Clinical Trials Register

Summary
EudraCT Number:	2020-005452-38
Sponsor's Protocol Code Number:	D910PC00001
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-06-23
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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2020-005452-38

A.3

Full title of the trial

A Phase III Randomized, Open-Label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab in Combination With Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer
(VOLGA)

Estudio en fase III aleatorizado, abierto y multicéntrico para determinar la eficacia y la seguridad de durvalumab en combinación con tremelimumab y enfortumab vedotina o durvalumab en combinación con enfortumab vedotina para el tratamiento perioperatorio en pacientes no aptos para cisplatino que se someten a cistectomía radical para cáncer de vejiga músculo-invasivo (VOLGA)

A.3.1

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

Treatment combination of Durvalumab, Tremelimumab, Enfortumab Vedotin in patients with muscle invasive bladder cancer ineligible to cisplatin

Combinación de tratamiento de Durvalumab, Tremelimumab, Enfortumab Vedotin en pacientes con cáncer de vejiga con invasión muscular no elegibles para cisplatino

A.3.2

Name or abbreviated title of the trial where available

Volga

A.4.1

Sponsor's protocol code number

D910PC00001

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	AstraZeneca AB
B.1.3.4	Country	Sweden
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	AstraZeneca AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AstraZeneca
B.5.2	Functional name of contact point	Clinical Study Information Center
B.5.3	Address:
B.5.3.1	Street Address	1800 Concorde Pike
B.5.3.2	Town/ city	Wilmington
B.5.3.3	Post code	19803
B.5.3.4	Country	United States
B.5.6	E-mail	information.center@astrazeneca.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	Yes
D.2.1.1.1	Trade name	IMFINZI
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca AB
D.2.1.2	Country which granted the Marketing Authorisation	Norway
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	Durvalumab
D.3.2	Product code	MEDI4736
D.3.4	Pharmaceutical form	Concentrate for 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	DURVALUMAB
D.3.9.1	CAS number	1428935-60-7
D.3.9.2	Current sponsor code	MEDI4736
D.3.9.4	EV Substance Code	SUB176342
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	50
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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	Tremelimumab
D.3.2	Product code	.
D.3.4	Pharmaceutical form	Concentrate for 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	Tremelimumab
D.3.9.1	CAS number	745013-59-6
D.3.9.2	Current sponsor code	.
D.3.9.3	Other descriptive name	TREMELIMUMAB
D.3.9.4	EV Substance Code	SUB37101
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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: 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.2.1.1.1	Trade name	Padcev
D.2.1.1.2	Name of the Marketing Authorisation holder	Astellas Pharma US, Inc
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Enfortumab vedotin
D.3.2	Product code	EV
D.3.4	Pharmaceutical form	Powder for 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	ENFORTUMAB VEDOTIN
D.3.9.1	CAS number	.
D.3.9.2	Current sponsor code	.
D.3.9.3	Other descriptive name	EV
D.3.9.4	EV Substance Code	SUB185524
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	20 to 30
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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

Cisplatin ineligible patients with histologically or cytologically documented muscle-invasive transitional cell carcinoma (TCC) of the bladder.

Pacientes no aptos para cisplatino con cáncer de vejiga músculo-invasivo (CVMI) histológica o citológicamente documentado

E.1.1.1

Medical condition in easily understood language

Cancer in thick muscle in the bladder wall

Cáncer en músculo grueso de la pared de la vejiga

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10005004
E.1.2	Term	Bladder cancer NOS
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Safety Run-In (SRI):To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin
Main Study: To compare the efficacy of durvalumab + tremelimumab + EV relative to cystectomy on pCR rate and EFS

Preinclusión de seguridad: Evaluar la seguridad y la tolerabilidad de durvalumab + tremelimumab + EV en participantes con CVIM que no son aptos para recibir cisplatino.
Principal: Comparar la eficacia de durvalumab + tremelimumab + EV en relación con la cistectomía en la tasa de RPc y la SSA

E.2.2

Secondary objectives of the trial

Safety Run-In (SRI): To evaluate the efficacy of durvalumab + tremelimumab + EV on pCR rate and EFS
Main Study:To compare the efficacy of durvalumab + EV relative to cystectomy on pCR rate, EFS, OS, EFS24, OS5, DFS, pDS rate, and DSS

Preinclusión de seguridad: Evaluar la eficacia de durvalumab + tremelimumab + EV en la tasa de RPc y la SSA
Principal: Comparar la eficacia de durvalumab + EV en relación con la cistectomía en la tasa de RPc, SSA, SG, SSA24, SG5, SSE, REp y SEE

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Histologically or cytologically documented muscle-invasive TCC of the bladder with clinical stage T2-T4aN0/1M0 with transitional and mixed transitional cell histology;
Medically fit for cystectomy and able to receive neoadjuvant therapy;
Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC;
ECOG performance status of 0, 1, 2 at enrollment.
Availability of tumor sample prior to study entry;
Must have a life expectancy of at least 12 weeks at randomization.

Carcinoma de células transicionales (CCT) vesical con invasión muscular documentado histológica o citológicamente con estadio clínico de T2-4aN0-N1M0
Médicamente aptos para cistectomía y capacidad para recibir tratamiento neoadyuvante.
Presentar un estado funcional de 0 a 2 según el Grupo Oncológico Cooperativo del Este (ECOG) sin deterioro durante las 2 semanas anteriores al inicio o al día de la primera administración de la dosis.
Entrega de la muestra de tejido más reciente del CVMI para evaluar el estado/la expresión de PD-L1 antes de la aleatorización.
Esperanza de vida mínima de 12 semanas en el momento de la aleatorización según la opinión del investigador.

E.4

Principal exclusion criteria

Evidence of lymph node (N2+) or metastatic TCC/UC disease at the time of screening.
Active infection
Uncontrolled intercurrent illness
Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin [BCG]), including but not limited to other anti-CTLA-4, anti-PD-1, anti PD-L1, or anti-PD-L2 antibodies.
Current or prior use of immunosuppressive medication within 14 days before the first dose of IPs.

Indicios de CCT/carcinoma urotelial (CU) metastásico o de varios ganglios linfáticos (N2+), CCT/CU extravesical que invade la pared pélvica o abdominal para cáncer de vejiga (T4b) o CCT/CU no vesical primario (es decir, de uréter, uretra o pelvis renal) del urotelio.
Nefroureterectomía requerida por el investigador en el momento de la aleatorización para el tumor del uréter medio, la pelvis renal o el sistema colector.
Se requiere ureterectomía si hay un tumor ureteral proximal a las arterias ilíacas comunes, además de la cistectomía programada.
1Exposición previa al tratamiento inmunomediado (con exclusión del bacilo de Calmette-Guérin [BCG]), incluidos, entre otros, otros anticuerpos anti-CTLA-4, anti-PD-1, anti PD L1 o anti-PD-L2.

E.5 End points

E.5.1

Primary end point(s)

Safety Run-In (SRI):
• Safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin.
Safety and tolerability will be evaluated in terms of AEs, vital signs, clinical laboratory assessments, ECGs, and WHO/ECOG performance status.
Main Study:
• Compare efficacy of durvalumab + tremelimumab + EV relative to cystectomy alone on pCR rate and EFS.
Pathologic complete response (pCR) rate is defined as the number of participants whose pathological staging was T0N0M0 as assessed per central pathological review using specimens obtained via cystectomy.
Event-free survival (EFS;) is defined as the time from randomization to the first occurrence of any of the following events: recurrence of disease post-radical cystectomy, the first documented progression in participants who did not receive radical cystectomy, failure to undergo radical cystectomy in participants with residual disease, or death due to any cause.

Preinclusión de seguridad: La seguridad y la tolerabilidad se evaluarán en términos de AA, constantes vitales, evaluaciones analíticas clínicas, ECG y estado funcional del ECOG o de la OMS.
Las evaluaciones relacionadas con los AA abarcan:
• Aparición/frecuencia
• Relación con el PEI, la quimioterapia de base y procedimiento quirúrgico según la evaluación del investigador
• Grado CTC
• Gravedad
• Muerte
• AA que provocan la interrupción del PEI
• Otras medidas adoptadas relacionadas con el PEI (p. ej., interrupciones, retrasos o ajustes de la dosis)
• AA de interés especial
• Otros AA significativos
Los parámetros de las constantes vitales incluyen presión arterial sistólica y diastólica, pulso, frecuencia respiratoria, temperatura corporal y peso. Las evaluaciones abarcan:
• Valor observado
• Valores absolutos y porcentaje de cambio desde el inicio a lo largo del tiempo
• Anomalías clínicamente significativas a lo largo del tiempo
Los parámetros analíticos incluyen hematología y bioquímica clínica, además de análisis de orina. En la sección 8.2.4. se presenta una lista completa de los parámetros. Las evaluaciones abarcan:
• Valor observado
• Valores absolutos y porcentaje de cambio desde el inicio a lo largo del tiempo
• Anomalías clínicamente significativas en los parámetros analíticos a lo largo del tiempo
• Estado analítico, incluido el cambio en las anomalías (p. ej., bajo, normal, alto) desde el inicio hasta el valor máximo durante el tratamiento.
• Estado analítico, incluido el cambio en anomalías (p. ej., bajo, normal, alto) desde el inicio hasta el valor mínimo durante el tratamiento.
• Cambios surgidos durante el tratamiento en los parámetros analíticos

Principal:
• Tasa de RPc según la definición anterior
• SSA según la definición anterior

E.5.1.1

Timepoint(s) of evaluation of this end point

Main Study
1) pCR rate defined as the number of participants whose pathological staging was T0N0M0 as assessed per central pathological review.
2) EFS as time from randomization to first occurrence of recurrence of disease post-radical cystectomy, first documented progression in participants who did not receive radical cystectomy, failure to undergo radical cystectomy in participants with residual disease, or death.

Estudio principal
1) Tasa de pCR definida como el número de participantes cuya estadificación patológica fue T0N0M0 según la evaluación patológica central.
2) SSC como el tiempo desde la aleatorización hasta la primera aparición de la recurrencia de la enfermedad después de la cistectomía radical, la primera progresión documentada en los participantes que no recibieron cistectomía radical, la imposibilidad de someterse a una cistectomía radical en los participantes con enfermedad residual o la muerte.

E.5.2

Secondary end point(s)

1. Pathologic complete response (pCR) rates at time of cystectomy in Arm 2 vs Arm 3
2. Event-free survival (EFS) defined as time from randomization to event in Arm 2 vs Arm 3
3. Overall survival defined as length of time from randomization until the date of death due to any cause
4. EFS at 24 months (EFS24) defined as proportion of participants alive and event-free at 24 months
5. Overall survival rate at 5 years
6. Disease-free survival (DFS) defined as time from radical cystectomy to recurrence or death
7. Pathologic down staging (pDS) rate-to < pT2
8. Disease-specific survival (DSS) defined as time from randomization until death due to bladder cancer
9. QoL in all arms
10. Immunogenicity of Durvalumab when used in combination with Tremelimumab as measured by presence of antidrug antibodies (ADA)
11. Assess the pharmacokinetics (PK) of Durvalumab and Tremelimumab

Preinclusión de seguridad:
• La respuesta patológica completa (RPc) se define como el número de participantes cuya estadificación patológica era T0N0M0 según la evaluación de la revisión anatomopatológica central usando las muestras obtenidas mediante cistectomía.
• La supervivencia sin acontecimientos (SSA; según RCIE o según revisión anatomopatológica central, si es necesario realizar una biopsia por una sospecha de lesión nueva) se define como el tiempo desde la aleatorización hasta la primera aparición de cualquiera de los siguientes acontecimientos: recidiva de la enfermedad después de la cistectomía radical, la primera progresión documentada en los participantes que no se sometieron a la cistectomía radical, no haberse sometido a cistectomía radical en los participantes con enfermedad residual, o la muerte por cualquier causa.

Principal:
• Tasa de RPc según la definición anterior
• SSA según la definición anterior
• La supervivencia global (SG) se define como el tiempo transcurrido desde la fecha de aleatorización hasta la fecha de la muerte por cualquier causa.
• La proporción de participantes vivos y sin complicaciones a los 24 meses (SSA24; por RCIE o mediante revisión anatomopatológica central, si es necesario realizar una biopsia para una sospecha de lesión nueva) se define como la estimación de Kaplan-Meier de la SSA a los 24 meses después de la aleatorización.
• La proporción de participantes vivos a los 5 años (SG5) se define como la estimación de Kaplan-Meier de la SG a los 5 años después de la aleatorización.
• La SSE (según RCIE o según revisión anatomopatológica central, si es necesario realizar una biopsia para una sospecha de lesión nueva) se define como el tiempo desde la fecha de la cistectomía radical hasta la primera recidiva de la enfermedad después de la cistectomía radical, o la muerte por cualquier causa, lo que ocurra primero, en participantes con CVIM que se sometan a cistectomía radical.
• La reducción del estadio tumoral patológico (REp) se define como la tasa de reducción a <pT2, incluidos pT0, pTis, pTa, pT1 y N0.
• La SEE (supervivencia específica de la enfermedad) se define como el tiempo desde la fecha de la aleatorización hasta la de la muerte por cáncer de vejiga.

E.5.2.1

Timepoint(s) of evaluation of this end point

OS:length of time from randomization until death
EFS24:proportion of subjects alive and event-free at 24mons as Kaplan-Meier estimate of EFS at 24mons after randomization OS5:Kaplan-Meier estimate of OS at 5yrs after randomization
DFS:time from date of radical cystectomy to first recurrence of disease post-radical cystectomy, or death pDS:rate of downstaging to<pT2, including pT0,pTis,pTa,pT1,N0. DSS:time from date of randomization until death

SG: período de tiempo desde la aleatorización hasta la muerte
EFS24: proporción de sujetos vivos y sin eventos a los 24 meses como estimación de Kaplan-Meier de la SSC a los 24 meses después de la aleatorización OS5: estimación de Kaplan-Meier de la SG a los 5 años después de la aleatorización
SSE: tiempo desde la fecha de la cistectomía radical hasta la primera recurrencia de la enfermedad después de la cistectomía radical, o muerte. PDS: tasa de disminución de la etapa a <pT2, incluyendo pT0, pTis, pTa, pT1, N0. DSS: tiempo desde la fecha de aleatorización hasta la muerte

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

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

Yes

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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

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

Cistectomía

Cystectomy

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

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

Brazil

Canada

Chile

Hong Kong

Israel

Japan

Korea, Republic of

Mexico

Russian Federation

Taiwan

Thailand

Turkey

Ukraine

United States

Vietnam

Austria

France

Germany

Greece

Italy

Netherlands

Poland

Spain

United Kingdom

Argentina

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 end of the study is defined as the date of the last visit/contact of the last participant in the study globally.

El final del estudio se define como la fecha de la última visita / contacto del último participante en el estudio a nivel mundial.

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)

Yes

F.1.2.1

Number of subjects for this age range:

380

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

450

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

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

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

379

F.4.2.2

In the whole clinical trial

830

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)

After final analysis no study drug will be provided

Después del análisis final, no se proporcionará ningún fármaco del estudio.

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

2021-09-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-09-27

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

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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