Clinical Trials Register

Summary
EudraCT Number:	2010-021196-85
Sponsor's Protocol Code Number:	BNIT-PRV-301
National Competent Authority:	Denmark - DHMA
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2012-12-11
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

Denmark - DHMA

A.2

EudraCT number

2010-021196-85

A.3

Full title of the trial

A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F ± GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer

A.3.1

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

To determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival in men with few or no symptoms from metastatic, castrate-resistant prostate cancer.

A.3.2

Name or abbreviated title of the trial where available

PROSPECT

A.4.1

Sponsor's protocol code number

BNIT-PRV-301

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01322490

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	Bavarian Nordic, Inc.
B.1.3.4	Country	United States
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	Bavarian Nordic, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bavarian Nordic, Inc.
B.5.2	Functional name of contact point	Clinical Research
B.5.3	Address:
B.5.3.1	Street Address	595 Penobscot Drive
B.5.3.2	Town/ city	Redwood City
B.5.3.3	Post code	CA 94063
B.5.3.4	Country	United States
B.5.4	Telephone number	+1 650 681 4660
B.5.5	Fax number	+1 866 268 2676
B.5.6	E-mail	olga.bandman@bavarian-nordic.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	PROSTVAC-V
D.3.2	Product code	PROSTVAC-V
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	.
D.3.9.1	CAS number	1225283-43-1
D.3.9.2	Current sponsor code	PROSTVAC-V
D.3.9.3	Other descriptive name	PROSTVAC-V-PSA-TRICOM in aqueous solution for injection
D.3.10	Strength
D.3.10.1	Concentration unit	Other
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200000000
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	Yes
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	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	PROSTVAC-F
D.3.2	Product code	PROSTVAC-F
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	.
D.3.9.1	CAS number	1225283-42-0
D.3.9.2	Current sponsor code	PROSTVAC-F
D.3.9.3	Other descriptive name	PROSTVAC-F: PROSTVAC-F-PSA-TRICOM in aqueous solution for injection
D.3.10	Strength
D.3.10.1	Concentration unit	Other
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1000000000
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	Yes
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	Yes
D.2.1.1.1	Trade name	Leukine
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi-Aventis
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	GM-CSF
D.3.4	Pharmaceutical form	Lyophilisate for 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.3.8	INN - Proposed INN	.
D.3.9.1	CAS number	123774-72-1
D.3.9.3	Other descriptive name	GRANULOCYTE MACROPHAGE COLONY STIM FACTOR
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	250
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	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.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	Suspension for injection
D.8.4	Route of administration of the placebo	Subcutaneous use
D.8 Placebo: 2
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

Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer

E.1.1.1

Medical condition in easily understood language

Prostate Cancer in men who experience few or no symptoms and do not respond to treatment with hormones.

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	19.0
E.1.2	Level	PT
E.1.2	Classification code	10060862
E.1.2	Term	Prostate 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 ascertain whether the survival of subjects randomized to Arm V+G
(PROSTVAC-V/F plus GM-CSF) or to Arm V (PROSTVAC-V/F) is superior
to that from subjects randomized to Arm P (placebo control).

E.2.2

Secondary objectives of the trial

To ascertain whether a greater proportion of subjects randomized to
Arm V+G or to Arm V remain event-free at six months (or early
termination) as compared to the subjects randomized to Arm P.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Signed Informed Consent
2.Men, ≥ 18 years of age with documented asymptomatic or minimally
symptomatic metastatic castration-resistant prostate cancer.
3. Castrate testosterone level < 50 ng/dl
4. Documented progressive disease post-surgical castration or during
androgen suppression therapy or during complete androgen blockade
therapy and withdrawal. Documented by either criterion a (Radiological
progression), OR criterion b (PSA progression).
a. Radiological progression defined as any new/enlarging bone
mestatases or new/enlarging lymph node disease, consistent with
prostate cancer.
OR
b. PSA progression defined by sequence of rising values separated by >
1 week (2 separate increasing values) over a threshold minimum of 2.0
ng/ml. (PCWG2 PSA eligibility criteria).
5. Chemotherapy naïve. No prior chemotherapy for metastatic prostate cancer. Neo-adjuvant or adjuvant chemotherapy for primary prostate
cancer is permissible if >3 years prior.
6. Vaccinia-experienced (previous smallpox vaccination).
7. ECOG Performance Score of 0 or 1.
8. Life expectancy ≥ 1 year.
9. Bone Marrow function:
- Absolute neutrophil count ≥ 1,500/mm3
- Hemoglobin ≥ 10 g/dL
- Platelet count ≥ 100,000/mm3
10. Hepatic Function:
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
11. Renal Function:
- Creatinine ≤ 2.0 times ULN
12. Currently using a GnRH agonist or antagonist (unless surgically
castrated)

E.4

Principal exclusion criteria

1. Cancer-related pain requiring scheduled opioid narcotics for control
(as needed. ≤ 2x per week is allowed).
2. Metastasis to organ systems other than lymph nodes and/or bone.
3. LDH ≥ 2 times ULN.
4. Alkaline phosphatase ≥ 2 times ULN.
5. Estimated PSA doubling time of <1 month as established within 6
months of the anticipated first dose of vaccine or placebo. A minimum of
3 PSA level determinations, at least 2 weeks apart (over a 6 month time period), are required for assessment.
6. Concurrent or prior Provenge (sipuleucel-T) immunotherapy for
prostate cancer
7. Receipt of an investigational agent within 30 days (or 60 days for an
antibody-based therapy) of the first planned dose of PROSTVAC-V/F.
There is no exclusion to previous experimental therapy provided
dosing/treatment is completed at least 30 days prior to the first planned
dose of vaccine unless otherwise noted.
8. History of prior malignancies other than prostate cancer within the
past 3 years, excluding successfully resected basal or squamous cell
carcinoma of the skin
9. Congestive heart failure (NYHA Class II, III, or IV), unstable angina,
ventricular or hemodynamically significant atrial arrhythmia, or
cardiovascular disease such as stroke or myocardial infarction (current
or within the past 6 months).
10. Confirmed positive for HIV, hepatitis B, and /or hepatitis C.
11. Prior solid organ or bone marrow transplant
12. Immunodeficiency or splenectomy
13. Chronic immunosuppressive therapy within 30 days of screening.
14. Inflammatory eye disease requiring steroid treatment.
15. Chronic administration (defined as daily or every other day for
continued use > 14 days) of systemic corticosteroids within 28 days of
the first planned dose of PROSTVAC-V/F. Use of inhaled steroids, nasal
sprays, and topical creams for small body areas is allowed.
16. History of or active autoimmune disease (e.g. autoimmune
neutropenia, thrombocytopenia, or hemolytic anemia, systemic lupus
erythematosis, Sjogren's syndrome, scleroderma, myasthenia gravis,
Goodpasture's syndrome, Addison's disease, Hashimoto's thyroiditis, or
Graves disease). Persons with vitiligo are not excluded. Diabetics are not
excluded if the condition is well controlled.
17. Known allergy to eggs, egg products, aminoglycoside antibiotics (for example, gentamicin or tobramycin), or GM-CSF. Subjects with a known or suspected allergy to radiological contrast agents are eligible, but this must be noted in the subject's medical history and in the chart notes.
18. History of atopic dermatitis or active skin condition (acute, chronic,
exfoliative) that disrupts the epidermis.
19. Previous adverse reactions to smallpox vaccination.
20. Unable to avoid close contact or household contact with the
following high-risk individuals for three to four weeks after the Day 1
vaccination or until the vaccination site heals completely: (a) children < 3 years of age, (b) pregnant or nursing women, (c) individuals with prior
or concurrent extensive eczema or other eczemoid skin disorders, or (d)
immunocompromised individuals, such as those with HIV.
21. Significant medical abnormality (defined as a pre-existing condition AE/condition ≥ Grade 3 according to NCI CTCAE v 4.0 and any condition which, in the opinion of the investigator, would prevent full participation in this trial (including the Long-Term Follow-
Up), or would interfere with the evaluation of the trial endpoints
22. Study personnel.

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

Study closure or death.

E.5.2

Secondary end point(s)

- the proportion of event-free subjects (radiological progression, pain
progression, chemotherapy initiation, or death) at six months (or early
termination) compared to placebo.

E.5.2.1

Timepoint(s) of evaluation of this end point

Six months.

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

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

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

Australia

Belgium

Canada

Denmark

Estonia

France

Germany

Iceland

Israel

Netherlands

Poland

Puerto Rico

Russian Federation

Spain

United Kingdom

United States

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 end of the trial is defined as the last anticipated visit of the last patient enrolled.

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:

300

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

900

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

500

F.4.2.2

In the whole clinical trial

1200

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)

Standard of care.

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

2012-12-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-02-04

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2017-09-25

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