Clinical Trials Register

Summary
EudraCT Number:	2020-005170-10
Sponsor's Protocol Code Number:	COMBI-TED
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:	2021-06-08
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

2020-005170-10

A.3

Full title of the trial

A multicenter, Phase II, open label, randomized trial evaluating the efficacy of Tedopi plus docetaxel or Tedopi plus nivolumab as second-line therapy in metastatic non-small-cell lung cancer progressing after first-line chemo-immunotherapy (Combi-TED)

Studio multicentrico, di fase II, in aperto, randomizzato per valutare l’efficacia di Tedopi e docetaxel o Tedopi e nivolumab come seconda linea di trattamento nel tumore al polmone non a piccole cellule metastatico e in progressione in seguito al trattamento in prima linea con chemio-immunoterapia (Combi-TED)

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

COMBI-TED

A.4.1

Sponsor's protocol code number

COMBI-TED

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	FONDAZIONE RICERCA TRASLAZIONALE (FORT)
B.1.3.4	Country	Italy
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	Bristol Myer Squibb International Corporation
B.4.2	Country	Belgium
B.4.1	Name of organisation providing support	OSE Immunotherapeutics
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Clinical Research Technology
B.5.2	Functional name of contact point	Clinical Operations & Regulatory Af
B.5.3	Address:
B.5.3.1	Street Address	Via San Leonardo trav. Migliaro
B.5.3.2	Town/ city	Salerno
B.5.3.3	Post code	84131
B.5.3.4	Country	Italy
B.5.4	Telephone number	089301545
B.5.5	Fax number	0897724155
B.5.6	E-mail	combi-ted@cr-technology.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 - 10 MG/ML- CONCENTRATO PER SOLUZIONE PER INFUSIONE- USO ENDOVENOSO- FLACONCINO (VETRO)- 10 ML- 1 FLACONCINO
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	Italy
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	Concentrate for 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	MDX1106, ONO-4538
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	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	TEDOPI
D.3.2	Product code	[OSE2101]
D.3.4	Pharmaceutical form	Emulsion for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	TEDOPI
D.3.9.3	Other descriptive name	OSE2101
D.3.9.4	EV Substance Code	SUB191632
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	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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)	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	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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

metastatic non-small-cell lung cancer

tumore del polmone non a piccole cellule metastatico

E.1.1.1

Medical condition in easily understood language

metastatic non-small-cell lung cancer

tumore del polmone non a piccole cellule metastatico

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	10062042
E.1.2	Term	Lung neoplasm
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 assess 1-year survival rate in patients treated with Tedopi plus docetaxel (arm A) or Tedopi plus nivolumab (arm B) or docetaxel as single agent (arm C) in subjects with advanced NSCLC progressing on first-line chemoimmunotherapy.

Valutare la Overall Survival (OS) a 1 anno in pazienti trattati con Tedopi più docetaxel (braccio A) e Tedopi più nivolumab (braccio B) o docetaxel come agente singolo (braccio C).

E.2.2

Secondary objectives of the trial

• To assess Overall Survival (OS)
• To assess Progression-free survival (PFS)
• To assess Objective Response Rate (ORR)
• To assess treatment safety
Exploratory
• To assess correlation of ORR, PFS and OS with biomarkers in tumor tissue or blood.

• Valutare la OS generale
• Valutare la Progression-free survival (PFS)
• Valutare il tasso di risposta obiettiva (ORR)
• Valutare la sicurezza del trattamento
Esploratorio
• Valutare la correlazione tra ORR, PFS, OS e biomarcatori nel sangue e nel tessuto tumorale.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male and female patients willing and able to give written informed consent;
2. Histological or cytological confirmed diagnosis of HLA-A2+ NSCLC with no evidence of EGFR mutations or ALK or ROS1 rearrangement;
3. Evidence of disease progression at the end of at least 4 cycles of chemo-immunotherapy or 2 cycles of chemo-immunotherapy followed by 2 cycles of immunotherapy (CheckMate9LA regimen) and eligible for treatment with docetaxel. This criterion implies that patients with immunotherapy primary resistance are excluded;
4. Patients must have experienced progressive disease (PD), either during or within 3 months of discontinuing treatment with anti-PD-(L)1-based therapy, occurring after previous clear benefit (any complete –CR- or partial response -PR), or after previous stable disease (SD);
5. Performance status 0-1 (ECOG);
6. Patient compliance to trial procedures;
7. Age = 18 years;
8. Adequate BM function (ANC = 1.5x109/L, Platelets = 100x109/L, HgB > 9g/dl);
9. Adequate liver function (bilirubin < G2, transaminases no more than 3xULN/<5xULN in present of liver metastases);
10. Normal level of creatinine;
11. Female patient: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of approved contraceptive method [complete abstinence, intrauterine contraceptive device (IUD), birth control pills, or barrier device] until 5 months after end of treatment.
or
Male patient: should practice complete abstinence or if sexually active with WOCBP must use any contraceptive method with failure rate less than 1%/year and they should not donate semen as follows: in arm A and C until 6 months since the last dose of docetaxel; in arm B until 3 months since last dose of tedopi.
12. Prior palliative radiotherapy to non-CNS lesions must have been completed at least 2 weeks prior to treatment. Subjects with symptomatic tumor lesions that may require palliative radiotherapy within 4 weeks of first treatment are strongly encouraged to receive palliative radiotherapy prior to treatment. Patients are eligible if CNS metastases are adequately treated and patients are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization;
13. Patients must be either off corticosteroids, or on a stable or decreasing dose of =10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization.

1. Pazienti maschi e femmine disposti e in grado di fornire un consenso informato scritto;
2. Diagnosi istologica o citologica confermata di NSCLC HLA-A2 + senza evidenza di mutazioni dell’EGFR o riarrangiamento di ALK o ROS1;
3. Evidenza della progressione della malattia al termine di almeno 4 cicli di chemioimmunoterapia o 2 cicli di chemioimmunoterapia seguiti da 2 cicli di immunoterapia (regime CheckMate9LA), ed eleggibile per il trattamento con docetaxel. Questo criterio implica che i pazienti con resistenza primaria all’immunoterapia sono esclusi;
4. I pazienti devono aver avuto progressione di malattia (PD), durante o entro 3 mesi dall'interruzione del trattamento con terapia anti-PD- (L) 1, verificatasi in seguito ad evidente beneficio (risposta completa -CR- o parziale -PR), o dopo malattia stabile (SD);
5. Performance status 0-1 (ECOG);
6. Il paziente rispetta le procedure dello studio;
7. Età = 18 anni;
8. Adeguata funzione BM (ANC = 1,5x109 / L, Piastrine = 100x109 / L, HgB> 9g / dl);
9. Funzionalità epatica adeguata (bilirubina <G2, transaminasi non più di 3xULN / <5xULN in presenza di metastasi epatiche);
10. Livello normale di creatinina;
11. Paziente di sesso femminile: abilità di procreare interrotta da intervento chirurgico, radioterapia o menopausa, o attenuato dall'uso di un metodo contraccettivo approvato [astinenza completa, dispositivo contraccettivo intrauterino (IUD), pillola anticoncezionale o dispositivo di barriera] durante e per 5 mesi dopo fine del trattamento.
o
Pazienti di sesso maschile: deve praticare l'astinenza completa o se sessualmente attivo con donne fertili deve utilizzare qualsiasi metodo contraccettivo con tasso di fallimento inferiore all'1% / anno e non devono donare sperma come indicato: nel braccio A e C fino a 6 mesi dall'ultima dose di docetaxel; nel braccio B fino a 3 mesi dall'ultima dose di tedopi.
12. La precedente radioterapia palliativa per lesioni non del SNC deve essere stata completata almeno 2 settimane prima del trattamento. I soggetti con lesioni tumorali sintomatiche che possono richiedere la radioterapia palliativa entro 4 settimane dal primo trattamento sono fortemente incoraggiati a ricevere la radioterapia palliativa prima del trattamento. I pazienti sono eleggibili se le metastasi del SNC sono adeguatamente trattate e i pazienti sono ritornati alla situazione del basale dal punto di vista neurologico (ad eccezione dei segni o sintomi residui correlati al trattamento del SNC) per almeno 2 settimane prima della randomizzazione;
13. I pazienti non devono essere in trattamento con corticosteroidi o possono essere in trattamento con una dose stabile o decrescente di prednisone =10 mg al giorno (o equivalente) per almeno 2 settimane prima della randomizzazione.

E.4

Principal exclusion criteria

1. Patient positive for actionable EGFR mutations or ALK or ROS1 rearrangement;
2. No previous chemoimmunotherapy for metastatic disease or evidence of disease progression during the first 4 cycles of chemoimmunotherapy (primary resistance). Patients with adjuvant resistance (documented loco-regionally and/or systemic relapse of their disease occurring <6 months after the last dose of anti-PD-(L)1-based systemic adjuvant therapy) are excluded;
3. Patients with intervening systemic therapy following prior anti-PD-(L)1-based therapy;
4. Symptomatic brain metastases. Asymptomatic brain metastases are allowed if not requiring corticosteroids use at a dose >10mg daily prednisone (or equivalent);
5. Diagnosis of any other malignancy during the last 3 years, except for in situ carcinoma of cervix uteri and cutaneous squamous cell carcinoma or other local tumors considered cured;
6. Pregnancy or lactating;
7. Patients with an active, known or suspected autoimmune disease. Patients with type I diabetes mellitus; hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll;
8. Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease;
9. Patients should be excluded if they are positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection;
10. Patients should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).

1. Paziente positivo per mutazioni dell’EGFR o riarrangiamento ALK o ROS1.
2. Nessuna precedente chemioimmunoterapia per la malattia metastatica o evidenza di progressione della malattia durante i primi 4 cicli di chemioimmunoterapia (resistenza primaria). I pazienti con resistenza adiuvante (recidiva loco-regionale e / o sistemica documentata della malattia che si verifica <6 mesi dopo l'ultima dose di terapia adiuvante sistemica a base di anti-PD- (L) 1) sono esclusi.
3. Pazienti con terapia sistemica intermedia dopo una precedente terapia a base di anti-PD- (L) 1.
4. Metastasi cerebrali sintomatiche. Le metastasi cerebrali asintomatiche sono consentite se non richiedono l'uso di corticosteroidi.
5. Diagnosi di qualsiasi altro tumore maligno negli ultimi 3 anni, ad eccezione del carcinoma in situ della cervice uterina e del carcinoma cutaneo a cellule squamose o altri tumori locali considerati guariti (es. Carcinoma prostatico localizzato e presunto curato)
6. Gravidanza o allattamento.
7. Pazienti con una malattia autoimmune attiva, nota o sospetta. Possono essere arruolati pazienti con diabete mellito di tipo I; con ipotiroidismo che richiede solo terapia di sostituzione ormonale, con disturbi della pelle (come vitiligine, psoriasi o alopecia) che richiedono un trattamento sistemico o con condizioni che non si prevede si ripresentino in assenza di un fattore scatenante esterno.
8. Pazienti con una condizione che richiede un trattamento sistemico con corticosteroidi (> 10 mg al giorno di prednisone equivalente) o altri farmaci immunosoppressori entro 14 giorni dalla randomizzazione. In assenza di malattia autoimmune attiva sono consentiti steroidi per via inalatoria o topici e steroidi sostitutivi surrenali> 10 mg al giorno di prednisone equivalente;
9. I pazienti devono essere esclusi se risultano positivi al test per l'antigene di superficie del virus dell'epatite B (HBV sAg) o l'acido ribonucleico del virus dell'epatite C (HCV RNA) indicanti un'infezione acuta o cronica;
10. I pazienti devono essere esclusi se hanno una storia nota di risultati positivi al test per il virus dell'immunodeficienza umana (HIV) o nota sindrome da immunodeficienza acquisita (AIDS).

E.5 End points

E.5.1

Primary end point(s)

• 1-year Survival Rate

• Tasso di sopravvivenza ad 1 anno

E.5.1.1

Timepoint(s) of evaluation of this end point

1 year

1 anno

E.5.2

Secondary end point(s)

• Overall Survival (OS) (1 and 2-year OS)
• Progression-free survival (PFS) (1 and 2-year PFS)
• Objective Response rate (ORR)
• Safety
Exploratory
• Correlation of ORR, PFS and OS with tumor biomarkers

• Overall Survival (OS) (mediana, OS a 1 e 2 anni)
• Progression-free survival (PFS) (1 and 2-year PFS)
• Tasso di risposta obiettiva (ORR)
• Sicurezza

E.5.2.1

Timepoint(s) of evaluation of this end point

1 and 2 years
1 and 2 years
Every 8 weeks
Every 3 weeks
Exploratory: 48 months

1 e 2 anni
1 e 2 anni
Ogni 8 settimana
Ogni 3 settimane
Esploratorio: 48 mesi

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Studio non comparativo

Non comparative study

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Studio non comparativo

Non comparative study

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

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

Information not present in EudraCT

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

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:

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

105

F.4.2

For a multinational trial

F.4.2.1

In the EEA

105

F.4.2.2

In the whole clinical trial

105

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)

A safety follow up will be performed 30 days since last dose. A contact follow up will be performed every 3 months until the study temination.

Un safety follow up sarà effettuato 30 giorni dall'ultima dose. Un follow up telefonico sarà poi eseguito ogni 3 mesi fino alla conclusione dello 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

2021-04-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-03-23

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

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