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    Summary
    EudraCT Number:2018-004567-31
    Sponsor's Protocol Code Number:XL184-313
    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:2021-01-28
    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 number2018-004567-31
    A.3Full title of the trial
    A Randomized, Double-Blind, Controlled Phase 3 Study of Cabozantinib in
    Combination with Nivolumab and Ipilimumab versus Nivolumab and
    Ipilimumab in Subjects with Previously Untreated Advanced or Metastatic
    Renal Cell Carcinoma of Intermediate or Poor Risk
    Studio controllato di fase 3, randomizzato, in doppio cieco per valutare cabozantinib
    in combinazione con nivolumab e ipilimumab rispetto a nivolumab
    e ipilimumab in soggetti con carcinoma a cellule renali a rischio “intermediate” o “poor”
    in stadio avanzato o metastatico precedentemente non trattato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a randomized, double-blind, controlled trial to evaluate the efficacy
    and safety of cabozantinib in combination with nivolumab and ipilimumab
    versus nivolumab and ipilimumab in previously untreated subjects with
    intermediate- and poor-risk advanced or metastatic RCC
    Questo è uno studio controllato, randomizzato, in doppio cieco per valutare l'efficacia
    e la sicurezza di cabozantinib in combinazione con nivolumab e ipilimumab
    rispetto a nivolumab e ipilimumab in soggetti con RCC a rischio “intermediate” o “poor”
    in stadio avanzato o metastatico precedentemente non trattato
    A.3.2Name or abbreviated title of the trial where available
    Cabozantinib with Nivolumab and Ipilimumab in Untreated Metastatic RCC
    Cabozantinib con Nivolumab e Ipilimumab in RCC metastatico non trattato
    A.4.1Sponsor's protocol code numberXL184-313
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03937219
    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 SponsorEXELIXIS, INC.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportExelixis, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationExelixis, Inc
    B.5.2Functional name of contact pointExelixis Medical Affairs
    B.5.3 Address:
    B.5.3.1Street Address1851 Harbor Bay Parkway
    B.5.3.2Town/ cityAlameda
    B.5.3.3Post codeCA 94502
    B.5.3.4CountryUnited States
    B.5.4Telephone number18883935494
    B.5.6E-maildruginfo@exelixis.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 No
    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 nameCabozantinib
    D.3.2Product code [XL184]
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCabozantinib
    D.3.9.1CAS number 1140909-48-3
    D.3.9.2Current sponsor codeXL184
    D.3.9.4EV Substance CodeSUB93452
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 No
    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 nameIpilimumab
    D.3.2Product code [-]
    D.3.4Pharmaceutical form Solution for injection
    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 INNIPILIMUMAB
    D.3.9.2Current sponsor codeBMS-734016 MDX-010
    D.3.9.4EV Substance CodeSUB29397
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 No
    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 [-]
    D.3.4Pharmaceutical form Solution for injection
    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.3.9.2Current sponsor codeBMS-936558 MDX1106 ONO-4538
    D.3.9.4EV Substance CodeSUB122750
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic Renal Cell Carcinoma
    Carcinoma a cellule renali metastatico
    E.1.1.1Medical condition in easily understood language
    Kidney Cancer
    Cancro al rene
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10050076
    E.1.2Term Metastatic renal carcinoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to evaluate the efficacy and safety of
    cabozantinib in combination with nivolumab and ipilimumab versus
    nivolumab and ipilimumab in previously untreated subjects with
    intermediate- and poor-risk advanced or metastatic RCC.
    L’obiettivo di questo studio è valutare l’efficacia e la sicurezza
    di cabozantinib in combinazione con nivolumab e ipilimumab rispetto
    a nivolumab e ipilimumab in soggetti precedentemente non trattati
    affetti da RCC a rischio “intermediate” e “poor” in stadio avanzato o metastatico.
    E.2.2Secondary objectives of the trial
    Not applicable
    Non Applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically confirmed advanced (not amenable to curative surgery or
    radiation therapy) or metastatic (AJCC Stage IV) renal cell carcinoma
    with a clear-cell component.
    - Intermediate- or poor-risk RCC as defined by International Metastatic
    RCC Database Consortium (IMDC) criteria.
    - Measurable disease per RECIST 1.1 as determined by the Investigator.
    - Karnofsky Performance Status (KPS) = 70%.
    - Adequate organ and marrow function.
    - Carcinoma a cellule renali in stadio avanzato (non idoneo a chirurgia curativa o radioterapia) o metastatico (stadio IV secondo il Comitato congiunto americano sul cancro [American Joint Committee on Cancer, AJCC]) confermato istologicamente con una componente di cellule chiare, compresi soggetti che presentano anche una caratteristica sarcomatoide.
    - RCC a rischio “intermediate” o “poor” secondo quanto definito dai criteri IMDC.
    - Malattia misurabile secondo quanto determinato dallo sperimentatore utilizzando i criteri RECIST 1.1.
    - Scala di valutazione secondo Karnofsky (KPS) =70%.
    - Adeguata funzionalità d’organo e midollare,
    E.4Principal exclusion criteria
    - Prior systemic therapy for unresectable locally advanced or metastatic
    RCC including investigational agents.
    - Uncontrolled, significant intercurrent or recent illness including, but
    not limited to serious cardiovascular disorders (including uncontrolled
    hypertension defined as sustained blood pressure (BP) > 150 mm Hg
    systolic or > 90 mm Hg diastolic despite optimal antihypertensive
    treatment), GI disorders associated with high risk for perforation or
    fistula formation, tumors invading GI tract, bowel obstruction, intraabdominal
    abscess, clinically significant bleeding events, cavitating
    pulmonary lesions, or lesion invading major pulmonary blood vessels.
    -Other clinically significant disorders such as:
    i. Any active, known or suspected autoimmune disease.
    ii. Any condition requiring systemic treatment with either
    corticosteroids (> 10 mg daily prednisone equivalent) or other
    immunosuppressive medications within 14 days of randomization.
    iii. Active infection requiring systemic treatment. Acute or chronic
    hepatitis B or C infection, known human immunodeficiency virus (HIV)
    or acquired
    immunodeficiency syndrome (AIDS)-related illness, or known positive
    test for tuberculosis infection.
    -Major surgery (eg, GI surgery, removal or biopsy of brain metastasis)
    within 8 weeks prior to randomization. Prior laparoscopic nephrectomy
    within 4 weeks prior to randomization. Minor surgeries within 10 days
    prior to randomization. Subjects must have complete wound healing
    from major surgery or minor surgery before randomization.
    - Any other active malignancy at time of randomization or diagnosis of
    another malignancy within 3 years prior to randomization that requires
    active treatment, 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.
    - Precedente terapia sistemica per RCC avanzato o metastatico localmente non resecabile,
    compreso l’uso di agenti sperimentali.
    - Intercorrente o recente malattia significativa non controllata, comprese, ma non limitate a patologie cardiovascolari
    (compresa ipertensione non controllata, definita come valori costanti di pressione arteriosa (PA) sistolica >150 mmHg
    o diastolica >90 mmHg nonostante una terapia antipertensiva ottimale),
    disturbi gastrointestinali (GI) associati a un alto rischio di perforazione
    o formazione di fistole, tumori che invadono il tratto GI, ostruzione intestinale, ascesso intra-addominale,
    eventi di sanguinamento clinicamente significativo, lesioni cavitarie
    polmonari o lesioni che invadono vasi sanguigni polmonari maggiori.
    - Altre patologie clinicamente significative, quali:
    i. Qualsiasi malattia autoimmune attiva, nota o sospetta.
    ii. Qualsiasi condizione che richieda un trattamento sistemico con
    corticosteroidi (>10 mg/giorno di prednisone equivalente)
    o altri farmaci immunosoppressori nei 14 giorni precedenti alla randomizzazione.
    iii. Infezione in atto che richieda una terapia sistemica. Infezione acuta o cronica
    da epatite B o C, nota malattia correlata al virus dell’immunodeficienza umana (human immunodeficiency virus, HIV)
    o alla sindrome da immunodeficienza acquisita (acquired immunodeficiency syndrome, AIDS)
    o nota positività al test per l’infezione da tubercolosi.
    - Intervento di chirurgia maggiore (es. chirurgia GI, rimozione o biopsia di metastasi cerebrali)
    nelle 8 settimane precedenti la randomizzazione. Precedente nefrectomia laparoscopica
    nelle 4 settimane prima della randomizzazione. Interventi chirurgici minori nei 10 giorni
    precedenti la randomizzazione. I soggetti devono presentare completa guarigione delle ferite
    provocate dall’intervento chirurgico maggiore o minore prima della randomizzazione.
    - Qualsiasi altro tumore maligno attivo al momento della randomizzazione o diagnosi
    di un altro tumore maligno nei 3 anni precedenti la randomizzazione che richieda un trattamento attivo, fatta eccezione per tumori localizzati curabili
    che sono stati apparentemente curati, quali carcinoma cutaneo a cellule basali o squamose, carcinoma
    superficiale della vescica o carcinoma in situ della prostata, del collo dell’utero o della mammella.
    E.5 End points
    E.5.1Primary end point(s)
    Duration of PFS (Progression-Free Survival), per Response Evaluation
    Criteria in Solid Tumors version 1.1 (RECIST 1.1), by Blinded
    Independent Radiology Committee (BIRC)
    Durata della PFS (Progression-Free Survival), valutata dal Comitato di
    radiologia indipendente in cieco (BIRC) secondo la versione 1.1
    dei Criteri di valutazione della risposta nei tumori solidi
    (Response Evaluation Criteria in Solid Tumors, RECIST 1.1)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The first tumor assessment after randomization should be performed at
    W10D1 (± 7 days). Subsequent tumor assessments should be performed
    every 8 weeks (± 7 days) from randomization through Week 50. Upon
    completion of 50 weeks on study, these assessments will be performed
    every 12 weeks (± 7 days). Additional imaging of potential disease sites
    should be performed whenever radiographic PD is suspected.
    la prima valutazione del tumore dopo la randomizzazione dovrebbe essere effettuata
    a W10D1 (+/- 7 giorni). Successive valutazioni del tumore dovrebbero
    essere effettuate ogni 8 settimane (+/- 7 giorni) dalla randomizzazione fino alla settimana 50.
    Dopo completamento della settimana 50 di studio, queste valutazioni saranno effettuate
    ogni 12 settimane (+/- 7 giorni). Ulteriori valutazioni di potenziali siti di malattia
    dovrebbero essere effettuate in caso di sospetta progressione radiografica.
    E.5.2Secondary end point(s)
    Duration of OS (overall survival)
    Durata dell’OS (overall survival)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Overall survival (OS) will continue to be assessed every 12 weeks (± 14
    days) after the second post-treatment follow-up visit (FU-2), which
    occurs 100 (±14) days after discontinuation of study treatment. Subjects
    will be followed until death or Sponsor decision to no longer collect
    these data
    La sopravvivenza complessiva (OS) sarà valutata ogni 12 settimane (± 14
    giorni) dopo la seconda visita di follow-up post-trattamento (FU-2), che
    avviene 100 (± 14) giorni dopo l'interrruzione del trattamento di studio.
    I soggetti saranno seguiti fino alla morte o fino alla decisione dello sponsor
    di cessare la raccolta di questi dati
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    immunogenicity, biomarkers
    immunogenicità, biomarkers
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Brazil
    Canada
    Chile
    Hong Kong
    Israel
    Mexico
    New Zealand
    Singapore
    United States
    France
    Germany
    Italy
    Poland
    Spain
    United Kingdom
    E.8.7Trial 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
    End of trial is defined as the last scheduled visit or scheduled procedure
    for the last subject (including Maintenance Phase assessments)
    la fine della sperimentazione è definita come l’ultima visita
    o procedura programmata per l’ultimo soggetto
    (comprese le valutazioni della fase di mantenimento).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days11
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    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: 418
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 258
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 676
    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)
    Treatment may continue after radiographic progression per RECIST 1.1 as long as the Investigator believes tha the subject is still receiving clinical benefit from study treatment and that the potential benefit of continuing study treatment outweighs potential risks.
    Il trattamento potrà proseguire dopo la progressione radiografica secondo i criteri RECIST 1.1 fintantoché lo sperimentatore sarà del parere che il soggetto stia ancora traendo beneficio clinico dal trattamento in studio e il potenziale beneficio di proseguire il trattamento in studio compensi i potenziali rischi.
    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 Decision2019-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-13
    P. End of Trial
    P.End of Trial StatusOngoing
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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