Clinical Trials Register

Summary
EudraCT Number:	2012-001410-41
Sponsor's Protocol Code Number:	IRST172.02
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-07-23
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

2012-001410-41

A.3

Full title of the trial

Vaccination with autologous dendritic cells loaded with autologous tumor lysate or homogenate combined with immunomodulating radiotherapy and/or preleukapheresis IFN-alfa in patients with metastatic melanoma: a randomized “proof-of-principle” phase II study.

Vaccinazione con cellule dendritiche autologhe caricate con lisato od omogenato tumorale autologo associata a radioterapia immunomodulante e/o IFN-alfa preleucaferesi in pazienti con melanoma metastatico: studio di fase II randomizzato “proof-of-principle”.

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

ABSIDE

A.4.1

Sponsor's protocol code number

IRST172.02

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	ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI
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	IRST
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	IRST
B.5.2	Functional name of contact point	data manager
B.5.3	Address:
B.5.3.1	Street Address	via Piero Maroncelli, 40
B.5.3.2	Town/ city	Meldola
B.5.3.3	Post code	47014
B.5.3.4	Country	Italy
B.5.4	Telephone number	0543 739242
B.5.5	Fax number	0543 739290
B.5.6	E-mail	l.valmorri@irst.emr.it

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	INTRONA*SC IV 1FL 18MUI 3ML
D.2.1.1.2	Name of the Marketing Authorisation holder	MSD ITALIA Srl
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.3.4	Pharmaceutical form	Injection
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.3.8	INN - Proposed INN	INTERFERON ALFA-2B
D.3.9.4	EV Substance Code	SUB12521MIG
D.3.10	Strength
D.3.10.1	Concentration unit	million IU million international units
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3
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.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	PROLEUKIN*EV 1F 18MUI
D.2.1.1.2	Name of the Marketing Authorisation holder	NOVARTIS FARMA SpA
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.3.4	Pharmaceutical form	Injection
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.3.8	INN - Proposed INN	ALDESLEUKIN
D.3.9.1	CAS number	110942-02-4
D.3.9.4	EV Substance Code	SUB05303MIG
D.3.10	Strength
D.3.10.1	Concentration unit	million IU million international units
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3
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.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	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	Autologous Dendritic Cell vaccine loaded with autologous tumor lysate or homogenate
D.3.2	Product code	NA
D.3.4	Pharmaceutical form	Injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intradermal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	Autologous Dendritic Cell vaccine loaded with autologous tumor lysate or homogenate
D.3.10	Strength
D.3.10.1	Concentration unit	Other
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	7 to 15
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)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Yes
D.3.11.3.1	Somatic cell therapy medicinal product	Yes
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	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 melanoma

melanoma metastatico

E.1.1.1

Medical condition in easily understood language

metastatic melanoma

melanoma con metastasi

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	15.1
E.1.2	Level	PT
E.1.2	Classification code	10025671
E.1.2	Term	Malignant melanoma stage IV
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	15.1
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

1- Clinical objective: to select the regimen that has the best immune related Disease Control Rate (irDCR) in the different external immunostimulant conditions utilized in combinations with autologous tumor lysate loaded DC vaccine. 2- Immunological objective: to compare between the different treatment arms the immunologic efficacy, defined as the proportion of subjects developing positive DTH to ATL and/or KLH, combined with quantification of tumor antigen-specific circulating immune effectors performed by IFN-ELISPOT analysis at the base line and after at least 4 immunizations, if DTH analysis will not detect differences in terms of immunologic efficacy between the different arms.

1- Obiettivo clinico: selezionare il regime terapeutico con il miglior tasso di controllo di malattia immuno-relato (irDCR) nelle diverse condizioni immunostimolanti esterne utilizzate in associazione al vaccino con cellule dendritiche caricate con lisato o omogenato tumorale autologo. 2- Obiettivo immunologico: comparare fra i diversi bracci di trattamento l’efficacia immunologica, definita come la proporzione di soggetti che sviluppa DTH positivo contro lisato tumorale e/o KLH, combinato alla quantificazione di effettori immuni antitumore circolanti, tramite analisi IFN-alfa-ELISPOT eseguita prima del trattamento e dopo almeno 4 immunizzazioni qualora il test DTH non rilevasse differenze fra i diversi bracci di trattamento.

E.2.2

Secondary objectives of the trial

- To assess safety, tolerability and feasibility of the different external immunostimulant combinations. - To evaluate the effects of preleukapheresis IFN-alfa on: a) Dendritic Cells yield b) Dendritic Cells potency c) TEM-8 upregulation at the mRNA level upon Dendritic Cells maturation. - To estimate immune-related Disease Control Rate (irDCR) in the whole series and in the different treatment arms, and to compare irDCR in the two different immunomodulating conditions (IFN-alfa vs Radiotherapy). - To further define the clinical efficacy of the different treatment arms.

- valutare la sicurezza,la tollerabilità e la fattibilità delle diverse combinazioni immunostimolanti esterne. - valutare gli effetti dell`IFN-alfa preleucaferesi su: a) la resa cellule dendritiche b) la potency delle cellule dendritiche c) l`upregulation di TEM-8 a livello dell`mRNA sulla maturazione delle cellule dendritiche. - stimare il tasso di controllo di malattia immuno-correlato(irDCR) in tutti i bracci di trattamento e confrontare l`irDCR nelle due diverse condizioni immunomodulanti (IFN-alfa vs radioterapia). - definire ulteriormente l`attività clinica dei differenti bracci di trattamento.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Signed Written Informed Consent: patients must be willing and able to give written informed consent, that have to be given before starting of screening procedure. 2. Availability of autologous tumor tissue fulfilling acceptance criteria prescribed by the “Product Specification File”. 3. Patients must have histologically or cytologically confirmed malignant unresectable stage III or stage IV melanoma; 4. Patients must have a minimum of two lesions, one of which must be measurable,(i.e. that can be accurately measured in two perpendicular dimensions, with at least 1 diameter >20 mm and the other dimension >10 mm with conventional techniques or at least 10 x 10 mm with spiral CT scan). 5. Pretreated brain metastases which have been clinically stable for at least 6 months and not requiring corticosteroids are allowed; 6. ECOG performance status 0-1 ; 7. Negative screening tests for HIV, HBV HCV and syphilis not older than 30 days before performing any of the GMP-regulated activities required (leukapheresis, collection of tumor biopsies to be used for tumor lysate/homogenate preparation); 8. Prior lines of chemotherapy, immunotherapy or biological therapy (e.g. inhibitors of B-Raf or c-Kit, Ipilimumab, etc.) for advanced disease are allowed (patients must have lasted prior treatments at least 4 weeks before the first vaccine dose); 9. Men and women aged 18-70 years. 10.Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up 8 weeks after the study, in order to minimize the risk of pregnancy; 11. Patients must have normal organ and marrow function as defined below: - leukocytes >1,500/microL - absolute neutrophil count >1,000/microL - platelets >80,000/microL - total bilirubin within 2 x ULN - AST(SGOT)/ALT(SGPT) <2.5 x ULN - creatinine ≤ 2 mg/dl

1. firma consenso informato scritto: i pazienti devono essere disposti e in grado di dare un consenso informato scritto, che deve essere somministrato prima dell`inizio della procedura di screening. 2. Disponibilità di tessuto tumorale autologo che soddisfi i criteri di accettazione previsti dal `File Product Specification`. 3. conferma istologica o citologica di melanoma maligno non resecabile di stadio III o IV stadio; 4. Minimo di due lesioni, una delle quali deve essere misurabile (cioè può essere misurata in due dimensioni perpendicolari, con almeno un diametro>20 mm e l`altra dimensione>10 mm, ottenute con tecniche convenzionali o almeno 10 x 10 mm con TAC spirale). 5. Sono consentite metastasi cerebrali pre-trattate clinicamente stabili da almeno 6 mesi e che non richiedono corticosteroidi; 6. ECOG performance status 0-1; 7. Test di screening negativi per HIV, HBV, HCV e sifilide non più di 30 giorni prima di eseguire le attività richieste regolamentate in GMP (leucaferesi, raccolta di biopsie tumorali da utilizzare per lisato tumorale / preparato omogeneizzato); 8. Sono ammesse linee precedenti di chemioterapia, immunoterapia o terapia biologica (ad esempio inibitori di B-Raf o c-Kit, Ipilimumab, ecc...) per malattia in stadio avanzato(i pazienti devono avere terminato i trattamenti precedenti almeno 4 settimane prima della prima dose di vaccino); 9. Uomini e donne di età compresa tra 18-70 anni. 10. le donne in età fertile (WOCBP) devono utilizzare un metodo contraccettivo adeguato per evitare la gravidanza durante lo studio e per un massimo di 8 settimane dopo lo studio, al fine di minimizzare il rischio di gravidanza; 11. I pazienti devono funzionalità d`organo e di midollo nella norma, come definito di seguito: - Leucociti> 1500 /microL - Conta assoluta dei neutrofili> 1.000 /microL - Piastrine> 80.000/microL - Bilirubina totale entro 2 x ULN - AST (SGOT) / ALT (SGPT) <2,5 x ULN - Creatinina ≤ 2 mg / dl

E.4

Principal exclusion criteria

1. Patients who have positive tests to HCV, HBV, HIV, or syphilis (specific blood testing must be performed within 30 days before any GMP-regulated activity (leukapheresis and collection of tumor biopsies to be used for tumor lysate/homogenate preparation). 2. Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. 3. Participation in another clinical trial with any investigational agents within 30 days prior to study screening. 4. Patients with known progressing and/or symptomatic brain metastases. 5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements (on physician’s judgment). 6. Other known malignant neoplastic diseases in the patient’s medical history with a disease-free interval of less than 3 years (except for previously treated basal cell carcinoma and in situ carcinoma of the uterine cervix); 7. Any contraindication to undergo leukapheresis as evaluated by transfusionist (e.g. severe anemia, piastrinopenia, oral anticoagulant therapy).

1. Pazienti con test positivi per HCV, HBV, HIV o sifilide (l`esame del sangue specifico deve essere effettuata entro 30 giorni prima di ogni attività regolamentata GMP (leucaferesi e raccolta di biopsie tumorali da utilizzare per lisato tumorale / preparato omogeneizzato). 2. Pazienti che hanno terminato la chemioterapia o la radioterapia entro 4 settimane prima di entrare in studio o quelli che non hanno recuperato da eventi avversi dovuti ad agenti somministrati più di 4 settimane prima. 3. La partecipazione a un altro studio clinico con eventuali farmaci sperimentali nei 30 giorni precedenti alle procedure di screening. 4. Pazienti con metastasi cerebrali note in progressione e / o sintomatiche. 5. Malattie intercorrenti incontrollate comprese, ma non limitate a, infezione in corso o attiva, insufficienza cardiaca congestizia sintomatica, angina pectoris instabile, aritmia cardiaca o malattia psichiatrica / sociale, situazioni che limiterebbero la conformità con i requisiti di studio (a giudizio del medico). 6. Altre note malattie neoplastiche maligne nella storia medica del paziente con un intervallo libero da malattia inferiore a 3 anni (tranne che per il carcinoma basocellulare ed il carcinoma in situ della cervice uterina precedentemente trattati); 7. Qualsiasi controindicazione a sottoporsi alla leucaferesi, valutata in base al giudizio del transfusionista (ad esempio una grave anemia, piastrinopenia o la terapia anticoagulante orale).

E.5 End points

E.5.1

Primary end point(s)

The clinical objective is to select the regimen with the best Disease Control Rate (irDCR) in different external immunostimulants conditions in combination with the Vaccination with autologous dendritic cells loaded with autologous tumor lysate or homogenate; The immunological objective is to compare the immunological activity among the different treatment arms, defined as the proportion of subjects who develop sensitization against tumor lysate and / or KLH protein (Key-Hole Lympet hemocyanin), combined with the quantification of antitumor circulating immune effectors after at least 4 doses of vaccine.

L’obiettivo clinico consiste nel selezionare il regime terapeutico con il miglior tasso di controllo di malattia immuno-relato (irDCR) nelle diverse condizioni immunostimolanti esterne utilizzate in associazione al vaccino con cellule dendritiche caricate con lisato o omogenato tumorale autologo, mentre l’obiettivo immunologico è quello di comparare, fra i diversi bracci di trattamento, l’attività immunologica, definita come la proporzione di soggetti che sviluppa una sensibilizzazione contro il lisato tumorale e/o la proteina KLH (Key-Hole Lympet Hemocyanin), combinato alla quantificazione di effettori immuni antitumore circolanti dopo almeno 4 dosi di vaccino.

E.5.1.1

Timepoint(s) of evaluation of this end point

36 months

36 mesi

E.5.2

Secondary end point(s)

Clinical endpoints: a) overall rate of adverse events recorded in each treatment group up to 30 days after vaccination b) irDCR in the different treatment arms and comparison between the two different conditions immunomodulatory (IFN and Radiotherapy). c) clinical activity: OS (Overall Survival), irTTP (immune-related Time To Progression), irORR (immune-related Overall Response Rate), irDOR (immune-related Duration Of Response), irTTR (immune-related Response Time To ) and irPFS (immune-related Progression Free Survival) Biological endpoints: a) effects of IFN-alpha pre-leukapheresis yield of vaccine b) effect of IFN-alpha pre-leukapheresis on the potency of dendritic cells, ie on the ability to co-stimulation of dendritic cells. c) Evaluation of the maturation of dendritic cells induced by the upregulation of TEM-8 expression

Endpoint clinici: a) Tasso globale di eventi avversi registrati in ciascun gruppo di trattamento fino a 30 giorni dopo la vaccinazione b) irDCR nei vari bracci di trattamento e confronto fra le due diverse condizioni immunomodulanti (IFN e Radioterapia). c) attività clinica intesa come OS (Overall Survival), irTTP (immune-related Time To Progression), irORR (immune-related Overall Response Rate), irDOR (immune-related Duration Of Response), irTTR (immune-related Time To Response) e irPFS (immune-related Progression Free Survival) Endpoint biologici: a) effetto dell’IFN-alfa pre-leucaferesi sulla resa del vaccino b) effetto dell’IFN-alfa pre-leucaferesi sulla potency delle cellule dendritiche, cioè sulla capacità di costimolazione delle cellule dendritiche. c) Valutazione della maturazione delle cellule dendritiche indotta dall’upregulation dell’espressione di TEM-8

E.5.2.1

Timepoint(s) of evaluation of this end point

36 months

36 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

Yes

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

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

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

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1

Number of subjects for this age range:

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

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)

Patients who completed treatment will be evaluated for clinical and laboratory conditions and tumor re-staging every 12 weeks until disease progression. Thereafter, patients enter the follow-up phase and will be contacted by telephone every 3 months to assess survival and to get info on anticancer regimens and adverse events (collected up to 70 days after the last dose of vaccine), until death or loss to the follo-up.

I pazienti che hanno completato il trattamento saranno oggetto di valutazione clinica, laboratoristica e di re-staging tumorale ogni 12 settimane fino a progressione di malattia. In seguito i pazienti entreranno nella fase di follow-up e saranno contattati telefonicamente ogni 3 mesi per valutare la sopravvivenza e per ottenere info sui regimi antitumorali e gli eventi avversi (raccolti fino a 70 giorni dopo l`ultima dose di vaccino), fino alla morte o alla perdita al follo-up.

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

2013-05-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-05-16

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2024-06-20

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