Clinical Trials Register

Summary
EudraCT Number:	2015-004429-15
Sponsor's Protocol Code Number:	GEM-1402
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:	2015-12-30
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

2015-004429-15

A.3

Full title of the trial

Phase II multicente, non randomized, open label trial of nivolumab in combination with ipilimumab in subjects with previously untreated metastatic uveal melanoma.

Ensayo clínico abierto, multicéntrico, no aleatorizado en fase II para evaluar la eficacia de Nivolumab en combinación con Ipilimumab en pacientes con melanoma uveal metastásico no tratados previamente

A.3.1

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

Phase II multicente, non randomized, open label trial of nivolumab in combination with ipilimumab in subjects with previously untreated metastatic uveal melanoma.

A.4.1

Sponsor's protocol code number

GEM-1402

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	GRUPO ESPAÑOL MULTICISPLINAR DE MELANOMA
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	BMS
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Secretaria técnica GEM
B.5.2	Functional name of contact point	Secretaria GEM
B.5.3	Address:
B.5.3.1	Street Address	Secretari Coloma, 64-68 Esc B Entlo 5ª
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08024
B.5.3.4	Country	Spain
B.5.4	Telephone number	34934344412
B.5.5	Fax number	34932531168
B.5.6	E-mail	investigacion@mfar.net

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	Yervoy
D.2.1.1.2	Name of the Marketing Authorisation holder	Bristol-Myers Squibb Pharma EEIG
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	ipilimumab
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	IPILIMUMAB
D.3.9.3	Other descriptive name	PR1
D.3.9.4	EV Substance Code	SUB29397
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	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	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	Yes
D.2.1.1.1	Trade name	Opdivo
D.2.1.1.2	Name of the Marketing Authorisation holder	Bristol-Myers Squibb Pharma EEIG
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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-936558-01
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	NIVOLUMAB
D.3.9.3	Other descriptive name	NIVOLUMAB
D.3.9.4	EV Substance Code	SUB122750
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Metastatic uveal melanoma non suitable for radical resection.

Melanoma uveal metastásico no resecable.

E.1.1.1

Medical condition in easily understood language

Metastatic uveal melanoma

Melanoma uveal metastásico

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	10053571
E.1.2	Term	Melanoma
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

Primary Objective
To determine the efficacy, in terms of overall survival at 12 months, after starting treatment with nivolumab combined with ipilimumab in patients with metastatic uveal melanoma.

Objetivo Principal
Determinar la eficacia, en términos de supervivencia global a los 12 meses, después de iniciar el tratamiento con nivolumab combinado con ipilimumab en pacientes con melanoma uveal metastásico.

E.2.2

Secondary objectives of the trial

Secondary Objective(s)

To evaluate the safety profile, response rate and overall survival.

Objetivo(s) secundario(s)

Evaluar el perfil de seguridad, la tasa de respuesta y la supervivencia global.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Exploratory Objectives
- Auto-antibodies profile (antithyroid, antinuclear, anti-DNA, and anticardiolipin, before treatment, after 12 weeks, and at maximum response) and correlation with anti-tumor activity.
- Auto-antibodies profile (p-ANCA, ASCA, anti-pancreatic, porin protein C of Escherichia coli, and anti-alpha-enolase) before treatment, after 12 weeks, and when grade 3-4 toxicity appears. Correlation with toxicity.
- Lymphocyte count after 2 doses of treatment (W7). Correlation with anti-tumor activity.
- Correlation between patient HLA type and clinical benefit and toxicity
- GNAQ and GNA11 status on tumor samples and circulating DNA. Evaluate circulating DNA GNAQ/GNA11 before treatment, after 12 weeks, and at maximum response. Correlation with anti-tumor activity.
- Peripheral lymphocyte, serum, and plasma isolation after 12 weeks, at maximum response, and when grade 3-4 first toxicity appears for exosomes studies. Correlation with anti-tumor activity and toxicity.
- DNA, RNA and paraffin from biopsy from unresectable or metastatic site of disease for whole-exome-seq, RNA-seq to evaluate presence of immunogenic neoepitopes, and multiplexed immunohistochemistry to evaluate immunogenic stroma (CD3; CD4; CD8; CD45RO; FoxP3, CD20, CD56; CD64; CD11b; CD68; among others), and lymphocyte exhaustion markers (PD-1; PD-L1; CD137; Granzyme B; Perforin; among others) in tumor and periphery (if represented in sample). Correlation with anti-tumor activity and toxicity.

Objetivos exploratorios

- Perfil de autoanticuerpos (antitiroideos, antinucleares, anti-ADN y anticardiolipinas, antes del tratamiento, después de 12 semanas, y en el momento de máxima respuesta) y correlación con la actividad antitumoral.
- Perfil de autoanticuerpos (p-ANCA, ASCA, antipancreáticos, porinas proteína C de Escherichia coli, y anti-alfa-enolasa) antes del tratamiento, después de 12 semanas y cuando aparezca toxicidad de grado 3-4. Correlación con la toxicidad.
- Descenso del recuento de linfocitos después de 2 dosis del tratamiento (S7). Correlación con la actividad antitumoral.
- Correlación entre el tipo de HLA del paciente, el beneficio clínico y la toxicidad.
- Estados GNAQ y GNA11 en muestras tumorales y en ADN circulante. Evaluar el estado GNAQ/GNA11 en ADN circulante antes del tratamiento, después de 12 semanas y en el momento de máxima respuesta. Correlación con la actividad antitumoral.
- Linfocitos periféricos, separación de suero y plasma después de 12 semanas, en el momento de la respuesta máxima, y cuando aparezca por primera vez toxicidad de grado 3 o 4 para estudios de exosomas. Correlación con la actividad antitumoral y la toxicidad.
- ADN, ARN y parafina a partir de una biopsia de la localización de la enfermedad irresecable o metastásica para secuenciación completa de exoma, secuenciación del ARN para evaluar la presencia de neoepítopos inmunogénicos, e inmunohistoquímica amplificada para evaluar el estroma inmunogénico (CD3; CD4; CD8; CD45RO; FoxP3, CD20, CD56; CD64; CD11b; y CD68, entre otros), y marcadores de agotamiento linfocítico (PD-1, PD-L1, CD137, granzima B y perforina, entre otros) en el tumor y su periferia (si está presente en la muestra). Correlación con la actividad antitumoral y la toxicidad.

E.3

Principal inclusion criteria

1. Written informed consent must be provided;
2. Patients must have a histological diagnosis of uveal melanoma;
3. Progressive metastatic disease at baseline. Progressive disease is defined asnew or progressive lesions on cross-sectional imaging;
4. Age>18 years;
5. ECOG performance status (PS) 0 to 1;
6. Measurable disease by CT or MRI per RECIST 1.1 criteria;
7. No active or chronic infection with HIV, Hepatitis B or Hepatitis C;
8. Adequate organ function as determine by the following criteria:
a. Absolute neutrophil count (ANC) ?1.500/uL.
b.WBC ?2.000/uL.
c.Platelet count ?100x 103
d. Haemoglobin ?9 g/dl.
e. Serum creatinine <2.5 x upper limit of normal (ULN) and creatinine clearance >40 mL/min
f. Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) <3 x ULN, or <5 x ULN if liver abnormalities are due to underlying malignancy.
g. Total bilirubin <= 1.5 x ULN, (except patients with Gilbert?s Syndrome, who must have a total bilirubin less than 3.0 mg/dL).

1. Deberá proporcionarse el consentimiento informado por escrito;
2. Los pacientes deben presentar diagnóstico histológico de melanoma uveal;
3. Progresión de la enfermedad metastásica en el periodo basal. La progresión de la enfermedad se define como la detección de lesiones nuevas o que están experimentando progresión según imágenes transversales;
4. Edad > 18 años;
5. Estado funcional del ECOG (EF) de 0 a 1;
6. Enfermedad medible mediante TAC o RMN según los criterios RECIST 1.1;
7. Ausencia de infección activa o crónica por VIH, hepatitis B o hepatitis C;
8. Función orgánica aceptable, determinada por los siguientes criterios:
a. Recuento absoluto de neutrófilos (RAN) ? 1500/µl.
b. Leucocitos ? 2000/µl.
c. Cifra de plaquetas ? 100 × 103/µl.
d. Hemoglobina ? 9 g/dl.
e. Creatinina sérica < 2,5 × límite superior de la normalidad (LSN) y aclaramiento de creatinina > 40 ml/min
f. Aspartato-aminotransferasa (AST) sérica y alanina-aminotransferasa (ALT) sérica < 3 × LSN, o < 5 × LSN en caso de anomalías hepáticas secundarias a una neoplasia maligna subyacente.
g. Bilirrubina total menor o igual 1,5 × LSN, (excepto en los pacientes con Síndrome de Gilbert, que deben tener un nivel de bilirrubina total inferior a 3,0

E.4

Principal exclusion criteria

1) Prior systemic treatment for metastatic uveal melanoma.
2) 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,
superficial bladder cancer, carcinoma in situ of cervix or breast, or incidental prostate
cancer.
3) Autoimmune disease: Patients with a history of inflammatory bowel disease,
including ulcerative colitis and Crohn?s Diseasse, are excluded from this study, as are
patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic
progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune
vasculitis [eg, Wegener?s Granulomatosis]); motor neuropathy considered of
autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis). Subjects
with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune
condition only requiring hormone replacement, psoriasis not requiring syatemic
treatment, or conditions not expected to recur in the absence of an external trigger are
permited to enroll.
4) Any underlying medical or psychiatric condition, which in the opinion of the
investigator will make the administration of nivolumab and ipilimumab hazardous or
obscure the interpretation of AEs, such as a condition associated with frequent
diarrhea.
5) Any non-oncology vaccine therapy used for prevention of infectious diseases (for up
to 1 month before or after any dose of nivolumab and ipilimumab).
6) A history of prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4
antibody, or any other antibody or drug specifically targeting T-cell costimulation or
immune checkpoint pathways.
7) Concomitant therapy with any of the following: IL-2, interferon, or other non-study
immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other
investigation therapies; or chronic use of systemic corticosteroids, defined as >10mg
daily prednisone equivalents. Inhaled or topical steroids, and adrenal replacement
doses > 10 mg daily prednisone equivalents are permitted in the absence of active
autoimmune disease.
8) Active brain metastases or leptomeningeal metastases. Subjects with brain metastases
are eligible if these have been treated and there is no magnetic resonance imaging
(MRI) evidence of progression for at least 8 weeks after treatment is complete and
within 28 days prior to first dose of study drug administration. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day
prednisone quivalents) for at least 2 weeks prior to study drug administration.
9) Women of childbearing potential (WOCBP) as defined below, who:
a. are unwilling or unable to use an acceptable method of contraception to avoid
pregnancy for their entire study period and for at least 8 weeks after cessation
of study drug, or
b. have a positive pregnancy test at baseline, or
c. are pregnant or breastfeeding.

1. Tratamiento sistémico previo para el melanoma uveal metastásico;
2. Neoplasia maligna previa activa en los últimos 3 años, excepto en caso de cáncer localizado curable que aparentemente se ha curado, como carcinoma cutáneo basocelular o epidermoide, cáncer superficial de vejiga, carcinoma in situ de cuello uterino o de mama, o cáncer de próstata incidental;
3. Enfermedad autoinmunitaria: Sujetos con antecedentes, sospecha o presencia de enfermedad autoinmunitaria activa. Está permitido incluir a sujetos con vitíligo, diabetes mellitus de tipo I, hipotiroidismo residual debido a enfermedad autoinmunitaria que solo necesitan tratamiento de sustitución hormonal psoriasis que no necesite tratamiento sistémico o procesos patológicos que no se espera que experimenten recurrencia en ausencia de un factor desencadenante externo;
4. Cualquier trastorno médico o psiquiátrico subyacente, que, en opinión del investigador, haga que la administración de ipilimumab y nivolumab sea peligrosa o que dificultaría la interpretación de los AA, como un trastorno asociado a brotes frecuentes de diarrea.
5. Cualquier tratamiento no oncológico con vacunas empleado para la prevención de enfermedades infecciosas (hasta 1 mes antes o después de cualquier dosis de ipilimumab y nivolumab).
6. Antecedentes de tratamiento previo con anti-PD-1, anti-PD-L1, anti-PD-L2, anticuerpo anti-CTLA-4, o cualquier otro anticuerpo o fármaco dirigido específicamente contra la coestimulación de los linfocitos T o las vías de control inmunitario.
7. Tratamiento concomitante con cualquiera de los siguientes: IL-2, interferón u otros tratamientos inmunoterápicos ajenos al estudio; quimioterapia citotóxica; fármacos inmunosupresores; otros tratamientos en fase de investigación; o uso crónico de corticosteroides, definido como fármacos equivalentes a > 10 mg al
día de prednisona. Están permitidos los corticosteroides inhalados o tópicos, y dosis de tratamiento de reemplazo suprarrenal > 10 mg al día de prednisona o equivalente, en ausencia de enfermedad autoinmunitaria activa.
8. Metástasis cerebrales activas o metástasis leptomeníngeas. Los sujetos con metástasis cerebrales son elegibles si estas han sido tratadas y no hay indicios de progresión en la resonancia magnética (RMN) durante al menos 8 semanas después de haber finalizado el tratamiento y en los 28 días anteriores a la administración de la primera dosis del fármaco del estudio. Tampoco debe haber necesidad de dosis inmunosupresoras de corticosteroides sistémicos (> 10 mg/día de prednisona o equivalente) durante al menos antes de la administración del fármaco del estudio.
9. Pacientes fértiles y sexualmente activos que no utilicen métodos anticonceptivos eficaces y mujeres embarazadas o en periodo de lactancia;

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is Overall Survival at 12 months defined as the percentage of patients
alive at 1-year from first dose of treatment.

El criterio principal de valoración es la supervivencia global a los 12 meses, definida como el porcentaje de pacientes vivos 1 año después de la primera dosis del tratamiento.

E.5.1.1

Timepoint(s) of evaluation of this end point

12 months after treatment start

12 meses después de comenzar el tratamiento

E.5.2

Secondary end point(s)

- Overall survival and overall survival at 24 months.
- PFS at 3 months according to RECIST 1.1 criteria.
- Global PFS according to RECIST 1.1 criteria.
- Objective Response Rate (ORR) according to RECIST 1.1 criteria.
- Disease Control Rate proportion
- Duration of response

- Supervivencia global y supervivencia global a los 24 meses.
- SLP a los 3 meses según los criterios RECIST 1.1.
- SLP global según los criterios RECIST 1.1.
- Tasa de respuesta objetiva (TRO) según los criterios RECIST 1.1.
- Porcentaje de tasa de control de la enfermedad
- Duración de la respuesta.

E.5.2.1

Timepoint(s) of evaluation of this end point

- Overall survival and overall survival at 24 months. - 24 months
- PFS at 3 months according to RECIST 1.1 criteria. - 3 months
- Global PFS according to RECIST 1.1 criteria. - at progression
- Objective Response Rate (ORR) according to RECIST 1.1 criteria - 12 months
- Disease Control Rate proportion - at progression
- Duration of response - at progression

- Supervivencia global y supervivencia global a los 24 meses. - 24 meses
- SLP a los 3 meses según los criterios RECIST 1.1. - 3 meses
- SLP global según los criterios RECIST 1.1. - Hasta progresión.
- Tasa de respuesta objetiva (TRO) según los criterios RECIST 1.1. - 12 meses
- Porcentaje de tasa de control de la enfermedad.- Hasta progresión.
- Duración de la respuesta. -Hasta progresión.

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

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

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

E.8.1.1

Randomised

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

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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 patient last visit

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

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:

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.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 discretion of treating physician

A criterio del investigador

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

2016-02-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-02-11

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

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