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    Summary
    EudraCT Number:2015-001712-35
    Sponsor's Protocol Code Number:N/2013/67
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-07-24
    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 ConcernedFrance - ANSM
    A.2EudraCT number2015-001712-35
    A.3Full title of the trial
    ANTICANCER THERAPEUTIC VACCINATION USING TELOMERASE-DERIVED UNIVERSAL CANCER PEPTIDES IN METASTATIC NON SMALL CELL LUNG CANCER
    Vaccination thérapeutique anti-cancer utilisant les peptides UCP dérivés de la télomérase chez des patients présentant un cancer bronchique non à petites cellules à un stade avancé
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ANTICANCER THERAPEUTIC VACCINATION USING TELOMERASE-DERIVED UNIVERSAL CANCER PEPTIDES IN METASTATIC NON SMALL CELL LUNG CANCER
    Vaccination thérapeutique anti-cancer utilisant les peptides UCP dérivés de la télomérase chez des patients présentant un cancer bronchique non à petites cellules à un stade avancé
    A.3.2Name or abbreviated title of the trial where available
    UCPVax
    UCPVax
    A.4.1Sponsor's protocol code numberN/2013/67
    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 SponsorCentre Hospitalier Régional Universitaire de Besançon
    B.1.3.4CountryFrance
    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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDRCI
    B.5.2Functional name of contact pointChef de projet
    B.5.3 Address:
    B.5.3.1Street Address2, place saint jacques
    B.5.3.2Town/ cityBesançon
    B.5.3.3Post code25030
    B.5.3.4CountryFrance
    B.5.4Telephone number0381218745
    B.5.5Fax number0381218995
    B.5.6E-mailsdepierre@chu-besancon.fr
    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.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameUCPVax
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    lung cancer non-small cell
    cancer du poumon non à petites cellules
    E.1.1.1Medical condition in easily understood language
    lung cancer
    cancer du poumon
    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
    - To estimate the Maximum Tolerated Dose (MTD) and select the Recommended Phase II Dose (RP2D).
    Phase II
    - To determine the immunogenicity of UCPVax according to the dose level.
    Phase I
    - Estimer la Dose Maximale Tolérée (MTD) et sélectionner la dose recommandée pour la phase II (RP2D).
    Phase II
    - Déterminer l’immunogénécité d’UCPVax selon la dose.
    E.2.2Secondary objectives of the trial
    Phase I
    - To evaluate the acute immunological safety.
    Phase II
    - To estimate objective response rates,
    - To estimate Progression-free survival (PFS) and overall survival,
    - To evaluate the vaccine-induced CD4 T helper polarization
    - To assess the efficacy of vaccine according to pre-existing antitumor immune response
    - To assess health related quality of life
    - To assess long-term safety
    Phase I
    - Evaluer la tolérance du vaccin
    Phase II
    - Estimer le taux de réponses objectives, la survie sans progression et la survie globale
    - Evaluer l’effet du vaccin sur la qualité de vie
    - Etudier les biomarqueurs immunologiques associés à l’efficacité du traitement
    - Evaluer la tolérance et l’innocuité globale du vaccin
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1- Male or female patients, age ≥ 18 and ≤ 89 years old
    2- Written informed consent
    3- Histologically or cytologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma, undifferentiated carcinoma or other)
    4- Stage IIIB not amenable to radiotherapy or stage IV cancer according to the TNM classification (7th edition ref) or recurrent NSCLC after surgery not amenable to loco-regional therapy.
    5- Pre-treated with at least 2 lines of systemic treatment (chemotherapy or targeted therapy) with a delay of at least three weeks between the last chemotherapy treatment and the first UCPVax injection, or 3 days after three last tyrosine kinase inhibitor dose and the first UCPVax injection. Chemoradiation for stage IIIB disease is considered as one treatment line.
    6- At least one measurable lesion by CT scan or MRI based on RECIST criteria version 1.1
    7- Performance status 0 or 1 on the ECOG scale
    8- Life-expectancy > 3 months
    9- Adequate hematological, hepatic, and renal function:
    o Hemoglobin ≥ 10.0 g/dL
    o White blood cells (WBC) ≥ 3.0 x 109/L including neutrophils ≥ 1.5 x 109/L and total lymphocytes count ≥ 1.0 x 109/L
    o Platelets count ≥ 100 x 109/L
    o Serum alkaline phosphatase ≤ 3 x ULN in the absence of liver or bone metastases and ≤ 5 x ULN in patients with documented bone or liver metastases
    o Serum transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST] ≤ 2.5 x ULN in the absence of liver metastases and ≤ 5 x ULN in case of liver metastases.
    o Total bilirubin ≤ 1.5 x ULN
    o Glomerular Filtration Rate ≥ 60 mL/min (according to Modification of the Diet in Renal Disease [MRDR] formula or Cockroft & Gault formula)
    o Serum albumin ≥ 30 g/L
    10- Effective contraception during the study period and for 1 month after the last study treatment administration. Male patients with a partner at risk of pregnancy should use an appropriate contraception method.
    11- Affiliation to French social security or receiving such a regime.
    1- Homme ou femme ≥ 18 ans et ≤ 89 ans
    2- Consentement éclairé de participation signé
    3- Tout cancer du poumon non à petites cellules (CBNPC) (adénocarcinome, carcinome spino-cellulaire, carcinome à grandes cellules, carcinome indifférencié ou autre)
    4- CBNPC de stade IIIb inéligible à la radiothérapie, ou de stade IV selon la classification TNM (7ème édition) ou en récidive d’un CBNPC après traitement chirurgical et inéligible pour traitement loco-régional.
    5- Patient ayant été déjà reçu au moins 2 lignes de traitements (chimiothérapie ou thérapie ciblée, TKI) avec un délai d’au moins 3 semaines entre la dernière chimiothérapie et la première vaccination ou d’au moins 3 jours entre l’arrêt du TKI et la première vaccination. La radio-chimiothérapie dans les stades IIIb est considérée comme une ligne de traitement.
    6- Présence d’au moins une lésion mesurable par CT scan ou IRM d’après les critères RECIST version 1.1.
    7- Performance status de 0 ou 1 sur l’échelle ECOG
    8- Survie du patient estimée à plus de 3 mois
    9- Valeurs biologiques dans les limites suivantes :
    o Hémoglobine ≥ 10.0 g/dL
    o Globules blancs ≥ 3.0 x 109/L incluant les neutrophiles ≥ 1.5 x 109/L et les lymphocytes totaux ≥ 1.0 x 109/L
    o Plaquettes ≥ 100 x 109/L
    o Phosphatase alcaline sérique ≤ 3 x LSN en l’absence de métastase de l’os ou du foie et ≤ 5 x LSN chez les patients avec metastases de l’os ou du foie documentées
    o Transaminases sériques (alanine aminotransferase [ALT] and aspartate aminotransferase [AST] ≤ 2.5 x LSN en l’absence de metastases du foie et ≤ 5 x LSN en cas de métastases du foie.
    o Bilirubine totale ≤ 1.5 x LSN
    o Taux de filtration glomérulaire ≥ 60 mL/min (selon la formule MDRD ou la formule de Cockroft & Gault)
    o Albumine sérique ≥ 30 g/L
    10- Utilisation d’une méthode de contraception efficace pendant toute la durée de l’étude et pendant 1 mois après la dernière vaccination de l’étude. Les patients masculins avec une partenaire à risque de grossesse devront utiliser une méthode de contraception appropriée.
    11- Patient affilié à un régime de sécurité sociale
    E.4Principal exclusion criteria
    1- Prior history of other malignancy except for: basal cell carcinoma of the skin, cervical intra-epithelial neoplasia and other cancer curatively treated with no evidence of disease for at least 5 years
    2- Symptomatic brain metastases. Patients with controlled brain metastases after radiation therapy or with asymptomatic brain metastases may be included.
    3- History of autoimmune diseases (lupus, rheumatoid arthritis, inflammatory bowel disease…)
    4- Patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed) for a period of at least 4 weeks and whose treatment was not stopped 1 week prior to the start of the study treatment
    5- Positive serology for Human Immunodeficiency Virus (HIV) or Hepatitis C virus (HCV); presence in the serum of the antigens HBs
    6- Participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment
    7- Pregnancy or lactating patients.
    8- Patients with any medical or psychiatric condition or disease,
    9- Patients under guardianship, curatorship or under the protection of justice.
    1- Antécédent d’autre cancer, à l’exception d’un carcinome baso-cellulaire ou spinocellulaire de la peau ou d’un carcinome in situ du col utérin, traité et autre cancer traité et guéri avec aucun signe de la maladie dans les 5 dernières années
    2- Métastases cérébrales symptomatiques. Les patients atteints de métastases cérébrales contrôlées après radiothérapie ou avec métastases asymptomatiques peuvent être inclus.
    3- Antécédent de maladie auto-immune évolutive (lupus, polyarthrite rhumatoïde, maladie inflammatoire de l’intestin)
    4- Patients sous corticoïdes systémiques au long cours, sous immunosuppresseurs (prednisone ou prednisolone ≤ 10 mg/jour est autorisée) ou autre immunothérapie pour une période d’au moins 4 semaines et dont le traitement n’a pas été arrêté au moins 1 semaine avant le début de la vaccination à l’étude
    5- Sérologie positive pour le VIH ou l’hépatite C ; présence dans le sérum d’antigènes HBs
    6- Participation à une autre étude clinique avec un produit expérimental dans les 4 semaines précédant le début du traitement à l’étude
    7- Patientes enceintes ou allaitantes
    8- Patients présentant une condition ou une maladie psychiatrique
    9- Patients sous tutelle, sous curatelle ou sous sauvegarde de justice
    E.5 End points
    E.5.1Primary end point(s)
    Phase I : Dose Limiting Toxicity (DLT) of UCPVax

    Phase II : UCP-specific CD4 T cell responses measured in peripheral blood using IFN- ELISPOT
    Phase I : Toxicité limitant la dose (DLT) du vaccin

    Phase II : Présence de lymphocytes TCD4 anti-UCP mesurées dans le sang par test ELISPOT
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase I : until day 57

    Phase II : at baseline, day 29 and prior 1st and 4th boost vaccination and at the end of treatment visit
    Phase I : dans les 15 jours après les 6 premières vaccinations

    Phase II : à l’inclusion, à J29, et avant la 1ème et 4ème vaccination de rappel et lors de la visite de fin de traitement
    E.5.2Secondary end point(s)
    Phase I :
    - Acute immunological safety measured at baseline, at day 29 (before vaccination n°4) and at day 57 (DLT evaluation):
    - Routine blood laboratory abnormalities (graded by NCI CTCAE v.4.03)
    - Circulating auto-antibodies (ANA)
    - Absolute cell counts of blood lymphocytes subset (B, T, NK) measured by flow cytometry.
    - Blood abnormalities linked to cytokines release measured by ELISA, (IL-1b, IL-6, IL-8, IL-2, TNFα, IFN-g, IL-17, sCD25)

    Phase II:
    - Tumor response evaluated per RECIST v1.1 at day 57 and then every 8 weeks. Objective response rate (ORR) is defined as the addition of complete response (CR) and partial response (PR) rates. Disease control rate is defined as ORR and SD (stable disease).
    - Progression-free survival (PFS) is defined as the delay from the date of inclusion to the disease progression (RECIST) or death from any cause whichever occurs first, censoring cases without progression at the date of last disease assessment.
    - Overall survival (OS) is defined as the delay from the date of inclusion to death from any cause.
    - UCP-specific CD4 T cell polarization measured by intracellular cytokine secretion assay (ICS) and ELISA at baseline, at days 29 and prior 1st and 4th boost vaccination and at the end of treatment visit.
    - Health related Quality of Life (QoL): EORTC-QLQ-C30 (time to QoL score deterioration). HrQoL will be assessed using EORTC QLQ-C30 and LC13 modules specific to lung cancer at baseline, at days 29 and 57, at each boost vaccine and at the end of treatment visit.
    - Adverse Events according to NCI CTCAE v.4.03

    Phase I :
    - Les évènements indésirables immunologiques seront mesurés à l’inclusion, à J29 (avant la vaccination n°4) et à J57 (visite d’évaluation de la DLT) par :
    - Anomalies biologiques détectées d’après les bilans sanguins de routine (graduation selon le NCI CTCAE v.4.03)
    - Dosage des auto-anticorps circulants (ANA, TPO)
    - Phénotypage lymphocytaire sanguin (B, T, NK) par cytométrie en flux.
    - Dosage plasmatique de relargage de cytokines par ELISA (IL-1b, IL-6, IL-8, TNFα, IFN-, IL-17, sCD25)

    Phase II :
    - Réponse tumorale évaluée par les critères Recist v1.1 à J57 puis toutes les 8 semaines. Le taux de réponse objective (ORR) est défini comme l’addition du taux de réponse complète (CR) et du taux de réponses partielles (PR). Le taux de contrôle de la maladie est défini comme ORR et maladie stable (SD).
    - La survie sans progression (PFS) est l’intervalle de temps entre la date d’inclusion et la date de la progression de maladie (selon les critères RECIST v1.1) ou le décès quelle qu’en soit la cause, suivant ce qui intervient en premier, censurée au cas où il n’y a pas de progression à la date de la dernière évaluation tumorale.
    - La survie globale (OS) est l’intervalle entre la date d’inclusion et la date du décès quelle qu’en soit la cause.
    - Qualité de vie relative à la santé (QoL) évaluée par le questionnaire spécifique du cancer (EORTC-QLQ-C30) et son module LC13 spécifique du cancer du poumon à l’inclusion, à J29, à J57, à chaque vaccination de rappel et lors de la visite de fin de traitement.
    - Les biomarqueurs immunologiques seront mesurés dans le sang à l’inclusion, à J29, avant la 1ème et 4ème vaccination de rappel et lors de la visite de fin de traitement.
    - Evènements indésirables suivant la cotation NCI CTCAE v.4.03

    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase I : at day 29 (before vaccination n°4) and at day 57

    Phase II : at day 57 and then every 8 weeks/to the disease progression (RECIST) or death
    Phase I : à l’inclusion, à J29 (avant la vaccination n°4) et à J57

    Phase II : à J57 puis toutes les 8 semaines
    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 Yes
    E.6.13.1Other scope of the trial description
    immunothérapie
    immunothérapie
    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 concerned5
    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 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
    dernier suivi du dernier patient inclus
    dernier suivi du dernier patient inclus
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state54
    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 Decision2015-09-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-15
    P. End of Trial
    P.End of Trial StatusOngoing
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