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    Summary
    EudraCT Number:2018-001028-21
    Sponsor's Protocol Code Number:D6070C00005
    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:2018-08-07
    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 number2018-001028-21
    A.3Full title of the trial
    A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of Oleclumab (MEDI9447) with or without Durvalumab in Combination with Chemotherapy in Subjects with Metastatic Pancreatic Ductal Adenocarcinoma
    Estudio de fase Ib/II para evaluar la seguridad, farmacocinética y actividad clínica de oleclumab (MEDI9447) con o sin durvalumab en combinación con quimioterapia en pacientes con adenocarcinoma ductal pancreático metastásico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Oleclumab (MEDI9447) with or without Durvalumab Combined with Chemotherapy in Subjects with Pancreatic Cancer
    Estudio de oleclumab (MEDI9447) con o sin durvalumab en combinación con quimioterapia en pacientes con cáncer de páncreas
    A.4.1Sponsor's protocol code numberD6070C00005
    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 SponsorMedImmune, LLC
    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 supportMedImmune, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedImmune LLC
    B.5.2Functional name of contact pointClinical Trial Enquiries
    B.5.3 Address:
    B.5.3.1Street AddressOne MedImmune Way
    B.5.3.2Town/ cityGaithersburg
    B.5.3.3Post code20878
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrialenquiries@medimmune.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 nameOleclumab
    D.3.2Product code MEDI9447
    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 INNnot assigned
    D.3.9.1CAS number not assigned
    D.3.9.2Current sponsor codeMEDI9447
    D.3.9.3Other descriptive nameOleclumab
    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.IMP: 2
    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 nameDurvalumab
    D.3.2Product code MEDI4736
    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 INNdurvalumab
    D.3.9.1CAS number 1428935-60-7
    D.3.9.2Current sponsor codeMEDI4736
    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.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.3.1Product namegemcitabine
    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 INNgemcitabine
    D.3.9.3Other descriptive namegemcitabine
    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.3.1Product namenab-paclitaxel
    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 INNnab-paclitaxel
    D.3.9.3Other descriptive namenab-paclitaxel
    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.3.2Product code mFOLFOX
    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 INNleucovorin
    D.3.9.3Other descriptive namefolinic acid
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN5-FU
    D.3.9.3Other descriptive name5-FU
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNoxaliplatin
    D.3.9.3Other descriptive nameoxaliplatin
    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
    Pancreatic Ductal Adenocarcinoma
    Adenocarcinoma Ductal Pancreatico
    E.1.1.1Medical condition in easily understood language
    Pancreatic Cancer
    Cancer Pancreatico
    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 10051971
    E.1.2Term Pancreatic adenocarcinoma
    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 assess the safety and tolerability of oleclumab plus durvalumab in combination with chemotherapy administered in subjects with metastatic PDAC. To evaluate the preliminary antitumor activity of oleclumab with or without durvalumab in combination with gemcitabine and nab-paclitaxel compared to gemcitabine and nab-paclitaxel administered in subjects with 1L metastatic PDAC. To evaluate the preliminary antitumor activity of oleclumab with or without durvalumab in combination with mFOLFOX compared to mFOLFOX administered in subjects with 2L metastatic PDAC.
    Evaluar la seguridad y tolerabilidad de oleclumab más durvalumab en combinación con quimioterapia administrados a pacientes con ACDP metastásico.
    Evaluar la actividad antitumoral preliminar de oleclumab con o sin durvalumab en combinación con gemcitabina y nab-paclitaxel en comparación con gemcitabina y nab-paclitaxel administrados a pacientes con ACDP metastásico en primera línea (1L).
    Evaluar la actividad antitumoral preliminar de oleclumab con o sin durvalumab en combinación con mFOLFOX en comparación con mFOLFOX administrados a pacientes con ACDP metastásico en segunda línea (2L).
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of oleclumab with or without durvalumab in combination with chemotherapy administered in subjects with metastatic PDAC. To evaluate the preliminary
    antitumor activity of oleclumab with or without durvalumab in combination with chemotherapy administered in subjects with 1L metastatic PDAC and in subjects with 2L metastatic PDAC.
    To evaluate the preliminary antitumor activity of oleclumab with or without durvalumab in combination with chemotherapy compared to chemotherapy alone in the population defined by CD73
    expression.
    To determine the PK profile of oleclumab and durvalumab in combination with chemotherapy administered in subjects with metastatic PDAC.
    Evaluar la seguridad y tolerabilidad de oleclumab con o sin durvalumab en combinación con quimioterapia administrados a pacientes con ACDP metastásico.
    Evaluar la actividad antitumoral preliminar de oleclumab con o sin durvalumab en combinación con quimioterapia administrados a pacientes con ACDP metastásico en 1L y a pacientes con ACDP metastásico en 2L.
    Evaluar la actividad antitumoral preliminar de oleclumab con o sin durvalumab en combinación con quimioterapia en comparación con quimioterapia sola en la población definida por la expresión de CD73.
    Determinar el perfil FC de oleclumab y durvalumab en combinación con quimioterapia administrados a pacientes con ACDP metastásico.
    Consulte el protocolo del estudio para obtener información detallada sobre los objetivos secundarios.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18
    2. Written and signed informed consent must be obtained
    3. ECOG Performance Status 0 or 1
    4. Weight ≥ 35 kg
    5. Subjects must have histologically or cytologically confirmed pancreatic adenocarcinoma:
    Cohort A: Subjects with previously untreated metastatic pancreatic adenocarcinoma (1 line metastatic disease) not previously treated with systemic therapies.
    Cohort B: Subjects with metastatic pancreatic adenocarcinoma previously treated with gemcitabine-based chemotherapy (without exposure to 5-FU, capecitabine, oxaliplatin) 2 line metastatic adenocarcinoma
    6. Subjects must have at least 1 measurable lesion according to RECIST v1.1
    7. All subjects must consent to providing archival tumor specimens
    1. Edad ≥18 años.
    2. Se debe obtener el consentimiento informado firmado y por escrito.
    3. Estado funcional según la escala del Grupo Oncológico Cooperativo de la Costa Este (ECOG) de 0 o 1.
    4. Peso ≥35 kg.
    5. Los pacientes deben tener un diagnóstico confirmado de forma histológica o citológica de adenocarcinoma pancreático:
    Cohorte A: pacientes con adenocarcinoma pancreático metastásico sin tratamiento previo (enfermedad metastásica en 1L) que no hayan recibido tratamientos sistémicos previos.
    Cohorte B: pacientes con adenocarcinoma pancreático metastásico tratado previamente con quimioterapia a base de gemcitabina (sin exposición a 5 FU, capecitabina u oxaliplatino); adenocarcinoma metastásico en 2L.
    6. Los pacientes deben presentar al menos 1 lesión medible según los Criterios de evaluación de la respuesta en tumores sólidos (RECIST) v1.1.
    7. Todos los pacientes deben otorgar su consentimiento para proporcionar muestras tumorales de archivo.
    E.4Principal exclusion criteria
    1. Receipt of any conventional or investigational anticancer therapy within 21 days or palliative radiotherapy within 14 days prior to the scheduled first dose of study treatment.
    2. Prior receipt of any immune-related therapy
    3. Concurrent enrollment in another therapeutic clinical study. Enrollment in observational studies will be allowed
    4. Subjects with a history of venous thrombosis within the past 3 months
    5. Subjects with prior history of myocardial infarction, transient ischemic attack, or stroke in the last 3 months prior to start of treatment
    6. Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment
    7. Other invasive malignancy within 2 years.
    8. Any history of leptomeningeal disease or cord compression.
    9. Current or prior use of immunosuppressive medication within 14 days prior to the first dose
    1. Haber recibido cualquier tratamiento antineoplásico convencional o en investigación en los 21 días previos a la administración de la primera dosis programada del tratamiento del estudio o radioterapia paliativa en los 14 días previos a la administración de la primera dosis programada del tratamiento del estudio.
    2. Haber recibido cualquier tratamiento previo relacionado con el sistema inmunitario.
    3. Inscripción simultánea en otro estudio clínico terapéutico. Se permitirá la inscripción en estudios observacionales.
    4. Pacientes con antecedentes de flebotrombosis en los últimos 3 meses.
    5. Pacientes con antecedentes de infarto de miocardio, accidente isquémico transitorio o accidente cerebrovascular en los 3 meses previos al inicio del tratamiento.
    6. Trastornos autoinmunitarios o inflamatorios activos o previamente documentados en los 3 años previos al inicio del tratamiento.
    7. Otras neoplasias malignas invasivas en los 2 años previos.
    8. Cualquier antecedente de carcinomatosis leptomeníngea o compresión medular.
    9. Uso actual o previo de inmunodepresores en los 14 días previos a la administración de la primera dosis.
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidence of adverse events as a measure of safety of oleclumab plus durvalumab in combination with chemotherapy in dose escalation as assessed by the presence of adverse events (AEs), serious adverse events (SAEs), dose limiting toxicities (DLTs) and clinically meaningful changes from baseline of laboratory and physical assessments

    2. Objective response rate as a measure of antitumor activity of oleclumab with or without durvalumab in combination with chemotherapy in dose expansion according to RECIST v1.1
    1. Incidencia de acontecimientos adversos como medida de la seguridad de oleclumab más durvalumab en combinación con quimioterapia durante la parte de aumento escalonado de la dosis, mediante la evaluación de la presencia de acontecimientos adversos (AA) y acontecimientos adversos graves (AAG), toxicidades limitantes de la dosis (TLD) y cambios clínicamente significativos respecto al inicio en las evaluaciones clínicas y físicas.
    2. Tasa de respuesta objetiva como medida de la actividad antitumoral de oleclumab con o sin durvalumab en combinación con quimioterapia durante la parte de ampliación de la dosis conforme a los criterios RECIST v1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Safety assessment from time of informed consent through 12 weeks after last dose of investigational product
    2. Objective response rates during treatment through study completion, about 2 years after the last subject dosed
    1. Evaluación de la seguridad desde el momento de la obtención del consentimiento informado hasta 12 semanas después de la última dosis del producto en investigación.
    2. Tasas de respuesta objetiva durante el tratamiento hasta la finalización del estudio, aproximadamente 2 años después de la administración del tratamiento al último paciente.
    E.5.2Secondary end point(s)
    1. Incidence of adverse events (AEs), serious adverse events (SAEs), and clinically meaningful changes from baseline of laboratory and physical assessments in dose expansion
    2. Objective response rate (OR) and disease control (DC) according to RECIST v1.1 in dose escalation
    3. Overall Survival (OS); Progression Free Survival (PFS), Duration of Response (DoR), and Disease Control (DC), defined as complete response (CR), partial response (PR) or stable disease (SD) according to RECIST v1.1 in dose expansion
    4. Overall Survival (OS); Objective Response (OR) and Progression-Free Survival (PFS) according to RECIST v1.1 by CD73 expression at baseline
    5. Immunogenicity. Development of detectable anti-drug antibody(ADA) to oleclumab (MEDI9447) and durvalumab
    6. Pharmacokinetic. Measure of serum Oleclumab (MEDI9447), durvalumab and selected chemotherapies and /or their metabolites
    1. Incidencia de acontecimientos adversos (AA) y acontecimientos adversos graves (AAG), así como cambios clínicamente significativos respecto al inicio en las evaluaciones clínicas y físicas durante la parte de ampliación de la dosis.
    2. Tasa de respuesta objetiva (RO) y control de la enfermedad (CE) conforme a los criterios RECIST v1.1 durante la parte de aumento escalonado de la dosis.
    3. Supervivencia global (SG); supervivencia sin progresión (SSP), duración de la respuesta (DdR) y control de la enfermedad (CE), definida como una respuesta completa (RC), respuesta parcial (RP) o enfermedad estable (EE) conforme a los criterios RECIST v1.1 durante la parte de ampliación de la dosis.
    4. Supervivencia global (SG); respuesta objetiva (RO) y supervivencia sin progresión (SSP) conforme a los criterios RECIST v1.1 por la expresión de CD73 en el momento basal.
    5. Inmunogenicidad. Desarrollo de anticuerpos antifármaco (AAF) detectables para oleclumab (MEDI9447) y durvalumab.
    6. Farmacocinética. Niveles séricos de oleclumab (MEDI9447), durvalumab y de quimioterapias seleccionadas y/o sus metabolitos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. From time of informed consent through 12 weeks after last dose of investigational product
    2. During treatment through study completion, about 2 years after the last subject dosed
    3. During treatment through study completion, about 2 years after the last subject dosed
    4. From time of screening through study completion, about 2 years after the last subject dosed
    5. From start of treatment through 12 weeks post last dose of investigational product
    6. During treatment through 12 weeks post last dose of investigational product and through the first 12 weeks of treatment for chemotherapies
    1. Desde el momento de la obtención del CI hasta 12 semanas después de la última dosis del producto en investigación.
    2. Durante el tratamiento (tto) hasta la finalización del estudio, aprox. 2 años después de la administración del tto al último paciente.
    3. Durante el tto hasta la finalización del estudio, aprox. 2 años después de la administración del tto al último paciente.
    4. Desde el momento de la selección hasta la finalización del estudio, aproximadamente 2 años después de la administración del tto al último paciente.
    5. Desde el inicio del tto hasta 12 semanas después de la última dosis del producto en investigación.
    6. Durante el tto hasta 12 semanas después de la última dosis del producto en investigación y durante las primeras 12 semanas de tto para las quimioterapias.
    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 Yes
    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
    Phase Ib: Safety and pharmacokinetics
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    gemcitabine, nab-paclitaxel, and mFOLFOX
    E.8.2.4Number of treatment arms in the trial6
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    Norway
    Spain
    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
    Last subject last visit
    Última visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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: 122
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 82
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 16
    F.4.2.2In the whole clinical trial 204
    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
    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 Decision2018-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-12
    P. End of Trial
    P.End of Trial StatusOngoing
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