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    Summary
    EudraCT Number:2019-000566-38
    Sponsor's Protocol Code Number:R2810-ONC-1788.01
    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:2019-07-30
    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 number2019-000566-38
    A.3Full title of the trial
    A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY OF ADJUVANT CEMIPLIMAB VERSUS PLACEBO AFTER SURGERY AND RADIATION THERAPY IN PATIENTS WITH HIGH RISK CUTANEOUS SQUAMOUS CELL CARCINOMA
    ÉTUDE RANDOMISÉE, CONTRÔLÉE PAR PLACEBO, EN DOUBLE AVEUGLE, VISANT À ÉVALUER LE CEMIPLIMAB EN TRAITEMENT ADJUVANT CONTRE UN PLACEBO APRÈS UNE INTERVENTION CHIRURGICALE ET UNE RADIOTHÉRAPIE CHEZ DES PATIENTS ATTEINTS DE CARCINOME ÉPIDERMOÏDE CUTANÉ À HAUT RISQUE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Adjuvant Cemiplimab Versus Placebo after Surgery and Radiation Therapy in Patients with High Risk Cutaneous Squamous Cell Carcinoma
    Étude portant sur le cémiplimab en traitement adjuvant contre un placebo après une intervention chirurgicale et une radiothérapie chez des patients atteints de carcinome épidermoïde cutané à haut risque
    A.4.1Sponsor's protocol code numberR2810-ONC-1788.01
    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 SponsorRegeneron Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportRegeneron Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trial Management
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown
    B.5.3.3Post code10591
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@regeneron.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 namecemiplimab
    D.3.2Product code REGN2810
    D.3.4Pharmaceutical form Solution for 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 INNcemiplimab
    D.3.9.2Current sponsor codeR2810-ONC-1788
    D.3.9.3Other descriptive nameREGN2810
    D.3.9.4EV Substance CodeSUB179369
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with features associated with high-risk of recurrent CSCC disease, who have completed surgery and post-operative RT radiation therapy
    Patients présentant des caractéristiques associées à un risque élevé de récurrence de CEC, ayant terminé l’intervention chirurgicale et la radiothérapie (RT) postopératoire.
    E.1.1.1Medical condition in easily understood language
    Patients who have high-risk of recurrent CSCC after surgery and radiation therapy.
    Patients ayant un risque élevé de récurrence de CEC après l’intervention chirurgicale et la radiothérapie.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10041823
    E.1.2Term Squamous cell carcinoma
    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 the study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT)
    L’objectif principal de l’étude est de comparer la survie sans maladie (SSM) de patients atteints d’un carcinome épidermoïde cutané (CEC) à risque élevé recevant un traitement adjuvant par cémiplimab à la SSM de patients recevant un placebo après une intervention chirurgicale et une radiothérapie (RT).
    E.2.2Secondary objectives of the trial
    -To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT
    - To compare the effect of adjuvant cemiplimab with that of placebo on patients’ freedom from locoregional recurrence (FFLRR) after surgery and RT
    - To compare the effect of adjuvant cemiplimab with that of placebo on patients’ freedom from distant recurrence (FFDR) after surgery and RT
    - To compare the effect of adjuvant cemiplimab with that of placebo on the cumulative incidence of second primary CSCC tumors (SPTs) after surgery and RT
    - To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC patients after surgery and RT
    - Comparer la survie globale (SG) de patients atteints d’un CEC à risque élevé recevant un traitement adjuvant par cémiplimab à la SG de patients recevant un placebo après une intervention chirurgicale et une RT
    - Comparer l’effet du traitement adjuvant par cémiplimab à l’effet du placebo sur la disparition de récidives locorégionales (DRLR) après une intervention chirurgicale et une RT
    - Comparer l’effet du traitement adjuvant par cémiplimab à l’effet du placebo sur la disparition de récidives à distance (DRD) après une intervention chirurgicale et une RT
    - Comparer l’effet du traitement adjuvant par cémiplimab à l’effet du placebo sur l’incidence cumulée des tumeurs primitives secondaires (TPS) du CEC après une intervention chirurgicale et une RT
    - Évaluer la sécurité d’emploi du traitement adjuvant par cémiplimab à la sécurité d’emploi du placebo chez des patients atteints d’un CEC à risque élevé après une intervention chirurgicale et une RT
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Men and women ≥18 years old
    - For Japan only, men and women ≥21 years old
    - Patient with resection of pathologically confirmed CSCC (primary CSCC lesion only, or primary CSCC with nodal involvement, or CSCC nodal metastasis with known primary CSCC lesion previously treated within the draining lymph node echelon), with macroscopic gross resection of all disease - High risk CSCC, as defined in the protocol
    - Completion of curative intent post-operative radiation therapy (RT) within 2 to 6 weeks of randomization
    - Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1
    - Adequate hepatic, renal, and bone marrow function as defined in the protocol
    - Hommes et femmes âgés de ≥ 18 ans
    - Pour le Japon uniquement, hommes et femmes âgés de ≥ 21 ans
    - Patient ayant subi une résection d’un CEC pathologiquement confirmé (lésion de CEC primitif seulement, CEC primitif avec atteinte ganglionnaire ou métastases ganglionnaires du CEC avec lésion de CEC primitif connu traité précédemment au niveau des ganglions lymphatiques drainants), avec résection macroscopique de l’ensemble des lésions pathologiques - CEC à risque élevé, défini dans le protocole
    - Fin de la RT postopératoire d’intention curative dans les 2 à 6 semaines suivant la randomisation
    - Indice de performance de l’Eastern Cooperative Oncology Group (IP ECOG) ≤ 1
    - Fonction hépatique, rénale, médullaire adéquate comme défini dans le protocole
    E.4Principal exclusion criteria
    - Squamous cell carcinomas (SCCs) arising in non-cutaneous sites as defined in the protocol
    - Concurrent malignancy other than localized CSCC and/or history of malignancy other than localized CSCC within 3 years of date of randomization as defined in the protocol
    - Patients with hematologic malignancies (eg, chronic lymphocytic leukemia (CLL))
    - Patients with history of distantly metastatic CSCC (visceral or distant nodal), unless the disease-free interval is at least 3 years (regional nodal involvement of disease in draining lymph node basin that was resected and radiated prior to enrollment will not be exclusionary
    - Ongoing or recent (within 5 years of randomization date) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs). The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that required only hormone replacement, or psoriasis that does not require systemic treatment.
    - Has had prior systemic anti-cancer immunotherapy for CSCC
    - Carcinomes épidermoïdes (CE) survenant au niveau de sites non cutanés comme défini dans le protocole
    - Tumeur maligne simultanée autre qu’un CEC localisé et/ou antécédents de tumeur maligne autre qu’un CEC localisé dans les 3 ans précédant la date de randomisation comme défini dans le protocole
    - Patients présentant des tumeurs malignes hématologiques (leucémie lymphoïde chronique [LLC], par exemple).
    - Patients ayant des antécédents de CEC avec métastases à distance (organe ou ganglion à distance), sauf si l’intervalle sans maladie est d’au moins 3 ans (une atteinte ganglionnaire régionale de la maladie au niveau des ganglions lymphatiques drainants, réséquée et irradiée avant l’inclusion ne constituera pas un critère d’exclusion.
    - Preuve actuelle ou récente (dans les 5 ans précédant la date de randomisation) d’une maladie auto-immune significative nécessitant un traitement par des traitements immunosuppresseurs systémiques, pouvant suggérer un risque d’événements indésirables d’origine immunitaire (EIoi). Les éléments ci-dessous ne constituent pas un critère d’exclusion : vitiligo, asthme infantile qui s’est résolu, diabète de type 1, hypothyroïdie résiduelle ayant nécessité uniquement des hormones de substitution ou psoriasis ne nécessitant pas de traitement systémique.
    - Administration d’une immunothérapie anticancéreuse systémique antérieure pour le CEC
    E.5 End points
    E.5.1Primary end point(s)
    DFS defined as time from randomization to the first documented disease recurrence (local, regional and/or distant); or death due to any cause.
    SSM, définie comme le temps écoulé entre la randomisation et la première récidive de la maladie documentée (locale, régionale ou à distance) ; ou le décès quelle qu’en soit la cause.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 54 months
    Jusqu’à 54 mois
    E.5.2Secondary end point(s)
    -Overall survival (OS), defined as time from randomization to the date of death. A patient who has not died will be censored on the last known date as alive
    -FFLRR defined as time from randomization to the date of first locoregional recurrence (LRR). Patients who died without a preceding LRR will be censored on the date of death
    -Freedom from distant recurrence (FFDR), defined as time from randomization to the date of first distant recurrence (DR). Patients who died without a preceding DR will be censored on the date of death
    -Cumulative occurrence of second primary cutaneous squamous cell carcinoma tumor (SPTs) for each patient from randomization to occurrence of first primary endpoint event or end of study.
    -Safety, as measured by the incidence and severity of treatment-emergent adverse events (TEAE), deaths, and laboratory abnormalities.
    - Survie globale (SG), définie comme le temps écoulé entre la randomisation et la date du décès. Un patient qui n’est pas décédé sera censuré à la dernière date connue à laquelle il était vivant
    - Absence de récidive locorégionale (DRLR), définie comme le délai entre la randomisation et la date de la première récidive locorégionale (RLR). Les patients décédés n’ayant pas présenté de RLR précédente seront censurés à la date du décès.
    - Absence de récidive à distance (DRD), définie comme le temps entre la randomisation et la date de la première rechute à distance (RD). Les patients qui sont décédés sans RD précédente seront censurés à la date du décès.
    - Survenue cumulée d’une deuxième tumeur primitive secondaire (TPS) du carcinome épidermoïde cutané pour chaque patient entre la randomisation et l’apparition du premier événement du critère d’évaluation principal ou la fin de l’étude.
    - Sécurité d’emploi, mesurée par l’incidence et la gravité des événements indésirables apparus sous traitement (EIAT), les décès et les anomalies au niveau des analyses biologiques.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 78 months for OS and Safety
    Up to 54 months for FFLRR, FFDR, Cumulative occurrence of SPT
    Jusqu’à 78 mois pour la SG et la sécurité d’emploi
    Jusqu’à 54 mois pour la DRLR, la DRD et la survenue cumulée d’une TPS
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    2 Part Study. Part 2 optional (unblinded)
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    Austria
    Belgium
    France
    Germany
    Greece
    Hungary
    Ireland
    Italy
    Netherlands
    Poland
    Portugal
    Spain
    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
    DERNIÈRE VISITE DU DERNIER SUJET
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days1
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 112
    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 state40
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 412
    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)
    None
    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 Decision2019-08-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-26
    P. End of Trial
    P.End of Trial StatusOngoing
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