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    Summary
    EudraCT Number:2019-000566-38
    Sponsor's Protocol Code Number:R2810-ONC-1788
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-07-04
    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 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
    ESTUDIO CON ENMASCARAMIENTO DOBLE, CONTROLADO CON PLACEBO Y ALEATORIZADO DE CEMIPLIMAB COMPLEMENTARIO COMPARADO CON PLACEBO TRAS TRATAMIENTO QUIRÚRGICO Y RADIOTERAPIA EN PACIENTES CON CARCINOMA EPIDERMOIDE CUTÁNEO DE ALTO RIESGO
    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
    Estudio de Cemiplimab complementario comparado con placebo tras tratamiento quirúrgico y radioterapia en pacientes con carcinoma epidermoide cutáneo de alto riesgo
    A.4.1Sponsor's protocol code numberR2810-ONC-1788
    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
    Pacientes con rasgos asociados a un elevado riesgo de padecer CEC recurrente y que hayan pasado por un tratamiento quirúrgico y radioterapia posoperatoria
    E.1.1.1Medical condition in easily understood language
    Patients who have high-risk of recurrent CSCC after surgery and radiation therapy.
    Pacientes con un elevado riesgo de padecer CEC recurrente tras la cirugía y la radioterapia.
    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 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)
    El objetivo principal del estudio es comparar la supervivencia sin enfermedad (SSE) de pacientes con carcinoma epidermoide cutáneo (CEC) de alto riesgo tratados con cemiplimab complementario, frente a los tratados con placebo, después de cirugía y radioterapia (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
    - Comparar la supervivencia global (SG) de los pacientes con CEC de alto riesgo tratados con cemiplimab complementario con la de los tratados con placebo, después de cirugía y RT.
    - Comparar el efecto del cemiplimab complementario con el del placebo en la ausencia de recidiva locorregional (freedom from locoregional recurrence, FFLRR) en los pacientes después de cirugía y RT.
    - Comparar el efecto del cemiplimab complementario con el del placebo en la ausencia de recidiva distante (freedom from distant recurrence, FFDR) en los pacientes después de cirugía y RT.
    - Comparar el efecto del cemiplimab complementario con el del placebo en la incidencia acumulada de segundos tumores CEC primarios (STP) en los pacientes después de cirugía y RT.

    - Evaluar la seguridad del cemiplimab complementario y la del placebo en pacientes con CEC de alto riesgo después de cirugía y 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
    - Mujeres y hombres >= 18 años
    - En Japón, mujeres y hombres >= 21 años
    - Pacientes con extirpación de CEC patológicamente confirmado (solo CEC primario o CEC primario con afectación ganglionar o CEC con metástasis ganglionar con CEC primario previamente tratado a nivel de los ganglios linfáticos), con extirpación macroscópica de toda la enfermedad - CEC de alto riesgo, según se define en el protocolo
    - Finalización de radioterapia posoperatoria con intención de sanar en un plazo de 2 a 6 semanas previas a la aleatorización
    - Estado funcional del Grupo de Oncología Cooperativo del Este (Eastern Cooperative Oncology Group) (ECOG PS) <= 1
    - Actividad hepática, renal y de la médula ósea adecuada según se define en el protocolo
    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
    - Carcinomas epidermoides (CE) en zonas no cutáneas según se define en el protocolo
    - Neoplasia maligna concomitante que no sea CEC localizado y antecedentes de neoplasia que no sea CEC localizado en un plazo de 3 años con respecto a la aleatorización, según se define en el protocolo
    - Pacientes con neoplasias hemáticas (como, leucemia linfocítica crónica —LLC—)
    - Pacientes con antecedentes de CEC metastásico (visceral o ganglionar) a distancia, a menos que el intervalo sin enfermedad sea de al menos 3 años (la afectación ganglionar regional de la enfermedad en la zona de los ganglios linfáticos extirpada y radiada antes de la inscripción no será excluyente)
    - Pruebas en curso o recientes (en un plazo de 5 años con respecto a la fecha de aleatorización) de enfermedad autoinmunitaria significativa que requiera tratamiento con inmunodepresores sistémicos y pueda sugerir un riesgo de sufrir acontecimientos adversos de tipo inmunitario (AAi). Los siguientes no son excluyentes: vitíligo, asma infantil resuelta, diabetes tipo 1, hipotiroidismo residual que haya requerido hormonoterapia de sustitución o psoriasis que no necesite tratamiento sistémico
    - Antecedentes de inmunoterapia antineoplásica sistémica para el 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.
    SSE, definida como el tiempo transcurrido desde la aleatorización hasta la primera recidiva de la enfermedad documentada (local, regional y/o distante) o la muerte por cualquier causa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 54 months
    Hasta 54 meses
    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.
    - Supervivencia global, definida como el tiempo transcurrido desde la aleatorización hasta la fecha de la muerte. Los pacientes que no han muerto se censurarán en la última fecha en que se sabe que estaban vivos.

    - Ausencia de recidiva locorregional, definida como el tiempo transcurrido desde la aleatorización hasta la fecha de la primera recidiva locorregional (LRR). Los pacientes que murieron sin una LRR precedente se censurarán en la fecha de la muerte.
    - Ausencia de recidiva distante, definida como el tiempo transcurrido desde la aleatorización hasta la fecha de la primera recidiva distante (RD). Los pacientes que murieron sin una RD precedente se censurarán en la fecha de la muerte.

    - Incidencia acumulada de STP de cada paciente desde la aleatorización hasta la aparición del primer acontecimiento del criterio de valoración principal o el final de estudio.

    - Seguridad, medida por la incidencia y gravedad de los acontecimientos adversos aparecidos durante el tratamiento (AAAT), muertes y anomalías analíticas.
    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
    Hasta 78 meses para la supervivencia global y la seguridad

    Hasta 54 meses para la ausencia de recidiva locorregional (FFLRR), para la ausencia de recidiva distante (FFDR) y para la incidencia acumulada de STP.
    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
    El estudio tiene dos partes. La parte 2 es opcional (sin enmascaramiento)
    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 concerned9
    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
    Australia
    Belgium
    Brazil
    Canada
    France
    Germany
    Greece
    Ireland
    Italy
    Korea, Republic of
    Mexico
    New Zealand
    Poland
    Russian Federation
    Spain
    United Kingdom
    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
    LVLS
    UVUP
    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 state19
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 174
    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
    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 Decision2019-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-23
    P. End of Trial
    P.End of Trial StatusOngoing
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