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    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2006-000753-22
    Sponsor's Protocol Code Number:TV2/003/06
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-04-10
    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 ConcernedUK - MHRA
    A.2EudraCT number2006-000753-22
    A.3Full title of the trial
    A phase I/II feasability trial to assess the safety, immunological activity and efficacy of TroVax plus interferon alpha in patients with advanced or metastatic renal cell cancer.
    A.4.1Sponsor's protocol code numberTV2/003/06
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOxford MioMedica UK 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 nameTroVax
    D.3.2Product code TV
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeTroVax
    D.3.10 Strength
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1.58 x 10e8 to 1.58 x 10e9
    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) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Roferon-A
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Products Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameRoferon-A
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInterferon A
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18 x 10e6
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeCellular metabolism modulator
    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 or Metastatic Renal Cell Cancer
    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 evaluate whether IFN-a markedly increases the cellular or humoral anti-5T4
    response to TroVax compared to that observed in previous studies using TroVax
    alone, in combination with IL-2 or with chemotherapy.
    E.2.2Secondary objectives of the trial
    Though this is a phase I/II feasibility study to assess the safety and immunological
    activity of TroVax combined with IFN-a, tumour response in each patient will also
    be evaluated using RECIST criteria.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Locally advanced or metastatic, histologically proven clear cell or papillary cell renal
    carcinoma.

    If previously treated at least four weeks from any previous therapy (except Interferon a) for renal cancer includi,ng surgery chemotherapy, immunotherapy, or radiotherapy. (Patients receiving interferon a whose renal cancer is stable may also be included in the study)

    Newly diagnosed or progressive of stable measurable disease as defined by the
    RECIST criteria

    Patients receiving first or second line treatment for locally advanced or metastatic renal cancer.

    Patients on stable doses of bisphosphonates that show subsequent tumor progression may continue on this medication; however, patients are not allowed to initiate bisphosphonate therapy within one month prior to starting therapy or throughout the study.

    Patients must be well enough to tolerate first or second line immunotherapy with
    interferon alpha.

    Measurable disease.

    Aged 18 years or more.

    Patients must comply with 2 out of 3 of the following:
    a. Karnofsky score greater than or equal to 80%.
    b. Haemoglobin concentration greater than or equal to 13g/dL (males) or 11.5 g/dL (females)
    c. Corrected calcium less than or equal to 10 g/dL (2.5 mmols/L).

    Clinically immunocompetent.

    Free of clinically apparent autoimmune disease (including no prior confirmed diagnosis or treatment for autoimmune disease including Systemic Lupus Erythematosis, Grave's disease, Hashimoto's thyroiditis, multiple sclerosis, insulin dependant diabetes mellitus or systemic (non-joint) manifestations of rheumatoid disease).

    Total white cell count greater than or equal to 3 x 10e9/L and lymphocyte count greater than or equal to 1 x 10e9/dL.

    Serum creatinine up to 1.5 times upper limit of normal.

    ALT, AST and bilirubin < 2 times the upper limit of normal.

    Able to give written informed consent and to comply with the protocol.

    Women must be either post menopausal, or rendered surgically sterile or, if of child
    bearing potential, must have been practising a reliable form of contraception (oral
    contraception + a barrier method) for at least three months prior to the first dose of
    TroVax and must continue while they are being treated with TroVax. Men must
    practise a reliable form of contraception while they are being treated with TroVax.

    No acute changes on 12-lead ECG.

    No clinical suspicion that cardiac ejection fraction is less than 45% (If clinically
    suspicion exists the ejection fraction should be measured according to local site
    procedures)
    E.4Principal exclusion criteria
    Serious infections within the 28 days prior to entry to the trial.

    Prior TroVax

    Patients that initiate bisphosphonate therapy within one month prior to starting therapy or throughout the study.

    Already completed prior second line therapy for advanced or metastatic renal cancer.
    (Note however that patients currently receiving interferon as second line therapy for
    advanced or metastatic renal cancer who are stable (ie do not demonstrate response or progression by RECIST criteria) may enter the study)

    Major surgery or radiation therapy completed less than or equal to 4 weeks prior to enrollment.

    Prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.

    Participation in any other clinical trial of a licensed or unlicensed drug within the
    previous 30 days. (except sorafanib or sutnitinib who may enter the study after 7 days discontinuation)

    Cerebral metastesis on MRI scan

    "Currently active" second malignancy, other than non-melanoma skin cancer. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at least less than 30% risk of relapse.

    Serious intercurrent infections or nonmalignant medical illnesses that are uncontrolled.

    Psychiatric illnesses/social situations that would limit compliance with protocol
    requirements.

    Creatinine 21.5 x ULN.

    Chronic oral corticosteroid use unless prescribed as replacement therapy in the case
    of adrenal insufficiency.

    Clinical indication of reduced cardiac function or an ejection fraction of r 40%.

    Requirement for radiotherapy (this is a sign of disease progression and is classed as a withdrawal criterion).

    Concurrent chemotherapy, immunotherapy and radiation therapy

    No investigational or commercial agents or therapies other than those included in protocol treatment may be administered with the intent to create regression of the
    patient's malignancy.

    Life threatening illness unrelated to cancer.

    Cerebral metastases on MRI scan.

    History of allergic response to previous vaccinia vaccinations.

    Participation in any other clinical trial of a licensed or unlicensed drug within the
    previous 30 days or during the course of this trial.

    Previous malignancies within the last 10 years other than successfully treated
    squamous carcinoma of the skin or in situ carcinoma of the cervix treated with cone
    biopsy.

    Previous history psychosis or of major a psychiatric disorder requiring hospitalization or any current psychiatric disorder that would impede the patient's ability to provide
    informed consent or to comply with the protocol.

    Known allergy to egg proteins.

    Known to test positive for HIV or hepatitis B or C.

    Pregnancy or lactation.

    Prior history of organ transplantation.
    E.5 End points
    E.5.1Primary end point(s)
    Immunology endpoints
    Antibody response to 5T4 as measured by ELISA
    Cellular response to 5T4 antigen as measured by lFN gamma Elispot

    Primary safety endpoints
    Assessment of the number of adverse events and serious adverse events
    Assessment of safety by analysis of clinical laboratory variables (complete blood
    count and chemistry panel).

    Efficacy endpoint
    Tumour outcomes will be reported according to RECIST criteria.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Tolerability in combination with IFN alpha
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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 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) 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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    Last visit of the last patient undergoing the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-04-10. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 10
    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 Decision2006-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-03-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-09-27
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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