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    Summary
    EudraCT Number:2012-001786-32
    Sponsor's Protocol Code Number:IRST172.03
    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:2012-07-23
    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 number2012-001786-32
    A.3Full title of the trial
    Radiotherapy as an immunological booster in patients with metastatic melanoma or renal cell carcinoma treated with High-dose Interleukin-2: evaluation of biomarkers of immunologic and therapeutic response
    Radioterapia come stimolo immunologico in pazienti con melanoma o carcinoma renale metastatico trattati con alte dosi di Interleuchina-2: studio della risposta immune e dei marcatori biologici potenzialmente predittivi di risposta clinica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Radiotherapy as an immunological booster in patients with metastatic melanoma or renal cell carcinoma treated with High-dose Interleukin-2: evaluation of biomarkers of immunologic and therapeutic response
    Radioterapia come stimolo immunologico in pazienti con melanoma o carcinoma renale metastatico trattati con alte dosi di Interleuchina-2: studio della risposta immune e dei marcatori biologici potenzialmente predittivi di risposta clinica
    A.3.2Name or abbreviated title of the trial where available
    IL2HD
    IL2HD
    A.4.1Sponsor's protocol code numberIRST172.03
    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 SponsorISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI
    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 supportMinistero della Salute-Ricerca Finalizzata 2009 (RF-2009-1547242)
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRST
    B.5.2Functional name of contact pointdata manager
    B.5.3 Address:
    B.5.3.1Street Addressvia Piero Maroncelli, 40
    B.5.3.2Town/ cityMeldola
    B.5.3.3Post code47014
    B.5.3.4CountryItaly
    B.5.4Telephone number0534 739261
    B.5.5Fax number0543 739290
    B.5.6E-maill.valmorri@irst.emr.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.2.1.1.1Trade name PROLEUKIN*EV 1F 18MUI
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS FARMA SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical form 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 INNALDESLEUKIN
    D.3.9.1CAS number 110942-02-4
    D.3.9.4EV Substance CodeSUB05303MIG
    D.3.10 Strength
    D.3.10.1Concentration unit million IU million international units
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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 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
    metastatic melanoma or renal cell carcinoma
    melanoma o carcinoma renale metastatico
    E.1.1.1Medical condition in easily understood language
    metastatic melanoma or renal cell carcinoma
    melanoma o carcinoma renale metastatico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10038414
    E.1.2Term Renal cell carcinoma stage IV
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10025671
    E.1.2Term Malignant melanoma stage IV
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10025670
    E.1.2Term Malignant melanoma stage III
    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
    1. to determine the tumor antigen-specific immune response induced by the treatment 2. to prospectively determine the predictive/prognostic value of pretreatment biological features in identifying patients who will benefit from HDIL-2-based therapy
    1. Determinare la risposta immunologica antitumorale antigene-specifica indotta dal trattamento. 2. Determinare in maniera prospettica il valore predittivo/prognostico di marcatori biologici pre-trattamento per una miglior selezione dei pazienti.
    E.2.2Secondary objectives of the trial
    1. Toxicity 2. Response Rate 3. Overall Survival.
    1.Tossicita' 2.Risposta obbiettiva 3.Sopravvivenza
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients, aged ≥ 18 years, with a diagnosis of histologically confirmed non resectable stage III or IV advanced melanoma or Renal Cell Carcinoma (RCC) 2. Patients with a minimum of two lesions, one of which must be measurable 3. At least one tumor lesion accessible for bioptic sampling. 4. Prior lines (maximum 4) of chemotherapy, immunotherapy or biological therapy for advanced disease are allowed (patients must have finished prior treatments at least 4 weeks before the first IL2 dose); 5. Good performance status (ECOG performance status ≤1 ) and adequate organ function: - leukocytes >3,500/microL - absolute neutrophil count >1,500/microL - platelets >100,000/microL - total bilirubin within normal institutional limits - AST(SGOT)/ALT(SGPT) <2.5 X ULN - creatinine <1,2 mg/dl - hemoglobin >9.0 gm/dl - ECG and echocardiogram within normal institutional limits - pulmonary function tests within normal institutional limits (to be performed only in patients with lung metastases or history of impaired lung function) 6. No contraindication for the use of vasopressor agents 7. An estimated survival of at least 3 months.
    1. Pazienti, con eta' ≥ 18 anni, con diagnosi istologicamente confermata di melanoma stadio III non resecabile o IV o carcinoma renale stadio IV (RCC) 2. Presenza di almeno 2 lesioni valutabili 3. Almeno 1 lesione biopsiabile. 4. Sono permesse al massimo 4 linee di terapia precedenti (sia chemioterapia, immunoterapia o terapie biologiche) per malattia avanzata (i pazienti devono aver terminato un precedente trattamento dal almeno 4 settimane) 5. Buon performance status (ECOG ≤1 ) ed esami ematologici nella norma o entro i seguenti parametri - leucociti &gt;3,500/microL - neutrofili (numero assoluto) &gt;1,500/microL - piastrine &gt;100,000/microL - bilirubina totale entro valori normali riferito al range del laboratorio analisi locale - AST(SGOT)/ALT(SGPT) &lt;2.5 X ULN - creatinina &lt;1,2 mg/dl - emoglobina &gt;9.0 mg/dl - ECG ed ecocardiogramma nella norma - test di funzionalita' respiratoria nella norma (da eseguirsi solo in pazienti con metastasi polmonari o malattie acute/croniche che possono compromettere la funzionalita' respiratoria) 6. Nessuna controindicazione ad assumere farmaci vasopressori 7. Aspettativa di vita di almeno 3 mesi.
    E.4Principal exclusion criteria
    1. Patients with stage I or II melanoma or RCC 2. Previous chemotherapy or radiotherapy or immunotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C). 3. Current brain metastases 4. History of allergic reactions attributed to IL2 or similar compounds 5. Any autoimmune disease which could be exacerbated by IL-2 6. A medical illness requiring chronic treatments with corticosteroids or other immunosuppressive agents 7. A history of significant cardiovascular disease, including myocardial infarction, congestive heart failure, primary cardiac arrhythmias, angina pectoris or cerebrovascular accident 8. Uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 9. Other malignant neoplasia with a disease-free interval of less than 5 years (except for previously treated basal cell carcinoma and in situ carcinoma of the uterine cervix) 10. HIV-positivity
    1. melanoma o RCC stadio I e II 2. Precedenti terapie per malattia metastatica terminate prima di 4 settimane (6 settimane per nitrosuree o mitomicina C). 3. Metastasi cerebrali 4. Anamnesi positiva per allergia al’IL-2 5. Malattie autoimmuni che possano essere esacerbate dall’IL-2 6. Qualsiasi patologia che richieda trattamenti cronici con corticosteroidi o farmaci immunosoppressivi. 7. Anamensi positiva per patologie cardiovascolari severe. 8. Gravi patologie cardiovascolari, infettive, o psichiatriche in corso e non controllate che possano compromettere la compliance allo studio. 9. Anamnesi positiva per neoplasia con disease-free survival inferiore ai 5 anni (eccezione per carcinoma basocellulare e carcinoma in situ della cervice uterina) 10. Positivita' all’HIV
    E.5 End points
    E.5.1Primary end point(s)
    1) immunological efficacy, as assessed by quantification of circulating immune effectors specific for a selected panel of tumor antigens. 2) predictive value of pretreatment serum biomarkers in identifying patients who will benefit from high dose IL-2 based therapy.
    1) l’efficacia immunologica, valutata tramite la quantificazione degli effettori immunologici circolanti specifici per un selezionato pannello di antigeni tumorali. 2) il valore predittivo dei biomarcatori sierici pre-trattamento per l’identificazione dei pazienti che potranno beneficiare della terapia con alte dosi di IL-2.
    E.5.1.1Timepoint(s) of evaluation of this end point
    36 months
    36 mesi
    E.5.2Secondary end point(s)
    Secondary endpoints will be toxicity, the response rate (RR) and the overall survival (OS).
    Gli endpoints secondari saranno la tossicita', il tasso di risposta (RR) e la sopravvivenza globale (OS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    36 months
    36 mesi
    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 Yes
    E.6.13.1Other scope of the trial description
    evaluation of immunological response factors and predictive factors of clinical response
    valutazione di fattori di risposta immunologica e di fattori predittivi di risposta clinica
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months36
    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.1.1Number of subjects for this age range: 0
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state19
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 19
    F.4.2.2In the whole clinical trial 19
    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)
    Patients who completed the treatment will enter in follow-up phase: every 3 months they will be evaluated for clinical conditions, laboratory tests and tumor re-staging will be performed and data on disease progression and the onset of cancer treatment will be collected.
    I pazienti che hanno completato il trattamento entreranno nella fase di follow-up: ogni 3 mesi saranno oggetto di valutazione clinica, laboratoristica, di re-staging tumorale e di raccolta di informazioni sull'eventuale progressione di malattia e l'inizio di nuove terapie antineoplastiche.
    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 Decision2012-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-16
    P. End of Trial
    P.End of Trial StatusOngoing
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