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    Summary
    EudraCT Number:2012-001852-20
    Sponsor's Protocol Code Number:UV1/hTERT-2012-L
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-09-13
    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 ConcernedNorway - NOMA
    A.2EudraCT number2012-001852-20
    A.3Full title of the trial
    A PHASE I/IIa STUDY OF UV1 VACCINATION IN PATIENTS WITH NON-SMALL CELL LUNG CANCER
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PHASE I/IIa STUDY OF VACCINE THERAPY IN PATIENTS WITH NON-SMALL CELL LUNG CANCER
    A.4.1Sponsor's protocol code numberUV1/hTERT-2012-L
    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 SponsorOslo University Hospital
    B.1.3.4CountryNorway
    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 supportUltimovacs AS
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportThe Norwegian Cancer Society
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportInnovation Norway
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportNorwegian Research Council
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportSouth-Eastern Norway Regional Health Authority
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOslo University Hospital
    B.5.2Functional name of contact pointPaal Brunsvig
    B.5.3 Address:
    B.5.3.1Street AddressPostbox 4953 Nydalen
    B.5.3.2Town/ cityOslo
    B.5.3.3Post codeNO-0424
    B.5.3.4CountryNorway
    B.5.4Telephone number4722934000
    B.5.5Fax number4722935808
    B.5.6E-mailPFB@ous-hf.no
    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 nameUV1
    D.3.4Pharmaceutical form Powder for solution 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.3.8INN - Proposed INN728
    D.3.9.1CAS number 524061
    D.3.9.2Current sponsor codeUV1 (code applied to the combination of 3 peptides in 1:1:1 molar ratio)
    D.3.9.3Other descriptive nameChemical name: L-Alanyl-L-glutamyl-L-arginyl-L-leucyl-L-threonyl-L-seryl-L-arginyl-L-valyl-L-lysyl-L-alanyl-L-leucyl-L-phenylalanyl-L-seryl-L-valyl-L-leucine, acetate salt; Abbreviated chemical name: H-Ala-Glu-Arg-Leu-Thr-Ser-Arg-Val-Lys-Ala-Leu-Phe-Ser-Val-Leu-OH, acetate salt.
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.25 to 1.75
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN719-20
    D.3.9.1CAS number 1331848-79-3
    D.3.9.2Current sponsor codeUV1 (code applied to the combination of 3 peptides in 1:1:1 molar ratio)
    D.3.9.3Other descriptive nameChemical name: L-Alanyl-L-leucyl-L-phenylalanyl-L-seryl-L-valyl-L-leucyl-L-asparaginyl-L-tyrosyl-L-glutamyl-L‑arginyl-L-alanyl-L-arginyl-L-arginyl-L-prolylglycyl-L-leucyl-L-leucylglycyl-L-alanyl-L-seryl-L-valyl-L-leucylglycyl-L-leucyl-L-aspartyl-L-aspartyl-L-isoleucyl-L-histidyl-L-arginyl-L-alanine, acetate salt
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.5 to 3.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN725
    D.3.9.1CAS number 1221082-45-6
    D.3.9.2Current sponsor codeUV1 (code applied to the combination of 3 peptides in 1:1:1 molar ratio)
    D.3.9.3Other descriptive nameChemical name: L-Arginyl-L-threonyl-L-phenylalanyl-L-valyl-L-leucyl-L-arginyl-L-valyl-L-arginyl-L-alanyl-L‑glutaminyl-L-aspartyl-L-prolyl-L-prolyl-L-prolyl-L-glutamine, acetate salt
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.25 to 1.75
    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 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 Yes
    D.2.1.1.1Trade name Leukine
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis (acquisition from Genzyme scheduled for 1st July 2012)
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 Solution 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.3.8INN - Proposed INNSARGRAMOSTIM
    D.3.9.1CAS number 83869-56-1
    D.3.9.3Other descriptive nameGM-CSF
    D.3.9.4EV Substance CodeSUB10450MIG
    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) No
    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
    Patient with metastatic Non Small Cell Lung Cancer (NSCLC) stage IV.
    E.1.1.1Medical condition in easily understood language
    Patients with metastatic 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 15.0
    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
    Immunological response to UV1 vaccine and assessment of safety and tolerability of UV1.
    E.2.2Secondary objectives of the trial
    Selection of biological dose of peptides for further clinical trials and assessment of anti-tumor activity.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patient with Non Small Cell Lung Cancer (NSCLC) who has been treated with palliative radiotherapy and/or at least three courses of chemotherapy, and has achieved stable disease (SD), partial response (PR) or complete response (CR) confirmed by CT scan at least 4 weeks after end of treatment. Previous curative radiotherapy is allowed as long as the patient has relapsed and received palliative chemotherapy.

    • No evidence of disease progression at the time of inclusion
    • Must be ambulatory with an ECOG performance status of 0, 1 or 2
    • Must be at least 18 years of age.
    • No sign of brain metastases (excluded by MRI of brain ).
    •Must have lab values as follows:
    - White Blood Cells >= 1.5 x 109/L
    - Platelets >= 100 x 109/L
    - Hemoglobin >= 9g/dL (>=5.6 mmol/L)
    - Creatinine <= 140 µmol/L
    - Bilirubin < 20% above the upper limit of normal
    - ASAT and ALAT <=1.5 the upper limit of normal
    - Albumin >= 2.5 g/L
    •Signed informed consent
    E.4Principal exclusion criteria
    • History of other prior malignancy, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin, cervical cancer stage IB or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.
    • Treatment with any other investigational medicinal product (IMP) within 4 weeks prior to first administration of study drug.
    • Adverse reactions to vaccines such as anaphylaxis or other serious reactions.
    • History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, sclerodermia, polymyositis-dermatomyositis, juvenile onset insulin-dependent diabetes, or a vasculitic syndrome.
    • Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia.
    • Active infection requiring antibiotic therapy.
    • Pregnancy or lactation.
    • Woman of childbearing potential not using any reliable and adequate contraceptive methods defined as use of oral, implanted, injectable, and mechanical or barrier products for the prevention of pregnancy.
    • Known sensitivity to any of the components of the vaccine
    • Known hypersensitivity to Leukine®, yeast derived products or any component of the product
    • Patients who test positive for hepatitis B, C or HIV.
    • Any other anti-tumor treatment within 4 weeks of study entry (including chemotherapy, immunotherapy, endocrine therapy, cytokines, interferons, protease inhibitors and gene therapy).
    • Use of not permitted concomitant medication:
    - chronic corticosteroids except for asthma inhalers / topical use
    - any alternative and complementary drugs.
    • Any reason why, in the opinion of the investigator, the patient should not participate.
    E.5 End points
    E.5.1Primary end point(s)
    - Frequency and severity of adverse events and serious adverse events. The NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE) will be used.
    Changes in laboratory values, vital signs and ECOG performance status will also be assessed.

    - Number of T-cell responses including time to T-cell responses (up to 6 months), level of response and duration of response.

    E.5.1.1Timepoint(s) of evaluation of this end point
    - Safety profile will be evaluated at each visit. Patient will come during week 1, 2, 3, 4, 6, 8, 10, every 4 weeks until week 26 and every 3 months during any additionnal vaccination period. FU will be done at 3 months post vaccination.

    -T cell response will be measured at baseline, during vaccination (every 4 weeks starting at week 2), end of treatment and at the end of the 3 months follow up period.
    E.5.2Secondary end point(s)
    - Tumor response and progression free survival (PFS). RECIST version 1.1 will be used.

    - Safety profile and immunological responses of each dose level.
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Tumor response and PFS will be evaluated by regular physical examination and CT-scan every 3 months during vaccination period and at the 3 month FU visit.

    -Safety profile and immunological responses of each dose level will be evaluated when patients have completed 6 months of vaccinations and have been followed up for at least a further 3 months. Additionnal evaluation will be done when patients have completed the remaining vaccination period and have been followed up for a further 3 months.
    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 Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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 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 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 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
    Main statistical analysis is planned at LPLV of the 6 months vaccination period + 3 months FU. This will provide sufficient information on the safety profile and immune responses to allow for a dose to be selected. Clinical Study Report will be prepared with these data.
    A further analysis of additional data from patients who enter the additional vaccinations phase will be completed at LPLV of the 2 years vaccination period + 3 months FU. These results will be included as an addendum to CSR.
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    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: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    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 state21
    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)
    Beyond week 26 (6 months), which is called the additionnal vaccination period, the investigator may offer patients continued boost vaccination every 3 months until week 104 (2 years). During this period regular evaluations of the patient are being conducted (physical examination, blood sampling, CT, AE reporting). At the end of the vaccination period the patient will be followed for an additionnal 3 months. After the end of the study (2 years and 3 months), all treatment/care will cease.
    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 Decision2013-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-17
    P. End of Trial
    P.End of Trial StatusCompleted
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