Clinical Trials Register

Summary
EudraCT Number:	2014-003626-40
Sponsor's Protocol Code Number:	CA209-274
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:	2016-04-01
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

2014-003626-40

A.3

Full title of the trial

A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab versus Placebo in Subjects with High Risk Invasive Urothelial Carcinoma

Estudio de fase 3 aleatorizado, doble ciego, multicéntrico, de Nivolumab como tratamiento adyuvante frente a placebo en sujetos con Carcinoma urotelial invasivo de alto riesgo

A.3.1

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

Nivolumab versus placebo after surgery in subjects with urinary tract cancer

Estudio de Nivolumab frente a placebo después de cirugía en sujetos con Carcinoma urotelial

A.3.2

Name or abbreviated title of the trial where available

CheckMate 274

A.4.1

Sponsor's protocol code number

CA209-274

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02632409

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1160-7285

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	Bristol-Myers Squibb International Corporation
B.1.3.4	Country	Belgium
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	Bristol-Myers Squibb International Corporation
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bristol-Myers Squibb International Corporation
B.5.2	Functional name of contact point	GCT-SU
B.5.3	Address:
B.5.3.1	Street Address	Parc de l'Alliance - Avenue de Finlande, 4
B.5.3.2	Town/ city	Braine-l'Alleud
B.5.3.3	Post code	1420
B.5.3.4	Country	Belgium
B.5.4	Telephone number	900 150 160
B.5.6	E-mail	clinical.trials@bms.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	Nivolumab
D.3.2	Product code	BMS-936558
D.3.4	Pharmaceutical form	Solution for injection/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	NIVOLUMAB
D.3.9.1	CAS number	946414-94-4
D.3.9.2	Current sponsor code	BMS-936558
D.3.9.3	Other descriptive name	BMS936558
D.3.9.4	EV Substance Code	SUB32944
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	10
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Intravenous use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Subjects with High Risk Invasive Urothelial Carcinoma

Sujetos con Carcinoma urotelial invasivo de alto riesgo

E.1.1.1

Medical condition in easily understood language

Subjects who have undergone radical resection of Invasive urothelial carcinoma originating in the bladder or upper urinary tract (renal pelvis or ureter) and are at high risk of recurrence.

Sujetos que se han sometido a resección radical del carcinoma urotelial invasivo originado en la vejiga o en el tracto urinario superior ( pelvis renal o ureter) con un alto riesgo de recidiva

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	18.1
E.1.2	Level	LLT
E.1.2	Classification code	10064467
E.1.2	Term	Urothelial carcinoma
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

To compare the disease free survival (DFS) for nivolumab versus placebo in:
- subjects with tumors expressing PD-L1 (>=1% membranous staining in tumor cells)
and
-all randomized subjects

Comparar la supervivencia libre de enfermedad (SLE) con nivolumab frente a placebo en:
- Sujetos con tumores que expresan PD-L1 (> =1% tinción membranosa en las células tumorales) y
-Todos los sujetos aleatorizados

E.2.2

Secondary objectives of the trial

-To compare Non-Urothelial Tract Recurrence Free Survival (NUTRFS) for nivolumab versus placebo in subjects with tumors expressing PD-L1 (>= 1% membranous staining in tumor cells) and all randomized subjects
-To compare the Disease Specific Survival (DSS) for nivolumab and placebo in subjects with tumors expressing PD-L1 (>=1% membranous staining in tumor cells) and all randomized subjects
-To compare the Overall Survival (OS) for nivolumab versus placebo in subjects with tumors expressing PD-L1 (>=1% membranous staining in tumor cells) and all randomized subjects.

Comparar la supervivencia libre de recidiva fuera de las vías uroteliales (SLRFVU) con nivolumab frente a placebo en sujetos con tumores que expresan PD-L1 (> =1% de tinción membranosa en células tumorales) y en todos los sujetos aleatorizados
Comparar la supervivencia específica de la enfermedad (SEE) con nivolumab y placebo en sujetos con tumores que expresan PD-L1 (>=1% de tinción membranosa en las células tumorales) y en todos los sujetos aleatorizados
Comparar la supervivencia global (SG) de nivolumab frente a placebo en sujetos con tumores que expresan PD L1 (> =1% de tinción membranosa en las células tumorales) y en todos los sujetos aleatorizados.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. All subjects must be status post radical surgical resection (R0) for Invasive Urothelial Carcinoma performed within 90 days prior to randomization.
2. All subjects must have pathologic evidence of urothelial carcinoma (originating in bladder, ureter, or renal pelvis) at high risk of recurrence (see protocol for more details)
3. Dominant component of histology needs to be urothelial carcinoma or transitional cell carcinoma. Foci of varied histologies (e.g. minor variants) are accepted
4. All subjects must have disease-free status defined as no measurable disease by RECIST 1.1 (see section 5.4.1 for RECIST 1.1 language) documented by a complete physical examination and imaging studies within 4 weeks prior to randomization. Imaging studies must include CT of chest and CT or MRI of abdomen, pelvis, and all known sites of resected disease including cystoscopy in subjects with upper GU primaries who still have bladder intact. Brain imaging (MRI except where contraindicated in which CT scan is acceptable) must be completed within 4 weeks prior to randomization for subjects with clinical suspicion of CNS disease at screening.
5. Tumor tissue from the most recently resected site of disease (preferable) or from the transurethral resection that
yielded the initial muscle invasive diagnosis must be provided for biomarker analyses. In order to be randomized, a subject must have a PD-L1 expression level classification (>=1%, < 1%, indeterminate) as determined by the central lab.
6. Life expectancy >= 6 months
7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. Subjects who have not received cisplatin based neoadjuvant chemotherapy and are considered ineligible for cisplatin adjuvant chemotherapy, may enter the study with ECOG PS 2 (see Appendix 2)
8. Prior surgery that required general anesthesia must be completed at least 4 weeks before study drug administration. Surgery requiring local/epidural anesthesia must be completed at least 72 hours before study drug administration

1.Todos los sujetos deben haberse sometido a resección quirúrgica radical (R0) por CUI realizada dentro de los 90 días antes de la aleatorización.
2. Todos los sujetos deben tener evidencia anatomopatológica de carcinoma urotelial (originado en la vejiga, el uréter o la pelvis renal) con alto riesgo de recidiva (ver protocolo para más detalles).
3. El componente dominante de la histología tiene que ser carcinoma urotelial o carcinoma de células transicionales. Se aceptan focos de diversas histologías (p. ej., variantes menores).
4. Todos los sujetos deben tener estado libre de enfermedad definido como enfermedad no medible por los RECIST 1.1 (véase la Sección 5.4.1 para ver el texto de los RECIST 1.1) documentado mediante una exploración física completa y estudios de imagen dentro del plazo de 4 semanas antes de la aleatorización. Los estudios de imagen deben incluir TC de tórax y TC o RM de abdomen, pelvis y todas las localizaciones conocidas de enfermedad resecada incluida cistoscopia en sujetos con tumores primarios de las vías GU superiores que todavía tienen la vejiga intacta. Las pruebas de imagen cerebrales (RM excepto cuando esté contraindicado en cuyo caso la TC es aceptable) deben realizarse dentro de las 4 semanas previas a la aleatorización en sujetos con sospecha clínica de enfermedad del SNC en la selección.
5. Debe facilitarse tejido tumoral de la localización de enfermedad resecada más recientemente (preferible) o de una resección transuretral que aportó el diagnóstico inicial de invasión muscular para el análisis de biomarcadores. Para ser aleatorizado, un sujeto debe tener una clasificación del nivel de expresión de PD L1 (>=? 1%, < 1%, indeterminado) valorada por el laboratorio central.
6. Esperanza de vida >= 6 meses
7. Estado funcional (EF) del Eastern Cooperative Oncology Group (ECOG) de 0 ó 1. Los sujetos que no hayan recibido quimioterapia neoadyuvante basada en cisplatino y se consideren inelegibles para quimioterapia adyuvante con cisplatino pueden entrar en el estudio con un EF de 2 del ECOG (véase el Apéndice 2)
8. La cirugía previa que precisara anestesia general debe haberse terminado al menos 4 semanas antes de la administración del medicamento del estudio. La cirugía que precise anestesia local/epidural debe haberse realizado al menos 72 horas antes de la administración del fármaco del estudio

E.4

Principal exclusion criteria

1. Partial cystectomy in the setting of bladder cancer primary tumor or partial nephrectomy in the setting of renal pelvis primary tumor.
2. Adjuvant systemic or radiation therapy for urothelial or prostatic carcinoma following radical surgical resection of urothelial carcinoma.
3. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
4. Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, prostate cancer with evidence of undetectable Prostate Specific Antigen (PSA) or carcinoma in situ of the prostate, cervix or breast.
5. Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
6. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
7. Subjects with history of life-threatening toxicity related to prior immune therapy (eg. anti-CTLA-4 or anti-PD-1/PD-L1 treatment or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures (eg, hormone replacement after adrenal crisis).
8. All toxicities attributed to prior anti-cancer therapy other than nephropathy, neuropathy, hearing loss, alopecia and fatigue must have resolved to Grade 1 (NCI CTCAE version 4) or baseline before administration of study drug. Subjects with toxicities attributed to prior anti-cancer therapy which are not expected to resolve and result in long lasting sequelae, such as neuropathy after platinum based therapy, are permitted to enroll. See protocol inclusion criterion 2) i) (5) for renal function eligibility. Neuropathy must have resolved to Grade 2 (NCI CTCAE version 4).
9. Treatment with any chemotherapy, radiation therapy, biologics for cancer, or investigational therapy within 28 days of first administration of study treatment.

1. Cistectomía parcial en el contexto del tumor primario de cáncer de vejiga o nefrectomía parcial en el contexto de tumor primario de la pelvis renal.
2. Tratamiento adyuvante sistémico o con radioterapia para carcinoma urotelial o prostático después de resección quirúrgica radical de carcinoma urotelial.
3. Cualquier trastorno médico grave o no controlado que, en opinión del investigador, pueda aumentar el riesgo asociado a la participación en el estudio o la administración del fármaco del estudio, deteriorar la capacidad del sujeto para recibir la terapia del protocolo o interferir en la interpretación de los resultados del estudio.
4. Tumor maligno activo previo dentro de los 3 años anteriores, excepto cánceres curables localmente que se hayan curado aparentemente, como cáncer de piel de células basales o escamosas, cáncer de próstata con pruebas de antígeno prostático específico (PSA) indetectable o carcinoma in situ de la próstata, el cérvix o la mama.
5. Sujetos con enfermedad autoinmune activa, conocida o de sospecha. Se permite reclutar a sujetos con vitiligo, diabetes mellitus de tipo I, hipotiroidismo residual debido a un problema autoinmunitario que sólo precisa sustitución hormonal, psoriasis que no requiere tratamiento sistémico o problemas que no se espera que recurran en ausencia de un desencadenante externo.
6. Sujetos con un problema que exija tratamiento sistémico con corticosteroides (> 10 mg de prednisona al día o equivalente) u otros medicamentos inmunosupresores dentro de los 14 días previos a la administración del fármaco del estudio. Se permiten esteroides inhalados o tópicos y dosis de reposición suprarrenal > 10 mg al día de prednisona o equivalentes en ausencia de enfermedad autoinmune activa.
7. Sujetos con antecedentes de toxicidad potencialmente mortal relacionada con tratamiento inmunitario previo (p. ej., tratamiento con anti-CTLA-4 o anti-PD-1/PD-L1 o cualquier otro anticuerpo o fármaco dirigido específicamente a las vías de coestimulación de los linfocitos T o del punto de control inmunitario) excepto aquellas que sea poco probable que vuelvan a producirse con contramedidas habituales (p. ej., reposición hormonal después de crisis suprarrenal).
8. Todas las toxicidades atribuidas al tratamiento oncológico previo aparte de nefropatía, neuropatía, pérdida auditiva, alopecia y cansancio deben haberse resuelto a grado 1 (CTCAE del NCI, versión 4) o a la situación basal antes de la administración del fármaco del estudio. Se permite reclutar a sujetos con toxicidades atribuidas al tratamiento oncológico previo que no se espere que se resuelvan y que conduzcan a secuelas de larga evolución, como neuropatía después de tratamiento basado en platino. Véase el criterio de inclusión 2) i) (5) del protocolo para la elegibilidad por función renal. La neuropatía debe haberse resuelto a grado 2 (CTCAE del NCI, versión 4).
9. Tratamiento con cualquier quimioterapia, radioterapia, agentes biológicos para el cáncer o tratamiento en investigación dentro de los 28 días previos a la primera administración del tratamiento del estudio.

E.5 End points

E.5.1

Primary end point(s)

Disease Free Survival - This endpoint will be analyzed in two different populations (co-primary): Subjects with PD-L1 expression level >=1% and all randomized subjects.

Ssupervivencia libre de enfermedad (SLE). Este objetivo se analizará en dos poblaciones distintas ( co-principales): sujetos con tumores que expresan PD-L1>= 1% y todos los sujetos aleatorizados

E.5.1.1

Timepoint(s) of evaluation of this end point

Approximately 5 years after the first subject is randomized.

Aproximadamente 5 años después de que el primer sujeto sea aleatorizado.

E.5.2

Secondary end point(s)

2 Comparar la supervivencia libre de recidiva fuera de las vías uroteliales (SLRFVU) con nivolumab frente a placebo en sujetos con tumores que expresan PD-L1 (>= 1% de tinción membranosa en células tumorales) y en todos los sujetos aleatorizados
Comparar la supervivencia específica de la enfermedad (SEE) con nivolumab y placebo en sujetos con tumores que expresan PD-L1 (>= 1% de tinción membranosa en las células tumorales) y en todos los sujetos aleatorizados
Comparar la supervivencia global (SG) de nivolumab frente a placebo en sujetos con tumores que expresan PD L1 (>= 1% de tinción membranosa en las células tumorales) y en todos los sujetos

E.5.2.1

Timepoint(s) of evaluation of this end point

For all secondary endpoints: approximately 5 years after the first subject is randomized.

Para todos los objetivos secundarios: aproximadamente 5 años después de que el primer sujeto sea aleatorizado

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

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Outcomes Research Assessments, Immunogenicity Assessments

Evaluaciones de Inmunogenicidad, evaluaciones de resultados en salud

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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

Yes

E.8.2.3

Other

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

Argentina

Australia

Austria

Belgium

Brazil

Canada

Chile

Colombia

Denmark

France

Germany

Greece

Ireland

Israel

Italy

Japan

Korea, Republic of

Mexico

Netherlands

Peru

Poland

Romania

Russian Federation

Spain

Sweden

Switzerland

Taiwan

United Kingdom

United States

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

Last follow-up visit of the last subject

Última visita de seguimiento del ultimo sujeto

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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

720

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

458

F.4.2.2

In the whole clinical trial

800

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)

At the end of the study, BMS will not continue to provide BMS supplied study drug to subjects/investigators unless BMS chooses to extend the study. The study is designed to have a maximum treatment duration of 1 year and at the end of the study no subjects are expected to be on treatment. The investigator should ensure that the subject receives appropriate standard of care to treat the condition under study.

Al final del estudio, BMS no seguirá proporcionando el Mto. del estudio suministrado por BMS a los sujetos/investigadores a menos que BMS decida ampliar el estudio. El estudio está diseñado para tener una duración máxima del tratamiento de 1 año y al final del estudio no se espera que ningún sujeto se mantenga en tratamiento. El investigador deberá garantizar que el paciente reciba un adecuado tratamiento estándar para tratar la enfermedad en 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

2016-04-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-02-08

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

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