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    Summary
    EudraCT Number:2016-003122-16
    Sponsor's Protocol Code Number:R2810-ONC-1620
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-07-04
    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 ConcernedSpain - AEMPS
    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
    Ensayo de fase 2 de RGN2810, un anticuerpo monoclonal totalmente humano contra proteína de muerte programada (PD-1) en pacientes con carcinoma basocelular avanzado que presentaron progresión de la enfermedad tras recibir terapia inhibidora de la vía de señalización Hedgehog, o fueron intolerantes a una terapia inhibidora de la vía de señalización Hedgehog previa
    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)
    Ensayo de REGN2810 en el carcinoma basocelular (CBC) inoperable localmente avanzado o metastásico
    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 number0034610 564 456
    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 IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.2Current sponsor codeREGN2810
    D.3.9.3Other descriptive nameAnti-PD-1 monoclonal antibody
    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
    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 basocelular metastásico o carcinoma basocelular inoperable localmente avanzado
    E.1.1.1Medical condition in easily understood language
    advanced basal cell carcinoma, which is a type of skin cancer
    carcinoma basocelular avanzado, que es un tipo de cáncer de piel
    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
    Calcular la tasa de respuesta global (TRG) para el carcinoma basocelular (CBC) metastásico (grupo 1) y el CBC inoperable localmente avanzado (grupo 2) cuando se tratan con REGN2810 en 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
    - Duración de la respuesta
    - Supervivencia sin progresión
    - Tasa de respuesta completa
    - Cambio en las puntuaciones de los resultados notificados por el paciente en el Cuestionario de calidad de vida de 30 ítems de la Organización Europea de Investigación y Tratamiento del Cáncer (EORTC QLQ-C30)
    - Cambio en las puntuaciones de los resultados notificados por el paciente en el Skindex-16
    - Supervivencia global
    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
    -Diagnóstico histológicamente confirmado de CBC invasivo
    - Al menos 1 lesión mensurable
    - Estado funcional en la escala del Eastern Cooperative Oncology Group (ECOG) <= 1
    - Al menos 18 años de edad.
    - Disposición y capacidad para acudir a las visitas al centro y someterse a los procedimientos relacionados con el estudio
    - Otorgamiento del consentimiento informado firmado antes de cualquier procedimiento de selección
    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
    -Indicios en curso o recientes (en los 5 últimos años) de enfermedad autoinmune significativa que precisó tratamiento con inmunodepresores sistémicos, lo que puede indicar un riesgo de sufrir acontecimientos adversos inmuno-mediados
    - Tratamiento previo con un medicamento que bloquee la vía del PD-1/PD-L1
    - Antecedentes de neumonitis en los 5 últimos años
    - Reacciones alérgicas o reacción de hipersensibilidad aguda atribuidas a los tratamientos con anticuerpos
    - Antecedentes de trasplante de órgano sólido
    - Tratamiento previo con otros agentes inmunomoduladores durante un plazo inferior a 28 días antes de la administración de la primera dosis de REGN2810. Entre los inmunomoduladores se encuentran las vacunas terapéuticas, los tratamientos con citoquinas o los medicamentos dirigidos contra el antígeno 4 del linfocito T citotóxico (CTLA-4), 4-1BB (CD137) u OX-40
    - Metástasis cerebral(es) sin tratar que pueda(n) considerarse activa(s)
    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)
    El criterio principal de valoración de la eficacia para este estudio es la TRG determinada mediante un análisis central. La TRG se evaluará por separado para los pacientes con CBC metastásico (grupo 1) y el CBC inoperable localmente avanzado (grupo 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 ciclos de tratamiento de 9 semanas y 4 ciclos de tratamiento de 12 semanas
    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
    -Duración de la respuesta
    -SSP
    -SG
    -Tasa de RC
    -Cambio en las puntuaciones de los resultados notificados por el paciente en el EORTC QLQ-C30 y el Skindex-16
    -AAs
    -Concentraciones séricas de REGN2810
    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 ciclos de tratamiento de 9 semanas y 4 ciclos de tratamiento de 12 semanas
    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 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 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 concerned4
    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 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
    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
    Cuando el último paciente que haya entrado en el re-tratamiento complete dicho re-tratamiento y el seguimiento de seguridad
    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.1.1.1In 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: 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 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 state8
    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
    Ninguno
    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 Decision2017-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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