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    Summary
    EudraCT Number:2015-004760-11
    Sponsor's Protocol Code Number:CA209-408
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-06-01
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-004760-11
    A.3Full title of the trial
    89Zirconium-labeled nivolumab and 18F-labeled anti-PD-L1 as predictive imaging biomarkers of response and toxicity in nivolumab treated patients with non-small-cell lung cancer – a feasibility study
    89Zirconium-gelabeld nivolumab en 18F-gelabeld anti-PD-L1 als voorspellende imaging biomarker van respons en toxiciteit in patiënten met niet-kleincellig longcarcinoom die worden behandeld met nivolumab - een haalbaarheidsstudie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immuno- and PD-L1 PET to predict response and toxicity during nivolumab treatment in NSCLC
    Immuno- en PD-L1 PET om de respons en toxiciteit tijdens nivolumab behandeling in niet-kleincellig longcarcinoom te voorspellen.
    A.4.1Sponsor's protocol code numberCA209-408
    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 SponsorVU Medical Centre
    B.1.3.4CountryNetherlands
    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.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVU Medical Centre
    B.5.2Functional name of contact pointJoop de Langen
    B.5.3 Address:
    B.5.3.1Street Addressde Boelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081HV
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031204444782
    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 Nivolumab BMS
    D.2.1.1.2Name of the Marketing Authorisation holderEuropean Commission
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Concentrate for 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.3.9.3Other descriptive nameNIVOLUMAB
    D.3.9.4EV Substance CodeSUB122750
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 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 nameZirconium-89-p-thioureabenzyldesferrioxamine-Nivolumab
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNivolumab
    D.3.9.3Other descriptive nameNIVOLUMAB
    D.3.9.4EV Substance CodeSUB122750
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.4
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product Yes
    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 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 name[18F]BMS-986192
    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 INNFLUORINE-18
    D.3.9.1CAS number 13981-56-1
    D.3.9.3Other descriptive nameFLUORINE-18
    D.3.9.4EV Substance CodeSUB74867
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number0
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product Yes
    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
    Non-small cell lung cancer
    Niet kleincellig longcarcinoom
    E.1.1.1Medical condition in easily understood language
    Lung cancer
    Longkanker
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess uptake of 18F-PD-L1 and 89Zr- nivolumab in tumor lesions.
    De opname van 18F-PD-L1 en 89Zr- nivolumab in tumor laesies te onderzoeken.
    E.2.2Secondary objectives of the trial
    To assess the safety of 18F-anti-PD-L1 and 89Zr-nivolumab.
    Characterize tumor uptake heterogeneity between patients and within and between tumor lesions of the same patient.
    Characterize the relationship between 18F-anti-PD-L1 and 89Zr- nivolumab tumor uptake and tumor cell and tumor infiltrating
    lymphocyte (TIL) PD-1 and PD-L1 expression as well as other blood and tissue parameters (see section 6.3.16).
    Explore the relationship between 89Zr- nivolumab and 18F-anti-PD-L1 organ uptake with irAEs. The focus will be on the gut, lung,
    liver, thyroid and pituitary.
    Assess uptake of 18F-anti-PD-L1 and 89Zr- nivolumab in normal tissues to evaluate the biodistribution and dosimetry.
    Het onderzoeken van de veiligheid van 18F-anti-PD-L1 en 89Zr-nivolumab.
    Het karakteriseren van de tumor opname heterogeniteit tussen patiënten en in en tussen de tumorlaesies in de indivuele patiënt.
    Het karakteriseren van de relatie tussen 18F-anti-PD-L1 en 89Zr-nivolumab tumor opname en tumor cel en tumor infiltrating lymphocyte (TIL) PD-1 en PD-L1 expressie als wel tussen andere bloed en weefsel parameters.
    Het exploreren van de relatie tussen 89Zr-nivolumab en 18F-anti-PD-L1 orgaan opname met irAEs. De focus zal liggen op de darmen, long, lever, schildklier en de hypofyse.
    Het onderzoeken van de opname van 18F-anti-PD-L1 en 89Zr-nivolumab in normale weefsels om biodistributie en dosismetrie te evalueren.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    - Have a histologically or cytologically confirmed diagnosis of stage IV, EGFR WT and EML4-ALK fusion negative NCSLC and have received at least one line of platinum based doublet chemotherapy. EGFR and EML4-ALK testing is not necessary in patients with squamous NSCLC.
    - Be willing and able to provide written informed consent/assent for the trial.
    - Be > 18 years of age on day of signing informed consent.
    - Have measurable disease based on RECIST 1.1.
    - Must provide tissue from a histological biopsy of a tumor lesion that is not radiated prior to biopsy and obtained after the last line of systemic therapy to determine the actual PD-L1 status.
    - Willing to undergo a second biopsy when the 18F-anti-PD-L1 or 89Zr-nivolumab PET scans show heterogeneous uptake.
    - Have a performance status of 0-1 on the ECOG Performance Scale (Appendix 2).
    - Demonstrate adequate organ function. All screening labs should be performed within 10 days of treatment initiation.
    - Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception during the study and for 23 weeks after the last dose of nivolumab. Women who are not of childbearing potential (i.e. who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception.
    - Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception during the study and for 31 weeks after the last dose of nivolumab.
    Om deel te kunnen nemen aan deze studie, moet de deelnemer
    - Histologische of cytologische bevestigde diagnose van stadium IV NSCLC, wildtype EGFR en EML4/ALK fusie negatief en op zijn minst een lijn platinum behoudende chemotherapie en progressie van ziekte na de laatste systemische behandeling.
    - Patienten dienen wilsbekwaam te zijn en in staat het informed consent te tekenen.
    - 18 jaar of ouder op de dag van het tekenen van informed consent
    - Meetbare ziekte op basis van RECIST 1.1
    - Moeten bereid zijn om een histologisch biopt van een laesie die niet eerder bestraald is, en na de laatste lijn van systemische therapie is te ondergaan om de huidige PD-L1 status te bepalen.
    - Moeten bereid zijn om een tweede biopt te ondergaan als de 18-F-anti-PD-L1 of 89Zr-nivolumab PET-scans heterogene uptake laten zien.
    - Hebben een performance status van 0-1 op de ECOG Performance Scale.
    - Adequate orgaanfunctie.
    - Vrouwelijke proefpersonen die in potentie zwanger kunnen worden moeten een adequate methode van anticonceptie gebruiken gedurende de studie en tot 23 weken na de laatste dosis nivolumab. Vrouwen die niet meer zwanger kunnen worden (bijvoorbeeld vanwege de menopauze of vanwege chirurgische sterilisatie) net zoals mannen die lijden aan azoöspermie behoeven geen anticonceptieve maatregelen te nemen.
    - Mannen die seksueel actief zijn met een vrouw die in potentie zwanger zou kunnen worden moeten een anticonceptiemiddel gebruiken met een betrouwbaarheidspercentage boven de 99%. Mannen die met nivolumab behandeld worden en die seksueel actief zijn met een vrouw die in potentie vruchtbaar is zullen geinstrueerd worden om anticonceptie te gebruiken gedurende de studie en gedurende 31 weken na de laatste gift nivolumab.
    E.4Principal exclusion criteria
    A subject who meets any of the following criteria will be excluded from participation in this study:
    - Is currently participating in or has participated in a study of an investigational agent within 4 weeks of the first dose of treatment or has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
    - Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 0 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
    - Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day 0. Inhaled or topical steroids, and adrenal replacement steroid > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
    - Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
    - Has symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: Subjects with asymptomatic CNS metastases are allowed to enter the study.
    - Has an active autoimmune disease requiring systemic steroid treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids.
    - Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
    - Has an active infection requiring systemic therapy.
    - Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
    - Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
    - Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 23 weeks after the last dose of trial treatment.
    - Has received prior therapy 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 costimulation or immune checkpoint pathways.
    - Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
    - Has known active Hepatitis B or C.
    Een persoon die voldoet aan een van de volgende criteria zal worden geëxcludeerd van deelname in deze studie:
    - neemt momenteel deel aan of heeft deelgenomen aan een studie met een onderzoeksmedicament in de vier weken voorafgaand aan de eerste gift van de behandeling of als men niet is hersteld van de bijwerkingen (dat wil zeggen, < graad 1 of op baseline) veroorzaakt door toegediende medicatie meer dan 4 weken geleden.
    - Heeft eerder chemotherapie, targeted therapy of bestraling gehad in de twee weken voor studiedag 0 of wie niet is hersteld van de bijwerkingen (dat wil zeggen, < graad 1 of op baseline) veroorzaakt door een eerder toegediende medicament.
    - Personen met een aandoening welke systemische behandeling van ofwel corticosteroiden (> 10 mg dagelijkse equivalent van prednison) of andere immunosuppressieve medicatie nodig heeft in de 14 dagen voorafgaand aan studiedag 0. Inhalatie of topicale steroiden en hormoonsuppletie bij bijnierschorsinsufficiëntie met een equivalent van prednison > 10 mg dagelijks is toegestaan in afwezigheid van een actieve autoimmuunziekte.
    - Heeft een bekende tweede primaire tumor die progressie vertoont of actieve therapie eist. Uitzonderingen daarop zijn basaalcelcarcinoom van de huid, plaveiselcelcarcinoom van de huid of in situ cervixcarcinoom die een in potentie curatieve therapie hebben ondergaan.
    - heeft een symptomatische metastase in het centraal zenuwstelsel of een meningitis carcinomatosa.
    - Heeft een actieve autoimmuunziekte waar systemische behandeling met steroiden in de afgelopen drie maanden nodig is geweest of met een gedocumenteerde voorgescheiedenis van klinisch ernstige autoimmuunziekte of een syndroom dat systemische steroiden vereist.
    - Heeft aanwijzingen voor een interstitiële longziekten oif een actieve, niet-infectieuze pneumonitis.
    - Heeft een actieve infectie welke systemische therapie behoeft.
    - Heeft een voorschiedenis of een huidige aanwijzingen voor een aandoening, therapie of laboratorium afwijkingen die mogelijk de resultaten van de studie kunnen beinvloeden, interfereren met de deelname van de patient of waarvan het voor de persoon niet het beste is om deel te nemen, in de ogen van de behandelend onderzoeker.
    - Is bekend met een psychiatrische aandoening of middelenmisbruik, wat zou kunnne interferen met de coöperatie van de vereisten van de studie.
    - Is zwanger of geeft borstvoeding, of is in verwachting vader te worden gedurende de duur van de studie ten tijden van de start van de studie of de periode tot 23 weken na de laatste gift van het studie medicament.
    - Heeft eerder therapie ontvangen met een anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antilichaam, of enige andere antilichamen of medicijnen die zich richten op T-cell costimulaite of immuun checkpoint pathways.
    - Heeft een voorgeschiedenis met HIV.
    - Is bekend met een actieve hepatitis B of C infectie.
    E.5 End points
    E.5.1Primary end point(s)
    Visual and quantitative 18F-anti-PD-L1 and 89Zr-nivolumab uptake measurements in tumor (both tracers) and target irAE tissues (89Zr-nivolumab) and its correlation with blood and tissue immune parameters.
    Visuele en kwantitatieve opname metingen van 18F-anti-PD-L1 en 89Zr-nivolumab (beide tracers) in de tumor en in de target irAE weefsels (89Zr-nivolumab) en de correlatie daarvan met bloed en weefselparameters
    E.5.1.1Timepoint(s) of evaluation of this end point
    Two years after start nivolumab.
    Twee jaar na de start van nivolumab.
    E.5.2Secondary end point(s)
    Not applicable.
    Niet van toepassing.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable.
    Niet van toepassing.
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 No
    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 end of the trial will be two years after the last subject started. Subjects will have post-treatment follow-up for experiencing disease progression, until death, withdrawing consent, becoming lost to follow-up or the start of new anti-neoplastic therapy.
    Het einde van de trial zal twee jaar na het starten van de laatste proefpersoon zijn. Proefpersonen zullen na behandeling worden gevolgd voor ziekteprogressie, tot de dood, het intrekken van het content, lost to follow up of bij de start van een nieuwe behandeling.
    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 months
    E.8.9.1In the Member State concerned days
    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: 7
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state10
    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 post-treatment follow-up for experiencing disease progression, until death, withdrawing consent, becoming lost to follow-up or the start of new anti-neoplastic therapy.
    Proefpersonen zullen na de behandeling gevolgd worden voor tekenen van progressie van ziekte, tot de dood, het intrekken van het consent, lost to folluw op of de start van een nieuwe behandeling gericht tegen kanker.
    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 Decision2016-06-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-25
    P. End of Trial
    P.End of Trial StatusOngoing
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