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    Summary
    EudraCT Number:2016-003122-16
    Sponsor's Protocol Code Number:R2810-ONC-1620
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-02-22
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-003122-16
    A.3Full title of the trial
    A PHASE 2 STUDY OF REGN2810, A FULLY HUMAN MONOCLONAL ANTIBODY TO PROGRAMMED DEATH-1, IN PATIENTS WITH ADVANCED BASAL CELL CARCINOMA WHO EXPERIENCED PROGRESSION OF DISEASE ON HEDGEHOG PATHWAY INHIBITOR THERAPY, OR WERE INTOLERANT OF PRIOR HEDGEHOG PATHWAY INHIBITOR THERAPY
    Studio di fase 2 di REGN2810, un anticorpo monoclonale interamente umano verso la morte cellulare programmata-1, in pazienti con carcinoma basocellulare avanzato che hanno manifestato progressione della malattia con la terapia di inibizione della via di segnalazione Hedgehog, o erano intolleranti alla precedente terapia di inibizione della via di segnalazione Hedgehog
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of REGN2810 in Unresectable Locally Advanced or Metastatic Basal Cell Carcinoma (BCC)
    Studio di REGN2810 in carcinoma non resecabile localmente avanzato o basocellulare metastatico (BCC)
    A.3.2Name or abbreviated title of the trial where available
    Study of REGN2810 in Unresectable Locally Advanced or Metastatic Basal Cell Carcinoma (BCC)
    Studio di REGN2810 in carcinoma non resecabile localmente avanzato o basocellulare metastatico (BCC)
    A.4.1Sponsor's protocol code numberR2810-ONC-1620
    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 Information
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown
    B.5.3.3Post codeNY 10591
    B.5.3.4CountryUnited States
    B.5.4Telephone number0000000000000
    B.5.5Fax number0000000000000
    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 nameREGN2810
    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 IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1801342-60-8
    D.3.9.2Current sponsor codeREGN2810
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 basal cell carcinoma or unresectable locally advanced basal cell carcinoma
    Carcinoma basocellulare metastatico o carcinoma basocellulare non resecabile localmente avanzato
    E.1.1.1Medical condition in easily understood language
    Advanced basal cell carcinoma, which is a type of skin cancer
    Carcinoma basocellulare avanzato, che è un tipo di cancro della pelle
    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 PT
    E.1.2Classification code 10004146
    E.1.2Term Basal 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
    To estimate the overall response rate (ORR) for metastatic Basal Cell Carcinoma (BCC) (group 1) or for unresectable locally advanced BCC (group 2) when treated with REGN2810 as a monotherapy
    Obiettivo primario dello studio è stimare il tasso complessivo di risposta (ORR) per il carcinoma basocellulare metastatico (BCC) (gruppo 1) o BCC non resecabile localmente avanzato (gruppo 2) quando trattato con RGN2810 come monoterapia
    E.2.2Secondary objectives of the trial
    - Duration of response
    - Progression free survival
    - Complete response rate
    - Change in scores of patient-reported outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
    - Change in scores of patient-reported outcomes in Skindex-16
    - Overall Survival
    - Durata della risposta
    - Sopravvivenza libera da progressione
    - Tasso di risposta completa
    - Modifica dei punteggi degli esiti riferiti dai pazienti nel questionario ”European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30” (EORTC QLQ-C30)
    - Cambio nei punteggi degli esiti riferiti dai pazienti in Skindex-16
    - Sopravvivenza globale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically confirmed diagnosis of invasive BCC
    - At least 1 measurable lesion
    - Eastern Cooperative Oncology Group (ECOG) performance status ≤1
    - At least 18 years old
    - Willing and able to comply with clinic visits and study-related procedures
    - Provide signed informed consent prior to any screening procedures
    - BCC (Carcinoma Basocellulare) invasivo confermato istologicamente
    - Almeno 1 lesione misurabile
    - Performance status ECOG (Eastern Cooperative Oncology Group) ≤1
    - Età minima 18 anni
    - Volontà e capacità di sottoporsi alle visite presso il centro e alle procedure dello studio
    - Fornire il consenso informato firmato prima di qualsiasi criterio di procedura di screening
    E.4Principal exclusion criteria
    - Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events
    - Prior treatment with an agent that blocks the PD-1/PD-L1 pathway
    - History of pneumonitis within the last 5 years
    - Allergic reactions or acute hypersensitivity reaction attributed to antibody treatments
    - Patients with a history of solid organ transplant
    - Prior treatment with other immune modulating agents within fewer than 28 days prior to the first dose of REGN2810. Examples of immune modulating include therapeutic vaccines, cytokine treatments, or agents that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), or OX-40
    - Untreated brain metastasis(es) that may be considered active
    - Evidenza in corso o recente (entro 5 anni) di malattia autoimmune significativa che richiede trattamento con terapie immunosoppressive sistemiche, che potrebbe porre il rischio di eventi avversi immuno-correlati
    - Trattamento precedente con un agente che blocca la via di segnalazione PD-1/PD-L1
    - Anamnesi di polmonite negli ultimi 5 anni
    - Reazioni allergiche o reazione di ipersensibilità acuta attribuita a trattamenti con anticorpi
    - Pazienti con anamnesi di trapianto d’organo solido
    -Precedente trattamento con altri agenti immuno-modulanti meno di 28 giorni prima della prima dose di REGN2810. Esempi di immuno-modulanti comprendono vaccini terapeutici, trattamenti a base di citochine o agenti che hanno come bersaglio l’antigene 4 del linfocita T citotossico (CTLA-4), 4-1BB (CD137) o OX-40
    - Una o più metastasi cerebrali non trattate che possono essere considerate attive
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint for this study is the ORR as determined by central review. The ORR will be assessed separately for patients with metastatic BCC (Group 1) or unresectable locally advanced BCC (Group 2)
    L’endpoint primario di efficacia per questo studio è l’ORR determinato secondo la revisione centrale. L’ORR verrà valutato separatamente per i pazienti con BCC metastatico (gruppo 1) o BCC non resecabile localmente avanzato (gruppo 2)
    E.5.1.1Timepoint(s) of evaluation of this end point
    5 treatment cycles of 9 weeks and 4 treatment cycles of 12 weeks
    5 cicli di trattamento di 9 settimane e 4 cicli di trattamento di 12 settimane.
    E.5.2Secondary end point(s)
    Duration of response, PFS, OS, CR rate, Change in scores of patient-reported outcomes in the EORTC QLQ-C30 and the Skindex-16, AEs, Concentrations of REGN2810 in serum
    Durata della risposta, PFS, OS, Tasso di CR,Variazione dei punteggi degli esiti riportati dal paziente in EORTC QLQ-C30 e Skindex-16 • Eventi avversi (EA) • Concentrazione di REGN2810 nel siero
    E.5.2.1Timepoint(s) of evaluation of this end point
    5 treatment cycles of 9 weeks and 4 treatment cycles of 12 weeks
    5 cicli di trattamento di 9 settimane e 4 cicli di trattamento di 12 settimane.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 Yes
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    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 trial1
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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 Information not present in EudraCT
    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
    Canada
    France
    Germany
    Greece
    Italy
    Spain
    Switzerland
    United States
    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
    When the last patient to enter retreatment completes the retreatment plus safety follow up
    Quando l'ultimo paziente entra nell'ultimo ciclo di trattamento e lo completa incluse le visite di follow up sulla sicurezza
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days22
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days22
    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: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 82
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 82
    F.4.2.2In the whole clinical trial 137
    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
    nessuno
    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 Decision2017-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-25
    P. End of Trial
    P.End of Trial StatusOngoing
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