Clinical Trials Register

Summary
EudraCT Number:	2021-002163-22
Sponsor's Protocol Code Number:	NANORAY-312
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:	2021-11-19
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

2021-002163-22

A.3

Full title of the trial

A Phase 3 (Pivotal Stage) Study of NBTXR3 Activated by Investigator's Choice of Radiotherapy Alone or Radiotherapy in Combination with
Cetuximab for platinum-based Chemotherapy-ineligible Elderly Patients with Locally Advanced Head & Neck Squamous Cell Carcinoma

Studio di Fase 3 (stadio cardine) su NBTXR3, attivato in base alla scelta dello sperimentatore mediante radioterapia da sola o radioterapia in combinazione con cetuximab, per pazienti anziani non idonei alla chemioterapia a base di platino con carcinoma a cellule squamose della testa e del collo localmente avanzato

A.3.1

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

NBTXR3 with or without cetuximab in Locally Advanced Head & Neck Squamous Cell Carcinoma (LA-HNSCC)

NBTXR3 con o senza cetuximab nel carcinoma a cellule squamose della testa e del collo localmente avanzato (HNSCC localmente avanzato)

A.3.2

Name or abbreviated title of the trial where available

NBTXR3 with or without cetuximab in LA-HNSCC

NBTXR3 con o senza cetuximab nell’HNSCC localmente avanzato

A.4.1

Sponsor's protocol code number

NANORAY-312

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT04892173

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	NANOBIOTIX SA
B.1.3.4	Country	France
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	Nanobiotix SA
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Nanobiotix SA
B.5.2	Functional name of contact point	NANORAY-312 CST
B.5.3	Address:
B.5.3.1	Street Address	60 rue de Wattignies
B.5.3.2	Town/ city	Paris
B.5.3.3	Post code	75012
B.5.3.4	Country	France
B.5.6	E-mail	nanoray-312@nanobiotix.com

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	Erbitux, 5 mg/mL, 20 mL vials
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Europe B.V.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Cetuximab
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Solution for injection/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	CETUXIMAB
D.3.9.1	CAS number	205923-56-4
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	SUB01178MIG
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	5
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)	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.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	Hensify
D.2.1.1.2	Name of the Marketing Authorisation holder	Nanobiotix SA
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Hensify
D.3.2	Product code	[NBTXR3]
D.3.4	Pharmaceutical form	Injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intratumoral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ossido di afnio (HfO2) funzionalizzato con gruppi fosfato (PO4) sulla superfice
D.3.9.2	Current sponsor code	NBTXR3
D.3.9.3	Other descriptive name	Nanoparticle radio-enhancer
D.3.10	Strength
D.3.10.1	Concentration unit	mg/l milligram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	54200
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	Yes
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	Yes
D.3.11.13.1	Other medicinal product type	il prodotto è un dispositivo medico, marcato CE per un'altra indicazione

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

Locally Advanced Head & Neck Squamous Cell Carcinoma

carcinoma a cellule squamose della testa e del collo localmente avanzato

E.1.1.1

Medical condition in easily understood language

The most common type of head and neck cancer is called squamous cell carcinoma coming from the membrane lining the mouth, and the parts of
the digestive and respiratory tubes of the neck.

tipo più comune di carcinoma della testa e del collo chiamato carcinoma a cellule squamose che proviene dalla membrana che riveste la bocca e le parti del tubo digerente e respiratorio del collo.

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	PT
E.1.2	Classification code	10067821
E.1.2	Term	Head and neck 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 evaluate survival outcomes in subjects treated with intratumorally injected NBTXR3 activated by investigator's choice of RT alone or RT in combination with cetuximab in comparison to Investigator's choice alone hereafter referred to as NBTXR3/RT±cetuximab versus RT±cetuximab

Valutare gli esiti in termini di sopravvivenza nei soggetti trattati con NBTXR3 iniettato per via intratumorale e attivato in base alla scelta dello Sperimentatore mediante radioterapia (RT) da sola o RT in combinazione con cetuximab rispetto alla monoterapia scelta dallo Sperimentatore di seguito indicata come NBTXR3/RT±cetuximab rispetto a RT±cetuximab

E.2.2

Secondary objectives of the trial

To evaluate long-term survival outcomes of NBTXR3/RT±cetuximab versus RT±cetuximab

Valutare gli esiti in termini di sopravvivenza a lungo termine di NBTXR3/RT±cetuximab rispetto a RT±cetuximab

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: 24-hr ECG evaluation sub-study (at selected sites)

Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Sottostudio di valutazione degli ECG delle 24 ore (presso centri selezionati)

E.3

Principal inclusion criteria

_Signed informed consent form (ICF) indicating that the subject
understands the purpose of, andprocedures required for the study, and
is willing to participate in the study
_Age >o =65 years
_Biopsy-confirmed SCC of the oral cavity, oropharynx, hypopharynx or supraglottic larynx (archived biopsies are allowed); if no biopsies are
available, a new biopsy must be obtained to provideconfirmation of SCC
_For subjects with oropharyngeal cancer, HPV status must be known
_Tumor categories T3-T4 according to the 8th edition of the American Joint Committee on CancerStaging Manual (AJCC v8)
_Has at least 1 tumor lesion that can be accurately measured according to RECIST 1.1 (per the central imaging vendor) and is amenable for
intratumoral injection, as determined by the Investigator
_A single invaded, biopsy confirmed, accessible LN in the neck of > o =3 cm and <10 cm and with <180-degree encasement of the carotid artery on
MRI or CT scan is eligible for intranodal injection
_If a LN is selected for injection, 1 of the 2 injected lesions must be the primary tumor itself
_Ineligible to receive platinum-based chemotherapy for the treatment of LA HNSCC as defined by having at least 1 of the following:
1. Estimated creatinine clearance =30 and <50 mL/min (calculated by Cockcroft and Gault)
2. Hearing loss or tinnitus Grade =2
3. Grade > o = 2 peripheral neuropathy
4. ECOG >2
5. Recent cardiac dysfunction (history of unstable angina pectoris, myocardial infarction, or NewYork Heart Association (NYHA) Class III
chronic heart failure <3 years prior to screening)
_Must be able to tolerate RT with curative intent as determined by the study Investigator.
_Amenable to definitive treatment with RT. For subjects with an oral cavity cancer the decision for definitive treatment with RT requires
consultation with the head and neck surgeon, and the site's multidisciplinary tumor board.
_ECOG performance status of 0 to < o =2
_Life expectancy =6 months
_Adequate organ and bone marrow function at screening as defined by:
1. Hemoglobin >9.0 g/dL
2. Platelet count >100,000 cells/mm3
3. Leukocytes >3000 cells/mm3
4. Absolute neutrophil count >1500 cells/mm3
5. Alanine aminotransferase (ALT) < o=3×upper limit of normal (ULN)
6. Aspartate aminotransferase (AST) < o = 3×ULN
7. Total bilirubin < o = 1.5 mg/dL (in subjects with Gilbert's syndrome, if
total bilirubin is >1.5×ULN,measure direct and indirect bilirubin and if
direct bilirubin is < o = 1.5×ULN, the subject may be eligible)
8. Total serum magnesium within normal ranges (1.7-2.2 mg/dL or 0.85 to 1.10 mmol/L)

_Modulo di consenso informato (ICF) firmato da cui risulta che il soggetto comprende lo scopo e le procedure richieste per lo studio ed è disposto a partecipare volontariamente allo studio
_Età>o =65 anni
_SCC confermato mediante biopsia della cavità orale, dell’orofaringe, dell’ipofaringe o della laringe sovraglottica (sono consentite biopsie archiviate); se non sono disponibili biopsie, occorre eseguire una nuova biopsia per fornire la conferma dell’SCC
_Per i soggetti con tumore orofaringeo, deve essere noto lo stato del virus del papilloma umano (HPV)
_Categorie di tumore T3-T4 secondo l’ottava edizione del Manuale per la stadiazione dei tumori del Comitato congiunto americano (AJCC v8)
_Presentare almeno 1 lesione tumorale che può essere misurata accuratamente in base ai criteri RECIST 1.1 (in base al fornitore di servizi centralizzati per immagini) ed è sottoponibile a iniezione intratumorale, come determinato dallo sperimentatore
_Un singolo LN invaso, confermato mediante biopsia, accessibile nel collo di > o =3 cm e <10 cm e con avviluppamento dell’arteria carotidea <180 gradi alla RMI o alla TC è idoneo per l’iniezione intranodale
Se viene selezionato un LN per l’iniezione, 1 delle 2 lesioni iniettate deve essere il tumore primario stesso
_Non idonei a ricevere chemioterapia a base di platino per il trattamento del LA-HNSCC, come definito dalla presenza di almeno 1 dei seguenti:
1. Clearance della creatinina stimata > o =30 e <50 ml/min (calcolata secondo l’equazione di Cockcroft e Gault)
2. Perdita dell’udito o tinnito di grado >o =2
3. Neuropatia periferica di grado > o =2
4. ECOG >2
5. Disfunzione cardiaca recente (anamnesi di angina pectoris instabile, infarto miocardico o insufficienza cardiaca cronica di classe III secondo la New York Heart Association [NYHA] <3 anni prima dello screening)
_Devono essere in grado di tollerare la RT con intento curativo, come stabilito dallo sperimentatore dello studio.
_Sottoponibile a trattamento definitivo con RT. Per i soggetti con un tumore della cavità orale, la decisione del trattamento definitivo con RT richiede la consultazione con il chirurgo della testa e del collo e il comitato tumorale multidisciplinare del centro.
_Stato di validità ECOG da 0 a < o=2
_Aspettativa di vita di >o=6 mesi
_Funzione d’organo e del midollo osseo adeguata allo screening, definita da:
1. Emoglobina >9,0 g/dl
2. Conta piastrinica >100.000 cellule/mm3
3. Leucociti >3000 cellule/mm3
4. Conta assoluta dei neutrofili >1.500 cellule/mm3
5. Alanina aminotransferasi (ALT)< o =3 × limite superiore della norma (ULN)
6. Aspartato aminotransferasi (AST) < o=3 × ULN
7. Bilirubina totale < o =1,5 mg/dl (nei soggetti con sindrome di Gilbert, se la bilirubina totale è >1,5 x ULN, misurare la bilirubina diretta e indiretta e se la bilirubina diretta è < o =1,5 x ULN, il soggetto potrebbe essere idoneo)
8. Magnesio sierico totale entro gli intervalli normali (1,7-2,2 mg/dl o 0,85-1,10 mmol/l)

E.4

Principal exclusion criteria

_HNSCC category T1, T2 or M1 according to the 8th edition of AJCC v8
_Has received prior antineoplastic systemic therapy or intervention (including pharmacological - both marketed and investigational, RT, or
surgery) for the treatment of HNSCC
_Subjects with known severe Grade 3 or 4 hypersensitivity reactions to cetuximab must be excluded from cetuximab treatment by the
Investigator
_Known history of HIV, active hepatitis B, or active hepatitis C infection
_Local regionally recurrent HNSCC
_Ulceration or other characteristics that may, in the opinion of the Investigator, increase the risk of severe tumor bleeding
_SCC originating in the nasopharynx or paranasal sinus, from the salivary gland, or thyroid gland, or on-squamous histology (e.g.,
melanoma or neuroendocrine carcinoma), or SCC of unknown primary origin
_Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the
investigational regimen
_Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes, second- or third-degree
atrioventricular heart block without a permanent pacemaker in place)
_Class IV congestive heart failure as defined by the NYHA functional classification system <6 months prior to screening
_A pregnant or nursing woman, or women of childbearing potential and men who are sexually active and not willing/able to use medically
acceptable forms of contraception starting from the time that the ICF is signed through 150 days after the last cetuximab dose/RT fraction. A
woman who is 2 years postmenopausal or surgically sterile is not considered to be of childbearing potential.
_A known history of areca nut (betel nut) consumption for 10 years or more
_Any condition for that, in the opinion of the Investigator, participation would not be in the best interest of the individual (e.g., compromises the
subject's well-being) or that could prevent, limit, or confound the protocol/CIP specified assessments
_Subject participating in another clinical study, except for a non interventional trial/registry at the time of signing the ICF

_HNSCC di categoria T1, T2 o M1 secondo l’ottava edizione dell’AJCC v8
_Precedente terapia o intervento sistemico antineoplastico (inclusi farmaci, sia disponibili in commercio che sperimentali, RT o intervento chirurgico) per il trattamento dell’HNSCC
_I soggetti con gravi reazioni di ipersensibilità note di grado 3 o 4 a cetuximab devono essere esclusi dallo sperimentatore dal trattamento con cetuximab
_Anamnesi nota di infezione da HIV, da epatite B attiva o da epatite C attiva
_HNSCC ricorrente locale-regionale
_Ulcerazione o altre caratteristiche che, a giudizio dello sperimentatore, potrebbero aumentare il rischio di grave sanguinamento tumorale
_SCC che ha origine nel nasofaringe o nel seno paranasale, dalla ghiandola salivare o dalla ghiandola tiroidea oppure istologia non squamosa (per es. melanoma o carcinoma neuroendocrino) o SCC di origine primaria non nota
_Tumore maligno concomitante o precedente, la cui anamnesi naturale o il cui trattamento abbia il potenziale per interferire con la valutazione della sicurezza o dell’efficacia del regime sperimentale
_Aritmie cardiache clinicamente significative (per es., tachicardia ventricolare, fibrillazione ventricolare, torsade de pointes, blocco cardiaco atrioventricolare di secondo o terzo grado senza pacemaker permanente in posizione)
_Insufficienza cardiaca congestizia di Classe IV definita dal sistema di classificazione funzionale della NYHA <6 mesi prima dello screening
_Una donna in gravidanza o allattamento, o donne in età fertile e uomini sessualmente attivi e non disposti/in grado di utilizzare forme di contraccezione accettabili dal punto di vista medico a partire dal momento della firma dell’ICF fino a 150 giorni dall’ultima dose di cetuximab/frazione della RT. Una donna in post-menopausa da 2 anni o chirurgicamente sterile non è considerata in età fertile.
_Un’anamnesi nota di consumo di noce areca (noce betel) per almeno 10 anni
_Il soggetto presenta qualsiasi condizione per la quale, a giudizio dello sperimentatore, la partecipazione non sarebbe nel suo migliore interesse (per es., comprometterebbe il benessere del soggetto) o che potrebbe impedire, limitare o confondere le valutazioni specificate dal protocollo/CIP
_Il soggetto partecipa a un altro studio clinico, a eccezione di una sperimentazione non interventistica/un registro, al momento della firma dell’ICF

E.5 End points

E.5.1

Primary end point(s)

PFS: time from randomization to local-regional recurrence, local-regional progression, distant progression, or death from any cause, whichever
occurs first

tempo dalla randomizzazione alla recidiva locale-regionale, progressione locale-regionale, progressione a distanza o decesso per qualsiasi causa, a seconda di quale evento si verifichi prima

E.5.1.1

Timepoint(s) of evaluation of this end point

ITT population

popolazione che si intende trattare (ITT)

E.5.2

Secondary end point(s)

OS: time from randomization to death from any cause

tempo dalla randomizzazione al decesso per qualsiasi causa

E.5.2.1

Timepoint(s) of evaluation of this end point

ITT population.

popolazione che si intende trattare (ITT)

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

Yes

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

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

NBTXR3 (dispositivo medico) in aggiunta alla scelta dello sperimentatore di radioterapia (RT) (+/- c

NBTXR3 (medical device) in addition to investigator's choice of RT (+/- cetuximab)

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

Canada

China

Georgia

India

Israel

Japan

Korea, Republic of

Malaysia

Philippines

Russian Federation

Serbia

Ukraine

United States

Austria

Belgium

Bulgaria

Croatia

Finland

France

Germany

Hungary

Italy

Portugal

Romania

Spain

Sweden

Switzerland

United Kingdom

Czechia

Greece

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 date when the required number of PFS (progression-free survival)
and OS (overall survival) events have occurred.

La data in cui si è verificato il numero richiesto di eventi di PFS (sopravvivenza libera da progressione)
e OS (sopravvivenza complessiva).

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)

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

500

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

367

F.4.2.2

In the whole clinical trial

500

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)

Post-RT neck dissection

Dissezione del collo post-RT.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	GONO
G.4.3.4	Network Country	Italy

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2022-02-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-04-26

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

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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