Clinical Trials Register

Summary
EudraCT Number:	2019-004365-41
Sponsor's Protocol Code Number:	MITO27
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:	2021-05-24
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

2019-004365-41

A.3

Full title of the trial

MITO27: Prospective, non randomized, Phase II study on MK-3475 in recurrent, platinum-resistant, CPS >1 positive ovarian, Fallopian tube and primary peritoneal cancer patients

MITO27: Studio di fase II, prospettico, non randomizzato su MK- 3475 (Pembrolizumab) in pazienti con carcinoma ovarico, delle tube di Falloppio e primitivo del peritoneo, ricorrente, platino resistente, con CPS >1

A.3.1

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

Study on MK-3475 in recurrent, platinum-resistant, ovarian, Fallopian tube and primary peritoneal cancer patients

Studio su MK-3475 in pazienti con carcinoma ricorrente e platino resistente, delle ovaie, delle tube di Falloppio e primitivo del peritoneo.

A.3.2

Name or abbreviated title of the trial where available

MITO 27

A.4.1

Sponsor's protocol code number

MITO27

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	FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
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	Merck Sharp & Dohme
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	FONDAZIONE POLICLINICO GEMELLI
B.5.2	Functional name of contact point	Direzione Scientifica Policlinico A
B.5.3	Address:
B.5.3.1	Street Address	Largo A. Gemelli 8
B.5.3.2	Town/ city	Roma
B.5.3.3	Post code	00168
B.5.3.4	Country	Italy
B.5.4	Telephone number	0630155701
B.5.6	E-mail	direzione.scientifica@policlinicogemelli.it

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	Yes
D.2.1.1.1	Trade name	KEYTRUDA (pembrolizumab, MK3475)
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Sharp & Dohme B.V.
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	KEYTRUDA
D.3.2	Product code	[MK-3475]
D.3.4	Pharmaceutical form	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	Pembrolizumab
D.3.9.1	CAS number	1374853-91-4
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB167136
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
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	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)	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	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.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.2.1.2	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	Pembrolizumab
D.3.2	Product code	[MK-3475]
D.3.4	Pharmaceutical form	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	PEMBROLIZUMAB
D.3.9.1	CAS number	1374853-91-4
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB167136
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
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	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)	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	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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Recurrent, platinum-resistant, CPS >1 positive ovarian, Fallopian tube and primary peritoneal cancer patients

Pazienti con carcinoma ovarico, delle tube di Falloppio e primitivo del peritoneo, ricorrente, platino resistente, con CPS >1

E.1.1.1

Medical condition in easily understood language

Platinum-resistant, ovarian, Fallopian tube and primary peritoneal cancer patients

Pazienti con carcinoma ovarico, delle tube di Falloppio e primitivo del peritoneo, che abbiano sviluppato una resistente ai farmaci a base di platino

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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10006888
E.1.2	Term	Ca ovary
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10016180
E.1.2	Term	Fallopian tube cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10039867
E.1.2	Term	Secondary malignant neoplasm of retroperitoneum and peritoneum
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 Compare overall survival (OS) in patients treated with Pembrolizumab single agent with historical controls

Comparare la sopravvivenza globale (OS) di pazienti che vengono trattate con Pembrolizumab singolo agente rispetto ai controlli storici

E.2.2

Secondary objectives of the trial

• To assess progression free survival (PFS) of patients receiving pembrolizumab
• To assess the activity of pembrolizumab
• To assess the safety and tolerability of patients receiving pembrolizumab
• To assess patient-reported outcome (PRO) of patients receiving pembrolizumab

Exploratory Objectives:
- To investigate the relationship between different CPS score cut off and response to Pembrolizumab treatment utilizing newly obtained or archival FFPE tumor tissue
- To investigate the relationship between lymphoid or myeloid-derived suppression cells (MDSC) or T-regulatory cells (T-regs) and response to Pembrolizumab treatment using archival FFPE tumor tissue and blood sampling

• Comparare con i controlli storici la sopravvivenza libera da progressione (PFS) in pazienti trattate con Pembrolizumab a singolo agente
• Valutare l'attività di pembrolizumab
• Valutare la sicurezza e la tollerabilità del trattamento
• Valutare la qualità di vita delle pazienti

Obiettivi esplorativi:
- Indagare la relazione esistente tra i livelli di espressione di PD-L1 e la risposta a pembrolizumab, attraverso l'analisi di tessuto tumorale d'archivio o ottenuto mediante nuova biopsia
- Indagare la relazione esistente tra la presenza nel microambiente tumorale di cellule MDSC e T-reg e la risposta al pembrolizumab, attraverso l'analisi del tessuto tumorale e di campioni ematici

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Platinum resistant (platinum free interval 1-6 months from last platinum dose) ovarian, Fallopian tube or primary peritoneal cancer
2. CPS score>1
3. Be willing and able to provide written informed consent/assent for the trial.
4. Be 18 years of age on day of signing informed consent.
5. Have measurable disease or evaluable based on RECIST 1.1 (patients with only CA 125 increase without evidence of disease are not included) .
6. Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen.
7. Have a performance status of 0 or 1 on the ECOG Performance Scale.
8. Demonstrate adequate organ function, all screening labs should be performed within 10 days of treatment initiation.

1 Pazienti con tumore ovarico, delle tube di Falloppio o primitivo del peritoneo platino resistenti (PFI <= 6 mesi dall’ultima dose di platino);
2 CPS score > 1;
3 Firma del consenso informato;
4. Pazienti con età >= 18 anni alla data della firma del consenso informato;
5. Malattia misurabile o valutabile secondo criteri RECIST 1.1 (Pazienti con solo aumento di CA125, senza riscontro radiologico di malattia, sono esclusi);
6. Fornire un campione di tessuto tumorale prelevato mediante precedente chirurgia citoriduttiva o di tessuto tumorale appena prelevato (entro 6 settimane dall’inizio della terapia). Pazienti per le quali non possano essere forniti campioni appena ottenuti, è accettabile un campione d’archivio;
7. ECOG performance status 0 o 1;
8. Adeguate funzionalità d’organo.

E.4

Principal exclusion criteria

1. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
2. Has received >2 previous CHT lines
3. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
4. Has a known history of active TB (Bacillus Tuberculosis)
5. Hypersensitivity to pembrolizumab or any of its excipients.
6. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., = Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
7. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., = Grade 1 or at baseline) from adverse events due to a previously administered agent.
8. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
9. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
10. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
11. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
12. Has an active infection requiring systemic therapy.
13. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
14. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
15. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
16. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication
17. Patients should not be breast-feeding during treatment and for 120 days following the end of treatment
18. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
19. Has a known history of Human Immunodeficiency Virus.
20. Has a known history of Hepatitis B or known active Hepatitis C virus infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority. Has received a live vaccine within 30 days of planned start of study therapy.

1. Sta attualmente partecipando o ha partecipato ad uno studio clinico e ha ricevuto un agente sperimentale o utilizzato un dispositivo sperimentale entro le 4 settimane precedenti la prima dose del trattamento dello studio;
2. Ha ricevuto più di 2 precedenti linee di chemioterapia;
3. Presenta una diagnosi di immunodeficienza o sta assumendo una terapia con steroidi sistemici o altra forma di terapia immunosoppressiva nei 7 giorni precedenti la prima dose del trattamento sperimentale;
4. Storia nota di TB attiva (Bacillus Tuberculosis);
5. Ipersensibilità nota a Pembrolizumab o a qualsiasi suo eccipiente;
6. Precedente trattamento con anticorpo monoclonale anti-cancro nelle 4 settimane precedenti il Giorno 1 dello studio o non recupero a tossicità grado = 1 o al basaline, da eventi avversi dovuti a mAb somministrati più di 4 settimane prima.
7. Si è sottoposto a chemioterapia, terapia mirata con piccole molecole oppure a radioterapia nelle 2 settimane precedenti il Giorno 1 dello studio o non recupero a tossicità grado = 1 o al basaline, da eventi avversi dovuti a un agente somministrato in precedenza. Nota: i soggetti con neuropatia di grado = 2 costituiscono un’eccezione a questo criterio e possono essere idonei per lo studio.
8. Presenta un altro tumore maligno noto in progressione o che richiede un trattamento attivo nei precedenti 2 anni. Le eccezioni comprendono carcinoma basocellulare della cute, carcinoma a cellule squamose della cute sottoposto a terapia potenzialmente curativa o carcinoma della cervice in situ;
9. Presenza di metastasi attive al sistema nervoso centrale (SNC) note e/o meningite carcinomatosa. I soggetti con metastasi cerebrali già trattate in precedenza possono partecipare purché siano stabili , non abbiano evidenze di metastasi cerebrali nuove o in progressione e non assumano steroidi da almeno 7 giorni prima del trattamento sperimentale. Questa eccezione non comprende la meningite carcinomatosa che è esclusa a prescindere dalla stabilità clinica.
10. Presenta una malattia autoimmune attiva che ha necessitato di trattamento sistemico nei 2 anni precedenti con uso di corticosteroidi o farmaci immunosoppressivi. La terapia sostitutiva non è considerata una forma di trattamento sistemico;
11. Storia, o qualsiasi prova effettiva di polmonite attiva, non infettiva che ha richiesto il trattamento con steroidi;
12. Presenta un’infezione attiva che richiede terapia sistemica
13. Presenta un’anamnesi o prova ricorrente di qualsiasi condizione, terapia o anomalia nelle analisi di laboratorio che potrebbe inficiare i risultati della sperimentazione, interferire con la partecipazione del soggetto per tutta la durata della sperimentazione oppure non rendere nel miglior interesse del soggetto parteciparvi, a giudizio dello sperimentatore;
14. Presenta disturbi psichiatrici o di abuso di sostanze noti che interferirebbero con l’adempimento degli obblighi posti dalla sperimentazione;
15. La paziente in età fertile deve avere un test di gravidanza su urine o siero negativo entro 72 ore prima di ricevere la prima dose di farmaco in studio. Se il test sulle urine è positivo o non può essere confermato come negativo, sarà richiesto un test di gravidanza nel siero;
16. Le donne in età fertile dovrebbero essere disposte ad usare 2 metodi contraccettivi o astenersi dall'attività sessuale per tutta la durata dello studio e fino a 120 giorni dopo l'ultima dose del farmaco in studio.
17. La paziente non deve allattare durante il trattamento e per i 12° giorni successivi al trattamento;
18. Ha assunto precedentemente una terapia con un farmaco anti-PD-1, anti-PD-L1 o anti-PD-L2;
19. Presenta un’anamnesi nota di virus dell’immunodeficienza umana.
20. Presenta un’epatite B attiva nota o epatite C ; Ha ricevuto un vaccino vivo nei 30 giorni che precedono l’inizio programmato della terapia dello studio.

E.5 End points

E.5.1

Primary end point(s)

Overall survival (OS)

Sopravvivenza Globale (OS)

E.5.1.1

Timepoint(s) of evaluation of this end point

44 months

44 mesi

E.5.2

Secondary end point(s)

• Tasso di risposta in pazienti trattati con pembrolizumab, secondo i criteri RECIST 1.1; Adverse Events and laboratory abnormalities evaluated according to CTCAE version 5.0; • Progression free survival (PFS) of patients receiving pembrolizumab; Funzionalità fisica (eventuali disagi/problemi riscontrati nella conduzione delle attività quotidiane), psicologica e sociale (stati emotivi, rapporti sociali, benessere psicofisico) in pazienti trattati con pembrolizumab, attraverso la somministrazione dei questionari (NCCN- FACT) FACT-Ovarian Symptom Index 18 (FOSI-18) ed Euro-Quality of Life 5D (eEQ-5D) tool.

• Response rate (RECIST 1.1 criteria) of patients receiving pembrolizumab; Eventi avversi e anomalie riscontrare negli esami di laboratorio, in accordo ai criteri CTCAE versione 5.0; • Tempo di sopravvivenza libera da progressione (PFS); Patient reported outcomes of patients receiving pembrolizumab utilizing the disease-related symptoms – physical (DRS–P) subscale of the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN- FACT) FACT-Ovarian Symptom Index 18 (FOSI-18) Changes and using Euro-Quality of Life 5D (eEQ-5D) tool.

E.5.2.1

Timepoint(s) of evaluation of this end point

44 months; 44 months; 44 months; 44 months

44 mesi; 44 mesi; 44 mesi; 44 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

Yes

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

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

controlli storici

historical control

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

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

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

100

F.4.2

For a multinational trial

F.4.2.1

In the EEA

100

F.4.2.2

In the whole clinical trial

100

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)

Subjects who discontinue experimental treatment for a reason other than disease progression should be evaluated every 8 weeks using radiological imaging to monitor the state of the disease. Once a person experiences a confirmed progression of the disease or begins a new anti-cancer therapy, the subject should be contacted by phone every 12 weeks to assess survival status

Le pazienti che interrompono il trattamento sperimentale per un motivo diverso dalla progressione della malattia dovrebbero essere valutati ogni 8 settimane mediante imaging radiologico per monitorare lo stato della malattia. In caso di progressione confermata di malattia, le pazienti verranno contattate telefonicamente ogni 12 settimane per valutare lo stato di sopravvivenza e le successive cure intraprese

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

2020-07-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-06-04

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

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