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    Summary
    EudraCT Number:2017-000562-30
    Sponsor's Protocol Code Number:NIVACTOR
    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:2021-09-06
    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.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-000562-30
    A.3Full title of the trial
    A Single-Arm, Open-Label, Multicenter, Phase IIIb Clinical Trial with NIVolumab in Subjects with Recurrent or Metastatic Platinum-refrACTORy Squamous Cell Carcinoma of the Head and Neck (SCCHN)
    Studio clinico a braccio singolo, in aperto, multicentrico, di Fase IIIb con NIVolumab in Soggetti con Carcinoma di testa-collo a cellule squamose, ricorrente o metastatico refrattario alla terapia con platino (SCCHN)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Single-Arm, Open-Label, Multicenter, Phase IIIb Clinical Trial with NIVolumab in Subjects with Recurrent or Metastatic Platinum-refrACTORy Squamous Cell Carcinoma of the Head and Neck (SCCHN)
    Studio clinico a braccio singolo, in aperto, multicentrico, di Fase IIIb con NIVolumab in Soggetti con Carcinoma di testa-collo a cellule squamose, ricorrente o metastatico refrattario alla terapia con platino (SCCHN)
    A.3.2Name or abbreviated title of the trial where available
    NIVACTOR
    NIVACTOR
    A.4.1Sponsor's protocol code numberNIVACTOR
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFondazione GONO
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBristol-Myers Squibb
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Research Technology Srl
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street Addressvia San Leonardo trav. Migliaro
    B.5.3.2Town/ citySalerno
    B.5.3.3Post code84131
    B.5.3.4CountryItaly
    B.5.4Telephone number089301545
    B.5.5Fax number0897724155
    B.5.6E-mailnivactor@cr-technology.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name OPDIVO - 10 MG/ML- CONCENTRATO PER SOLUZIONE PER INFUSIONE- USO ENDOVENOSO- FLACONCINO (VETRO)- 10 ML- 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderBRISTOL-MYERS SQUIBB PHARMA EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namenivolumab
    D.3.2Product code BMS-936558
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnivolumab
    D.3.9.1CAS number 946414-94-4
    D.3.9.2Current sponsor codenivolumab
    D.3.9.4EV Substance CodeSUB32944
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another 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.1.1Medical condition(s) being investigated
    Subjects with Recurrent or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN)”
    Soggetti con Carcinoma a Cellule Squamose della Testa e del Collo (SCCHN) ricorrente o metastatico refrattario a terapie a base di platino
    E.1.1.1Medical condition in easily understood language
    Subjects with Recurrent or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck
    Soggetti con Carcinoma a Cellule Squamose della Testa e del Collo (SCCHN) ricorrente o metastatico refrattario a terapie a base di platino
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10060121
    E.1.2Term Squamous cell carcinoma of head and neck
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the incidence of high-grade (CTCAE v 4.03 Grade 3 or higher), treatment-related, select adverse events in patients with Recurrent or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN) treated with nivolumab monotherapy
    Determinare l’incidenza di eventi avversi di alto grado (CTCAE v4.03 Grado 3 o maggiore), correlate al trattamento, in pazienti con Carcinoma di testa-collo a cellule squamose ricorrente o metastatico (SCCHN) refrattario a terapia con platino trattati con nivolumab in monoterapia
    E.2.2Secondary objectives of the trial
    • To determine the incidence and to characterize the outcome (duration of serious adverse events [SAE] treatment, dose of immune-modulating agents [ie, steroids] dose of agents used, time to event onset, and event resolution, and worst grade of event) of all high-grade (CTCAE v4.03 Grade 3 or higher) adverse events;
    • To assess safety, tolerability in all treated subjects;
    • To estimate Overall Survival (OS) in all treated subjects;
    • To estimate Investigator-assessed Objective Response Rate (ORR) and Progression-Free Survival (PFS) in all treated subjects;
    • Determinare l’incidenza e caratterizzare l’outcome di tutti gli eventi avversi di grado elevato (CTCAE v4.03 grado 3 o superiore) in termini di durata del trattamento, degli eventi avversi seri (SAE), dose degli agenti immunomodulanti (per esempio steroidi), dose degli agenti utilizzati, tempo di comparsa dell'evento e risoluzione dell’evento, peggior grado degli eventi;
    • Valutare la sicurezza e la tollerabilità in tutti i soggetti trattati;
    • Stimare la Sopravvivenza Globale (OS) in tutti i soggetti trattati;
    • Stimare il tasso di risposta obiettiva (ORR) e Sopravvivenza libera da progressione (PFS) valutate dallo Sperimentatore in tutti i soggetti trattati;
    • Stimare Tasso di Risposta Obiettiva (ORR) e la Sopravvivenza Libera da Progressione (PFS) valutati dallo Sperimentatore in tutti i soggetti trattati;
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full 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: A) IDENTIFICATION OF GENOMIC MARKERS
    v 1.0, 30 May 2017
    Purpose: To identify pre-existing and/or treatment induced genomic markers associated to Nivolumab response in R/M HNSCC patients entered into the trial and potentially useful as predictive surrogate markers:

    B) CHANGES IN MAJOR CIRCULATING IMMUNE CELLS AND CYTOKINES
    v 1.0, 30 May 2017
    Purpose: To identify treatment induced changes in circulating immune cells and cytokines which may impact on the outcome differently according to clinical conditions.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: A) Identificazione dei marcatori genomici
    v 1.0, 30 Maggio 2017
    Obiettivo: Estrazione del materiale genetico (DNA) da campioni di sangue e da tessuto tumorale per la valutazione di varianti in particolari regioni del DNA responsabili dell’espressione di molecole, definite marcatori, che possono essere di aiuto nel predire la risposta al trattamento;

    B) Cambiamenti nelle cellule immunitarie circolanti maggiori e nelle citochine durante il trattamento con nivolumab
    v 1.0, 31 Maggio 2017
    Obiettivo: Indagine sui cambiamenti nelle principali cellule immunitarie circolanti e nelle citochine (proteine del sistema immunitario) e collegamento di questi cambiamenti all'esito del trattamento sperimentale con nivolumab e alle caratteristiche cliniche dei pazienti.
    E.3Principal inclusion criteria
    • Signed Written Informed Consent;
    • Willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study
    • Males and Females, 18 years of age;
    • Histologically confirmed recurrent or metastatic SCCHN (oral cavity, pharynx, larynx) not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy), p16 positive SCCHN of unknown primary;
    • Eastern Cooperative Oncology Group (ECOG) performance status = 2;
    • Tumor progression or recurrence within 6 months of last dose of platinum therapy in the adjuvant (ie, with radiation after surgery), primary (ie, with radiation or prior to it or to surgery as induction chemotherapy), recurrent, or metastatic setting;
    • Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria;
    • Documentation of p16-positive or p16-negative disease to determine human papillomavirus (HPV) status of oropharyngeal cancer
    • Tumor tissue (archival or fresh biopsy specimen) must be available;
    • Patients with CNS metastases
    • Immunosuppressive doses of systemic medication, such as steroids or absorbed topical steroids (doses > 10 mg/day prednisone or equivalent) must be discontinued at least 2 weeks before study drug administration;
    • Prior curative radiation therapy must have been completed at least 4 weeks prior to study drug administration. Prior focal palliative radiotherapy must have been completed at least 2 weeks before study drug administration
    • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test;
    • Screening laboratory values must meet protocol criteria
    • Women must not be breastfeeding.
    • WOCBP and males subjects must agree to follow instructions for method(s) of contraception
    • Consenso informato firmato;
    • Disponibilità a rispettare le visite programmate, il programma di trattamento, i test di laboratorio e altri requisiti dello studio;
    • Maschi e femmine, 18 anni di età;
    • SCCHN ricorrente o metastatico confermato istologicamente (cavità orale, faringe, laringe) non idoneo a terapia locale con intento curativo (chirurgia o radioterapia con o senza chemioterapia), SCCHN p-16 positivo con primario non conosciuto;
    • Eastern Cooperative Oncology Group (ECOG) performance status = 2;
    • Progressione tumorale o recidiva entro 6 mesi dall'ultima dose di terapia con platino nel setting in adiuvante (ovvero con radiazioni dopo l'intervento chirurgico), primario (cioè con radiazioni o prima di esso o prima dell’intervento chirurgico come terapia di induzione), nel setting ricorrente o metastatico;
    • I soggetti devono avere una malattia misurabile mediante CT o MRI secondo i criteri RECIST v. 1.1;
    • Documentazione della malattia p-16-positiva o p-16-negativa, marker surrogato per determinare lo stato di papillomavirus umano (HPV) del cancro orofaringeo;
    • Disponibilità di tessuto tumorale (campione da biopsia archiviato o fresco);
    • pazienti con metastasi al Sistema Nervoso Centrale (CNS)
    • Dosi immunosoppressive di farmaci sistemici, quali steroidi o steroidi topici assorbiti (dosi> 10 mg / giorno di prednisone o equivalenti) devono essere sospese almeno 2 settimane prima della somministrazione del farmaco in studio;
    • Precedente radioterapie sistemiche devono essere state completate almeno 4 settimane prima della somministrazione del farmaco in studio. Precedente radioterapie focali devono essere state completate almeno 2 settimane prima della somministrazione del farmaco in studio.
    • Le donne in età fertile (WOCBP) devono avere un test di gravidanza negativo su siero o urina;
    • I valori di laboratorio allo screening devono soddisfare i criteri del protocollo
    • Le donne non devono essere in allattamento;
    • Le donne potenzialmente fertili ed i maschi deve accettare di seguire le istruzioni sui metodi di contraccezione
    E.4Principal exclusion criteria
    • Patients with untreated, symptomatic CNS metastases are excluded;
    • Histologically confirmed recurrent or metastatic carcinoma of the nasopharynx, p16 negative squamous cell carcinoma of unknown primary, and salivary gland or non-squamous histologies (eg, mucosal melanoma) are not allowed;
    • Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results;
    • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways;
    • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast;
    • Subjects with active, known or suspected autoimmune disease. Subjects with experienced GVH disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition or previous neck RT only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
    • Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease;
    • All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to Grade 1 (NCI CTCAE version 4.03) or baseline before administration of study drug. Subjects with toxicities attributed to prior anti-cancer therapy which are not expected to resolve and result in long lasting sequelae, such as neuropathy after platinum-based therapy, are permitted to enroll.
    • Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection. Subjects who test positive for HCV antibody but negative for HCV ribonucleic acid are permitted to enroll;
    • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS);
    • Any Grade 4 laboratory abnormalities;
    • History of allergy to study drug components;
    • History of severe hypersensitivity reaction to any monoclonal antibody;
    • Prisoners or subjects who are involuntarily incarcerated.
    • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
    • Consenso informato firmato;
    • Disponibilità a rispettare le visite programmate, il programma di
    trattamento, i test di laboratorio e altri requisiti dello studio;
    • Maschi e femmine, 18 anni di età;
    • SCCHN ricorrente o metastatico confermato istologicamente (cavità
    orale, faringe, laringe) non idoneo a terapia locale con intento
    curativo (chirurgia o radioterapia con o senza chemioterapia),
    SCCHN p-16 positivo con primario non conosciuto;
    • Eastern Cooperative Oncology Group (ECOG) performance status =
    2;
    • Progressione tumorale o recidiva entro 6 mesi dall'ultima dose di
    terapia con platino nel setting in adiuvante (ovvero con radiazioni
    dopo l'intervento chirurgico), primario (cioè con radiazioni o prima
    di esso o prima dell’intervento chirurgico come terapia di induzione),
    nel setting ricorrente o metastatico;
    • I soggetti devono avere una malattia misurabile mediante CT o MRI
    secondo i criteri RECIST v. 1.1;
    • Documentazione della malattia p-16-positiva o p-16-negativa, per
    determinare lo stato di papillomavirus umano (HPV) del cancro
    orofaringeo;
    • Disponibilità di tessuto tumorale (campione da biopsia archiviato o
    fresco);
    • pazienti con metastasi al Sistema Nervoso Centrale (CNS):
    • Dosi immunosoppressive di farmaci sistemici, quali steroidi o steroidi topici assorbiti (dosi> 10 mg / giorno di prednisone o equivalenti) devono essere sospese almeno 2 settimane prima della
    somministrazione del farmaco in studio;
    • Precedente radioterapie sistemiche devono essere state completate
    almeno 4 settimane prima della somministrazione del farmaco in
    studio. Precedente radioterapie focali devono essere state completate
    almeno 2 settimane prima della somministrazione del farmaco in
    studio.
    • Le donne in età fertile (WOCBP) devono avere un test di gravidanza
    negativo su siero o urina;
    • I valori di laboratorio allo screening devono soddisfare i criteri del protocollo
    • Le donne non devono essere in allattamento;
    • Le donne potenzialmente fertili ed i maschi devono accettare di seguire le istruzioni
    sui metodi di contraccezione
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of high-grade (CTCAE v 4.03 Grade 3 or higher), treatment-related, select adverse events;
    Incidenza di eventi avversi selezionati di grado elevato (CTCAE v 4.03 Grado 3 o superiore), correlati al trattamento,
    E.5.1.1Timepoint(s) of evaluation of this end point
    Approximately 6 months
    approssimativamente 6 mesi
    E.5.2Secondary end point(s)
    Incidence of all high-grade (Grades 3-5), select adverse events; Median time to onset and median time to resolution (Grades 3-4) of select adverse events (resolution of an AE is a subject experiencing complete resolution or improvement to the baseline grade for the AE);; Overall Survival defined as the time from first dosing date to the date of death. A subject who has not died will be censored at last known date alive;; Safety and tolerability measured by the incidence of all AEs, treatment-related AEs, serious AEs, deaths, laboratory abnormalities, and select AEs such as pulmonary, gastrointestinal, skin, renal, hepatic, pancreatic, neurologic, endocrine, infusionrelated, or hypersensitivity;; Objective Response Rate (ORR) defined as the number of subjects with a Best Overall Response (BOR) of a complete response (CR) or Partial Response (PR) divided by the number of all treated (at least 1 dose of nivolumab) subjects. BOR is defined as the best response designation, recorded between the date of first dose and the date of the initial objectively documented tumor progression by the investigator per RECIST v1.1 or the date of subsequent therapy, whichever occurs first.
    For subjects without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination;; Investigator-assessed Progression Free Survival (PFS) defined as radiological evidence of progression, significant clinical symptomatic progression, the need to introduce a non-study drug therapy or death from any cause;
    Incidenza di tutti gli eventi avversi selezionati di grado elevato (grado 3-5); Il tempo mediano di insorgenza e il tempo mediano alla risoluzione (gradi 3-4) di eventi avversi selezionati (la risoluzione di un AE avviene quando un soggetto sperimenta una completa risoluzione o miglioramento nel grado dell’evento avverso rispetto al valore del di base);; La Sopravvivenza Globale definita come il tempo dal primo giorno di trattamento alla data di decesso. Un soggetto che non è deceduto sarà censurato all’ultima data in cui è risultato essere ancora in vita;; La sicurezza e la tollerabilità saranno misurate con l'incidenza di tutti gli eventi avversi correlati al trattamento, gli eventi avversi seri, i decessi, le anomalie di laboratorio e gli eventi avversi selezionati (polmonari, gastrointestinali, cutanei, renali, epatici, pancreatici, neurologici, endocrini, quelli correlati con l'infusione o le ipersensibilità);; Il Tasso di Risposta Obiettiva (ORR) definito come il numero di soggetti con una migliore risposta obiettiva (BOR) tra il numero di una migliore Risposta Obiettiva (BOR) tra una Risposte Complete (CR) o Risposte Parziali (PR) diviso per il numero di tutti i soggetti trattati (almeno 1 dose di nivolumab). La migliore risposta obiettiva (BOR), sia CR o PR, è definita come la designazione della migliore risposta, registrata tra la data della prima dose e la data della progressione del tumore iniziale oggettivamente documentata dallo
    sperimentatore secondo le RECIST v1.1 o la data della successiva terapia, a seconda di quale si verifica prima.
    Per i soggetti senza progressione documentata o terapia successiva, tutte le designazioni di risposta disponibili contribuiranno alla determinazione della BOR;; La Sopravvivenza libera da Progressione (PFS) valutata dallo sperimentatore definita come evidenza radiologica di progressione, significativa progressione sintomatica clinica, la necessità di introdurre una terapia non sperimentale o decesso per qualsiasi causa;
    E.5.2.1Timepoint(s) of evaluation of this end point
    apporoximately 6 months; from 1 to 8 months after enrolment; 24m FU; from 1 to 8 months after enrolment; at week 9 and at 6 months after enrolment; at week 9 and at 6 months after enrolment
    approssimativamente 6 mesi; da 1 a 8 mesi dopo l'arruolamento; Follow-up a 24 mesi ; da 1 a 8 mesi dopo l'arruolamento; alla settimana 9 e a 6 mesi dall'arruolamento; alla settimana 9 e a 6 mesi dall'arruolamento
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned18
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA24
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    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 study will end when analysis of survival is complete, in any case till 24 mnths from LPLV
    Lo studio finirà quando l'analisi della sopravvivenza sarà completa e comunque due anni dall'ultima visita dell'ultimo paziente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    subjects unable to give consent for physical reason
    soggetti incapaci di dare il consenso per impedimenti fisici
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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 will have two follow-up visits (FU1 and FU2) for safety within approximately 100 days from the last dose of study therapy. Beyond this time period, subjects will be followed for ongoing drug related adverse events until these toxicities are resolved, return to baseline or are deemed irreversible.All subjects will be followed for overall survival every 3 months until death, lost to follow-up or withdrawal of study consent.
    I soggetti riceveranno due visite di follow-up (FU1 e FU2) per il monitoraggio della safety entro 100 giorni dall'ultima dose di terapia con nivolumab. Successivamente a queste visite, i soggetti saranno seguiti fino a quando gli eventi avversi in corso non saranno risolti, ritorneranno al valore del basale o verranno considerati irreversibili.Tutti i soggetti saranno seguiti per il monitoraggio della sopravvivenza globale ogni 3 mesi fino al decesso, perdita al follow-up o ritiro del consenso.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-09-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-20
    P. End of Trial
    P.End of Trial StatusOngoing
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