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    Summary
    EudraCT Number:2017-000350-19
    Sponsor's Protocol Code Number:R2810-ONC-1676
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-09-18
    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 number2017-000350-19
    A.3Full title of the trial
    An open-label, randomized, phase 3 clinical trial of REGN2810 versus therapy of investigator's choice chemotherapy in recurrent or metastatic platinum-refractory cervical carcinoma
    Ensayo clínico en fase III abierto y aleatorizado de REGN2810 en comparación con el tratamiento de quimioterapia a elección del investigador para el carcinoma cervicouterino resistente a platino recurrente o metastásico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of REGN2810 in Adults With Cervical Cancer
    Ensayo clinico de REGN2810 en adultos con cancer cervicouterino
    A.4.1Sponsor's protocol code numberR2810-ONC-1676
    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 pointMatthew Fury
    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 number9148473741
    B.5.5Fax number9148477735
    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 INNN/A
    D.3.9.1CAS number 1801342-60-8
    D.3.9.2Current sponsor codeREGN2810
    D.3.9.3Other descriptive nameHUMAN IGG4 ISOTYPE MONOCLONAL (GDF8) ANTIBODY
    D.3.9.4EV Substance CodeSUB130944
    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 Yes
    D.3.11.13.1Other medicinal product typea recombinant human antibody
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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.2.5The 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.3.4Pharmaceutical form Concentrate for 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 INNPEMETREXED DISODIUM
    D.3.9.1CAS number 150399-23-8
    D.3.9.3Other descriptive namePEMETREXED DISODIUM
    D.3.9.4EV Substance CodeSUB03669MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) No
    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: 3
    D.1.2 and D.1.3IMP RoleComparator
    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.2.5The 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.3.4Pharmaceutical form Powder for concentrate for 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 INNTOPOTECAN HYDROCHLORIDE
    D.3.9.1CAS number 119413-54-6
    D.3.9.3Other descriptive nameTOPOTECAN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB04921MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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) No
    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: 4
    D.1.2 and D.1.3IMP RoleComparator
    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.2.5The 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.3.4Pharmaceutical form
    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 INNIrinotecan hydrochloride
    D.3.9.3Other descriptive nameIRINOTECAN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02772MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) No
    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: 5
    D.1.2 and D.1.3IMP RoleComparator
    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.2.5The 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 nameGemcitabine
    D.3.4Pharmaceutical form Powder for 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 INNgemcitabine hydrochloride
    D.3.9.3Other descriptive nameGEMCITABINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02324MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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) No
    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: 6
    D.1.2 and D.1.3IMP RoleComparator
    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.2.5The 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 nameVinorelbine
    D.3.4Pharmaceutical form Concentrate for 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 INNVINORELBINE TARTRATE
    D.3.9.3Other descriptive nameVINORELBINE TARTRATE
    D.3.9.4EV Substance CodeSUB20777
    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 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) No
    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.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
    recurrent or metastatic, platinum-refractory cervical cancer
    carcinoma cervicouterino resistente a platino recurrente o metastásico
    E.1.1.1Medical condition in easily understood language
    cervical carcinoma
    carcinoma cervicouterino
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare overall survival (OS) for patients with recurrent or metastatic, platinum-refractory cervical cancer
    treated with either REGN2810 or investigator’s choice (IC) chemotherapy.
    Comparar la supervivencia general (SG) de las pacientes con cáncer cervicouterino resistente a platino recurrente o metastásico tratado con REGN2810 o la quimioterapia a elección del investigador
    E.2.2Secondary objectives of the trial
     To compare progression-free survival (PFS) of REGN2810 versus IC chemotherapy
     To compare overall response rate (ORR) (partial response [PR] + CR) of REGN2810 versus IC chemotherapy
    per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
     To compare the duration of response (DOR) of REGN2810 versus IC chemotherapy
     To compare the safety profiles of REGN2810 versus IC chemotherapy by describing adverse events (AE)
     To compare quality of life for patients treated with REGN2810 versus IC chemotherapy using European Organization for Research and Treatment of CancerQuality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
    • Comparar la supervivencia sin progresión (SSP) de REGN2810 en comparación con la quimioterapia a elección del investigador.
    • Comparar la tasa de respuesta global (TRG) (respuesta parcial + respuesta completa [RC]) de REGN2810 en comparación con la quimioterapia a elección del investigador según los Criterios de evaluación de la respuesta en tumores sólidos 1.1.
    • Comparar la duración de la respuesta (DR) de REGN2810 en comparación con la quimioterapia a elección del investigador.
    • Comparar los perfiles de seguridad de REGN2810 en comparación con la quimioterapia a elección del investigador mediante la descripción de los acontecimientos adversos (AA).
    • Comparar la calidad de vida (CdV) de las pacientes tratadas con REGN2810 en comparación con la quimioterapia a elección del investigador mediante el Cuestionario de calidad de vida de 30 ítems de la Organización Europea de Investigación y Tratamiento del Cáncer (QLQ-C30 de la EORTC)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The criteria listed below are not intended to contain all considerations relevant to a patient’s potential participation in this clinical trial.
    1. Recurrent, persistent, and/or metastatic cervical cancer, for which there is not a curativeintent option (surgery or radiation therapy with or without chemotherapy). Acceptable histologies are squamous carcinoma, adenocarcinoma, and adenosquamous carcinoma. Sarcomas and neuro-endocrine carcinomas are not eligible histologies.
    2. Tumor progression or recurrence within 6 months of last dose of platinum therapy that was used to treat metastatic, persistent or current cervical cancer
    3. Patient must have measurable disease as defined by RECIST
    4. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
    5. ≥18 years old
    6. Adequate organ or bone marrow function
    7. Received prior bevacizumab therapy or had clinically documented reason why not administered
    8. Received prior paclitaxel therapy or had clinically documented reason why not administered
    Los criterios listados a continuación no pretenden contener todas las consideraciones relevantes para una posible participación del paciente en este ensayo clínico.
    1. Cáncer de cuello de útero recurrente, persistente y/o metastásico para el que no existe una opción con intención curativa (cirugía o radioterapia con o sin quimioterapia). Las histologías aceptables son carcinoma epidermoide, adenocarcinoma y carcinoma adeno-epidermoide. Los sarcomas y los carcinomas neuroendocrinos no son histologías aptas.
    2. Progresión o recurrencia tumoral en los 6 meses posteriores a la última dosis de tratamiento con platino que se empleó para tratar el cáncer de cuello de útero metastásico, persistente o recurrente.
    3. La paciente debe presentar enfermedad medible de acuerdo con los criterios.
    4. Estado general ≤1 conforme a la escala ECOG (Eastern Cooperative Oncology Group).
    5. ≥18 años de edad.
    6. Función de la médula ósea adecuada.
    7. Haber recibido anteriormente un tratamiento que contuviera bevacizumab o haber existido razones clínicas documentadas por las que no se administró.
    8. Haber recibido anteriormente un tratamiento que contuviera paclitaxel o haber existido razones clínicas documentadas por las que no se administró.
    E.4Principal exclusion criteria
    1. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments.
    2. Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
    3. Prior treatment with immune modulating agents (other than anti-PD-1/PD-L1 agents) within 28 days (within 90 days if there was an immune-related adverse event)prior to enrollment date.
    4. KActive or untreated brain metastases.
    5. Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810.
    6. Active infection requiring systemic therapy.
    7. History of pneumonitis within the last 5 years
    8. Documented allergic or acute hypersensitivity reaction attributed to antibody treatments
    9. Known allergy to doxycycline or other tetracycline antibiotics
    10. History of malignancy other than cervical cancer within 3 years of first planned dose of REGN2810, except for tumors with negligible risk of metastasis
    1. Indicios actuales o recientes (en el plazo de 5 años) de enfermedad autoinmune significativa que requirió tratamiento con inmunosupresores sistémicos.
    2.Tratamiento previo con un agente que bloquea la vía PD-1/PD-L1.
    3. Tratamiento previo con otros agentes inmunomoduladores (diferentes a agentes anti PD-1/PD-L1) administrados en los 28 dias antes de la fecha de inscripción(90 dias si hubo algún acontecimiento adverso relacionado con el sistema inmunitario).
    4. Metástasis cerebrales activas o sin tratamiento.
    5.Dosis inmunosupresoras de corticosteroides (>10 mg diarios de prednisona o equivalente) en las 4 semanas anteriores a la primera dosis de REGN2810.
    6.Infección activa que requiera terapia sistémica.
    7. Antecedentes de neumonitis en los últimos 5 años.
    8. Reacciones alérgicas o reacciones de hipersensibilidad agudas documentadas que se atribuyan a tratamientos con anticuerpos.
    09. Alergia conocida a la doxiciclina u otros antibióticos del grupo tetraciclina.
    10. Antecedentes de neoplasia maligna diferente del cáncer de cuello de útero en los 3 años anteriores a la fecha de la primera dosis planificada de REGN2810, excepto para tumores con riesgo insignificante de metástasis.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is OS, defined as the time from randomization to the date of death. A patient who has not died will be censored at the last known date of contact.
    El criterio de valoración principal es la SG, definida como el tiempo desde la aleatorización hasta la fecha de la muerte. A las pacientes que no fallezcan, se les censurará en la última fecha de contacto que se conozca.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint is OS, defined as the time from randomization to the date of death.
    El criterio de valoración principal es la SG, definida como el tiempo desde la aleatorización hasta la fecha de la muerte.
    E.5.2Secondary end point(s)
     Compare progression-free survival (PFS) of REGN2810 versus IC chemotherapy

     To compare overall response rate (ORR) (partial response + complete response [CR]) of REGN2810 versus IC chemotherapy per Response Evaluation Criteria in Solid Tumors 1.1
     To compare the duration of response (DOR) of REGN2810 versus IC chemotherapy
     To compare the safety profiles of REGN2810 versus IC chemotherapy by describing adverse events (AE)
     To compare quality of life (QOL) for patients treated with REGN2810 versus IC chemotherapy using the European Organization for Research and Treatment of Cancer Quality of Life
    Questionnaire-Core 30 (EORTC QLQ-C30)
    •Comparar la supervivencia sin progresión (SSP) del REGN2810 en comparación con el tratamiento de quimioterapia a elección del investigador
    •Comparar la tasa de respuesta global (TRG) (respuesta parcial + respuesta completa [RC]) de REGN2810 en comparación con la quimioterapia a elección del investigador según los Criterios de evaluación de la respuesta en tumores sólidos 1.1.
    • Comparar la duración de la respuesta (DR) de REGN2810 en comparación con la quimioterapia a elección del investigador.
    • Comparar los perfiles de seguridad de REGN2810 en comparación con la quimioterapia a elección del investigador mediante la descripción de los acontecimientos adversos (AA).
    • Comparar la calidad de vida (CdV) de las pacientes tratadas con REGN2810 en comparación con la quimioterapia a elección del investigador mediante el Cuestionario de calidad de vida de 30 ítems de la Organización Europea de Investigación y Tratamiento del Cáncer (QLQ-C30 de la EORTC)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Progression-free survival will be defined as the time from randomization to the date of the first documented tumor progression using RECIST 1.1, or death due to any cause.
    La supervivencia sin progresión se definirá como el tiempo desde la aleatorización hasta la fecha de la primera progresión tumoral documentada empleando los criterios RECIST 1.1, o la muerte por cualquier causa.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Quimioterapia
    Chemotherapy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    comparar REGN2810 REGN2810 con el tratamiento de quimioterapia a elección del investigador
    comparing REGN2810 versus IC of chemotherapy
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Brazil
    Canada
    Korea, Republic of
    Poland
    Russian Federation
    Spain
    Taiwan
    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
    LPLV
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 349
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 87
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 58
    F.4.2.2In the whole clinical trial 436
    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)
    Patients who complete 16 cycles of treatment enter the follow up period . If they have not experienced PD (Progressive disease) during the study, radiologic assessments will continue until PD is occurred.If a patient experiences PD during the follow-up period, retreatment with the same drug that was given during the treatment period is an option. The patients will be treated in the retreatment period in accordance with their initial randomization
    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 Decision2017-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-15
    P. End of Trial
    P.End of Trial StatusCompleted
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