Clinical Trials Register

Summary
EudraCT Number:	2021-002614-13
Sponsor's Protocol Code Number:	ElechtraPlatinum
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:	2021-12-10
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

2021-002614-13

A.3

Full title of the trial

Electrochemotherapy with Carboplatinum plus Bleomycin versus Bleomycin alone in vulvar cancer: the ElechtraPlatinum Study. A Randomized Controlled Trial

Elettrochemioterapia a base di carboplatino e bleomicina versus sola bleomicina nel trattamento del cancro vulvare: studio ElechtraPlatinum. Trial randomizzato controllato.

A.3.1

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

Electrochemotherapy with Carboplatinum plus Bleomycin versus Bleomycin alone in vulvar cancer: the ElechtraPlatinum Study. A Randomized Controlled Trial

Elettrochemioterapia a base di carboplatino e bleomicina versus sola bleomicina nel trattamento del cancro vulvare: studio ElechtraPlatinum. Trial randomizzato controllato.

A.3.2

Name or abbreviated title of the trial where available

ElechtraPlatinum

A.4.1

Sponsor's protocol code number

ElechtraPlatinum

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	AOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI
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	AOU di Bologna Policlinico S.Orsola
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AOU di Bologna Policlinico S.Orsola
B.5.2	Functional name of contact point	SSD Oncologia Ginecologica - De Iac
B.5.3	Address:
B.5.3.1	Street Address	via Albertoni 15
B.5.3.2	Town/ city	Bologna
B.5.3.3	Post code	40138
B.5.3.4	Country	Italy
B.5.6	E-mail	myriam.perrone@aosp.bo.it

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
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	BLEOPRIM - 15 MG POLVERE PER SOLUZIONE INIETTABILE 1 FLACONCINO
D.2.1.1.2	Name of the Marketing Authorisation holder	SANOFI-AVENTIS 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	bleomicina
D.3.2	Product code	[bleomicina]
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
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	BLEOMICINA SOLFATO
D.3.9.2	Current sponsor code	bleomicina
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	30
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	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	Yes
D.2.1.1.1	Trade name	CARBOPLATINO AHCL - 10 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO DI VETRO DA 5 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	ACCORD HEALTHCARE LIMITED
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	carboplatino
D.3.2	Product code	[carboplatino]
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
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	CARBOPLATINO
D.3.9.2	Current sponsor code	carboplatino
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	140
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	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

relapsing vulvar carcinoma already subjected to multiple treatments

carcinoma vulvare recidivante già sottoposto a plurimi trattamenti

E.1.1.1

Medical condition in easily understood language

cancer of the vulva

tumore della vulva

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	10026642
E.1.2	Term	Malignant neoplasm of vulva recurrent
E.1.2	System Organ Class	100000004864

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

• Evaluate the oncology response to electroporation after administration of BLM + CBP to BLM alone in terms of local progression-free survival (LPFS) in women with relapsed vulvar cancer after multimodal treatments.

• Valutare la risposta oncologica alla elettroporazione dopo somministrazione di BLM + CBP verso la sola BLM in termini di Local progression free survival nelle donne con carcinoma vulvare recidivante dopo trattamenti multimodali.

E.2.2

Secondary objectives of the trial

• Compare quality of life (HR-QoL) in the two groups of patients with questionnaires (FACT-V, FACT-PAL, E5-5L-D5).
• To compare Overall Survival in the two study arms.
• To compare local and systemic toxicity, morbidity and mortality, intraoperative and post-operative complications among the two study arms.
• To compare costs and cost-effectiveness between the two study arms.

• Confrontare la qualità della vita (HR-QoL) nei due gruppi di pazienti con questionari (FACT-V, FACT-PAL, E5-5L-D5).
• Confrontare l'Overall Survival nei due bracci dello studio.
• valutare la tossicità locale e sistemica, e gli eventi le complicanze intra e post-procedura tra i due bracci in studio.
• Confrontare i costi e il rapporto costo-efficacia tra i due gruppi in studio

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Age = 18 years old
2. Recurrent vulvar carcinoma confirmed by histological examination (sec. WHO 2020)
3. Patient who underwent multiple treatments (surgery and radiation therapy or chemoradiation, radiation therapy or chemoradiation and chemotherapy), alternatively patient not eligible for standard therapies due to the performance
4. Status life expectancy more than three months
5. Measurable disease according to RECIST 1.1
6. Adequate bone marrow, liver, and kidney function (creatinine <1.5 mg/dl), and coagulation parameters as follows:

- Bone marrow (Hemoglobin = 8.0 g/dL with or without transfusion support, Platelet count = 75 × 109/L?)
- INR> 1,5
- Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic-pyruvate transaminase (SGPT) =3.0 × upper limit of normal (ULN)
- Total bilirubin =2.0 × ULN or =3 × ULN except for subjects with Gilbert’s
syndrome
- Serum creatinine <1.5 mg/dl
7. For females of childbearing potential, a pregnancy test on negative serum within 15 days of Day 1 of the study.
8. Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient’s awareness and willingness to comply the study requirements.

1. Età = 18 anni
2. Carcinoma vulvare ricorrente confermato dall'esame istologico (sec. WHO 2020)
3. Pazienti sottoposte a più trattamenti (chirurgia e radioterapia o chemioradioterapia, radioterapia o chemioradioterapia e chemioterapia), in alternativa pazienti non idonee alle terapie standard a causa del performance status
4. Aspettativa di vita superiore a tre mesi
5. Malattia misurabile secondo RECIST 1.1
6. Adeguata funzionalità del midollo osseo, del fegato e dei reni e parametri di coagulazione come segue:
- Midollo osseo (emoglobina = 8,0 g/dL con o senza supporto trasfusionale, conta piastrinica = 75 × 109 / L)
- INR> 1,5;
- Aspartato aminotransferasi (AST) / transaminasi glutammico-ossalacetica sierica (SGOT), alanina aminotransferasi (ALT) / glutammico-piruvato transaminasi sierica (SGPT) =3,0 × limite superiore della norma (ULN)
- Bilirubina totale =2,0 × ULN o =3 × ULN ad eccezione dei soggetti con sindrome di Gilbert
- Creatinina sierica <1,5 mg / dl
7. Per le donne in età fertile, un test di gravidanza su siero negativo entro 15 giorni dal Giorno 1 dello studio.
8. Consenso informato firmato ottenuto prima dell'inizio di qualsiasi procedura o trattamento specifici per lo studio, come conferma della consapevolezza e della volontà del paziente di soddisfare i requisiti dello studio.

E.4

Principal exclusion criteria

1. History of other malignancies in the previous five years, except basal cell carcinoma of the skin.
2. History of psychological, familial, sociological, or geographical condition potentially preventing compliance with the study protocol and follow-up schedule.
3. Allergic reactions to the two chemotherapy drugs (BLM and CBP) and/or their excipients.
4. Evidence of pulmonary fibrosis.
5. History of clinically significant cardiovascular abnormalities such as congestive heart failure (New York Heart Association classification =II [NYHA 1994]), myocardial infarction within 6 months of study entry.
6. Patients requiring treatment for systemic bacterial, fungal, or viral infection ongoing at the day of the procedure. (Patients on antimicrobial, antifungal, or antiviral prophylaxis are not excluded).
7. Pregnant or breastfeeding.
8. Disability to understand and complete the questionnaire due to language difficulties, severe psychiatric illness or dementia. Unstable or severe uncontrolled medical condition (e.g., unstable cardiac function, unstable pulmonary condition, uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the Investigator’s judgment, increase the risk to the patient associated with his or her participation in the study.

1. Storia di altre neoplasie maligne nei cinque anni precedenti, ad eccezione del carcinoma basocellulare della pelle.
2. Storia di condizioni psicologiche, familiari, sociologiche o geografiche che potenzialmente impediscono l'osservanza del protocollo di studio e del programma di follow-up.
3. Reazioni allergiche ai due farmaci chemioterapici (BLM e CBP) e / o ai loro eccipienti.
4. Evidenza di fibrosi polmonare.
5. Anamnesi di anomalie cardiovascolari clinicamente significative come insufficienza cardiaca congestizia (classificazione della New York Heart Association =II [NYHA 1994]), infarto miocardico entro 6 mesi dall'ingresso nello studio.
6. - Pazienti che necessitano di trattamento per infezione sistemica batterica, fungina o virale in corso il giorno della procedura. (I pazienti in profilassi antimicrobica, antimicotica o antivirale non sono esclusi).
7. Pazienti incinte o in allattamento.
8. Incapacità di comprendere e completare il questionario a causa di difficoltà di linguaggio, malattia psichiatrica grave o demenza Condizione medica instabile o grave non controllata (p. Es., Funzione cardiaca instabile, condizione polmonare instabile, diabete incontrollato) o qualsiasi malattia medica importante o riscontro di laboratorio anormale che potrebbe, a giudizio dello sperimentatore, aumentare il rischio per il paziente associato alla sua partecipazione allo studio.

E.5 End points

E.5.1

Primary end point(s)

local progression free survival

sopravvivenza libera da progressione locale

E.5.1.1

Timepoint(s) of evaluation of this end point

2 months

2 mesi

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)

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

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)

Yes

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

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

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

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

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)

At the end of the study participation, the patients will continue their follow-up checks as per normal care practice or in the event of a further relapse they will receive treatment as appropriate.
OR
None (normal care pathway)

Al termine della partecipazione dello studio le pazienti continueranno i loro controlli di follow up come da nomrale pratica assistenziale o nel caso di ulteriore recidiva riceveranno le cure a seconda del caso.
OPPURE
Nessuno (normale percorso assistenziale)

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

2022-03-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-01-20

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

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