Clinical Trials Register

Summary
EudraCT Number:	2019-002567-96
Sponsor's Protocol Code Number:	CA209-7G8
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2021-08-02
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2019-002567-96

A.3

Full title of the trial

A phase 3, randomized, double-blind trial of nivolumab in combination with
intravesical BCG versus standard of care BCG alone in participants with
high-risk non-muscle invasive bladder cancer that is persistent or
recurrent after treatment with BCG

Sperimentazione in doppio cieco di fase 3, randomizzata, volta a valutare nivolumab in combinazione con BCG intravescicale rispetto alla monoterapia standard con BCG in partecipanti affetti da tumore della vescica non muscolo-invasivo ad alto rischio che è persistente o ricorrente dopo il trattamento con BCG

A.3.1

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

A Study Comparing Nivolumab and Intravesical BCG to BCG Alone in Highrisk
Non-muscle Invasive Bladder Cancer

Studio volto a confrontare nivolumab e BCG intravescicale con BCG in monoterapia nel tumore della vescica non muscolo-invasivo ad alto rischio

A.3.2

Name or abbreviated title of the trial where available

not available

non disponibile

A.4.1

Sponsor's protocol code number

CA209-7G8

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1235-2749

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
B.4.2	Country
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	Head of the 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.5.6	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	Yes
D.2.1.1.1	Trade name	Opdivo (100 mg/10 ml)
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	European Union
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 - 10ml vial- COMMERCIAL
D.3.2	Product code	[BMS-936558]
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.3.9.1	CAS number	946414-94-4
D.3.9.2	Current sponsor code	BMS-936558
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Bacillus Calmette Guerin (BCG)
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
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	.
D.3.2	Product code	[.]
D.3.4	Pharmaceutical form	Intravesical solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravesical use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Bacillus Calmette Guerin (BCG)
D.3.9.2	Current sponsor code	.
D.3.9.3	Other descriptive name	BCG (BACILLUS CALMETTE-GUÉRIN) BACTERIA
D.3.9.4	EV Substance Code	SUB20565
D.3.10	Strength
D.3.10.1	Concentration unit	U unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	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	BCG Culture SSI
D.2.1.1.2	Name of the Marketing Authorisation holder	AJ Vaccines A/S
D.2.1.2	Country which granted the Marketing Authorisation	Denmark
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	BCG Culture SSI
D.3.2	Product code	[.]
D.3.4	Pharmaceutical form	Intravesical solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravesical use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Bacillus Calmette Guerin
D.3.9.2	Current sponsor code	.
D.3.9.3	Other descriptive name	BCG
D.3.9.4	EV Substance Code	SUB 20565
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.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 infusion
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 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

Bladder Cancer

Tumore della vescica

E.1.1.1

Medical condition in easily understood language

Bladder Cancer

Tumore della vescica

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	PT
E.1.2	Classification code	10005003
E.1.2	Term	Bladder cancer
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 compare the EFS per PRC of nivolumab plus BCG vs BCG alone in all randomized participants.

Confrontare l’EFS valutata dal comitato di revisione patologica (Pathology Review Committee, PRC) di nivolumab più BCG rispetto a BCG in monoterapia in tutti i partecipanti randomizzati

E.2.2

Secondary objectives of the trial

To compare the WFS of nivolumab plus BCG vs BCG alone in all randomized participants;
To compare the OS of nivolumab plus BCG vs BCG alone in all randomized participants;
To evaluate the CRR at first disease assessment (Week 13) in all randomized participants with CIS (+/- papillary disease) at study entry by treatment arm (nivolumab plus BCG and BCG alone);
evaluate the duration of response (DoR) in all randomized participants with CIS (+/- papillary disease) at study entry who achieved CRR at first disease assessment by treatment arm (nivolumab plus BCG and BCG alone);
To describe the safety and tolerability of nivolumab plus BCG and BCG
alone in all treated participants.

• Confrontare la WFS di nivolumab più BCG rispetto a BCG in monoterapia in tutti i partecipanti randomizzati
• Confrontare l’OS di nivolumab più BCG rispetto a BCG in monoterapia in tutti i partecipanti randomizzati
• Valutare il CRR alla prima valutazione della malattia (Settimana 13) in tutti i partecipanti randomizzati con CIS (+/- malattia papillare) all’ingresso nello studio in base al braccio di trattamento (nivolumab più BCG e BCG in monoterapia)
• Valutare la durata della risposta (Duration of Response, DoR) in tutti i partecipanti randomizzati con CIS (+/- malattia papillare) all’ingresso nello studio che hanno raggiunto il CRR alla prima valutazione della malattia in base al braccio di trattamento (nivolumab più BCG e BCG in monoterapia)
• Descrivere la sicurezza e la tollerabilità di nivolumab più BCG e BCG in monoterapia in tutti i partecipanti trattati

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

_Signed Written Informed Consent;
_Histologically confirmed persistent or recurrent high-risk non-muscleinvasive UC (TaHG and/or T1 and/or CIS);
_Treated with at least 1 adequate course of induction BCG therapy (at least 5 out of 6 doses);
_Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2;
_Males and females, ages 18 or age of majority, and older.

• Consenso informato scritto firmato
• Conferma istologica di carcinoma uroteliale (Urothelial Carcinoma, UC) non muscolo-invasivo ad alto rischio, persistente o ricorrente (Ta di alto grado [High Grade, HG] [TaHG] e/o T1 e/o CIS)
• Trattati con almento 1 ciclo adeguato di terapia di induzione di BCG (almeno 5 di 6 dosi)
• Stato di validità secondo l’Eastern Cooperative Oncology Group (ECOG) pari a 0-2
• Maschi e femmine di età pari o superiore a 18 anni o alla maggiore età

E.4

Principal exclusion criteria

_Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured or not requiring treatment;
_Patients with serious or uncontrolled medical disorders;
_Participants with an active, known, or suspected autoimmune disease;
_Recurrent high-risk NMIBC that is classified as BCG unresponsive;
_Has any contraindication to intravesical BCG therapy, including evidence of active tuberculosis

• Partecipanti con una cancro attivo in precedenza (entro i 3 anni precedenti) eccetto per per il tumori localmente curabili che sono stati apparentemente curati o che non richiedono trattamento
• Pazienti con serie o incontrollate condizioni mediche
• Partecipanti con una conosciuta o sospetta attiva malattia autoimmune
• Tumore della vescica non muscolo-invasivo (NMIBC) ad alto rischio ricorrente, classificato come non responsivo a BCG
• Presenza di qualsiasi controindicazione della terapia intravescicale con BCG, inclusa l’evidenza di tubercolosi attiva

E.5 End points

E.5.1

Primary end point(s)

_EFS, defined as the time from randomization until any of the following events: recurrence (TaHG, T1 or CIS) or progression of disease, or death from any cause

EFS, definita come l’intervallo di tempo dalla randomizzazione a uno qualsiasi degli eventi che seguono: recidiva (TaHG, T1 o CIS) o progressione della malattia o decesso per qualsiasi causa

E.5.1.1

Timepoint(s) of evaluation of this end point

_recurrence (TaHG, T1 or CIS) or progression of disease, or death from any cause.

recidiva (TaHG, T1 o CIS) o progressione della malattia o decesso per qualsiasi causa

E.5.2

Secondary end point(s)

_WFS, defined as the time from randomization to progression to muscle invasive disease, cystectomy, systemic chemotherapy, radiotherapy, or death from any cause;
_OS, defined as the time from randomization to death from any cause;
_CRR, defined as the proportion of participants with CIS (+/- papillary disease) at study entry who are disease free at the first disease assessment;
_DoR is restricted to participants with CIS (+/- papillary disease) at study entry who are disease free at the first disease assessment and is defined as the time between the date of the first CR to the date of first
documented recurrence, progression, or death due to any cause;
_Overall safety and tolerability will be measured by the incidence of AEs, SAEs, AEs leading to discontinuation, IMAEs, deaths, and laboratory abnormalities and changes from baseline.

• WFS, definita come l’intervallo di tempo dalla randomizzazione alla progressione in malattia muscolo-invasiva, cistectomia, chemioterapia sistemica, radioterapia o decesso per qualsiasi causa.
• OS, definita come l’intervallo di tempo dalla randomizzazione al decesso per qualsiasi causa.
• CRR, definito come la percentuale di partecipanti con CIS (+/- malattia papillare) all’ingresso nello studio che sono liberi da malattia alla prima valutazione della stessa.
• La DoR è limitata ai partecipanti con CIS (+/- malattia papillare) all’ingresso nello studio che sono liberi da malattia alla prima valutazione della stessa ed è definita come l’intervallo di tempo tra la data della prima risposta completa (Complete Response, CR) e la data della prima documentazione di recidiva, progressione o decesso per qualsiasi causa.
• La sicurezza e la tollerabilità complessive saranno misurate in base all’incidenza di eventi avversi (Adverse Event, AE), eventi avversi gravi (Serious Adverse Event, SAE), AE che portano all’interruzione, AE immuno-mediati (Immune-Mediated Adverse Event, IMAE), decessi, anomalie di laboratorio e variazioni rispetto al basale.

E.5.2.1

Timepoint(s) of evaluation of this end point

_(WFS) progression to muscle invasive disease, cystectomy, systemic chemotherapy, radiotherapy, or death from any cause;
_(OS) death from any cause;
_(CRR) first disease assessment;
_(DoR ) first documented recurrence, progression, or death due to any cause;
__(Overall safety and tolerability) discontinuation, IMAEs, deaths, and laboratory abnormalities and changes from baseline.

• WFS: progressione in malattia muscolo-invasiva, cistectomia, chemioterapia sistemica, radioterapia o decesso per qualsiasi causa.
• OS: decesso per qualsiasi causa.
• CRR: prima valutazione della malattia.
• DoR: prima documentazione di recidiva, progressione o decesso per qualsiasi causa.
• Sicurezza e la tollerabilità complessive: discontinuazione, AE immuno-mediati (Immune-Mediated Adverse Event, IMAE), decessi, anomalie di laboratorio e variazioni rispetto al basale.

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

Yes

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

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)

Yes

E.8.2.2

Placebo

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

Information not present in EudraCT

E.8.6.3

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

Australia

Brazil

Canada

Chile

Russian Federation

United States

Austria

Belgium

Denmark

Finland

France

Germany

Ireland

Italy

Netherlands

Romania

Spain

Sweden

Switzerland

United Kingdom

Argentina

Greece

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

LVLS

Ultima visita dell'ultimo soggetto

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:

219

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

656

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

500

F.4.2.2

In the whole clinical trial

875

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 treatment period as defined in the protocol, BMS will not continue to provide BMS-supplied study treatment to participants/investigators unless BMS chooses to extend the study. The investigator should ensure that the participant receives appropriate Standard Of Care to treat the condition under study

Alla fine del periodo di trattamento, come definite nel protocollo, BMS non continuerà a fornire trattamenti BMS-supplied a partecipanti/investigatori, tranne il caso in cui BMS non scelga di estendere lo studio.
L’investigaotore si dovrebbe assicurare che i partecipanti ricevano le appropriate cure standard per trattare la condizione oggetto di studio.

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

2020-03-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-01-30

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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Clinical trials