Clinical Trials Register

Summary
EudraCT Number:	2011-005968-24
Sponsor's Protocol Code Number:	Vx-001-201
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2012-08-07
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

2011-005968-24

A.3

Full title of the trial

A multicenter, randomized, double-blind, placebo-controlled Phase IIb Efficacy Study of Vx-001, a peptide-based cancer vaccine aimed to maintain disease control after first line treatment in HLA-A*0201 positive patients with TERT positive NSCLC (stage IV or recurrent stage I-III)

Studio di fase IIb, multicentrico, randomizzato, a doppio cieco, placebo controllato, atto a valutare l'efficacia di Vx-001, un vaccino antitumorale a base peptidica, per il controllo della malattia dopo il trattamento di prima linea in pazienti HLA-A*0201 positivi con NSCLC TERT positivo stadio IV o stadio I-III recidivato.

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

VaxLung

A.4.1

Sponsor's protocol code number

Vx-001-201

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	VAXON BIOTECH
B.1.3.4	Country	France
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	VAXON BIOTECH
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	Vaxon Biotech
B.5.2	Functional name of contact point	Marina Iche
B.5.3	Address:
B.5.3.1	Street Address	rue de l´Arrivee
B.5.3.2	Town/ city	Paris
B.5.3.3	Post code	75015
B.5.3.4	Country	France
B.5.4	Telephone number	00330662183548
B.5.5	Fax number	00330662183548
B.5.6	E-mail	marina.iche@vaxon-biotech.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	C(2007)6738
D.3 Description of the IMP
D.3.1	Product name	peptide-based cancer vaccine
D.3.2	Product code	Vx-001
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	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	ARG-Vx001
D.3.9.3	Other descriptive name	peptide-based cancer vaccine
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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	TYR-Vx001
D.3.9.3	Other descriptive name	peptide-based cancer vaccine
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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MONTANIDE ISA 51 VG
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	595
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	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 injection
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients with stage IV or recurrent stage I-III NSCLC with documented disease control (objective response or stabile disease) within 3 months after platinum based 1st line chemotherapy, only HLA-A*0201 positive patients with TERT expressing tumors will be included.

Pazienti NSCLC stadio IV o stadio I-III recidivato con controllo documentato della malattia (risposta obiettiva o malattia stabile) entro 3 mesi dalla chemioterapia di prima linea a base di platino; saranno inclusi esclusivamente pazienti HLA-A*0201 positivi con tumori che esprimono TERT.

E.1.1.1

Medical condition in easily understood language

Patients with stage IV or recurrent stage I-III NSCLC with documented disease control.

Pazienti NSCLC stadio IV o stadio I-III recidivato con controllo documentato della malattia.

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	14.1
E.1.2	Level	PT
E.1.2	Classification code	10061873
E.1.2	Term	Non-small cell lung 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 survival rate at 12 months in Vx-001treated vs placebo treated patients.

Paragonare il tasso di sopravvivenza a 12 mesi dei pazienti trattati con Vx-001 Vs quelli trattati con placebo.

E.2.2

Secondary objectives of the trial

Time-to-event comparision of overall survival (OS) in Vx-001treated vs placebo treated patients. Comparision of Time to treatment failure in Vx-001 treated vs placebo treated patients.

Confrontare in termini di ''time-to-event) la sopravvivenza totale (ST) dei pazienti trattati con Vx-001 vs quelli trattati con placebo.Confrontare il tempo necessario all'insuccesso del trattamento nei pazienti trattati con Vx-001 vs quelli trattati con placebo

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- MF from 18 years of age; - Documented stage IV NSCLC or recurrent stage I-III disease; - Patients treated with 4 cycles platinum based 1st line chemotherapy; - Documented HLA-A*0201 positive; - TERT-positive NSCLC.

- MF dai 18 anni compiuti; - NSCLC stadio IV documentato o stadio I-III recidivato; - Pazienti trattati con 4 cicli di chemioterapia di prima linea a base di platino; - Documentata positività HLA-A*0201; - NSCLC TERT-positivo.

E.4

Principal exclusion criteria

- Mixed small cell and NSCLC histologies; - Patients with stage IV or recurrent NSCLC who have been previously treated with therapy other than platinum-based first-line chemotherapy; - Prior treatment with cancer vaccines; - Prior treatment with immunotherapy within four weeks prior to randomization.

- Istologie NSCLC e a piccole cellule miste; - Pazienti con NSCLC stadio IV o recidivato trattati in precedenza con terapie diverse dalla chemioterapia di prima linea a base di platino; - Trattamento precedenta con vaccini antitumorali; - Trattamento precedente con immunoterapia entro quattro settimane prima della randomizzazione.

E.5 End points

E.5.1

Primary end point(s)

The survival rate at 12 months.

La percentuale di sopravvivenza a 12 mesi.

E.5.1.1

Timepoint(s) of evaluation of this end point

12 months

12 mesi

E.5.2

Secondary end point(s)

- Time to event OS; - Time to treatment failure.

- Tempo necessario fino all'evento ST; _ Tempo necessario fino all'insuccesso del trattamento.

E.5.2.1

Timepoint(s) of evaluation of this end point

Change according to disease progression.

Varia in relazione alla progressione della malattia

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

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

E.8.1.3

Single blind

Yes

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)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

The study will be completed at the desease progression of the last patient.

Lo studio verrà concluso alla progressione della malattia dell'ultimo paziente.

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

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)

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

150

F.4.2.2

In the whole clinical trial

150

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)

The patients will continue to receive the treatment (vaccine or placebo)every 12 weeks starting from week 27 until disease prograssion.

I pazienti continueranno a ricevere il trattamento (vacciono o placebo) ogni 12 settimane dalla settimana 27 fino a progressione della malattia.

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

2012-06-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-04-04

P. End of Trial
P.	End of Trial Status	Ongoing

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