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    Summary
    EudraCT Number:2010-022757-42
    Sponsor's Protocol Code Number:IMM-101-002
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-19
    Trial results View 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 number2010-022757-42
    A.3Full title of the trial
    A Randomised, Open-Label, Proof-of-Concept, Phase II Trial Comparing Gemcitabine with and without IMM-101 in Advanced Pancreatic Cancer
    Studio proof-of-concept di fase II, randomizzato, in aperto, finalizzato a confrontare la Gemcitabina (GEM) con e senza IMM-101 nel trattamento del Carcinoma Pancreatico Avanzato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II Study Comparing the effects of Gemcitabine with and without IMM-101 in Advanced Pancreatic Cancer
    Studio di fase II finalizzato a confrontare gli effetti della Gemcitabina con e senza IMM-101 nel Carcinoma Pancreatico Avanzato
    A.4.1Sponsor's protocol code numberIMM-101-002
    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 SponsorIMMODULON THERAPEUTICS LTD
    B.1.3.4CountryUnited Kingdom
    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 supportImmodulon Therapeutics Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImmodulon Therapeutics Limited
    B.5.2Functional name of contact pointClinical Trials co-ordinator
    B.5.3 Address:
    B.5.3.1Street AddressThe London Clinical Cancer Centre
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW1G 6JA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 0203 219 3568
    B.5.5Fax number+44 0207 224 280
    B.5.6E-mailIlda@immodulon.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 nameIMM-101
    D.3.2Product code Heat-killed whole cell Mycobaterium obuense
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeIMM-101
    D.3.9.3Other descriptive nameM. obuense
    D.3.9.4EV Substance CodeNA
    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 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 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 Yes
    D.3.11.13.1Other medicinal product typecellule intere di mycobacterium obuense inattivato con calore
    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
    Advanced pancreatic cancer. The overall objective of this clinical study is to evaluate a potential synergy between gemcitabine and IMM-101 and any beneficial effect this may have on safety and tolerability, QoL, clinical signs and symptoms of disease, disease outcome and selected markers of tumour burden and immunological status in patients with inoperable, locally advanced or metastatic pancreatic cancer.
    Carcinoma Pancreatico Avanzato. Obiettivo generale di questo studio clinico è valutare una potenziale sinergia tra gemcitabina e IMM-101 in pazienti con cancro al pancreas inoperabili localmente avanzato o metastatico e ogni altro effetto benefico che si potrebbe avere su: sicurezza e tollerabilità, qualità di vita, segni e sintomi clinici della malattia, esito della malattia e marcatori selezionati del carico tumorale e lo stato immunologico
    E.1.1.1Medical condition in easily understood language
    Advanced pancreatic cancer
    Cancro al pancreas avanzato
    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 LLT
    E.1.2Classification code 10033606
    E.1.2Term Pancreatic cancer non-resectable
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    No clinically relevant deleterious effect of IMM-101 on safety and tolerability profiles as judged by: • Local and systemic toxicities. • Number, type and degree of toxicities as measured by the NCI CTCAE v4.0. • QoL (EORTC QLQ-C30 supplemented with EORTC QLQ-PAN26).
    Nessun effetto clinicamente rilevante di IMM-101 su profili di sicurezza e tollerabilità valutato con: • tossicità locale e sistemica. • numero, tipo e grado di tossicità, misurato con NCI CTCAE v4.0. • qualità di vita (EORTC QLQ-C30 integrato con EORTC QLQ-PAN26).
    E.2.2Secondary objectives of the trial
    A clinically relevant improvement in one or more markers of disease status and progression: • Overall survival (OS). • Progression-free survival (PFS). • Overall response rate (ORR). • Reduction in metastatic disease • Circulating levels of carbohydrate antigen 19.9 (CA19.9). • Circulating levels of carcinoembryonic antigen (CEA). • Nutritional status (weight, appetite, serum albumin). • Pain control and analgesic use. Exploratory endpoints may include:•A change in levels of circulating tumour cells consistent with a reduction or stabilisation of tumour burden. •A change in one or more markers of immune status based on cellular involvement or cytokine/immune mediator production.
    Un miglioramento clinicamente rilevante in una o più marcatori dello stato e della progressione della malattia: • sopravvivenza complessiva (OS). • la sopravvivenza libera da progressione (PFS). • percentuale di risposta complessiva (ORR). • Riduzione nella malattia metastatica • livelli circolanti di antigene carboidratico 19.9 (CA19.9). • livelli circolanti di antigene carcino-embrionario (CEA). • Stato nutrizionale (peso, appetito, albumina sierica). • controllo deldolore e uso di analgesici. Gli endpoint esploratori possono comprendere: • un cambiamento nei livelli di cellule tumorali circolanti in linea con la riduzione o la stabilizzazione del carico tumorale. • Un cambiamento di uno o più marcatori dello stato immunitario basato sul coinvolgimento cellulare o produzione citochine / mediatore immunitario
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Histologically and/or cytologically confirmed inoperable ductal adenocarcinoma of the pancreas, including the mucinous variant. This will include locally advanced and metastatic disease (stage III/IV). Presence of measurable lesions in at least one site which have not been previously irradiated (bone lesions, ascites and pleural effusions are not considered as measurable), described as any of the following: • Any primary tumour with at least bi-dimensionally measurable disease. • a) Palpable lymph nodes, b) Deep seated lymph nodes. • Liver metastases measurable by computerised tomography (CT) scan. • Deep seated soft tissue lesions measurable by CT scan. WHO performance status of 0-2. Serum creatinine <140 ╬╝mol/L. White blood cell (WBC) count, including differential counts within the normal range. Life expectancy, in the opinion of the Investigator, of >3 months from randomisation. Provide written informed consent to participate as shown by a signature and date on the patient's informed consent form (ICF)
    Adenocarcinoma duttale inoperabile del pancreas, compresa la variante mucinosa, confermato all’esame istologico e/o citologico; sono inclusi il tumore localmente avanzato e metastatico (stadio III/IV). Presenza in almeno un sito di lesioni misurabili, non precedentemente irradiate (non sono considerate misurabili lesioni ossee, asciti ed effusioni pleuriche), descritte come una qualsiasi delle seguenti: • qualsiasi tumore primario con almeno una malattia misurabile bidimensionalmente; • a) linfonodi palpabili, b) linfonodi profondi; • metastasi epatiche misurabili alla tomografia computerizzata (TC); • lesioni profonde dei tessuti molli misurabili alla TC; Presentano un Performace Status secondo l’OMS di 0-2; Livelli di creatinina sierica &lt;140 µmol/l; Conta dei globuli bianchi (WBC), compresa la conta differenziata, entro i limiti di norma; Aspettativa di vita, secondo l'opinione dello Sperimentatore, &gt;3 mesi dalla randomizzazione; Aver dato consenso informato scritto a partecipare, come confermato dalla firma e dalla data apposte sul Modulo di consenso informato del paziente (ICF).
    E.4Principal exclusion criteria
    Patients will be ineligible if one or more of the following statements are applicable: Patient has acinar cell carcinoma, neuroendocrine tumours, lymphomas or squamous cell carcinomas. Patient has severe, active uncontrolled infection requiring systemic antibiotics, antiviral or antifungal treatments. Patient has been on any previous chemotherapy treatment for pancreatic cancer. Patient is eligible for resection of the pancreatic primary tumour but has either refused the operation or is considered to be medically unfit for the operation. Patient has clinical or CT evidence of central nervous system (CNS) metastases. Patient has any previous or concurrent malignancy, except adequately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin and/or non-melanoma skin cancer, or if previous malignancy was more than 5 years prior and there are no signs of recurrence. Patient has serum albumin < 26 g/L. Patient has a C-reactive protein (CRP) > 70 mg/L. Patient has had radiotherapy in the 6 weeks prior to screening. Patient has used depot corticosteroids in the 6 weeks prior to screening. Patient has had chronic use of any systemic corticosteroids (>10 mg per day of prednisolone or equivalent for a period of 2 weeks or more) and/or immunosuppressant drugs (such as azathioprine, tacrolimus, cyclosporin) within the 2-week period prior to the first administration of study drug. Female patient of child-bearing potential who is not, in the opinion of the Investigator, using an approved method of birth control (e.g. physical barrier [patient and partner], contraceptive pill or patch, spermicide and barrier, or intrauterine device [IUD]). Those patients that utilise hormonal contraceptives must have used the same method for at least three months before study dosing. Patient of non-child-bearing potential are defined as having 12 month amenorrhoea or are surgically sterile. Female patient who is pregnant, breast feeding or planning a pregnancy during the course of the study. A pretreatment serum pregnancy test measuring human chorionic gonadotrophin (HCG) must be negative. Patient has been administered any investigational drug, vaccine or device in the 3 months prior to screening. Patient has a surgical or medical condition which, in the judgement of the Investigator, might interfere with the activity of IMM-101, or with the performance of this study. Patient has presence of any uncontrolled concomitant disease (e.g. unstable angina pectoris, congestive heart failure, myocardial infarction, arrhythmias, uncontrolled severe hypertension) which, in the judgement of the Investigator, might interfere with the activity of IMM-101, or with the performance of this study. Patient has a history of serious adverse reaction or serious hypersensitivity to any drug. Patient has had any previous treatment with IMM-101 or related mycobacterial immunotherapy. Patient is known to have a history of human immunodeficiency virus (HIV) or syphilis, current symptomatic Hepatitis B or C. Testing is not required in the absence of clinical signs and symptoms suggestive of infection with HIV. Patient is unable or unwilling to comply with the protocol.
    Non saranno eleggibili i pazienti che soddisfano uno o più dei seguenti criteri: Paziente con carcinoma a cellule acinari, tumori neuroendocrini, linfomi o carcinomi a cellule squamose; Paziente con grave infezione in atto, non controllata, che necessita di trattamento antibiotico sistemico, antivirale o antifungino; Somministrazione di qualsiasi precedente chemioterapia per carcinoma pancreatico;. Il paziente è eleggibile per l‘asportazione del tumore pancreatico primario, ma ha rifiutato l'intervento o è stato considerato non medicamente idoneo per l'intervento; Presenza di evidenza clinica o alla TC di metastasi al sistema nervoso centrale (SNC); Presenza di qualsiasi neoplasia maligna, pregressa o concomitante, ad eccezione del carcinoma in situ adeguatamente trattato della cervice, carcinoma basocellulare della cute e/o neoplasia cutanea non-melanoma, oppure se la precedente neoplasia maligna si è manifestata da più di 5 anni e sono assenti segni di recidiva; Concentrazione di albumina sierica &lt;26 g/l; Concentrazione della proteina C reattiva (PCR) &gt;70 mg/l; Ricevimento di radioterapia nelle 6 settimane precedenti lo screening; Uso di corticosteroidi depot nelle 6 settimane precedenti lo screening; Uso cronico di qualsiasi corticosteroide sistemico (&gt;10 mg/die di prednisolone o equivalente per un periodo di 2 o più settimane) e/o di farmaci immunosoppressivi (quali azatioprina, tacrolimus, ciclosporina) nelle 2 settimane precedenti la prima somministrazione del farmaco in studio; Donne in età fertile che, a giudizio dello Sperimentatore, non adottano un metodo contraccettivo approvato (ad es. barriera fisica [paziente e partner], pillola contraccettiva, patch contraccettivo, spermicida e barriera, o dispositivo intrauterino [IUD]); le pazienti che fanno uso di contraccettivi ormonali devono aver utilizzato lo stesso metodo da almeno tre mesi prima della somministrazione della dose del farmaco in studio; per paziente potenzialmente non fertile si intende una paziente con amenorrea da almeno 12 mesi o sottoposta a sterilizzazione chirurgica; Donne in gravidanza, che allattano o che prevedono di iniziare una gravidanza nel corso dello studio; il test di gravidanza sul siero, effettuato prima del trattamento per misurare la gonadotropina corionica umana (HCG) deve essere negativo; Somministrazione di qualsiasi prodotto sperimentale, ad es. farmaco, vaccino o dispositivo, nei 3 mesi precedenti lo screening; Presenza di una condizione chirurgica o medica che, a giudizio dello Sperimentatore, potrebbe interferire con l’attività di IMM-101 o con l’esecuzione di questo studio; Presenza di qualsiasi patologia concomitante non controllata (ad es. angina pectoris instabile, insufficienza cardiaca congestizia, infarto miocardico, aritmie, grave ipertensione non controllata) che, a giudizio dello sperimentatore, potrebbero interferire con l’attività di IMM-101 o con l’esecuzione del presente studio; Anamnesi di reazione avversa seria o di grave ipersensibilità a qualsiasi farmaco; Ricevimento di qualsiasi precedente trattamento con IMM-101 o immunoterapia micobatterica correlata; Anamnesi nota di infezione da virus dell’immunodeficienza umana (HIV) o di sifilide, di epatite B o C sintomatica in atto; in assenza di segni e sintomi clinici indicativi di infezione da HIV, il test non è richiesto; Paziente non è in grado o non vuole rispettare il protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    No clinically relevant deleterious effect of IMM-101 on safety and tolerability profiles as judged by: Local and systemic toxicities.Number, type and degree of toxicities as measured by the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) v4.0. QoL (EORTC QLQ-C30 questionnaire supplemented by the pancreas cancer specific EORTC QLQ-PAN26 questionnaire).
    Nessun effetto clinicamente rilevante di IMM-101 su profili di sicurezza e tollerabilità valutato con: • tossicità locale e sistemica. • numero, tipo e grado di tossicità, misurato con NCI CTCAE v4.0. • qualità di vita (EORTC QLQ-C30 integrato con EORTC QLQ-PAN26).
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 6 months and 12 months treatment
    Dopo 6 e 12 mesi di trattamento.
    E.5.2Secondary end point(s)
    A clinically relevant improvement in one or more markers of disease status and progression: • Overall survival (OS). • Progression-free survival (PFS). • Overall response rate (ORR). • Reduction in metastatic disease. • Circulating levels of carbohydrate antigen 19.9 (CA19.9). • Circulating levels of carcinoembryonic antigen (CEA). • Nutritional status (weight, appetite, serum albumin). • Pain control and analgesic use
    Un miglioramento clinicamente importante in uno o più marcatori dello stato e della progressione della patologia: • Sopravvivenza totale • Sopravvivenza libera da progressione • Percentuale di risposta complessivo • Riduzione della malattia metastatica • Livelli circolanti dell’antigene carboidratico 19.9 (CA19.9) • Livelli circolanti dell’antigene carcinoembrionico (CEA) • Stato nutrizionale (peso, appetito, albumina sierica) • Controllo del dolore e uso di analgesici
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 6 months and 12 months treatment
    Dopo 6 e 12 mesi di trattamento.
    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 Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Trattamento standard (Gemcitabina)
    Standard of care (Gemcitabine)
    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 EEA20
    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 months42
    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 months0
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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)
    At the end of the 12-cycle treatment phase, all surviving patients will be offered the opportunity to enter a longterm follow-up study (under a separate protocol - still to be defined) or their oncologist can continue to treatment on a named patient basis
    Alla fine della fase di trattamento di 12 cicli, a tutti i pazienti sopravvissuti sarà data la possibilità di entrare in una sperimantazione di follow up a lungo termine (con un protocollo separato – ancora da definire) o il loro oncologo continuerà il trattamento in base all’esigenza del paziente
    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 Decision2011-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-01-14
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