Clinical Trials Register

Summary
EudraCT Number:	2014-004944-37
Sponsor's Protocol Code Number:	MK3475-054
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:	2015-04-27
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

Spain - AEMPS

A.2

EudraCT number

2014-004944-37

A.3

Full title of the trial

Adjuvant immunotherapy with anti-PD-1 monoclonal antibody Pembrolizumab (MK-3475) versus placebo after complete resection of high-risk Stage III melanoma: A randomized, double-blind Phase 3 trial of the EORTC Melanoma Group.

Inmunoterapia complementaria con pembrolizumab (MK-3475), un anticuerpo monoclonal anti-PD-1, en comparación con placebo tras resección completa de melanoma en estadio III de alto riesgo: un ensayo en fase III, aleatorizado y doble ciego del grupo de melanoma de la EORTC

A.3.1

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

Immunotherapeutic treatment with Pembrolizumab (antibody) in melanoma patients at high risk of recurrence after complete surgical resection

Tratamiento de inmunoterapia con Pembrolizumab (anticuerpos) en pacientes con melanoma de alto riesgo de recurrencia después de resección quirúrgica completa

A.3.2

Name or abbreviated title of the trial where available

Immunotherapy with anti-PD in stage III melanoma

Inmunoterapia con anti-PD-1 en melanoma en estadio III

A.4.1

Sponsor's protocol code number

MK3475-054

A.5.4

Other Identifiers

Name:

EORTC

Number:

1325-MG

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	Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co. Inc
B.1.3.4	Country	United States
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	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., 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	Merck Sharp & Dohme de España S.A.
B.5.2	Functional name of contact point	Investigación Clínica
B.5.3	Address:
B.5.3.1	Street Address	C/ Josefa Valcárcel, 38
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28027
B.5.3.4	Country	Spain
B.5.4	Telephone number	+3491 3210600
B.5.5	Fax number	+3491 3210590
B.5.6	E-mail	ensayos_clinicos@merck.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	MK-3475
D.3.2	Product code	MK-3475
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	PEMBROLIZUMAB
D.3.9.1	CAS number	1374853-91-4
D.3.9.2	Current sponsor code	MK-3475
D.3.9.3	Other descriptive name	Anti-PD-1 monoclonal antibody
D.3.9.4	EV Substance Code	SUB167136
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	25
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)	Yes
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	Powder for solution for infusion
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

Stage III melanoma (AJCC R0) with histologically confirmed cutaneous melanoma metastatic to lymph node, classified as (AJCC, 2010): Stage IIIA with metastasis > 1 mm; any Stage IIIB or IIIC (no in-transit metastases)

Melanoma en estadio III (AJCC R0), con melanoma cutáneo metastásico a ganglios linfáticos confirmado histológicamente, clasificado como (AJCC, 2010): estadio IIIA con metástasis >1 mm; cualquier estadio IIIB o IIIC (sin metástasis en tránsito).

E.1.1.1

Medical condition in easily understood language

Clinical and histologic stage III melanoma with a high risk of recurrence

Clínico e histológico melanoma en estadio III con alto riesgo de recurrencia

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	18.0
E.1.2	Level	PT
E.1.2	Classification code	10025670
E.1.2	Term	Malignant melanoma stage III
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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 prospectively assess whether post-operative adjuvant therapy with pembrolizumab improves recurrence-free survival, as compared to placebo in high-risk patients with complete resection of Stage IIIA (>1 mm metastasis), IIIB and IIIC melanoma.
- To prospectively assess whether in the subgroup of patients with PD-L1-positive tumor expression, pembrolizumab improves recurrence-free survival as compared to placebo.

- Evaluar prospectivamente si el tratamiento adyuvante posquirúrgico con
pembrolizumab mejora la supervivencia sin recidiva (SSR) en comparación con placebo en pacientes de alto riesgo con resección completa de melanoma en estadios IIIA (metástasis >1 mm), IIIB y IIIC.
- Evaluar prospectivamente si en el subgrupo de pacientes con expresión tumoral positiva del ligando de muerte celular programada 1 (PD-L1), pembrolizumab mejora la supervivencia sin recidiva en comparación con placebo.

E.2.2

Secondary objectives of the trial

- To prospectively assess whether post-operative adjuvant therapy with pembrolizumab improves distant metastasis free survival as compared to placebo.
- To prospectively assess whether in the subgroup of patients with PD-L1-positive tumor expression pembrolizumab improves distant metastasis free survival as compared to placebo.
- To prospectively assess whether post-operative adjuvant therapy with pembrolizumab improves overall survival, as compared to placebo.
- To prospectively assess whether in the subgroup of patients with PD-L1-positive tumor expression pembrolizumab improves overall survival as compared to placebo.
- To compare adverse event profiles (AE and Serious Adverse Event (SAE)) between patients receiving pembrolizumab versus patients in the placebo arm.
- To evaluate the pharmacokinetics (PK) of pembrolizumab when pembrolizumab is administered at 200 mg every three weeks.

- Evaluar prospectivamente si el tratamiento adyuvante posquirúrgico con pembrolizumab mejora la supervivencia sin metástasis en comparación con placebo.
- Evaluar prospectivamente si en el subgrupo de pacientes con expresión tumoral positiva de PD-L1 pembrolizumab mejora la supervivencia sin metástasis en comparación con placebo.
- Evaluar prospectivamente si el tratamiento adyuvante posquirúrgico con pembrolizumab mejora la supervivencia general en comparación con placebo.
- Evaluar prospectivamente si en el subgrupo de pacientes con expresión tumoral positiva de PD-L1 pembrolizumab mejora la supervivencia general en comparación con placebo.
- Comparar los perfiles de acontecimientos adversos (AA y acontecimientos adversos graves [AAG]) de los pacientes del grupo que recibe pembrolizumab frente a los del grupo de placebo.
- Evaluar la farmacocinética (FC) de pembrolizumab si se administran 200 mg de pembrolizumab cada tres semanas.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- At least 18 years of age.
- Complete resection of Stage III melanoma (AJCC R0) with histologically confirmed cutaneous melanoma metastatic to lymph node, classified as (AJCC, 2010): Stage IIIA with metastasis > 1 mm; any Stage IIIB or IIIC (no in-transit metastases).
- Melanoma with unknown origin of the primary is eligible
- Mandatory to ship tumor sample for evaluation of PD-L1 expression.
- The treatment should start no later than 13 weeks after surgery and only after complete wound healing from the surgery.
- Disease status for the post-surgery baseline assessment must be documented by full Chest/Abdomen/Pelvis CT and/or MRI with Neck CT and/or MRI (for Head and Neck primaries) and complete clinical examination after the informed consent and prior to enrollment.
- Disease-free (no loco-regional relapse or distant metastasis); no clinical evidence for brain metastases.
- BRAF mutation status
- ECOG performance status of 0 or 1.
- Patient demonstrates adequate organ function as defined in the protocol
- Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior to the first dose of study treatment.
- Patients of childbearing / reproductive potential should use adequate birth control methods.
- Female patients who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 120 days after the last dose of study drug .

-Tener un mínimo de 18 años de edad.
- Resección completa de melanoma en estadio III (R0 AJCC), con melanoma cutáneo metastásico a ganglios linfáticos confirmado histológicamente, clasificado como (AJCC,2010): estadio IIIA con metástasis >1 mm; cualquier estadio IIIB o IIIC (sin metástasis en tránsito).
-Los melanomas de sitio primario desconocido son aptos.
-Es obligatorio enviar la muestra tumoral para evaluar su expresión de PD-L1.
-El tratamiento debe iniciarse 13 semanas después de la intervención quirúrgica a más tardar y únicamente tras la cicatrización completa de la intervención.
-Debe dejarse constancia del estado de la enfermedad para la evaluación inicial posquirúrgica mediante una TC de tórax/abdomen/pelvis o RM con TC de cuello o RM (para los tumores primarios de cabeza y cuello), así como una exploración clínica completa tras la obtención del consentimiento informado y antes de la inscripción.
-Sin cáncer (sin recidiva locorregional o metástasis); sin signos clínicos de metástasis cerebral.
-Estado de la mutación de BRAF
-Estado funcional según la escala del ECOG de 0 o 1.
-El paciente muestra una función suficiente de los órganos según lo definido en protocolo.
-Las mujeres en edad fértil (MEF) deben presentar una prueba de embarazo en suero (u orina) con resultado negativo en el plazo de las 72 horas anteriores a la primera dosis del tratamiento del estudio.
-Los pacientes en edad fértil/con capacidad reproductiva deben usar métodos anticonceptivos adecuados
-Las mujeres en periodo de lactancia deben interrumpirla antes de la primera dosis de tratamiento del estudio y hasta los 120 días después de la última dosis del fármaco en estudio.

E.4

Principal exclusion criteria

- Mucosal or ocular melanoma.
- Prior therapy for melanoma except surgery for primary melanoma lesions.
- history of pneumonitis requiring treatment with steroids, no history of interstitial lung disease.
- history of a hematologic or primary solid tumor malignancy, unless no evidence of that disease for 5 years.
- active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- active infection requiring therapy.
- diagnosis of immunodeficiency, no systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
- known history of human immunodeficiency virus (HIV), active Hepatitis B or Hepatitis C.
- treatment with live vaccines within 30 days prior to the first dose of study medication are not eligible.
- prior treatment with any anti-CTLA4 monoclonal antibody or anti-PD-1, or PD-L1 or PD-L2 agent.
- Patient is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks prior to the first dose of treatment
- patient is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or Sponsor staff directly involved with this trial, unless prospective IRB approval (by chair or designee) is given allowing exception to this criterion for a specific subject.
- female patients who are Breast feeding

-Melanoma mucoso u ocular.
-Tratamiento previo para el melanoma excepto la intervención quirúrgica de las lesiones del melanoma primario.
- Antecedentes de neumonía que haya requerido tratamiento con esteroides, sin antecedentes de neumopatía intersticial.
- Antecedentes de neoplasias malignas hematológicas o con tumores sólidos primarios, excepto si noha habido signos de tal enfermedad durante 5 años
- Enfermedad autoinmunitaria activa que haya requerido un tratamiento sistémico en los 2 últimos años (es decir, con agentes modificadores de la enfermedad, corticosteroides o inmunodepresores). Las terapias sustitutivas (p. ej. tiroxina, insulina o terapia sustitutiva fisiológica con corticosteroides para tratar la insuficiencia suprarrenal o pituitaria, etc.) no se consideran formas de tratamiento sistémico.
- Infecciones activas que requieran tratamiento
-Diagnóstico de inmunodeficiencias, sin tratamientos sistémicos con esteroides u otro tipo de tratamientos inmunodepresores dentro de los 7 días anteriores a la primera dosis del tratamiento del estudio
- Antecedentes conocidos de infección por el virus de la inmunodeficiencia humana (VIH), hepatitis B activa o hepatitis C.
- pacientes que hayan recibido tratamiento con vacunas atenuadas dentro de los 30 días anteriores a la primera dosis del medicamento en estudio.
-Haber recibido ningún tratamiento anterior con anticuerpos monoclonales anti-CTLA-4 o fármacos anti-PD-1 o PD-L1 o PD-L2.
- Participa actualmente en ningún estudio ni recibe tratamientos en estudio ni ha participado en un estudio de un fármaco en investigación ni ha recibido tratamientos en estudio ni ha usado un dispositivo en investigación en las 4 semanas anteriores a la primera dosis del tratamiento
-Él mismo o algún familiar directo (p. ej. cónyuge, progenitor/tutor legal, hermano o hijo) forma parte del personal del centro de investigación o del promotor implicado directamente en este ensayo, a menos que lo aprobase el presidente o la persona designada del CEIC, en cuyo caso se haría una excepción de este criterio para un sujeto en concreto
- Mujeres en periodo de lactancia

E.5 End points

E.5.1

Primary end point(s)

1. Recurrence free survival (RFS)
2. RFS in subgroup of patients with PD-L1-positive tumor expression receiving either pembrolizumab or placebo

1. Supervivencia sin recidiva (SSR)
2. SSR en pacientes con expresión positiva de PD-L1, recibiendo pembrolizumab o placebo

E.5.1.1

Timepoint(s) of evaluation of this end point

E.5.2

Secondary end point(s)

1. Distant metastases-free survival (DMFS)
2. DMFS in subgroup of patients with PD-L1-positive tumor expression receiving either pembrolizumab or placebo
3. Overall survival (OS)
4. OS in subgroup of patients with PD-L1-positive tumor expression receiving either pembrolizumab or placebo
5. Toxicity profile according to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
6. To evaluate the PK of pembrolizumab when pembrolizumab is administered 200 mg every 3 weeks

1. Supervivencia sin metástasis (SSM)
2. SSM en el subgrupo de pacientes con expresión tumoral positiva de PD-L1 que reciben pembrolizumab o placebo
3. Supervivencia general (SG)
4. SG en el subgrupo de pacientes con expresión tumoral positiva de PD-L1 que reciben pembrolizumab placebo
5. Perfil de toxicidad conforme a los criterios de terminología común para acontecimientos adversos (Common Terminology Criteria for Adverse Events, CTCAE) v. 4.0
6. Evaluar la FC de pembrolizumab si se administran 200 mg de pembrolizumab cada tres semanas.

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Every 12 weeks during treatment and for the first two years. From year 3 to 5, every 6 months and yearly thereafter.
2. Every 12 weeks during treatment and for the first two years. From year 3 to 5, every 6 months and yearly thereafter.
3. OS will be measured from the date of randomization until the date of
death.
4. OS will be measured from the date of randomization until the date of
death.
5. Every 6 weeks during treatment and at 12 weeks after the last treatment
6. prior to traetment start (before injection 1), week 4 (before injection N°2), week 10 (before injection N°4 ), week 22 (before injection N°8 ) and at 12 months (before injection 16). At 30 days and 3 months after the last treatment

1.Cada 12 semanas durante el tratamiento y los 2 primeros años. Del año 3 al 5 cada 6 meses y anual a partir de entonces.
2.Cada 12 semanas durante el tratamiento y los 2 primeros años. Del año 3 al 5 cada 6 meses y anual a partir de entonces.
3.Supervivencia general (SG) se medirá desde fecha randomización hasta fecha muerte.
4.Supervivencia general (SG) se medirá desde fecha randomización hasta fecha muerte.
5. Cada 6 meses durante tratamiento y en semana 12 tras último tratamiento.
6.Antes de inicio de tratamiento ( antes inyección 1), Semana 4( antes inyección 2), Semana 10 ( antes inyección 4), semana 22( antes inyección 8) y en mes 12 ( antes inyección 16). A los 30 días, y a los 3 meses tras el último tratamiento.

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

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)

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

E.8.1.6

Cross over

Yes

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

Australia

Austria

Belgium

Canada

Czech Republic

Denmark

Finland

France

Germany

Israel

Italy

Japan

Korea, Republic of

Netherlands

New Zealand

Norway

Poland

Portugal

Russian Federation

Serbia

Singapore

Slovenia

Spain

Sweden

Switzerland

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

When all criteria have been satisfied:
1. 30 days after all patients have stopped protocol treatment
2. The trial is mature for the 3 final analyses of the efficacy endpoints: one for RFS (overall, and in PD-L1-positive), one for DMFS (overall, and in PD-L1-positive) and one for OS (overall, and in PD-L1-positive)
3. The database has been fully cleaned and frozen
4. As in other EORTC melanoma adjuvant trials, a very long term follow-up, when all patients have a 10-year follow-up is foreseen

Cuando cumplan todos lo siguiente:
1. 30 dias tras final todos ptes
2. Ensayo desarrollado x llevar a cabo los 3 análisis finales de los criterios de valoración de la eficacia según protocolo: de la SSR , la SSM y la SG ( todos general y para expresión positiva de PD-L1)
3. Base de datos revisada y bloqueada x 3 análisis finales
4. como en otros E-complementarios de melanoma de la EORTC, prevé seguimiento a muy largo plazo: todos los pacientes durante 10 años

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:

738

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

162

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

540

F.4.2.2

In the whole clinical trial

900

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

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

2015-06-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-06-11

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