summary
EudraCT Number:	2021-005744-29
Sponsor's Protocol Code Number:	GCT3013-06
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2022-09-19
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2021-005744-29

A.3

Full title of the trial

A RANDOMIZED, OPEN-LABEL, MULTICENTER, GLOBAL, PHASE 2 TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF EPCORITAMAB (GEN3013; DUOBODY®-CD3×CD20) AS MONOTHERAPY OR IN COMBINATION WITH LENALIDOMIDE AS FIRST-LINE THERAPY FOR ANTHRACYCLINE-INELIGIBLE SUBJECTS WITH DIFFUSE LARGE B CELL LYMPHOMA

Sperimentazione globale di fase 2, multicentrica, randomizzata, in aperto volta a valutare l’efficacia e la sicurezza di epcoritamab (GEN3O13; DuoBody®-CD3 x CD20) come monoterapia o in combinazione con lenalidomide come terapia di prima linea per soggetti affetti da linfoma diffuso a grandi cellule B non idonei alle antracicline

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

EFFICACY AND SAFETY TRIAL OF EPCORITAMAB WITH OR WITHOUT LENALIDOMIDE AS FIRST LINE THERAPY FOR SUBJECTS WITH DIFFUSE LARGE B-CELL LYMPHOMA

Sperimentazione sull’efficacia e la sicurezza di epcoritamab con o senza lenalidomide come terapia di prima linea per soggetti affetti da linfoma diffuso a grandi cellule B

A.3.2

Name or abbreviated title of the trial where available

EPCORE™ DLBCL-3

GCT3013-06

A.4.1

Sponsor's protocol code number

GCT3013-06

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	GENMAB A/S
B.1.3.4	Country	Denmark
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Genmab A/S
B.4.2	Country	Denmark
B.4.1	Name of organisation providing support	Genmab US, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Genmab A/S
B.5.2	Functional name of contact point	Clinical Trial Information
B.5.3	Address:
B.5.3.1	Street Address	Kalvebod Brygge 43
B.5.3.2	Town/ city	Copenhagen V
B.5.3.3	Post code	DK-1560
B.5.3.4	Country	Denmark
B.5.4	Telephone number	0000000
B.5.5	Fax number	0000000
B.5.6	E-mail	clinicaltrials@genmab.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Epcorimatab
D.3.2	Product code	[GEN3013]
D.3.4	Pharmaceutical form	Concentrate for solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Epcoritamab
D.3.9.1	CAS number	2134641-34-0
D.3.9.2	Current sponsor code	na
D.3.9.4	EV Substance Code	SUB190479
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Epcoritamab
D.3.2	Product code	[GEN3013]
D.3.4	Pharmaceutical form	Concentrate for solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Epcoritamab
D.3.9.1	CAS number	2134641-34-0
D.3.9.2	Current sponsor code	na
D.3.9.3	Other descriptive name	Epcoritamab
D.3.9.4	EV Substance Code	SUB190479
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	60
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Lenalidomide
D.3.2	Product code	[L04AX04]
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Lenalidomide
D.3.9.1	CAS number	191732-72-6
D.3.9.2	Current sponsor code	na
D.3.9.4	EV Substance Code	SUB25389
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	If the IMP has a marketing authorisation in the Member State concerned by this application, but the trade name and marketing authorisation holder are not fixed in the protocol, go to section D.2.2.
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Lenalidomide
D.3.2	Product code	[na]
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Lenalidomide
D.3.9.1	CAS number	191732-72-6
D.3.9.2	Current sponsor code	na
D.3.9.4	EV Substance Code	SUB25389
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 5
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	RoActemra
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	RoActemra
D.3.2	Product code	[L04AC07]
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TOCILIZUMAB
D.3.9.1	CAS number	375823-41-9
D.3.9.2	Current sponsor code	375823-41-9
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

B-cell Lymphoma

Linfoma a cellule B

E.1.1.1

Medical condition in easily understood language

Lymphoma of B-cell origin

Linfoma a cellule B di origine

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluate the clinical efficacy of epcoritamab monotherapy or epcoritamab and lenalidomide

valutare l'efficacia clinica di epcoritamab in monoterapia o epcoritamab e lenalidomide

E.2.2

Secondary objectives of the trial

1. Evaluate other efficacy measures of epcoritamab monotherapy or epcoritamab and lenalidomide
2. Evaluate safety and tolerability of epcoritamab monotherapy or epcoritamab and lenalidomide
3. Evaluate immunogenicity
4. Assess the pharmacokinetics of epcoritamab
5. Evaluate patient-reported outcomes related to lymphoma symptoms

1. Valutare altre misure di efficacia di epcoritamab in monoterapia o epcoritamab e lenalidomide
2. Valutare la sicurezza e la tollerabilità di epcoritamab in monoterapia o epcoritamab e lenalidomide
3. Valutare l'immunogenicità
4. Valutare la farmacocinetica di epcoritamab
5. Valutare gli esiti riportati dai pazienti relativi ai sintomi del linfoma

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•Must have newly diagnosed CD20+ large cell lymphoma
•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.
•Have Ann Arbor Stage II-IV disease.
•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.

•Deve avere un linfoma a grandi cellule CD20+ di nuova diagnosi
•Non è idoneo per la terapia a base di antracicline/chemioterapia citotossica a causa di:
oEtà = 80 anni; E/O
o Avere un'età = 75 anni e avere importanti condizioni di comorbidità, che possono avere un impatto negativo sulla tollerabilità della terapia a base di antracicline/chemioterapia citotossica, avere un punteggio di encefalopatia associata alle cellule immunoeffettori (ICE) di almeno 8 su 10.
•Avere la malattia di Ann Arbor in stadio II-IV.
•Avere ECOG PS di 0, 1 o 2; (Può essere preso in considerazione un ECOG PS di 3 se la compromissione è attribuita al linfoma/DLBCL in corso e se il trattamento pre-fase durante la fase di screening determina un miglioramento di ECOG PS a = 2 prima dell'arruolamento.)
•Avere una malattia misurabile secondo i criteri di Lugano.
• Avere una funzione d'organo accettabile in base alle analisi del sangue di base.
•Deve avere materiale bioptico fresco (preferito) o d'archivio allo screening.

E.4

Principal exclusion criteria

•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:
oMajor surgery within 4 weeks prior to the first dose of epcoritamab;
oNon-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;
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.
•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.

•Ha conosciuto infezioni batteriche, virali, fungine, micobatteriche, parassitarie o di altro tipo attive e clinicamente significative al momento dell'iscrizione allo studio, inclusa l'infezione da COVID-19.
•Ha una grave malattia cardiovascolare (diversa da quei criteri di ammissibilità che precludono al soggetto di ricevere una terapia a base di antracicline/chemioterapia citotossica),
• È stato esposto/ricevuto una delle seguenti terapie, trattamenti o procedure precedenti entro i tempi specificati:
oChirurgia importante entro 4 settimane prima della prima dose di epcoritamab;
o Agenti antineoplastici non sperimentali (tranne gli anticorpi monoclonali anti-CD20) o qualsiasi farmaco sperimentale entro 4 settimane o 5 emivite, a seconda di quale sia più breve, prima della prima dose di epcoritamab;
oTrapianto autologo di cellule staminali ematopoietiche (HSCT), CAR-T, trapianto allogenico di cellule staminali o trapianto di organi solidi;
oVaccini vivi attenuati entro 30 giorni prima dell'inizio di epcoritamab;
oVaccini sperimentali entro 28 giorni prima della prima dose programmata di epcoritamab (cioè non sono consentite vaccinazioni e terapie sperimentali e/o non autorizzate contro il SARS-CoV-2);
o Uso invasivo di dispositivi medici sperimentali entro 28 giorni prima della prima dose pianificata di epcoritamab.
• Presenta un tumore primario del sistema nervoso centrale (SNC) o un coinvolgimento noto del sistema nervoso centrale o un coinvolgimento intracranico, come confermato dalla risonanza magnetica cerebrale/tomografia computerizzata (MRI/TC) obbligatoria allo screening e, se clinicamente indicato, dalla puntura lombare.
• Ha un disturbo convulsivo che richiede una terapia antiepilettica o ha avuto una crisi entro 6 mesi dalla firma di un modulo di consenso informato.
•Ha conosciuto tumori maligni passati o attuali diversi dalla diagnosi di inclusione, con eccezioni come indicato nel protocollo.
• Ha note o sospette allergie, ipersensibilità o intolleranza a uno dei trattamenti di prova o ha note o sospette controindicazioni all'uso di tutte le terapie anti-citochine disponibili localmente secondo le linee guida locali per la gestione della sindrome da rilascio di citochine (CRS).
•Ha un'infezione attiva da virus dell'epatite B (HBV) (reazione a catena della DNA polimerasi [PCR]-positivo) o virus dell'epatite C (HCV) (RNA PCR-positivo), abuso di alcol o cirrosi.
•Ha un'infezione attiva da citomegalovirus (CMV) (DNA PCR-positivo) che richiede un trattamento.
•Ha sospetta tubercolosi latente attiva o non adeguatamente trattata.
•Ha una storia nota di sieropositività all'HIV. Nota: il test HIV è richiesto allo screening solo se richiesto dalle autorità sanitarie locali o dagli standard istituzionali.

E.5 End points

E.5.1

Primary end point(s)

Complete response (CR) rate determined by Lugano criteria

Tasso di risposta completa (CR) determinato dai criteri di Lugano

E.5.1.1

Timepoint(s) of evaluation of this end point

Please refer to the protocol.

Tasso di risposta completa (CR) determinato dai criteri di Lugano

E.5.2

Secondary end point(s)

1. Duration of response (DOR) determined by Lugano criteria
2. Duration of complete response (DOCR) determined by Lugano criteria
3. Time to response (TTR) determined by Lugano criteria
4. Overall response rate (ORR) determined by Lugano criteria
5. Progression-free survival (PFS) determined by Lugano criteria
6. Time to next (anti-lymphoma) therapy (TTNT)
7. Rate and duration of minimal residual disease (MRD) negative status
8. Overall survival (OS)
9. Incidence of dose-limiting toxicities (DLTs)
10. Incidence and severity of adverse events (AEs)
11. Incidence and severity of changes in laboratory values
12. Incidence of antidrug antibodies (ADAs) to epcoritamab
13. PK parameters (clearance, volume of distribution, area under-the-concentration-time curve [AUC0-last and AUC0-8], maximum concentration [Cmax], time of Cmax [Tmax], predose values, and half-life [t½])
14. Changes in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy – Lymphoma (FACT-Lym)

1. Durata della risposta (DOR) determinata dai criteri di Lugano
2. Durata della risposta completa (DOCR) determinata dai criteri di Lugano
3. Tempo di risposta (TTR) determinato dai criteri di Lugano
4. Tasso di risposta globale (ORR) determinato dai criteri di Lugano
5. Sopravvivenza libera da progressione (PFS) determinata dai criteri di Lugano
6. Tempo per la prossima terapia (anti-linfoma) (TTNT)
7. Tasso e durata dello stato negativo di malattia minima residua (MRD).
8. Sopravvivenza globale (OS)
9. Incidenza delle tossicità dose-limitanti (DLT)
10. Incidenza e gravità degli eventi avversi (EA)
11. Incidenza e gravità dei cambiamenti nei valori di laboratorio
12. Incidenza degli anticorpi anti-farmaco (ADA) verso epcoritamab
13. Parametri farmacocinetici (clearance, volume di distribuzione, curva area sotto la concentrazione-tempo [AUC0-last e AUC0-8], concentrazione massima [Cmax], tempo di Cmax [Tmax], valori predose ed emivita [t½])
14. Cambiamenti nei sintomi del linfoma misurati dalla valutazione funzionale della terapia del cancro – linfoma (FACT-Lym)

E.5.2.1

Timepoint(s) of evaluation of this end point

Please refer to the Protocol.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Terapia combinata

Combination therapy

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Japan

Korea, Republic of

United States

Austria

France

Poland

Spain

Czechia

Germany

Italy

Belgium

Denmark

Portugal

United Kingdom

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

The trial is considered completed when the last subject dies or withdraws from the trial. The maximum trial duration is approximately 3 years after the last subject’s first treatment in the trial.

Il processo si considera concluso quando l'ultimo soggetto muore o si ritira dal processo. La durata massima dello studio è di circa 3 anni dopo il primo trattamento dell'ultimo soggetto nello studio.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

180

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

105

F.4.2.2

In the whole clinical trial

180

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

Nessuno

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2022-12-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-11-11

P. End of Trial
P.	End of Trial Status	Ongoing

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials