Clinical Trials Register

Summary
EudraCT Number:	2014-004026-17
Sponsor's Protocol Code Number:	MK-3475-057
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:	2021-01-20
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2014-004026-17

A.3

Full title of the trial

A Phase II Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Subjects with High Risk Non-muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy

Studio clinico di fase II per studiare l'efficacia e la sicurezza di Pembrolizumab (MK-3475) in soggetti con tumore non muscolo invasivo della vescica (NMIBC) ad alto rischio non responsivi alla terapia del bacillo di Calmette-Guerin (BCG).

A.3.1

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

Pembrolizumab (MK-3475) in High Risk Non-muscle Invasive Bladder Cancer (NMIBC) Patients Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy

Pembrolizumab (MK-3475) in soggetti con tumore non muscolo invasivo della vescica (NMIBC) ad alto rischio non responsivi alla terapia del bacillo di Calmette-Guerin (BCG).

A.3.2

Name or abbreviated title of the trial where available

Pembrolizumab (MK-3475) in high risk NMIBC patients unresponsive to BCG

Pembrolizumab (MK-3475) in pazienti con NMIBC ad alto rischio che non rispondono a BCG

A.4.1

Sponsor's protocol code number

MK-3475-057

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	MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. 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	Merck Sharp & Dohme Corp., a subsidiary of Merck &
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	MSD Italia Srl
B.5.2	Functional name of contact point	Divisione Ricerca Clinica
B.5.3	Address:
B.5.3.1	Street Address	Via Vitorchiano, 151
B.5.3.2	Town/ city	Roma
B.5.3.3	Post code	00189
B.5.3.4	Country	Italy
B.5.4	Telephone number	+390636191371
B.5.5	Fax number	+390636380371
B.5.6	E-mail	gcto.italy@merck.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	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	MK-3475
D.3.9.3	Other descriptive name	MK-3475
D.3.9.4	EV Substance Code	SUB91641
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

Non-Muscle Invasive Bladder Cancer (NMIBC)

tumore non muscolo invasivo della vescica (NMIBC)

E.1.1.1

Medical condition in easily understood language

Bladder Cancer

Tumore alla vescica

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	PT
E.1.2	Classification code	10005003
E.1.2	Term	Bladder 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

In: Cohort A - Subjects with CIS at baseline (CIS only, Ta+CIS, or T1+CIS)
And
Cohort B - Subjects without CIS at baseline (High Grade Ta or Any Grade T1)
To evaluate anti-tumor activity of pembrolizumab (MK-3475) by evaluating the absence of high risk NMIBC or progressive disease, as determined by cystoscopy, cytology, biopsy (if applicable), and radiologic imaging by central pathology and radiology review.

Nella coorte A-Soggetti con CIS al basale (CIS da solo, Ta+CIS, o T1+CIS)
e
Nella coorte B-Soggetti senza CIS al basale (Ta ad alto grado o T1 di qualsiasi grado)

Valutare l'attività antitumorale di pembrolizumab (MK-3475), in riferimento all'assenza di NMIBC ad alto rischio o di progressione della malattia, come determinato mediante cistoscopia, citologia, biopsia (ove applicabile) e imaging radiologico in base alla revisione centrale patologica e radiologica.

E.2.2

Secondary objectives of the trial

To evaluate anti-tumor activity of MK-3475: Cohort A -CIS at baseline 1. by CR rate of any disease 2. by DOR of high risk NMIBC and any disease (responders only) 3. in PD-L1+ subjects by CR rate of high risk NMIBC and any disease 4. in PD-L1+ subjects by DOR of high risk NMIBC and any disease (responders only) 5. in the study population and in PD-L1+ subjects by: a. DOR rate at specific time points of both high risk NMIBC and any disease (responders only) b. PFS, to worsening of grade or stage or death c. PFS, to muscle invasive or metastatic disease or death d. OS
Cohort B -no CIS at baseline 1. by DFS rate of any disease 2. in PD-L1 + subjects by 12-month DFS rate of high risk NMIBC and any disease 3. in the study population and in PD-L1+ subjects by: a. Overall DFS and 3-month/6-month DFS rates of high risk NMIBC and any disease b. PFS, to worsening of grade or stage or death c. PFS, to muscle invasive or metastatic disease or death d. OS

Valut l'attività antitumorale di MK3475:
CoorteA-CIS al basal 1.Tramite il tasso CR di qls malatt;2. Tramite il DOR di NMBIC ad alto rischio e di qls malatt (solo per responsivi);3.In sogg PD-L1+ tramite tasso CR di NMBIC ad alto rischio e di qls malatt;4.In sogg PD-L1+ tramite tasso DOR di NMBIC ad alto rischio e di qls malatt (solo per responsivi);5.Nella popolaz in stu ed in sogg PD-L1+ tramite: tasso DOR in specifici momenti sia di NMIBC ad alto rischio sia di qls malatt (solo per responsivi) b. PFS, al peggioram del grado o dello stadio o della morte c.PFS,malatt muscol invasiva o metastatica o morte d.OS. Coorte B-no CIS al basal:1.tramite tasso DFS di qls malatt;2.in sogg PD-L1+ tramite tasso DFS a 12 mesi di NMIBC ad alto rischio e qls malatt;3.nella popolaz in stu e sogg PD-L1+ tramite:a. tasso DFS compless e DFS a 3mesi/6mesi di NMIBC ad alto rischio e qls malatt;b.PFS,al peggioram del grado o dello stadio o della morte c.PFS,malatt muscol invasiva o metastatica o morte d.OS

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Other types of substudies
Specify title, date and version of each substudy with relative objectives: Merck will conduct Future Biomedical Research on DNA (blood) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be
conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding
of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.

Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Merck condurrà una Ricerca Biomedica Futura su campioni di DNA (estratti dal sangue) raccolti nel corso di questo studio clinico. Tale ricerca ha lo scopo di esaminare vari biomarcatori per rispondere a domande che stanno emergendo e che non sono descritte in altre parti del protocollo (nell ambito dello studio principale), e verrà condotta solo su campioni di soggetti che abbiano rilasciato apposito consenso. L'obiettivo della raccolta dei campioni per la Ricerca Biomedica Futura è quello di esplorare e identificare biomarcatori che contribuiscano scientificamente alla comprensione delle malattie e/o delle relative terapie. L'obiettivo ultimo è quello di utilizzare tali informazioni per sviluppare farmaci più sicuri e più efficaci, e/o per garantire che i soggetti ricevano la dose giusta del giusto farmaco al momento giusto.

E.3

Principal inclusion criteria

1. Have a histologically-confirmed diagnosis of high risk non-muscle-invasive (T1, High Grade Ta and/or CIS) transitional cell carcinoma of the bladder.
2. In subjects who have papillary tumors (Ta and T1), a complete TURBT must have been performed as characterized by:
- Attainment of a visually complete resection of all papillary tumors (Ta and T1)
- Residual CIS not amenable to complete transurethral resection is acceptable
- The most recent cystoscopy / TURBT must have been performed within 12 weeks of the first dose of trial treatment
3 . Have been treated with adequate BCG therapy and have developed high risk NMIBC that is unresponsive to BCG therapy.
4 . Have elected not to undergo, or are considered ineligible for radical cystectomy, as determined by the treating surgeon.
5 . Have provided tissue for biomarker analysis from the most recent cystoscopy/TURBT procedures, from which tumor sample is available.
6. Have a performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG)
Performance Scale. (Max of 5% ECOG of 2.)
7. Demonstrate adequate organ function.
8. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication and be willing to use contraception in accordance with the Protocol.

1. Avere una diagnosi istologicamente confermata di carcinoma a cellule transizionali della vescica, ad alto rischio, non muscolo-invasivo (T1, Ta ad alto grado e/o CIS).
2. In soggetti con tumori papillari (Ta e T1) deve essere stata eseguita la procedura TURBT completa con le seguenti caratteristiche
- Raggiungimento di una resezione visivamente completa di tutti i tumori papillari (Ta e T1)
- CIS non suscettibile al completamento della resezione transuretrale è accettabile
- La cistoscopia/TURBT più recente deve essere stata effettuata entro 12 settimane dalla prima dose del trattamento in studio
3. Essere stato trattato con terapia con BCG adeguata ed aver sviluppato NMIBC ad alto rischio che è non responsivo a tale terapia.
4. Aver scelto di non sottoporsi, o essere considerato non eleggibile all’intervento di cistectomia radicale, come stabilito dal chirurgo responsabile del trattamento.
5. Aver fornito tessuto per l’analisi dei biomarcatori derivante dalle più recenti procedure di cistoscopia/TURBT, da cui è disponibile un campione tumorale.
6. Avere uno stato di validità di 0, 1 o 2 sulla Scala di validità dell’Eastern Cooperative Oncology Group (ECOG)
7. Dimostrare una funzionalità d’organo adeguata
8. I soggetti di sesso femminile in età fertile devono presentare un test di gravidanza sulle urine o sul siero negativo entro 72 ore prima di ricevere la prima dose del farmaco dello studio e devono essere disponibili a utilizzare un metodo contraccettivo adeguato come nel protocollo

E.4

Principal exclusion criteria

1. Has muscle invasive (i.e. T2, T3, T4) locally advanced non-resectable or metastatic urothelial carcinoma.
2. Has concurrent extra-vesical (i.e. urethra, ureter or renal pelvis) non-muscle invasive transitional cell carcinoma of the urothelium.
3. 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.
4. Has undergone any intervening intravesical chemotherapy or immunotherapy from the time of most recent cystoscopy/TURBT to starting trial treatment.
5. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Cycle 1, Day 1 or who has not recovered (i.e., <= Grade 1 or at baseline) from adverse events due to a previously administered agent.
6. Has a known additional malignancy that is progressing or requires active treatment.
7. Has an active autoimmune disease that has required systemic treatment in past 2 years.
8 . Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the planned first dose of the study. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.
9. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
10. Has an active infection requiring systemic therapy, including active or intractable urinary tract infection (UTI) in the last month.
11. Is pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
12. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 agent, or with an agent directed to another co-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137).
13. Has a known history of Human Immunodeficiency Virus (HIV) (HIV-1/2 antibodies).
14. Has known active Hepatitis B or Hepatitis C.
15. Has received a live virus vaccine within 30 days of planned start of trial treatment
16. Has had an allogeneic tissue/solid organ transplant.

1. Presenta un carcinoma uroteliale muscolo-invasivo (ovvero T2, T3, T4) localmente avanzato non resecabile o metastatico.
2. Presenta un concomitante carcinoma a cellule transizionale dell’urotelio, non muscolo-invasivo, a sede extra-vescicale (ovvero, uretra, uretere o pelvi renale).
3. Sta attualmente partecipando a uno studio e ricevendo la terapia dello studio oppure ha partecipato a uno studio su un agente sperimentale e ha ricevuto la terapia dello studio o utilizzato un dispositivo sperimentale entro 4 settimane prima della prima dose del trattamento.
4. Ha ricevuto qualsiasi chemioterapia o immunoterapia intravescicale intercorrente dal momento della cistoscopia/TURBT più recente all’avvio del trattamento sperimentale.
5. Si è precedentemente sottoposto a chemioterapia, terapia mirata con piccole molecole o radioterapia nelle 2 settimane precedenti il Ciclo 1, Giorno 1 o ha avuto una ripresa non completa (ossia, grado <=1 o valore basale) da eventi avversi dovuti a un agente somministrato in precedenza.
6. Presenta un altro tumore maligno noto che sia in progressione o richieda un trattamento attivo.
7. Presenta una malattia autoimmune in fase attiva che ha richiesto un trattamento per via sistemica negli ultimi 2 anni.
8. Presenta diagnosi di immunodeficienza o sta ricevendo una terapia sistemica steroidea o qualunque altra forma di terapia immunosoppressiva entro i 7 giorni precedenti la prima dose programmata dello studio. L’uso di dosi fisiologiche di corticosteroidi può essere approvato dopo aver consultato lo Sponsor.
9. Presenta un'anamnesi polmonite (non infettiva) o polmonite attiva.
10. Presenta un’infezione in fase attiva che richiede una terapia sistemica, inclusa un’infezione del tratto urinario (ITU) attiva o non trattabile nell’ultimo mese.
11. È incinta o sta allattando, o prevede di concepire entro la durata stimata della sperimentazione, a partire dalla visita di screening fino a 120 giorni dopo l’ultima dose del trattamento sperimentale.
12. Ha ricevuto una terapia precedente con un agente anti-PD-1, anti-PD-L1, anti-PD-L2 o con un agente diretto contro un altro recettore co-inibitorio delle cellule T (ad es., CTLA-4, OX-40, CD137).
13. Presenta un’anamnesi nota di infezione da virus dell’immunodeficienza umana (human immunodeficiency virus, HIV) (anticorpi anti-HIV-1/2).
14. Presenta un’infezione attiva nota da epatite B, o da epatite C
15. Ha ricevuto un vaccino virale vivo nei 30 giorni precedenti l’inizio programmato del trattamento sperimentale
16. Ha avuto un trapianto di tessuto allogenico/organo solido.

E.5 End points

E.5.1

Primary end point(s)

Cohort A: CR rate of high risk NMIBC in the overall population. Cohort B: 12-month DFS rate of high risk NMIBC in the overall population.

Coorte A: Tasso CR di NMIBC ad alto rischio nella popolazione complessiva.
Coorte B: tasso DFS a 12 mesi di NMIBC ad alto rischio nella popolazione complessiva

E.5.1.1

Timepoint(s) of evaluation of this end point

Interim Analysis Proof of Concept (IA POC) = 20 Cohort A subjects @ 12 weeks Interim Analysis II (IA 2) = 50 Cohort A subjects @ 24 weeks Final Analysis = Full Enrollment plus 9 months

Analisi ad interim di conferma (IA POC) = 20 soggetti della Coorte A alla settimana 12
Analisi ad interim II (IA) = 50 soggetti della Coorte A alla settimana 24.
Analisi Finale= arruolamento completo più 9 mesi

E.5.2

Secondary end point(s)

Cohort A: CR rate of any disease in the overall population; DOR of high risk NMIBC and any disease. Cohort B: 12-month DFS rate of any disease in the overall population.

Coorte A:tasso CR di qualsiasi malattia nella popolazione complessiva; DOR di NMIBC ad alto rischio e qualsiasi malattia. Coorte B: tasso DFS a 12 mesi di qualsiasi malattia nella popolazione complessiva.

E.5.2.1

Timepoint(s) of evaluation of this end point

Interim Analysis Proof of Concept (IA POC) =20 Cohort A subjects @ 12 weeks
Interim Analysis II (IA 2) =50 Cohort A subjects @ 24 weeks
Final Analysis =Full Enrollment plus 9 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

Yes

E.6.12

Pharmacoeconomic

Yes

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

E.8.1.1

Randomised

E.8.1.2

Open

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

Yes

E.8.1.7.1

Other trial design description

IN APERTO

OPEN

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

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

Information not present in EudraCT

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

Brazil

Canada

Japan

Korea, Republic of

Russian Federation

Turkey

United States

Austria

Finland

France

Greece

Italy

Netherlands

Sweden

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

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:

174

F.2 Gender

F.2.1

Female

Yes

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

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

260

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 complete study treatment will continue into the post treatment tumor assessment period for an additional 3 years for a total of 5 years.
Subjects who don't complete treatment and discontinue, depending on reason, will continue to have post treatment tumor assessments for follow-up of disease status for a
total duration of 5 years, or will enter survival follow-up.
All participants will be followed for overall survival until death, withdrawal of consent, or the end of the study.

I sogg che completano il tratt in studio continueranno nel periodo di valutaz del tumore post-tratt per altri 3 anni per un tot di 5 anni
I sogg che non completano il tratt e interrompono,a seconda del motivo,continueranno ad avere valutaz tumorali post-tratt per il follow-up dello stato della malattia per una durata tot di 5 anni o entreranno in follow-up di sopravvivenza
Tutti i partecip saranno seguiti per la sopravv globale fino alla morte, alla revoca del consenso, o alla fine dello studio

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

2016-04-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-03-22

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

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