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    Summary
    EudraCT Number:2016-002543-41
    Sponsor's Protocol Code Number:64041757LUC2002
    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:2017-11-08
    Trial results View 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 number2016-002543-41
    A.3Full title of the trial
    An Open-label Randomized Phase 1b/2 Study of the Efficacy and Safety of JNJ-64041757, a Live Attenuated Listeria monocytogenes Immunotherapy, in Combination with Nivolumab Versus Nivolumab Monotherapy in Subjects With Advanced Adenocarcinoma of the Lung
    Estudio de fase 1b/2, abierto y aleatorizado, de la eficacia y la seguridad de JNJ-64041757, una inmunoterapia con gérmenes vivos atenuados de listeria monocytogenes, en combinación con nivolumab frente a nivolumab en monoterapia en sujetos con adenocarcinoma de pulmón avanzado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the Efficacy and Safety of JNJ-64041757 in combination with Nivolumab versus Nivolumab Monotherapy in Patients with Advanced Lung Cancer
    Estudio para evaluar la eficacia y la seguridad de JNJ-64041757 en combinación con nivolumab frente a nivolumab en monoterapia en sujetos con cáncer de pulmón avanzado
    A.4.1Sponsor's protocol code number64041757LUC2002
    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 SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPAREXEL International S.L.
    B.5.2Functional name of contact pointPC-CTRS
    B.5.3 Address:
    B.5.3.1Street AddressEdificio Sollube- Plaza de Carlos Trías Bertrán, 7 - 7ª plta
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28020
    B.5.3.4CountrySpain
    B.5.4Telephone number+3491 391 3443
    B.5.5Fax number+34913914925
    B.5.6E-mailclinicaltrial.enquiries@PAREXEL.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 nameJNJ-64041757
    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 INNJNJ-757
    D.3.9.3Other descriptive nameJNJ-64041757
    D.3.9.4EV Substance CodeSUB189069
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/ml colony forming unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000000000
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    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 Yes
    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: 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.2.1.1.1Trade name Opdivo
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.2Product code BMS-936558
    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 INNNIVOLUMAB
    D.3.9.1CAS number 946414-94-4
    D.3.9.2Current sponsor codeBMS-936558-01
    D.3.9.4EV Substance CodeSUB122750
    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 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
    Advanced adenocarcinoma of the lung
    Adenocarcinoma de pulmón avanzado
    E.1.1.1Medical condition in easily understood language
    A specific type of lung cancer called "adenocarcinoma of the lung"
    Un tipo específico de cáncer de pulmón llamado "adenocarcinoma de pulmón"
    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 LLT
    E.1.2Classification code 10001164
    E.1.2Term Adenocarcinoma lung stage III
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001165
    E.1.2Term Adenocarcinoma lung stage IV
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate whether the efficacy of JNJ-757 combined with nivolumab is better than the efficacy of nivolumab monotherapy for subjects with mesothelin-positive relapsed/refractory Stage IIIB or Stage IV adenocarcinoma of the lung, by PD-L1 level
    Evaluar si la eficacia de JNJ-757 combinado con nivolumab es superior a la eficacia de nivolumab en monoterapia en sujetos con adenocarcinoma de pulmón recidivado/resistente positivo para mesotelina, en estadios IIIB o IV, según el nivel de PD-L1.
    E.2.2Secondary objectives of the trial
    - To compare the clinical benefit of JNJ-757 combined with nivolumab versus nivolumab monotherapy
    - To evaluate the safety of JNJ-757
    - To correlate PD-L1 levels with clinical activity
    - To assess the blood culture and shedding profile of JNJ-757
    - To assess the pharmacokinetics and immunogenicity of nivolumab
    -Comparar el beneficio clínico del JNJ-757 combinado con nivolumab frente a la monoterapia con nivolumab.
    -Evaluar la seguridad del JNJ-757
    -Relacionar el nivel de PD-L1 con la actividad clínica
    -Evaluar el hemocultivo y el perfil de excreción de JNJ-757
    -Evaluar la farmacocinética y la capacidad inmunógena de nivolumab
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional translational sub-study: CT- or FDG-PET/CT-guided core needle tumor biopsy samples will be collected from approximately 20 subjects and correlated with mesothelin-directed peripheral adaptive immune response.
    Subestudio traslacional opcional: Se tomarán biopsias del tumor con aguja gruesa guiada por CT- o FDG-PET/CT a aproximadamente 20 pacientes y sus hallazgos se relacionarán con la respuesta inmunitaria adaptativa periférica dirigida por la mesotelina
    E.3Principal inclusion criteria
    - Histologically documented adenocarcinoma of the lung
    - Stage IIIB or Stage IV disease
    - Biopsy material available for central assessment of PD-L1 and mesothelin
    - In Phase 2 only: Mesothelin-positive status
    - ECOG performance status of 0 or 1
    - Progressive disease during or after platinum-based doublet chemotherapy, administered in the metastatic setting
    - Adequate bone marrow function, defined as:
    • Absolute neutrophil count (ANC) ≥1500/μL (or 1.5×10 to the power of 9/L)
    • Platelets ≥100,000/μL (or 100×10 to the power of 9/L)
    • Hemoglobin ≥10.0 g/dL
    - Adequate hepatic function, defined as:
    • Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) ≤ 1.5 times the upper limit of normal (ULN)
    • Total serum bilirubin ≤1.5xULN
    - Adequate renal function, defined as:
    • Calculated creatinine clearance ≥40 mL/min using the Cockcroft-Gault equation
    - A woman of childbearing potential must have a negative serum (β-human chorionic gonadotropin [β-hCG]) or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of hCG) within 14 days before the first dose of nivolumab and a second negative test within 24 hours before the first dose of nivolumab.
    - Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for subject participating in clinical studies. Further details see protocol
    - A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction while on the study agent and for 5 months after the last dose of study agent
    - To avoid risk of drug exposure through the ejaculate (even men with vasectomies), subjects must use a condom during sexual activity while on the study agent and for 5 months (female subjects) or 7 months (male subjects) after the last dose of study agent.
    - Adenocarcinoma de pulmón con confirmación histológica documentada
    - Enfermedad estadio IIIB o IV
    - Material de biopsia para estudio centralizado de PD-L1 y mesotelina
    - Solo en fase 2: estado positivo para mesotelina
    - estado funcional del ECOG de 0 ó 1
    - Los sujetos deben haber presentado enfermedad progresiva durante o después de un doblete de quimioterapia con platino, administrado en un entorno metastásico.
    - Adecuada función medular, definida como:
    o Recuento absoluto de neutrófilos (ANC) >o=1500/microL (o 1.5×10E9/L)
    o Plaquetas >o=100,000/microL (o 100×10E9/L)
    o Hemoglobina >o=10.0 g/dL
    - Adecuada función hepática, definida como:
    o aspartato aminotransferasa sérica (AST) y alanina aminotransferasa sérica (ALT) <o= 1.5 veces el límite superior de normalidad (ULN)
    o Bilirubina sérica total <o=1.5xULN
    o Aclaramiento de creatinica caalculada >o=40 mL/min usando la fórmula de Cockcroft-Gault.
    - Las mujeres potencialmente fértiles deben tener una prueba negativa en suero (gonadotropina coriónica humana [β-hCG]) o un test de embarazo de orina (sensibilidad mínima de 25UI/L unidades equivalentes de hCG) en los 14 dias previos a la primera dosis de nivolumab y un segundo test negativo las 24 horas antes de la primera dosis de nivolumab
    - Los métodos anticonceptivos usados por hombres y mujeres deben ser consistentes con la regulación local relativa a los métodos anticonceptivos de sujetos participantes en ensayos clínicos. Más detalles en el protocolo.
    - Las mujeres deben acceder a no donar óvulos (u oocitos) para reproducción asistida mientras estén recibiendo el producto del estudio y durante 5 meses después de la última dosis del producto de estudio.
    - Para evitar el riesgo de exposición al fármaco a través de la eyaculación (incluso los hombres con vasectomías), los pacientes deberán usar un condón durante la actividad sexual mientras que estén recibiendo el fármaco de estudio y durante 5 meses (mujeres) o 7 meses (hombres) después de la última dosis del agente de estudio.
    E.4Principal exclusion criteria
    - Untreated brain metastases or other active central nervous system (CNS) metastases. Subjects with a history of brain metastasis must have completed treatment for brain metastasis for at least 28 days, and be neurologically stable and off steroids before enrollment (Phase 1b) or randomization (Phase 2).
    - Tumor with activating EGFR mutation or ALK translocation (EGFR and ALK results must be confirmed in the Screening Period for all non-smokers).
    - More than 1 prior line of chemotherapy for metastatic disease (not including therapy given in the maintenance setting, or neoadjuvant or adjuvant therapy for locally advanced disease).
    - History of symptomatic interstitial lung disease.
    - History of disallowed therapies, as follows:
    • In Phase 1b only: Prior exposure to anti-PD1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte associated antigen 4 (CTLA-4) antibody within 28 days before the first dose of study agent
    • In Phase 2 only: Prior exposure to anti-PD1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte associated antigen 4 (CTLA-4) antibody
    • History of listeriosis or vaccination with a Listeria-based vaccine or prophylactic vaccine (eg, influenza, pneumococcal, diphtheria, tetanus, and pertussis [dTP/dTAP]) within 28 days before the first dose of study agent
    • Chemotherapy within 28 days before the first dose of study agent
    • Radiation within 14 days before the first dose of study agent (exception: palliative radiotherapy for pain can be used ≥ 7 days before or after study agent)
    - Any uncontrolled active systemic infection, active noninfectious pneumonitis, or any life-threatening illness, medical condition, or organ system dysfunction
    - Any active autoimmune disease or a documented history of autoimmune disease
    - History of any other condition that may require the initiation of anti-tumor necrosis factor alpha (TNFα) therapies or other immunosuppressant medications during the study.
    - Known allergy to both penicillin/amoxicillin and trimethoprim/sulfamethoxazole.
    - Concurrent treatment with anti-TNFα therapies, systemic corticosteroids (prednisone dose >10 mg per day or equivalent), or other immunosuppressive drugs <14 days before randomization. Steroids that are topical, inhaled, nasal (spray), or ophthalmic solution are permitted.
    - Positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS).
    - History of major implant(s) or device(s)
    - History of clinically significant cardiovascular disease within 6 months of randomization
    - Known active or chronic hepatitis B or hepatitis C as demonstrated by hepatitis B surface antigen (HBsAg) positivity and/or anti-hepatitis C virus (HCV) positivity, respectively. Subjects with clinically active or chronic liver disease, including liver cirrhosis, are also excluded.
    - Active second malignancy within 2 years prior to randomization (exceptions see protocol)
    - Evidence of active viral, bacterial, or systemic fungal infection requiring systemic treatment within 7 days before the first dose of the study agent.
    - Known allergies, hypersensitivity, or intolerance to JNJ-757 or nivolumab or its excipients
    - metástasis cerebrales no tratadas u otras metástasis activas del sistema nervioso central (SNC). Los pacientes con historial de metástasis deben haber completado el tratamiento para dichas metástasis al menos 28 días antes, y estar neurológicamente estables y sin esteroides antes del reclutamiento (fase 1b) o aleatorización (fase 2).
    - Tumor con mutación activadora del receptor del factor de crecimiento epidérmico o translocación de ALK (los resultados de EGFR y ALK deben ser confirmados en el periodo de selección para todos los no fumadores).
    - Más de 1 línea previa de quimioterapia para enfermedad metastásica (no incluida la terapia para mantenimiento o terapia neoadyuvante o adyuvante para la enfermedad localmente avanzada).
    - Antecedentes de neumopatía intersticial sintomática
    - Antecedentes de terapias no permitidas, tales como:
    • En fase 1b solo: exposición previa a anticuepos anti-PD1, anti-PD-L1, anti-PD-L2, anti-CD137 o anti antígeno 4 del linfocito T citotóxico (CTLA-4) en los 28 días antes de la primera dosis del agente de estudio
    • En fase 2 sólo: exposición previa a anticuepos anti-PD1, anti-PD-L1, anti-PD-L2, anti-CD137 o anti antígeno 4 del linfocito T citotóxico (CTLA-4)
    - Antecedentes de listeriosis o vacunación con vacunas basadas en Listeria o vacunas profilácticas (ej. Influenza, neumocócica, difteria, tétanos y tos ferina [dTP/dTAP]) en los 28 días antes de la primera dosis del agente de estudio
    - Quimioterapia en los 28 días antes de la primera dosis del agente de estudio
    - Radiación en los 14 días antes de la primera dosis del agente de estudio (excepción: puede usarse radioterapia paliativa para el dolor ≥ 7 días antes o después del agente de estudio)
    - alguna infección sistémica activa, neumonía no infecciosa active, o alguna enfermedad que amenace la vida, condición médica o disfunción orgánica.
    - alguna enfermedad autoinmune activa o antecedentes documentados de enfermedad autoinmune
    - antecedentes de cualquier otra condición que requiera el comienzo de terapias con anti factor de necrosis tumoral alfa (TNFα ) u otra medicación inmunosupresora durante el estudio.
    - Alergia a la penicilina/amoxicilina y trimetoprim/sulfametoxazol.
    -Tratamiento concurrente con terapias anti-TNFα, corticoesteroides sistémicos (dosis de prednisona > 10 mg por día o equivalente), u otras drogas inmunosupresivas < 14 días antes de la aleatorización. Se permiten esteroides tópicos, inhalados, nasales (aerosol), o solución oftálmica.
    -Resultado positivo para el virus de inmunodeficiencia humana (VIH) o síndrome de inmunodeficiencia adquirida (SIDA).
    - Antecedentes de implantes mayores o dispositivos.
    -Antecedentes de enfermedad cardiovascular clínicamente significativa en los 6 meses previos a la aleatorización
    - Hepatitis B activa o crónica o hepatitis C, evidenciado como positivo en antígeno de superficie (HBsAg) de la hepatitis B y/o positivo en anticuerpos del virus hepatitis C (HCV), respectivamente. También quedan excluidos los sujetos con enfermedad hepática clínicamente activa o crónica, incluyendo cirrosis hepática.
    - Malignidad secundaria activa dentro de 2 años antes de la aleatorización (excepciones ver protocolo)
    -evidencia de i9nfecciones activas virales, bacterianas o fúngicas sistémicas que requieren tratamiento sistémico dentro de 7 días antes de la primera dosis de lo agente de estudio.
    - Alergias conocidas, hipersensibilidad o intolerancia a JNJ-757 o nivolumab o a sus excipientes
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate (complete response plus partial response, based on RECIST 1.1 criteria)
    Tasa de respuesta objetiva (respuesta completa más respuesta parcial, según los criterios RECIST 1.1)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 8 weeks (±7d) during the first year, and then every 12 weeks (±7d) thereafter.
    Cada 8 semanas (±7 días) durante el primer año, y a partir de entonces cada 12 semanas (±7 días).
    E.5.2Secondary end point(s)
    - Disease control rate (stable disease for 16 weeks, complete response, or partial response)
    - Duration of objective response
    - Progression-free survival
    - Overall survival
    - Incidence of adverse events
    - Tasa de control de la enfermedad (enfermedad estable durante 16 semanas, respuesta completa o respuesta parcial)
    - Duración de la respuesta objetiva
    - Supervivencia sin progresión
    - Supervivencia global
    - Incidencia de acontecimientos adversos
    E.5.2.1Timepoint(s) of evaluation of this end point
    - DCR, DOR, PFS: Every 8 weeks (±7d) during the first year, and then every 12 weeks (±7d) thereafter.
    - OS: throughout the whole study, after discontinuation of treatment every 3 months
    - Adverse events: throughout the whole study until 100 days after the last dose of nivolumab
    TCE, DRO, SSP: Cada 8 semanas (±7 días) durante el primer año, y a partir de entonces cada 12 semanas (±7 días).
    SG: durante todo el estudio, y tras discontinuar el tratamiento, cada 3 meses.
    - Efectos adversos: durante todo el estudio y hasta 100 días después de la última dosis de nivolumab
    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 No
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Ib
    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 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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    nivolumab plus or minus JNJ-64041757
    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 EEA7
    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
    United States
    E.8.7Trial has a data monitoring committee No
    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
    The end of the study will occur when 80% of the randomized subjects have died, or approximately 3 years after the last subject is randomized, or the sponsor terminates the study.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 4
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 11
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 7
    F.4.2.2In the whole clinical trial 15
    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)
    No post-trial medication will be provided, the further treatment of patients after end of trial will be carried out according to their physicians' decision.
    No se proporcionará ninguna medicación después del ensayo, el tratamiento de los pacientes después de final del ensayo se llevará a cabo según decisión de sus médicos.
    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 Decision2018-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-10-09
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