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    Summary
    EudraCT Number:2020-003680-25
    Sponsor's Protocol Code Number:CNAO_44-2021C_ICONIC
    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:2021-06-04
    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 number2020-003680-25
    A.3Full title of the trial
    Immune checkpoint inhibitors and Carbon iON radiotherapy In solid Cancers with stable disease (ICONIC)
    Gli inibitori dei checkpoint immunitari e la radioterapia con ioni carbonio in pazienti con tumori solidi e malattia stabile (ICONIC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to investigate the combination of carbon ions radiation therapy to
    immunotherapy in advanced stage cancers treatment
    Studio clinico per indagare sull'associazione tra la radioterapia con ioni carbonio e
    l'immunoterapia per il trattamento di tumori in stadio avanzato
    A.3.2Name or abbreviated title of the trial where available
    ICONIC
    ICONIC
    A.4.1Sponsor's protocol code numberCNAO_44-2021C_ICONIC
    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 CNAO Centro Nazionale di Adroterapia Oncologica
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCNAO
    B.5.2Functional name of contact pointDirezione Scientifica
    B.5.3 Address:
    B.5.3.1Street Addressstrada Campeggi 53
    B.5.3.2Town/ cityITALIA (IT)
    B.5.3.3Post code27100
    B.5.3.4CountryItaly
    B.5.4Telephone number0382078613
    B.5.6E-mailcristina.bono@cnao.it
    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.2.5The 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 namePembrolizumab
    D.3.2Product code [044386]
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravesical use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEMBROLIZUMAB
    D.3.9.2Current sponsor codeAIC 044386
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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
    • Unresectable or metastatic melanoma
    • Locally advanced or metastatic non-small cell lung cancer
    (NSCLC)
    • Untreated recurrent/metastatic head & neck sqamous cell carcinoma
    (HNSCC)
    • Locally advanced or metastatic urothelial carcinoma
    • Melanoma non resecabile o metastatico
    •. Cancro del polmone non a piccole cellule (NSCLC) localmente avanzato o
    metastatico
    • Carcinoma a cellule squamose del testa-collo (HNSCC) non trattato, r
    recidiva/metastatico
    • Carcinoma uroteliale localmente avanzato o metastatico
    E.1.1.1Medical condition in easily understood language
    Metastatic tumors, locally advanced/unresectable (melanoma, lung cancer, head-neck carcinoma, urothelial carcinoma)
    Tumore con metastasi, localmente avanzato o non operabile (melanoma, cancro del polmone, carcinoma testa-collo, carcinoma uroteliale)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10027467
    E.1.2Term Metastases to specified sites
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 estimate the effect, in terms of clinical response, of immunotherapy associating carbon ion treatment in the palliative setting across different malignancies, for which immunotherapy is currently the standard of care.
    Valutare l’effetto, in termini di risposta clinica, della immunoterapia associata al trattamento con ioni carbonio, in situazioni palliative e in differenti patologie per le quali l’immunoterapia è oggi pratica clinica.
    E.2.2Secondary objectives of the trial
    1. To describe the safety profile of the association of carbon ion radiation therapy and systemic immunotherapy in the palliative setting across different malignancies, for which immunotherapy is currently the standard of care
    2. To estimate the effect, in terms of survival, of immunotherapy with the association of carbon ion radiation treatment in the palliative setting across different malignancies, for which immunotherapy is currently the standard of care.
    1. Descrivere il profilo di sicurezza dell’associazione CIRT-immunoterapia in situazioni palliative in diverse patologie, per le quali l’immunoterapia è attualmente pratica clinica
    2. Valutare l’effetto, in termini di sopravvivenza, dell’immunoterapia associata alla CIRT in situazioni palliative in diverse patologie, per le quali l’immunoterapia è attualmente pratica clinica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Signed written informed consent
    2) Histologic confirmation of malignancies under treatment with single agent anti-PD1/PDL1 immunotherapy per clinical practice (see cohort specific inclusion criteria) with immune checkpoint inhibitors approved by Italian national drug regulatory agencies (Agenzia Italiana del Farmaco, AIFA)
    3) Having a disease stability as assessed by AIFA monitoring sheet
    4) Presence of at least 2 measurable target lesions, of which at least one to be followed up as per RECIST and one suitable for CIRT
    5) Willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study
    6) Females and males, 18 years of age or older (no upper limit for age)
    7) Eastern Cooperative Oncology Group (ECOG) performance status = 2
    8) Subjects must have measurable disease by CT or MRI per RECIST 1.1
    1) Consenso informato rilasciato per iscritto
    2) Conferma istologica di patologie sotto trattamento con un singolo agente immunoterapico anti PD1/PDL come da pratica clinica (criteri d’inclusione specifici per ogni coorte), possibilmente con principi approvati (ove applicabile) dalle agenzie regolatorie del farmaco nazionali e/o internazionali (es. FDA, EMA or AIFA)
    3) Malattia stabile come definito dalla scheda di monitoraggio AIFA
    4) Presenza di almeno 2 lesioni bersaglio, delle quali una da monitorare secondo i criteri RECIST ed una adeguata alla somministrazione di CIRT
    5) Volontà e capacità di rispettare le visite programmate, il programma di trattamento, gli esami di laboratorio ed altre eventuali necessità dello studio
    6) Uomini e donne =18 anni
    7) Eastern Cooperative Oncology Group (ECOG) performance status = 2
    8) Soggetti con malattia quantificabile da TC o RMN secondo i criteri RECIST
    E.4Principal exclusion criteria
    1) Patients treated with chemo-immunotherapy associations
    2) Patients treated with immunotherapy combinations (e.g. subjects treated with anti-CTLA4 + anti-PD1/PDL1 are excluded)
    3) Patients receiving immunotherapy within clinical trials
    4) Patients receiving off-label immunotherapy or within expanded access programs or as compassionate use
    5) Patients with high tumor burden defined as > 10 lesions and/or sum of diameters > 19 cm
    6) Patients with distant metastases only located in the CNS are excluded
    7) 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
    8) Patients with autoimmune diseases (ADs), including local and systemic collagen-vascular (CVD) and inflammatory bowel diseases (IBD). Controlled
    9) Previous RT, regardless of energy, on the metastatic site selected to be irradiated.
    10) Any immune-related CTCAE grade 4 adverse event, before study entry.
    11) Any CTCAE grade=3 immune-related adverse event observed within 3 weeks prior to CIRT start
    12) Presence of metal prostheses or any other condition to prevent adequate imaging for identification of the target volume and calculation of the dose
    13) Loco-regional conditions not allowing hadron therapy (e.g. active infections in RT target region)
    14) Prisoners or subjects who are involuntarily incarcerated
    15) Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness (e.g. infectious disease)
    1) Pazienti sottoposti a trattamento chemo-immunoterapico
    2) Pazienti trattati con combinazioni di farmaci immunoterapici (es. soggetti sottoposti a trattamento combinato anti-CTLA4 + anti PD1/PDL1 sono esclusi)
    3) Pazienti trattati con immunoterapia arruolati in trial clinici
    4) Pazienti trattati con farmaci immunoterapici off-label o nell'ambito di un programma di uso compassionevole o accesso esteso
    5) Pazienti con un alto carico tumorale definito come > 10 lesioni e/o somma dei diametri >19 cm
    6) Pazienti con metastasi a distanza localizzate solo nel sistema nervoso centrale (SNC)
    7) Ogni problema medico serio o incontrollato che, a giudizio dello sperimentatore, potrebbe aumentare il rischio associato alla partecipazione allo studio o alla somministrazione del farmaco, compromettere l’abilità del soggetto di ricevere la terapia dello studio, o interferire con l’interpretazione dei risultati dello studio.
    8) Soggetti con malattie autoimmuni (AD), compresa la malattia vascolare del collagene locale e sistemica, e con malattia infiammatoria intestinale (IBD)
    9) Qualsiasi evento avverso di grado 4, come da CTCAE, prima dell’arruolamento
    10) Qualsiasi evento avverso di grado = 3 da CTCAE immuno-correlato, osservato nelle 3 settimane precedenti all’inizio della CIRT
    11) Presenza di protesi metalliche o qualsiasi altra condizione che impedisca un imaging adeguato per l’identificazione del volume bersaglio e del calcolo della dose
    12) Condizioni loco-regionali che non permettano l’adroterapia (es. infezioni attive nella regione bersaglio della RT)
    13) Prigionieri o soggetti involontariamente detenuti
    14) Soggetti trattenuti obbligatoriamente per trattamenti psichiatrici e per malattie fisiche (es. malattie infettive).
    E.5 End points
    E.5.1Primary end point(s)
    objective response rate (ORR) according to RECIST, assessed at least 8 weeks after CIRT
    Tasso di risposta obiettiva (ORR) secondo i criteri RECIST, almeno 8 settimane dopo CIRT
    E.5.1.1Timepoint(s) of evaluation of this end point
    at least 8 weeks after CIRT
    almeno 8 settimane dopo CIRT
    E.5.2Secondary end point(s)
    progression-free survival (PFS); overall survival (OS); Tasso di risposta obiettiva (ORR) secondo i criteri irRECIST; percentage of patients with disease progression as best response; objective response of the metastatic lesion treated with CIRT; disease control rate (DCR) according to RECIST, defined as ORR+SD; toxicity according to CTCAE version 5.0
    Sopravvivenza libera da progressione (PFS); 3. Sopravvivenza complessiva (OS); objective response rate (ORR) according to irRECIST; Percentuale di pazienti con progressione di malattia come migliore risposta; Risposta obiettiva della lesione metastatica trattata con CIRT; 7. Tasso di controllo della malattia secondo RECIST, definito come ORR + SD; 1. Tossicità in accordo con CTCAE, versione 5.0
    E.5.2.1Timepoint(s) of evaluation of this end point
    at least 8 weeks after CIRT; at least 8 weeks after CIRT; at least 8 weeks after CIRT; at least 8 weeks after CIRT; at least 8 weeks after CIRT; at least 8 weeks after CIRT; at least 8 weeks after CIRT
    almeno 8 settimane dopo CIRT; almeno 8 settimane dopo CIRT; almeno 8 settimane dopo CIRT; Almeno 8 settimane dopo CIRT; almeno 8 settimane dopo CIRT; almeno 8 settimane dopo CIRT; almeno 8 settimane dopo CIRT
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 Yes
    E.8.1.7.1Other trial design description
    Studio a canestro
    basket trial
    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.8.2.4Number of treatment arms in the trial1
    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 concerned3
    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 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
    LVSL
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 27
    F.4.2.2In the whole clinical trial 27
    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)
    During immunotherapy and after radiation therapy, the patient will undergo to assessments and evaluation according to the referring physician. 24 months is the follow up period foreseen by the study when the patient will be followed by the referring physician. If there is evidence of progression disease the referring physician, together with radiation oncologists, who have provided radiation therapy, will decide other therapies.
    Durante l'immunoterapia e dopo la radioterapia il paziente verrà sottoposto agli accertamenti e valutazione come da indicazione del medico curante. Il periodo di follow-up previsto dallo studio è di 24 mesi e verrà seguito dal medico curante. Se si verifica progressione di malattia, il medico curante con gli oncologi radioterapisti che hanno somministrato la radioterapia valuteranno le eventuali terapie.
    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 Decision2021-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-16
    P. End of Trial
    P.End of Trial StatusOngoing
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