Clinical Trials Register

Summary
EudraCT Number:	2013-001323-38
Sponsor's Protocol Code Number:	SOV02
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-07-01
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

Czechia - SUKL

A.2

EudraCT number

2013-001323-38

A.3

Full title of the trial

A randomized, open-label, parallel group, multi-center Phase II clinical
trial evaluating effect of addition of DCVAC/OvCa to standard
chemotherapy (carboplatin and gemcitabine) in women with relapsed
platinum sensitive epithelial ovarian carcinoma

Randomizované, nezaslepené, multicentrické klinické hodnocení fáze II s paralelními skupinami, vyhodnocující účinek přídavku DCVAC/OvCa ke standardní chemoterapii (karboplatina a gemcitabin) u žen s recidivujícím epiteliálním ovariálním karcinomem citlivým na platinu

A.3.1

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

Evaluation of efficacy and safety of DCVAC/OvCa (therapeutic ovarian cancer vaccine) in women with relapsed platinum sensitive ovarian carcinoma

A.4.1

Sponsor's protocol code number

SOV02

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 Trial 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	17000
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/OvCa
D.3.2	Product code	DCVAC/OvCa
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	DCVAC/OvCa
D.3.9.1	CAS number	DCVAC/OvCa
D.3.9.2	Current sponsor code	DCVAC/OvCa
D.3.9.3	Other descriptive name	CELL SUSPENSION CONTAINING DENDRITIC CELLS
D.3.9.4	EV Substance Code	SUB120526
D.3.10	Strength
D.3.10.1	Concentration unit	Other
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10000000
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)	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	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

epithelial ovarian carcinoma

epiteliální ovariální karcinom

E.1.1.1

Medical condition in easily understood language

epithelial ovarian carcinoma

E.1.1.2

Therapeutic area

Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	PT
E.1.2	Classification code	10061328
E.1.2	Term	Ovarian epithelial 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

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

To explore the effect of adding DCVAC/OvCa to Standard of Care chemotherapy on PFS in women with ovarian cancer who experienced relapse >6 months after complete remission following Pt-based first line chemotherapy

E.2.2

Secondary objectives of the trial

OS
Objective response rate (ORR) = complete response(CR) + partial response (PR)
Biological progression free interval
Immunological response
Safety
Changes in quality of life (QoL)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Female aged ≥18 years
2. Patients with histologically confirmed, FIGO (Féderation Internationale de Gynécologie et d’Obstétrique) stage III and IV epithelial ovarian, primary peritoneal or fallopian tube carcinoma (serous, endometrioid or mucinous), who had complete remission after first line platinum (Pt)-based chemotherapy and are selected to
receive second line Standard of Care chemotherapy
3. Radiologically confirmed relapse after >6 months of remission (Pt-sensitive patients), found up to 4 weeks prior study entry.
4. The patient must have at least one measureable target lesion as defined by the RECIST 1.1 criteria to be eligible for enrolment in the study
5. Laboratory criteria (results must be obtained <14 days before randomization, including results obtained before giving informed consent):
 White blood cells (WBC) >4,000/mm3 (4.0 x109/L)
 Neutrophil count >1,500/mm3 (1.5 x109/L)
 Hemoglobin (Hb) ≥10g/dL (100g/L)
 Platelet count ≥100,000/mm3 (100 x109/L)
 Total bilirubin within normal limits (benign hereditary hyperbilirubinaemias, e.g. Gilbert´s syndrome are permitted)
 Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2x upper limit of normal (ULN),
serum creatinine ≤2.0mg/dL
 Blood Urea Nitrogen (BUN) <2.0x ULN
6. Adequate coagulation parameters (results must be obtained <14 days before randomization, including results obtained before giving informed consent):
 Activated partial thromboplastin time (APTT) ≤1.5x ULN and
 International Normalized Ratio (INR) ≤1.5
7. Life expectancy of at least 12 months based on Investigator’s judgment
8. Eastern Cooperative Oncology Group (ECOG) Performance status 02
9. Signed informed consent including patient’s ability to comprehend its contents
10. Females of childbearing potential (assessed by Investigator) must have had a negative serum pregnancy test at screening (β-human chorionic gonadotropin [β-HCG])

E.4

Principal exclusion criteria

1. FIGO I,II epithelial ovarian cancer
2. FIGO III, IV clear cells epithelial ovarian cancer
3. Non-epithelial ovarian cancer
4. Borderline tumors (tumors of low malignant potential)
5. Prior or current systemic anti-cancer therapy for ovarian cancer (for example chemotherapy, monoclonal antibody therapy , tyrosine kinase inhibitor therapy, vascular endothelial growth factor [VEGF] therapy or hormonal therapy) except first line Pt-based chemotherapy (with or without bevacizumab)
6. Previous or concurrent radiotherapy to the abdomen and pelvis
7. Malignancy other than epithelial ovarian cancer, except those that have been in CR for a minimum of 3 years, and except carcinoma in-situ of the cervix or non-melanoma skin carcinomas
8. Patient co-morbidities:
 Human immunodeficiency virus (HIV) positive, human T-lymphotropic virus (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 infarction or ventricular arrhythmia or stroke within a 6 month period before inclusion, ejection fraction
(EF) <40% or serious cardiac conduction system disorders, if a pacemaker is not present
 Pericardial effusion of any National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) grade
 Peripheral neuropathy having a CTCAE ≥Grade 2
 Active autoimmune disease requiring treatment
 History of severe forms of primary immune deficiencies
 History or anaphylaxis or other serious reaction following vaccination
 Uncontrolled co-morbidities including, psychiatric or social conditions which, in the Investigator’s opinion, would prevent participation in the trial
9. Known hypersensitivity to any constituent in the DCVAC/OvCa
10. Systemic immunosuppressive therapy for any reason
11. Refusal to sign the informed consent
12. Participation in a clinical trial using experimental therapy within the last 4 weeks before study entry; patients previously enrolled in protocol SOV01 who did not receive treatment with DCVAC/OvCa can be included in this study
13. Fertile woman of childbearing potential not willing to use highly effective method of contraception or combination of methods resulting into PEARL Index < 1 (implants, injectables, combination of
oral contraceptives with intrauterine devices or barrier method of contraception or spermicidal jelly, vasectomized / sterilized partner or sexual abstinence) for the study duration and at least six months
afterwards
14. Pregnant or lactating women

E.5 End points

E.5.1

Primary end point(s)

PFS measured by modified RECIST criteria version 1.1. PFS is defined as the time from randomization to tumor progression or death from any cause. PFS will be followed until 72 weeks after 2nd line SoC chemotherapy initiation and the median PFS will be presented if at least 50% of patients progress

E.5.1.1

Timepoint(s) of evaluation of this end point

PFS will be followed up until 72 weeks after 2nd line SoC chemotherapy initiation.

E.5.2

Secondary end point(s)

OS until End of Study. OS is defined as the time from randomization until death due to any cause
ORR = CR + PR measured by the RECIST criteria
Biological progression free interval defined by increasing CA 125 levels (PFIBIO)
Immunological response – detection of entire anti-tumor response (samples to be collected and frozen)
Adverse Events (AEs), including laboratory abnormalities
Evaluation of QoL using standardized FACT-O questionnaire (Functional Assessment of Cancer Therapy- Ovarian)

E.5.2.1

Timepoint(s) of evaluation of this end point

OS will be followed until EOS.

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

Yes

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

standard chemotherapy (carboplatin and gemcitabine)

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 is ot be terminated after a sufficient number of events have been observed to evaluate OS.
The main goal is that at least 50% of the total evaluable patients should have had a survival event at the time of OS analysis.

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

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)

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

2013-08-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-07-24

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-05-17

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