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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2008-007785-39
    Sponsor's Protocol Code Number:CV-9201-003
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-12-19
    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 ConcernedGermany - PEI
    A.2EudraCT number2008-007785-39
    A.3Full title of the trial
    Safety and efficacy phase I/IIa trial of an RNActive®-derived cancer vaccine in stage IIIB/IV non small cell lung cancer (NSCLC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to evaluate safety and efficacy of an RNA active vaccine against non-small cell lung cancer in stage IIIB/IV
    A.4.1Sponsor's protocol code numberCV-9201-003
    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 SponsorCureVac GmbH
    B.1.3.4CountryGermany
    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 supportCureVac GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCureVac GmbH
    B.5.2Functional name of contact pointKarl-Josef Kallen
    B.5.3 Address:
    B.5.3.1Street AddressPaul-Ehrlich-Strasse 15
    B.5.3.2Town/ cityTübingen
    B.5.3.3Post code72076
    B.5.3.4CountryGermany
    B.5.4Telephone number4907071920530
    B.5.5Fax number49070719205311
    B.5.6E-mailkarl-josef.kallen@curevac.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 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 nameCurevac
    D.3.2Product code CV9201
    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.3.9.2Current sponsor codeCV9201-1, CV9201-2, CV9201-3, CV9201-4, CV9201-5
    D.3.9.3Other descriptive nameCTAG1B, MAGEC2, MAGEC1, BIRC5, TPBG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/µl microgram(s)/microlitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1600
    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 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 nameCurevac
    D.3.2Product code CV9201
    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.3.9.2Current sponsor codeCV9201-1, CV9201-2, CV9201-3, CV9201-4, CV9201-5
    D.3.9.3Other descriptive nameCTAG1B, MAGEC2, MAGEC1, BIRC5, TPBG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/µl microgram(s)/microlitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1600
    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.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
    It will be conducted in stage IIIB/IV NSCLC cancer patients with documented stable disease or objective response according to RECIST criteria after initial chemotherapy or chemo-radiotherapy
    E.1.1.1Medical condition in easily understood language
    lung cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    Phase I part:
    Primary:
    Determination of recommended dose (RD) for exploration in the phase IIa part of the study.

    Phase IIa part:
    Assessment of safety and tolerability of the trial regimen
    E.2.2Secondary objectives of the trial
    Phase I part:
    Assessment of safety of the treatment regimen
    Evaluation of induction of immune response
    Assessment of anti-tumor activity.

    Phase IIa part:
    Evaluation of induction of immune response.
    Asessment of anti-tumor actvity.
    Correlation between tumor-associated antigen (TAA) expression and survival/progression/immunological response.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female and age ≥ 18 yrs and ≤ 75

    2. Histologically or cytologically confirmed and documented stage IIIB/IV NSCLC

    3. Documented stable disease or objective response according to RECIST criteria after initial chemotherapy or chemo-radiotherapy for advanced, unresectable disease:
    • Patients must have received a minimum of two cycles of standard chemotherapy, and adequate and effective radiotherapy if used in conjunction with chemotherapy (sequentially or concomitantly).
    Prophylactic brain radiation is allowed.

    • Surgery, radiotherapy and/ or chemotherapy can have been previously administered for non-advanced disease.

    • All therapies must be completed 4 weeks before start of study treatment.

    4. Performance status: Eastern Cooperative Oncology Group (ECOG) 0 – 1.

    5. Life expectancy > 6 months as assessed by the investigator.

    6. Adequate organ function:

    • Bone marrow function: hemoglobin ≥ 100 g/L; white blood cell count (WBC) ≥ 3.0 x 10 9/L; lymphocyte count ≥ 1.0 x 10 9/L; absolute neutrophil count (ANC) ≥ 1.5 x 10 9/L; platelet count ≥ 100 x 10 9/L

    • Hepatic: aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times upper limit of normal (ULN) (≤5 x ULN if hepatic metastases present); bilirubin ≤ 1.5 x ULN

    • Renal: creatinine ≤ 2 mg/dL and creatinine clearance ≥ 45 mL/min

    7. Patients of child-producing potential must agree to use contraception while enrolled in the study and for one month after the last immunization

    8. Written informed consent must be obtained prior to conducting any study-specific procedures
    E.4Principal exclusion criteria
    1. History of anti-cancer therapy for advanced disease other than initial chemotherapy or chemo-radiotherapy or surgery

    2. Immunotherapy within 4 weeks prior to study enrollment, including cytokines such as granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage colony stimulating factor (GM-CSF) or interferons

    3. Treatment with investigational anti-cancer agents during initial therapy for advanced disease or any investigational agents within 4 weeks prior to study enrollment

    4. Concurrent anti-tumor therapy or concurrent immunotherapy such as lectins, unspecific immunostimulants, etc.

    5. Previous anti-cancer immunotherapy comprising RNA-transfected dendritic cells or DNA vaccines targeting any tumor-associated antigens.

    6. Concurrent systemic steroids except topical (inhaled, topical, nasal) for the last 28 days, except replacement therapy

    7. Concurrent major surgery or planned surgery

    8. Prior splenectomy

    9. Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy such as sarcoidosis, lupus erythematosus, rheumatoid arthritis, glomerulonephritis or systemic vasculitis (except autoimmune thyroiditis with only thyroid hormone replacement and stable disease > 1 year)

    10. Primary or secondary immune deficiency

    11. Active allergy requiring continuous medication or active infections requiring anti-infectious therapy

    12. Seropositive for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

    13. History of other malignancies over the last 5 years (except basal cell carcinoma of the skin or carcinoma in situ of the cervix)

    14. Uncontrolled medical condition considered as high risk for the treatment with an investigational drug including unstable diabetes mellitus, vena-cava-syndrome, known ascites and/or uncontrolled pleural effusion.

    15. Brain metastases (symptomatic or asymptomatic) or leptomeningeal involvement

    16. Symptomatic congestive heart failure (New York Heart Association [NYHA] 3 or 4); unstable angina pectoris within 6 months prior to enrollment; significant cardiac arrhythmia, history of stroke or transient ischemic attack

    17. History of seizures, encephalitis or multiple sclerosis

    18. Gastric ulcer or inflammatory bowel disease or Crohn´s disease or ulcerative colitis; no active diverticulitis

    19. Active drug abuse or chronic alcoholism

    20. Patients being committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
    E.5 End points
    E.5.1Primary end point(s)
    Phase I:

    Primary endpoint:Occurrence of DLT between treatment initiation and the week 5 visit in patients evaluable for determination of RD.

    Additional endpoints in the phase I part of the study are the same as those listed below for the phase IIa part.

    Phase IIa:

    Safety endpoints (evaluated in the treated population):

    •incidence and severity of treatment-related adverse events and laboratory abnormalities, graded according to NCI-CTCAE version 3.0 criteria

    •occurrence of Serious Adverse Events

    •occurrence of treatment discontinuation due to treatment-related adverse events

    •incidence of treatment-emergent autoimmune disease or development of autoimmune antibodies

    Immune endpoints (evaluable for immune response population):

    •rate of vaccine antigen-specific cellular and humoral immune response (ELISpot and ELISA assessment of immune reaction to vaccine antigens) at weeks 5 and 9 phase I only, and at end of treatment compared to baseline

    •evolution of regulatory T cell levels during the course of treatment

    Efficacy endpoints:

    •objective disease response in patients evaluable for RECIST response

    •progression-free survival, from initiation of vaccine and from initiation of initial chemotherapy

    •overall survival, from initiation of vaccine and from initiation of initial chemotherapy

    •evaluation of carcinoembryonic antigen / cytokeratin fragment 21-1 (CEA/CYFRA 21-1) tumor marker levels during the course of treatment

    •evaluation of influence of TAA expression on tumor specimens (if available) on survival / progression / immunological response.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not applicable
    E.5.2Secondary end point(s)
    Additional endpoints in the phase I part of the study are the same as those listed in E.5.1 for the
    phase IIa part.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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 No
    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
    Determine the recommended dose for exploration in the phase IIa
    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 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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Switzerland
    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 patient,last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    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.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 46
    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)
    After the end of the study, no particular treatment of the patients is intended. The patients are being treated during and after the study with the best medical care available, and will be treated according to their individual needs after the end of the study participation.
    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 Decision2009-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-25
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