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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   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:2020-005170-10
    Sponsor's Protocol Code Number:COMBI-TED
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-04-25
    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 number2020-005170-10
    A.3Full title of the trial
    A multicenter, Phase II, open label, randomized trial evaluating the efficacy of Tedopi
    plus docetaxel or Tedopi plus nivolumab as second-line therapy in metastatic non-smallcell
    lung cancer progressing after first-line chemo-immunotherapy (Combi-TED)
    Essai multicentrique, de phase II, ouvert et randomisé, évaluant l'efficacité de Tedopi plus docetaxel ou de Tedopi plus nivolumab en traitement de seconde ligne dans le cancer du poumon non à petites cellules métastatique progressant après une chimio-immunothérapie de première ligne (Combi-TED)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter, Phase II, open label, randomized trial evaluating the efficacy of Tedopi
    plus docetaxel or Tedopi plus nivolumab as second-line therapy in metastatic non-smallcell
    lung cancer progressing after first-line chemo-immunotherapy (Combi-TED)
    Essai multicentrique, de phase II, ouvert et randomisé, évaluant l'efficacité de Tedopi plus docetaxel ou de Tedopi plus nivolumab en traitement de seconde ligne dans le cancer du poumon non à petites cellules métastatique progressant après une chimio-immunothérapie de première ligne (Combi-TED)
    A.3.2Name or abbreviated title of the trial where available
    COMBI-TED
    A.4.1Sponsor's protocol code numberCOMBI-TED
    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 SponsorFONDAZIONE RICERCA TRASLAZIONALE (FORT)
    B.1.3.4CountryItaly
    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 supportOSE Immunotherapeutics
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportBristol Myer Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Research Technology
    B.5.2Functional name of contact pointPaola Schiavo
    B.5.3 Address:
    B.5.3.1Street AddressVia San Leonardo trav. Migliaro
    B.5.3.2Town/ citySalerno
    B.5.3.3Post code84131
    B.5.3.4CountryItaly
    B.5.6E-mailcombi-ted@cr-technology.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 nameTEDOPI
    D.3.2Product code OSE2101
    D.3.4Pharmaceutical form Emulsion for injection/infusion
    D.3.4.1Specific paediatric formulation No
    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 INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeTEDOPI
    D.3.9.3Other descriptive nameOSE2101
    D.3.9.4EV Substance CodeSUB191632
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.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 OPDIVO
    D.2.1.1.2Name of the Marketing Authorisation holderBRISTOL-MYERS SQUIBB PHARMA EEIG
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameNIVOLUMAB
    D.3.2Product code BMS-936558
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNivolumab
    D.3.9.1CAS number 946414-94-4
    D.3.9.2Current sponsor codeBMS-936558
    D.3.9.3Other descriptive nameMDX1106, ONO-4538
    D.3.9.4EV Substance CodeSUB32944
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    metastatic non-small-cell lung cancer
    Cancer du poumon non à petites cellules métastatique
    E.1.1.1Medical condition in easily understood language
    metastatic non-small-cell lung cancer
    Cancer du poumon non à petites cellules métastatique
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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
    To assess 1-year survival rate in patients treated with Tedopi plus docetaxel (arm A)
    or Tedopi plus nivolumab (arm B) or docetaxel as single agent (arm C) in subjects
    with advanced NSCLC progressing on first-line chemoimmunotherapy.
    Évaluer le taux de survie globale (OS) à un an chez les patients traités par Tedopi plus docétaxel (bras A) ou Tedopi plus nivolumab (bras B) ou docétaxel en monothérapie (bras C).
    E.2.2Secondary objectives of the trial
    • To assess Overall Survival (OS)
    • To assess Progression-free survival (PFS)
    • To assess Objective Response Rate (ORR)
    • To assess treatment safety
    Exploratory
    • To assess correlation of ORR, PFS and OS with biomarkers in tumor tissue or blood.
    - Évaluer la survie globale (OS)
    - Evaluation de la survie sans progression (PFS)
    - Évaluer le taux de réponse objective (ORR)
    - Évaluer la sécurité du traitement
    Ancillaire
    - Évaluer la corrélation entre l'ORR, la PFS et la OS avec les biomarqueurs présents dans les tissus tumoraux ou le sang.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female patients willing and able to give written informed consent;
    2. Histological or cytological confirmed diagnosis of HLA-A2+ NSCLC with no evidence of
    EGFR mutations or ALK or ROS1 rearrangement;
    3. Evidence of disease progression at the end of at least 4 cycles of chemoimmunotherapy
    or 2 cycles of chemo-immunotherapy followed by 2 cycles of immunotherapy
    (CheckMate9LA regimen) and eligible for treatment with docetaxel. This criterion implies
    that patients with immunotherapy primary resistance are excluded;
    4. Patients must have experienced progressive disease (PD), either during or within 3
    months of discontinuing treatment with anti-PD-(L)1-based therapy, occurring after
    previous clear benefit (any complete –CR- or partial response -PR), or after previous
    stable disease (SD);
    5. Performance status 0-1 (ECOG);
    6. Patient compliance to trial procedures;
    7. Age = 18 years;
    1. Patients masculins et féminins disposés et en capacité de donner un consentement éclairé écrit ;
    2. Diagnostic histologiquement ou cytologiquement confirmé d'un CBNPC HLA-A2+ sans preuve de mutations de l'EGFR ou de réarrangement de ALK ou ROS1 ;
    3. Présence d’une progression de la maladie après 4 cycles de chimio-immunothérapie ou de 2 cycles de chimio-immunothérapie suivis de 2 cycles d'immunothérapie (schéma CheckMate9LA) et éligibilité à un traitement par docétaxel. Ce critère implique que les patients présentant une résistance primaire à l'immunothérapie sont exclus ;
    4. Les patients doivent avoir présenté une maladie progressive (P), soit pendant ou dans les 3 mois suivant l'arrêt du traitement à base d'anti-PD-(L)1, survenant après un bénéfice clair antérieur (toute réponse complète -RC- ou partielle -RP), ou après une maladie stable antérieure (SD) ;
    5. Statut de performance 0-1 (ECOG) ;
    6. Compliance du patient aux procédures de l'essai ;
    7. Âge ≥ 18 ans ;
    E.4Principal exclusion criteria
    1. Patient positive for actionable EGFR mutations or ALK or ROS1 rearrangement;
    2. No previous chemoimmunotherapy for metastatic disease or evidence of disease
    progression during the first 4 cycles of chemoimmunotherapy (primary resistance).
    Patients with adjuvant resistance (documented loco-regionally and/or systemic relapse of
    their disease occurring <6 months after the last dose of anti-PD-(L)1-based systemic
    adjuvant therapy) are excluded;
    3. Patients with intervening systemic therapy following prior anti-PD-(L)1-based
    therapy;
    4. Symptomatic brain metastases. Asymptomatic brain metastases are allowed if not
    requiring corticosteroids use at a dose >10mg daily prednisone (or equivalent);
    5. Diagnosis of any other malignancy during the last 3 years, except for in situ
    carcinoma of cervix uteri and cutaneous squamous cell carcinoma or other local tumors
    considered cured;
    6. Pregnancy or lactating;
    1. Patient positif pour les mutations de l'EGFR ou le réarrangement de ALK ou ROS1.
    2. Absence de chimio-immunothérapie antérieure pour une maladie métastatique ou preuve de progression de la maladie au cours des 4 premiers cycles de chimio-immunothérapie (résistance primaire). Les patients présentant une résistance au traitement (rechute locorégionale et/ou systémique documentée de leur maladie survenant <6 mois après la dernière dose de traitement systémique à base d'anti-PD-(L)1) sont exclus.
    3. Les patients ayant reçu un traitement systémique intermédiaire après un traitement antérieur à base d'anti-PD-(L)1.
    4. Métastases cérébrales symptomatiques. Les métastases cérébrales asymptomatiques sont autorisées si elles ne nécessitent pas l'utilisation de corticostéroïdes.
    5. Diagnostic de toute autre tumeur maligne au cours des 3 dernières années, à l'exception du carcinome in situ du col de l'utérus et du carcinome épidermoïde cutané ou d'autres tumeurs locales considérées comme guéries (par exemple, cancer de la prostate localisé et présumé guéri).
    6. Grossesse ou allaitement.
    E.5 End points
    E.5.1Primary end point(s)
    1-year Survival Rate
    Taux de survie à un an
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year
    1 an
    E.5.2Secondary end point(s)
    • Overall Survival (OS) (1 and 2-year OS)
    • Progression-free survival (PFS) (1 and 2-year PFS)
    • Objective Response rate (ORR)
    • Safety
    Exploratory
    • Correlation of ORR, PFS and OS with tumor biomarkers
    - Survie globale (OS) (médiane, OS à 1 et 2 ans)
    - Survie sans progression (PFS) (PFS à 1 et 2 ans)
    - Taux de réponse objective (ORR)
    - Tolérance
    Ancillaire :
    - Corrélation de l'ORR, de la PFS et de la OS avec des biomarqueurs dans le tissu tumoral ou le sang.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 and 2 years
    1 and 2 years
    Every 8 weeks
    Every 3 weeks
    Exploratory: 48 months
    1 et 2 ans
    1 et 2 ans
    Toutes les 8 semaines
    Toutes les 3 semaines
    Exploratoire : 48 mois
    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 No
    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 No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    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.8.2.4Number of treatment arms in the trial3
    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 EEA24
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial months48
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 105
    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)
    A safety follow up will be performed 30 days since last dose. A contact follow up will be performed every 3 months until the study termination.
    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 Decision2022-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-08-01
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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