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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2012-002790-55
    Sponsor's Protocol Code Number:116389
    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:2013-03-19
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-002790-55
    A.3Full title of the trial
    A double blind, randomized, placebo controlled phase II study to assess the efficacy of recPRAME +AS15 Antigen-Specific Cancer Immunotherapeutic as adjuvant therapy in patients with resected PRAME-positive, Non-Small Cell Lung Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II study to demonstrate the benefit of a new kind of anti-cancer treatment (PRAME Immunotherapy) for patients with a certain type of lung cancer, after removal of their tumor
    A.3.2Name or abbreviated title of the trial where available
    PRAME-AS15-NSC-002 (ADJ)
    A.4.1Sponsor's protocol code number116389
    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 SponsorGlaxoSmithKline Biologicals
    B.1.3.4CountryBelgium
    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 supportGlaxoSmithKline Biologicals
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Biologicals
    B.5.2Functional name of contact pointClinical Disclosure Advisor
    B.5.3 Address:
    B.5.3.1Street AddressRue de l'Institut 89
    B.5.3.2Town/ cityRixensart
    B.5.3.3Post code1330
    B.5.3.4CountryBelgium
    B.5.4Telephone number+442089904466
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 namerecPRAME + AS15 Antigen-Specific Cancer Immunotherapeutic
    D.3.2Product code PRAME ASCI
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.2Current sponsor coderecPRAME
    D.3.9.3Other descriptive namePD1/3-PRAME-HIS PROTEIN
    D.3.9.4EV Substance CodeSUB31424
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder and solvent for suspension for injection
    D.8.4Route of administration of the placeboIntramuscular use
    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 (Stage IA-T1b, IB, II or IIIA)
    E.1.1.1Medical condition in easily understood language
    Patients with Non-Small cell Lung Cancer
    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 10061873
    E.1.2Term Non-small cell lung cancer
    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
    The primary objective of this study is to evaluate the clinical efficacy of the PRAME ASCI versus placebo in terms of Disease-Free Survival (DFS).
    E.2.2Secondary objectives of the trial
    Secondary objectives are to evaluate in the overall study population, but also separately in the population of patients who did or did not receive adjuvant chemotherapy and presents or does not present the previously identified MAGE-A3 gene signature (GS):
    •The clinical efficacy of the PRAME ASCI versus placebo in terms of overall survival (OS).
    •The clinical efficacy of the PRAME ASCI versus placebo in terms of lung-cancer-specific survival.
    •The clinical efficacy of the PRAME ASCI versus placebo in terms of 2-year, 3-year, 4-year and 5-year DFS rates.
    •The clinical efficacy of the PRAME ASCI versus placebo in terms of disease-free specific survival.
    •The safety of the PRAME ASCI versus placebo in terms of clinical and biological indicators.
    •The immune humoral response to the PRAME ASCI.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •The patient has radically resected (R0) NSCLC
    •The NSCLC is of pathological stage IA-T1b, IB, II or IIIA NSCLC according to the American Joint Cancer Committee (AJCC) TNM Cancer Staging Manual (7th Edition) (TNM classification)
    •The surgical technique for resection of the patient's tumor is anatomical, involving at least a segmentectomy (wedge-resections are not allowed for inclusion in the study)
    •The patient's tumor shows expression of PRAME
    Note: Analysis will be performed on formalin-fixed paraffin-embedded (FFPE) tissue samples.
    •The patient is >= 18 years of age at the time of first consent.
    •Written informed consent has been obtained from the patient prior to performance of any study-specific procedure.
    Note: all procedures conducted as part of the patient’s routine clinical management and done prior to obtaining the informed consent to screening may be used for screening or baseline assessments, provided these procedures were done as specified in the protocol and within the protocol-defined timeframes.
    •The patient is free of disease (no residual tumor, no loco-regional recurrence, no distant metastasis), as confirmed by a post- thoracic surgery contrast-enhanced computed tomography (CT scan) of the chest, upper abdomen and by a contrast-enhanced CT scan or Magnetic Resonance Imaging (MRI) of the brain. Other examinations should be performed as clinically indicated.
    Note that post-thoracic surgery contrast-enhanced chest and upper abdomen CT scans performed up to 6 weeks before randomization and contrast-enhanced brain CT scan or brain MRI performed up to 12 weeks before randomization do not have to be repeated unless clinically indicated.
    In case a post-thoracic surgery contrast-enhanced CT scan of the chest and upper abdomen cannot be performed, this must be replaced by a post-thoracic surgery chest and upper abdomen MRI performed in addition to a post-thoracic surgery CT scan with no-contrast or a Positron emission tomography (PET)-CT scan.
    Note that equivocal findings at imaging should be carefully discussed by the investigator with the radiologist to avoid having ineligible patients entered into the study.
    •ECOG performance status of 0, 1 or 2 at the time of randomization
    •Adequate bone-marrow reserve, adequate renal, hepatic and adrenal function as assessed by standard laboratory criteria, and defined as:
    1. Aboslute neutrophil count- >= 1.0 x 109/L
    2. Platelet count- >= 75x 109/L
    3. Serum cortisol- >= Lower Limit of Normal (LLN)
    4. Serum Creatinine- <= 1.5 times the Upper Limit of Normal (ULN)
    5. Total bilirubin-<= 1.5 times the ULN (Except for patients with Gilbert’s syndrome for whom the limit is <=2 x ULN).
    6. Alanine transaminase (ALT)- <= 1.5 times the ULN
    7. Aspartate aminotransferase (AST)- <= 1.5 times the ULN
    8. Alkaline phosphatase (ALP)- <= 2.5 times the ULN
    •If the patient is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to administration of study product, have a negative pregnancy test and continue such precautions during all study treatment period and for 2 months after last treatment administration.
    •Patients who the investigator believes can and will comply with the requirements of this protocol (e.g. return for active follow-up visits).
    E.4Principal exclusion criteria
    •The patient is diagnosed with a concomitant malignancy AND/OR has a history of malignancy within the past five years OR has had a malignancy that has been in complete remission for less than 5 years. Patients with effectively treated non - melanoma skin cancers or effectively treated carcinoma in situ of the cervix both of which in remission for less than 5 years will be eligible.
    •The patient has received any anti-cancer specific treatment, including radiotherapy, immunotherapy, hormonal therapy, chemotherapy or neo-adjuvant chemotherapy, except for:
    -Administration of adjuvant platinum-based doublet chemotherapy for the treatment of the current NSCLC allowed between surgery and randomization.
    -Treatment of previous malignancies as allowed by the protocol (Please refer to Exclusion criterion 1).
    •The patient has been diagnosed with a pIMD. Patients with vitiligo are not excluded from the study.
    Note: In the event of a patient presenting with a condition considered by the investigator as pIMD but not listed in Table 13 inclusion should be discussed with the sponsor prior to randomization.
    •The patient has a history of confirmed adrenal dysfunction.
    •The patient requires concomitant treatment with any immunosuppressive agent, or with systemic corticosteroids prescribed for chronic treatment (more than 7 consecutive days).
    Note: The use of prednisone (or equivalent) at <= 0.5 mg/kg/day (absolute maximum 40 mg/day) for more than 7 days or at > 0.5 mg/kg/day but for less than 7 consecutive days is allowed. The use of inhaled corticosteroids or topical steroids is also permitted.
    •The patient needs chronic long term oxygen therapy (LTOT), defined as >15hr/day as per the Physicians Consortium for Performance Improvement, American Medical Association (AMA).
    •The patient has medically uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease or myocardial infarction) or uncontrolled arrhythmia at the time of randomization.
    •The patient has an uncontrolled bleeding disorder.
    •The patient has undergone splenectomy.
    •The patient is known to be Human Immunodeficiency Virus (HIV)-positive.
    •The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the trial procedures.
    •The patient has other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
    •The patient has a history of allergic disease or reactions likely to be exacerbated by any component of the study investigational product.
    •The patient has received any investigational or non-registered product within the 30 days preceding randomization, or planned use during the study period.
    •For female patients: the patient is pregnant or lactating or is planning to become pregnant.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be Disease-Free Survival (DFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Disease Free Survival: Once the pre-defined number of events is reached
    E.5.2Secondary end point(s)
    •Overall Survival (OS)
    •Lung-cancer-specific survival
    •Disease-free specific survival (DFSS)
    •DFS at 2, 3, 4 and 5 years after randomization
    •The anti-PRAME antibody concentrations
    •Occurrence of adverse events, including abnormal hematological and biochemical parameters
    •Occurrence of serious adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Overall Survival (OS)- at time of analysis
    •Lung-cancer-specific survival- at time of analysis
    •Disease-free specific survival (DFSS)- at time of analysis
    •DFS at 2, 3, 4 and 5 years after randomization- at time of analysis
    •The anti-PRAME antibody concentrations-Post-treatment
    and 8 months after concluding visit
    •Occurrence of adverse events , including abnormal hematological and biochemical parameters- up to 30 days post last dose of study product administration
    •Occurrence of serious adverse events- during the whole study duration or up to 30 days after the last study product administration
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Translational research
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Japan
    Korea, Republic of
    Russian Federation
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 taking part in the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days10
    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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 110
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 135
    F.4.2.2In the whole clinical trial 220
    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)
    Expected normal treatment
    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 Decision2013-04-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-08-24
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