Clinical Trials Register

Summary
EudraCT Number:	2015-003389-10
Sponsor's Protocol Code Number:	HepaVac-101
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:	2021-09-10
Trial results	View 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

2015-003389-10

A.3

Full title of the trial

A phase I/II trial of IMA970A plus CV8102 following a single prevaccination infusion of cyclophosphamide in patients with very early, early and intermediate stage of hepatocellular carcinoma after any standard treatments

Studio di fase I/II su IMA970A pi¿ CV8102 dopo una singola infusione pre-vaccinazione di ciclofosfamide in pazienti con carcinoma epatocellulare in stadio molto precoce, precoce e intermedio dopo qualsiasi trattamento standard

A.3.1

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

A Phase I/II clinical study of IMA970A plus CV8102 and Cyclophosphamide for patients with liver cancer

IMA970A pi¿ CV8102 in pazienti con carcinoma epatocellulare in stadio molto precoce, precoce e intermedio

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

HepaVac-101

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 NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
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	EU Seventh Framework Program EU FP7
B.4.2	Country	European Union
B.4.1	Name of organisation providing support	Istituto Nazionale Tumori "G.Pascale" di Napoli
B.4.2	Country	Italy
B.4.1	Name of organisation providing support	Immatics Biotechnologies GmbH
B.4.2	Country	Germany
B.4.1	Name of organisation providing support	Curevac AG
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	HepaVac Consortium @ Istituto Nazionale Tumori "G. Pascale"
B.5.2	Functional name of contact point	Clinical Trial Information
B.5.3	Address:
B.5.3.1	Street Address	Via Mariano Semmola, 142
B.5.3.2	Town/ city	Napoli
B.5.3.3	Post code	80131
B.5.3.4	Country	Italy
B.5.4	Telephone number	00390815903624
B.5.5	Fax number	00390815903624
B.5.6	E-mail	info@hepavac.eu

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	IMA970A
D.3.2	Product code	NA
D.3.4	Pharmaceutical form	Powder for solution for 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.3.9.2	Current sponsor code	IMA970
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10200
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)	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	Yes
D.3.11.13.1	Other medicinal product type	Vaccino terapeutico per il cancro
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	ENDOXAN BAXTER - 1 G POLVERE PER SOLUZIONE INIETTABILE1 FLACONE
D.2.1.1.2	Name of the Marketing Authorisation holder	BAXTER S.P.A.
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	Ciclofosfamide
D.3.2	Product code	Cy
D.3.4	Pharmaceutical form	Powder for solution for injection
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	CICLOFOSFAMIDE
D.3.9.1	CAS number	50-18-0
D.3.9.2	Current sponsor code	Ciclofosfamide
D.3.9.4	EV Substance Code	SUB06859MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(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	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)	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	Yes
D.3.11.13.1	Other medicinal product type	Immunomodulatore
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	CV8102
D.3.2	Product code	NA
D.3.4	Pharmaceutical form	Solution for 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.3.9.2	Current sponsor code	R2025
D.3.10	Strength
D.3.10.1	Concentration unit	mg/l milligram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500
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	Yes
D.3.11.13.1	Other medicinal product type	RNA-Based Immunomodulatore

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

Very early, early and intermediate stage hepatocellular carcinoma

carcinoma epatocellulare in stadio molto precoce, precoce e intermedio

E.1.1.1

Medical condition in easily understood language

liver cancer

carcinoma epatocellulare in stadio molto precoce, precoce e intermedio

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	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10049010
E.1.2	Term	Carcinoma hepatocellular
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of the present phase I/II study is to investigate whether treatment with IMA970A plus CV8102 following a single prevaccination infusion of cyclophosphamide (CY) is safe and tolerable, and able to induce a T-cell response in very early, early and intermediate stage hepatocellular carcinoma (HCC) patients after any standard treatment and without any evidence of active disease that warrant further treatment.

L'obiettivo primario del presente studio di fase I/II ¿ stabilire se il trattamento con IMA970A pi¿ CV8102 dopo una singola infusione pre-vaccinazione di ciclofosfamide (CY) sia sicuro e tollerabile e in grado di indurre una risposta delle cellule T in pazienti con carcinoma epatocellulare (HCC) in stadio molto precoce, precoce e intermedio che hanno ricevuto un qualsiasi trattamento standard e non presentano alcuna evidenza di malattia attiva che giustifichi un ulteriore trattamento.

E.2.2

Secondary objectives of the trial

Secondary/exploratory objectives are the investigation of additional immunological parameters, infiltrating T-lymphocytes, immune cells and potential other (bio)markers in tumor tissue, influence of standard therapy on natural immune response to IMA970A, time to progression and overall survival.

Gli obiettivi secondari/esplorativi sono l'analisi di ulteriori parametri immunologici, dei linfociti T infiltranti, delle cellule immunitarie e di altri potenziali (bio)marcatori nel tessuto tumorale, l'influenza della terapia standard sulla risposta immunitaria naturale a IMA970A, il tempo alla progressione e la sopravvivenza globale.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Aged at least 18 years
2. HLA type: HLA-A*02 and/or HLA-A*24 positive (Screening 1)
3. Very early, early and intermediate stage (Barcelona Clinic Liver Cancer (BCLC) stage 0, A, B disease) hepatocellular carcinoma (HCC) diagnosed
by biopsy or resected tissue (pathohistological diagnosis), or imaging findings (non-invasive criteria) following any standard treatment (e.g.
hepatic resection, RFA/PEI, TACE, and SIRT) and without any evidence of active disease that warrant further treatment
4. Patients for whom no standard anti-tumor therapy is indicated for the next 3 months (until after visit 7); thereafter any standard anti-tumor
therapies applied for the treatment of BCLC stage 0, A and B HCC (e.g. RFA/PEI, TACE, and SIRT) are allowed to be applied in combination with
the study treatment. Patients for whom treatment for advanced disease (e.g. sorafenib) is indicated will be withdrawn from study treatment.
5. Eastern Cooperative Oncology Group (ECOG) performance status 0
6. Child-Pugh A5-6 and B7 or no liver function impairment

1. Età minima 18 anni
2. Tipizzazione HLA: HLA-A*02 e/o HLA-A*24 positivo (screening 1)
3. Carcinoma epatocellulare in stadio molto precoce, precoce e intermedio (stadio 0, A, B secondo la scala Barcelona Clinic Liver Cancer (BCLC)) diagnosticato tramite biopsia o resezione di tessuto (diagnosi istopatologica) o diagnostica per immagini (criteri non invasivi) dopo qualsiasi tipo di trattamento standard (ad es. resezione epatica, RFA/PEI, TACE e SIRT) e senza evidenza di malattia attiva che giustifichi un ulteriore trattamento
4. Pazienti per i quali non sono indicate terapie antitumorali standard nei 3 mesi successivi (fino a dopo la visita 7); successivamente è consentita qualsiasi terapia antitumorale standard per il trattamento dell’HCC in stadio BCLC 0, A e B (ad es. RFA/PEI,TACE e SIRT) in combinazione con il trattamento dello studio. I pazienti per i quali è indicato un trattamento per malattia in stadio avanzato (ad es. sorafenib) verranno ritirati dal trattamento dello studio.
5. Performance status 0 secondo l'Eastern Cooperative Oncology
Group (ECOG)
6. Child-Pugh A5-6 e B7 oppure nessuna compromissione della funzionalità epatica

E.4

Principal exclusion criteria

1. Any prior systemic anti-tumor treatment (including drug or treatment regimen, approved or experimental) within 2 weeks before CY application
2. Liver transplanted patients; patients who are on the liver transplantation waiting list are allowed to be enrolled
3. Patients with a history or evidence of systemic autoimmune disease, e.g. rheumatoid arthritis, multiple sclerosis, systemic lupus
erythematodes (SLE), scleroderma, Sjögren's syndrome, Wegener's
granulomatosis, Guillain-Barre syndrome
4. Need for concomitant treatment with immunosuppressive drugs or other immune-modifying drugs. The use of inhaled and nasally applied steroids, as well as topical steroids outside the vaccination area are permitted
5. Any medically diagnosed or suspected condition of immunodeficiency or medical history thereof
6. Known HIV infection
7. Acute and active infections requiring oral or intravenous antibiotics, antiviral or antifungal therapy within 30 days prior to signing of the IC 2 by the patient (exception: HBV and/or HCV infections; direct-acting antivirals may be applied as medically indicated.)
8. Patients undergoing renal dialysis or with relevant chronic renal failure
9. Abnormal laboratory values as specified
10. Clinically relevant ascites with the only exception of patients that remain free from symptomatic ascites under low-dose diuretics
(Spironolactone > 100 mg daily and Furosemide > 40 mg daily).
11. Evidence of current alcohol or drug abuse
12. History of other malignancies within the last 3 years except for adequately treated cervical carcinoma in situ, basal cell carcinoma and, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to signing of IC 2 by the patient

1. Qualsiasi trattamento sistemico antitumorale (comprendente farmaci o regimi terapeutici approvati o sperimentali) nelle 2 settimane precedenti l'infusione di CY
2. Pazienti già sottoposti a trapianto di fegato; i pazienti in lista d'attesa per il trapianto di fegato possono essere arruolati
3. Pazienti con anamnesi o evidenza di malattia autoimmune sistemica, ad es. artrite reumatoide, sclerosi multipla, lupus eritematoso sistemico (SLE), sclerodermia, sindrome di Sjögren, granulomatosi di Wegener, sindrome di Guillain-Barre
4. Necessità di un trattamento concomitante con farmaci immunosoppressori o altri farmaci modificanti la malattia. L'uso di steroidi per inalazione o uso nasale e di steroidi per uso topico
fuori dalla sede di vaccinazione è consentito
5. Qualsiasi immunodeficienza diagnosticata o sospetta o anamnesi di immunodeficienza
6. Nota infezione da HIV
7.Infezioni acute e attive che richiedono l'uso di antibiotici, antivirali o antimicotici per via orale o endovenosa nei 30 giorni precedenti la firma della dichiarazione IC 2 da parte del paziente (eccezione:
infezione da HBV e/o HCV; possono essere somministrati antivirali ad azione diretta, secondo indicazione medica)
8. Pazienti in dialisi renale o con insufficienza renale cronica rilevante
9. Alterazioni dei valori di laboratorio, come specificato
10. Ascite clinicamente rilevante, con l'unica eccezione dei pazienti la cui ascite rimane asintomatica con diuretici a basse dosi (spironolattone >100 mg al giorno e furosemide >40 mg al giorno)
11. Evidenza di abuso attuale di alcool o droghe
12. Tumore maligno pregresso negli ultimi 3 anni, con l'eccezione del carcinoma cervicale in situ, del carcinoma a cellule basali e dei tumori superficiali della vescica [Ta, Tis e T1] o di qualsiasi tumore maligno sottoposto a trattamento > 3 anni prima della firma della dichiarazione IC 2 da parte del paziente

E.5 End points

E.5.1

Primary end point(s)

The primary endpoints of the study are safety and tolerability, and immunogenicity (T-cell response in peripheral blood).

Gli endpoint primari dello studio sono la sicurezza e la tollerabilità nonché l'immunogenicità (risposta delle cellule T nel sangue periferico).

E.5.1.1

Timepoint(s) of evaluation of this end point

Safety and Tolerability: continuous full safety surveillance between S2 and EOV visit. Limited safety surveillance between S1 and S2 and during the non-interventional follow-up starting after EOV Visit. Immunogenicity: PBMCs for immunogenicity assessment will be drawn at visits S1, S2, C, 4, 5, 6, 7, 9, EOV

Sicurezza e tollerabilità: sorveglianza continua degli aspetti di sicurezza tra S2 e visita EOV. Sorveglianza limitata tra S1 e S2 e durante la fase di follow-up non interventistico che inizia dopo la visita EOV. Immunogenicità: alle visite S1, S2, C, 4,5,6,7,9,EOV verranno prelevate PMBCs per valutazioni di immunogenicità

E.5.2

Secondary end point(s)

¿ Additional immunological parameters in blood (e.g. regulatory T-cells,
myeloid-derived suppressor cells)
¿ Infiltrating T-lymphocytes, immune cells and potential other
(bio)markers in tumor tissue (depending on availability of tissue)
¿ Assessment of the potential impact of the standard therapy on the
natural immune response to peptides contained in IMA970A
¿ Time to progression (TTP)
¿ Overall survival (OS)

¿ Altri parametri immunologici nel sangue (ad es. cellule T
regolatorie, cellule suppressor di derivazione mieloide)
¿ Linfociti T infiltranti, cellule immunitarie e altri potenziali
(bio)marcatori nel tessuto tumorale (in base alla disponibilit¿ di
tessuto)
¿ Valutazione del potenziale impatto della terapia standard sulla
risposta immunitaria naturale ai peptidi contenuti in IMA970A
¿ Tempo alla progressione (time to progression, TTP)
¿ Sopravvivenza globale (overall survival, OS)

E.5.2.1

Timepoint(s) of evaluation of this end point

Additional immunological parameters in blood: PBMCs for
immunogenicity assessment will be drawn at visits S1, S2, C, 4, 5, 6, 7,9, EOV.
Infiltrating T-lymphocytes: depending on availability of tumor tissue
Assessment of potential impact of standard therapy: S1 and S2
TTP: S1, S2, V7, EOV visit
OS: continues capture until end-of-trial.

Rilevazione di ulteriori parametri immunologici nel sangue: alle visite S1, S2, C, 4,5,6,7,9,EOV verranno prelevate PMBCs per valutazioni di immunogenicit¿. Linfociti T infiltranti: in base alla disponibilit¿ di tessuto tumorale.
Valutazione del potenziale impatto della terapia standard: S1 e S2.
TTP : S1,S2,V7,Visita EOV.
OS: osservazione continua fino alla fine dello Studio

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)

Yes

E.7.1.1

First administration to humans

Yes

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

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

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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 the study treatment as defined in the clinical protocol as well as prematurely withdrawn patients will be offered best medical care according to local standard of procedures. In addition, suitable HepaVac-101 patients enrolled in Germany may be invited to participate in an extension clinical study investigating APVACs.

Ai pazienti che hanno completato il trattamento dello studio definito nel protocollo clinico e a quelli che sono stati ritirati prematuramente verr¿ offerta la terapia migliore in conformit¿ alle procedure standard locali. Inoltre, i pazienti HepaVac-101 idonei arruolati in Germania possono essere invitati a partecipare a uno studio clinico di estensione sugli APVAC.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	Immatics Biotechnologies GmbH
G.4.3.4	Network Country	Germany
G.4 Investigator Network to be involved in the Trial: 2
G.4.1	Name of Organisation	FGK Clinical Research GmbH
G.4.3.4	Network Country	Germany
G.4 Investigator Network to be involved in the Trial: 3
G.4.1	Name of Organisation	Hippocrates Research srl
G.4.3.4	Network Country	Italy

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-10-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-04-19

P. End of Trial
P.	End of Trial Status	Completed

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IMP with orphan designation in the indication
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