Clinical Trials Register

Summary
EudraCT Number:	2012-002814-38
Sponsor's Protocol Code Number:	SP005
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2015-09-30
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

France - ANSM

A.2

EudraCT number

2012-002814-38

A.3

Full title of the trial

A Randomized, Double Blind, Multicenter, Parallel-group, Phase III study to evaluate efficacy and safety of DCVAC/PCa versus Placebo in Men with metastatic Castration Resistant Prostate Cancer eligible for 1st line chemotherapy

Étude de phase III, randomisée, multicentrique, en double aveugle et groupes parallèles visant à évaluer l’efficacité et la sécurité d’emploi du DCVAC/PCa par rapport au placebo chez des hommes présentant un cancer de la prostate métastatique résistant à la castration (CPmRC) et admissibles à une chimiothérapie de première intention.

A.3.1

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

Comparison of efficacy and safety of DCVAC/PCa (therapeutic prostate cancer vaccine) against placebo in men with metastatic prostate cancer eligible for chemotherapy

A.3.2

Name or abbreviated title of the trial where available

VIABLE

A.4.1

Sponsor's protocol code number

SP005

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	SOTIO a.s.
B.1.3.4	Country	Czech Republic
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	SOTIO a.s.
B.4.2	Country	Czech Republic
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	SOTIO a.s.
B.5.2	Functional name of contact point	Clinical Trials Sotio
B.5.3	Address:
B.5.3.1	Street Address	Jankovcova 1518/2
B.5.3.2	Town/ city	Prague 7
B.5.3.3	Post code	170 00
B.5.3.4	Country	Czech Republic
B.5.4	Telephone number	+420224175111
B.5.5	Fax number	+420224175498
B.5.6	E-mail	clinicaltrial@sotio.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	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	DCVAC/PCa
D.3.2	Product code	DCVAC/PCa
D.3.4	Pharmaceutical form	Suspension 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.3.8	INN - Proposed INN	Not applicable
D.3.9.3	Other descriptive name	PROSTATE CANCER CELL-PULSED AUTOLOGOUS DENDRITIC CELLS
D.3.9.4	EV Substance Code	SUB96122
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not applicable
D.3.9.3	Other descriptive name	AUTOLOGOUS T-LYMPHOCYTES
D.3.9.4	EV Substance Code	SUB96123
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not applicable
D.3.9.3	Other descriptive name	AUTOLOGOUS B-LYMPHOCYTES
D.3.9.4	EV Substance Code	SUB96124
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not applicable
D.3.9.3	Other descriptive name	AUTOLOGOUS NK CELLS
D.3.9.4	EV Substance Code	SUB96126
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
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

metastatic castrate-resistant prostate cancer

E.1.1.1

Medical condition in easily understood language

metastatic castrate-resistant prostate cancer

E.1.1.2

Therapeutic area

Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

MedDRA Classification

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 is to show superiority of treatment with DCVAC/PCa in addition to Standard of Care Chemotherapy over placebo in addition to Standard of Care Chemotherapy in men with mCRPC as measured by overall survival (OS)

E.2.2

Secondary objectives of the trial

The secondary objectives include assessments of safety, time to tumour progression, time to prostate-specific antigen progression, progression free survival, occurrence of skeletal related events (SRE), proportion of patients requiring second line treatment introduction and time to second line therapy and changes in quality of life (QoL)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Male 18 years and older.
2.Histologically or cytologically confirmed prostate adenocarcinoma.
3.Presence of skeletal or soft-tissue/visceral/nodal metastasis according to one of the following criteria:
-Confirmed pathological fracture related to the disease.
-Confirmation of bone and/or soft-tissue and/or visceral metastases through MRI, scintigraphy, PET or CT scan.
-Positive pathology report of metastatic lesion.
4.Disease progression despite androgen deprivation therapy (ADT) as indicated by:
-PSA increase by at least 2 ng/ml between two assessments performed at least 14-days apart from each other with the absolute value ≥5ng/ml and ≥ 50% above the minimum PSA as reached during ADT or above the pre-treatment level, if no response was observed;
OR
-Progression of measurable lymph nodes (≥ 15mm) or visceral lesion measurable per RECIST v1.1 criteria;
OR
-Two or more new lesions appearing on bone scan/imaging compared with a prior scan.
5.Maintenance of castrate conditions: Patients, who have not had a surgical orchiectomy, must continue with hormone therapy (GnRH/LHRH agonists or antagonists) to reach levels of serum testosterone of ≤1.7nmol/l (50ng/dl). The duration of the castration period must be at least 4 months prior to inclusion of the patient into the study.
6.Laboratory criteria:
-White blood cells greater than 4,000/mm3 (4.0 x109/L).
-Neutrophil count greater than 1,500/mm3 (1.5 x109/L).
-Hemoglobin of at least 9g/dL (100g/L).
-Platelet count of at least 100,000/mm3 (100 x109/L).
-Total bilirubin within normal limits (benign hereditary hyperbilirubinaemias, e.g. Gilbert´s syndrome are permitted).
-Serum alanine aminotransferase and aspartate aminotransferase, and creatinine <1.5 times the ULN.
-Blood Urea Nitrogen <2.0 times the ULN.
7.Life expectancy of at least 6 months based on Investigators judgment.
8.Eastern Cooperative Oncology group (ECOG) Performance status 0-2.
9.At least 4 weeks after surgery or radiotherapy.
10.A minimum of 28 days beyond initiation of bisphosphonate or denosumab therapy.
11.No radiopharmaceutical within 8 weeks prior to screening.
12.Recovery from primary local surgical treatment, radiotherapy or orchiectomy.
13.Signed informed consent including patient’s ability to comprehend its contents

E.4

Principal exclusion criteria

1.Confirmed brain and/or leptomeningeal metastases.
2.Current symptomatic cord compression requiring surgery or radiation therapy.
3.Prior chemotherapy for prostate cancer.
4.Patient co-morbidities:
-Patients who are not indicated for chemotherapy treatment with first line Standard of Care chemotherapy (docetaxel and prednisone).
-HIV positive, HTLV positive.
-Active hepatitis B (HBV), active hepatitis C (HCV), active syphilis.
-evidence of active bacterial, viral or fungal infection requiring systemic treatment.
-Clinically significant cardiovascular disease including:
-symptomatic congestive heart failure.
-unstable angina pectoris.
-serious cardiac arrhythmia requiring medication.
-uncontrolled hypertension.
-myocardial infarct or ventricular arrhythmia or stroke within a 6 month period prior to inclusion, ejection fraction EF <40% or serious cardiac conduction system disorders, if a pacemaker is not present.
-Pleural and pericardial effusion of any CTCAE grade.
-Peripheral neuropathy having a CTCAE ≥Grade 2.
-History of malignant disease (with the exception of non-melanoma skin tumours) in the preceding five years.
-Active autoimmune disease requiring treatment.
-History of severe forms of primary immune deficiencies.
-History or anaphylaxis or other serious reaction following vaccination.
-known hypersensitivity of any constituent of DCVAC/PCa or placebo
-Uncontrolled co-morbidities including, psychiatric or social conditions which, in the Investigator’s opinion, would prevent participation in the trial.
5.Systemic corticosteroids at doses greater than 40mg hydrocortisone daily or equivalent for any reason other than treatment of prostate cancer (PCa) within the previous 6 months.
6.Systemic immunosuppressive therapy for any reason.
7.Treatment with anti-androgens, inhibitors of adrenal-produced androgens or other hormonal tumour-focused treatment performed on the day of screening or within previous four weeks (except for GnRH/LHRH agonists or antagonists), due to possible anti-androgen withdrawal response. (This criterion does not apply for subjects, who have never responded to anti-androgen treatment).
8.Refusal to sign the informed consent.
9.Participation in a clinical trial using experimental therapy within the last 4 weeks

E.5 End points

E.5.1

Primary end point(s)

Overall Survival

E.5.1.1

Timepoint(s) of evaluation of this end point

Time from randomisation until death due to any cause

E.5.2

Secondary end point(s)

-Time to tumour progression (TTP)
-Time to prostate-specific antigen (PSA) progression
-Radiological Progression free survival
-Incidence of Skeletal Related Events

E.5.2.1

Timepoint(s) of evaluation of this end point

TTP: composite endpoint defined as time from randomisation to date of earliest objective evidence of progression

Time to PSA progression: time from randomisation to date of earliest objective evidence of PSA progression

Radiological progression free survival: defined as the time from randomization to the date of earliest objective evidence of either:
a. radiographic progression of bone lesions or
b. radiographic progression of soft tissue lesions or
c. death due to any cause

Incidence of Skeletal Related Events:defined as the proportion of skeletal related events that occur for each patient after randomization

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)

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)

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

125

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

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

Belgium

Bulgaria

Croatia

Czech Republic

France

Germany

Hungary

Italy

Netherlands

Poland

Portugal

Serbia

Spain

Sweden

Turkey

United Kingdom

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

Total study duration of approximately 40 months to observe the required event-driven timeframe of 633 total events for the final analysis. If the anticipated 633 events are not attained during the trial timeline, the study could be prolonged by SOTIO

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:

500

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

670

F.2 Gender

F.2.1

Female

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

870

F.4.2.2

In the whole clinical trial

1170

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)

None

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

2013-07-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-05-25

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-01-28

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