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    Summary
    EudraCT Number:2015-001697-17
    Sponsor's Protocol Code Number:R1979-ONC-1504
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2015-10-15
    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 number2015-001697-17
    A.3Full title of the trial
    A Phase 1 Study to Assess Safety and Tolerability of REGN1979, an anti-CD20 x anti- CD3 bispecific monoclonal antibody, and REGN2810, an anti-programmed death-1 (PD-1) monoclonal antibody, in Patients with B-cell Malignancies
    Estudio de fase I para evaluar la seguridad y la tolerabilidad del REGN1979, un anticuerpo monoclonal biespecífico contra CD20 y CD3, y el REGN2810, un anticuerpo monoclonal contra la proteína de muerte celular programada 1, en pacientes con neoplasias malignas de linfocitos B
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of REGN1979 (anti-CD20 and anti- CD3) and REGN2810 (anti-PD-1) in Patients with a Specific Type of Blood Cancer
    Estudio de REGN1979 (anti-CD20 y anti- CD3) y REGN2810 (anti-PD-1) en pacientes con un tipo específico de cáncer en la sangre
    A.4.1Sponsor's protocol code numberR1979-ONC-1504
    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.5.4Telephone number+34900834223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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.3.4Pharmaceutical 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 N/A
    D.3.9.2Current sponsor codeREGN2810
    D.3.9.3Other descriptive nameanti-PD-1 monoclonal antibody
    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 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 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: 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 nameREGN1979
    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 N/A
    D.3.9.2Current sponsor codeREGN1979
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 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
    B-cell malignancies
    en pacientes con neoplasias malignas de linfocitos B
    E.1.1.1Medical condition in easily understood language
    Cancer in the Blood
    Cáncer en la sangre
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10003903
    E.1.2Term B-cell lymphoma refractory
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10003917
    E.1.2Term B-cell type acute leukaemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10026945
    E.1.2Term Mature B-cell type acute leukaemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10067184
    E.1.2Term Burkitt's leukaemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10020267
    E.1.2Term Hodgkin's disease refractory
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10003890
    E.1.2Term B precursor type acute leukaemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10020266
    E.1.2Term Hodgkin's disease recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10003902
    E.1.2Term B-cell lymphoma recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to assess safety, tolerability and dose limiting toxicity (DLT) of:

    · Single-agent REGN2810 in patients with B-cell malignancies including HL

    · Single-agent REGN1979 in patients with ALL

    · Combination REGN1979 and REGN2810 in patients with B-cell NHL

    · Combination REGN1979 and REGN2810 in patients with ALL
    El objetivo principal del estudio es evaluar la seguridad, la tolerabilidad y la toxicidad limitante de la dosis (TLD) de:
    ? REGN2810 en monoterapia en pacientes con neoplasias malignas de linfocitos B, incluido el linfoma de Hodgkin (LH).
    ? REGN1979 en monoterapia en pacientes con leucemia linfoblástica aguda (LLA).
    ? REGN1979 y REGN2810 en politerapia en pacientes con linfoma no hodgkiniano (LNH) de linfocitos B.
    ? REGN1979 y REGN2810 en politerapia en pacientes con LLA.
    E.2.2Secondary objectives of the trial
    · To determine a recommended dose for:

    o REGN2810 as a single agent in patients with B-cell malignancies including HL

    o REGN1979 as a single agent in patients with ALL

    o REGN1979 and REGN2810 administered in combination in patients with B-cell NHL.

    o REGN1979 and REGN2810 administered in combination in patients with ALL

    · To characterize the PK profile of REGN1979 and REGN2810 when administered as single agent and in combination

    · To assess the immunogenicity of REGN1979 and REGN2810 when administered as single agent and in combination

    · To study the preliminary antitumor activity of REGN1979 and REGN2810 when administered as single agents in specific indications and in combination as measured by overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), median, and rate at 6 and 12 months
    ? Determinar la dosis recomendada para:
    - REGN2810 en monoterapia en pacientes con neoplasias malignas de linfocitos B, incluido el LH.
    - REGN1979 en monoterapia en pacientes con LLA.
    - REGN1979 y REGN2810 en politerapia en pacientes con LNH de linfocitos B.
    - REGN1979 y REGN2810 en politerapia en pacientes con LLA.
    ? Definir el perfil farmacocinético del REGN1979 y el REGN2810 en monoterapia y en politerapia.
    ? Evaluar la inmunogenicidad del REGN1979 y el REGN2810 en monoterapia y en politerapia.
    ? Estudiar la actividad antitumoral preliminar del REGN1979 y el REGN2810 en monoterapia y en politerapia para indicaciones específicas, determinada mediante la tasa de respuesta global, la duración de la respuesta y la supervivencia sin progresión (mediana y tasa a los 6 y 12 meses).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Principal Inclusion Criteria for B-cell NHL and HL Treatment Arms:

    Hematologic malignancy defined by either:

    a. NHL: Documented CD20+ B-cell malignancy, with active disease that is either refractory to or relapsed after most recent prior therapy, for whom no standard of care options exist, or for whom alternative available options are not considered appropriate and for whom treatment with an anti-CD20 antibody may be appropriate:

    i. B-NHL confirmed by the Lugano Classification, 2014

    b. Documented Hodgkin?s lymphoma (HL), with active disease not responsive to prior therapy or relapsed after prior therapy for whom no standard of care options exist or for whom alternative available options are not considered appropriate. (REGN2810 single-agent therapy cohorts ONLY)

    All patients must have at least one bi-dimensionally measurable lesion (?1.5 cm) documented by diagnostic imaging (CT or MRI).

    Age ?18 years

    Adequate bone marrow function documented by:

    a. Platelet counts ?75 x 109/L

    b. Hb level ?9 g/dL

    c. ANC ?1 x 109/L

    Adequate hepatic function:

    a. Total bilirubin ?1.5 x ULN (?3 x ULN if liver involvement)

    b. Transaminases ?2.5 x ULN (?5 x ULN if liver involvement)

    c. Alkaline phosphatase (ALP) ?2.5 x ULN (?5 x ULN if liver involvement)

    Inclusion Criteria for Acute Lymphoblastic Leukemia Study Arms

    A patient must meet the following criteria to be eligible for inclusion in the study:

    Documented relapsed or refractory CD20+ B-precursor ALL (defined as CD20 expression by flow cytometry on ?20% of leukemic lymphoblasts) after induction and one cycle of consolidation chemotherapy

    a. Patients with Philadelphia chromosome positive (Ph+) ALL are required to have failed or be intolerant to second generation TKI

    Age ?18 years

    Central Nervous System (CNS) negative disease, confirmed by LP, within 28 days of starting study drug.

    Adequate bone marrow function documented by:

    a. Platelet counts ?10 x 109/L

    b. Hb level ?7 g/dL

    c. Absolute phagocyte count (APC) ?0.5 x 109/L (phagocytes: neutrophils, bands and monocytes)

    Adequate hepatic function:

    a. Total bilirubin ?1.5 x ULN (?3 x ULN if liver involvement)

    b. Transaminases ?2.5 x ULN (?5 x ULN if liver involvement)

    c. Alkaline phosphatase (ALP) ?2.5 x ULN (?5 x ULN if liver involvement)
    Criterios de inclusión para los grupos de tratamiento con LNH de linfocitos B y LH
    - Neoplasia maligna hematológica definida como una de las siguientes:
    a. LNH: neoplasia maligna de linfocitos B CD20+ comprobada, con enfermedad activa que es resistente al tratamiento o que ha recidivado después del último tratamiento, para la cual no existen opciones de tratamiento de referencia o las opciones alternativas disponibles no se consideran adecuadas, y para la cual puede ser oportuno el tratamiento con anticuerpos anti CD20:
    i. LNH de linfocitos B confirmado mediante la clasificación de Lugano, 2014 (Cheson 2014)
    b. LH comprobado, con enfermedad activa que no ha respondido al tratamiento o que ha recidivado después del tratamiento previo, para la cual no existen opciones de tratamiento de referencia o las opciones alternativas disponibles no se consideran adecuadas. (SOLO para cohortes de monoterapia con REGN2810)
    - Todos los pacientes deben tener al menos una lesión mensurable en dos dimensiones (? 1,5 cm), documentada mediante estudios de imagen (TC o RM).
    - Edad ? 18 años.
    - Función adecuada de la médula ósea, confirmada mediante:
    a. Recuento de plaquetas ?75 x 109/l
    b. Concentración de hemoglobina ? 9 g/dl.
    c. RAN ? 1 x 109/l.
    - Función hepática adecuada:
    a. Bilirrubina total ? 1,5 veces el límite superior de la normalidad (LSN) (?3 x LSN en caso de afectación hepática).
    b. Transaminasas ? 2,5 x LSN (? 5 x LSN en caso de afectación hepática)
    c. Fosfatasa alcalina ? 2,5 x LSN (? 5 x LSN en caso de afectación hepática)

    Criterios de selección para los grupos del estudio con leucemia linfoblástica aguda
    Para poder participar en el estudio, los pacientes deberán cumplir los criterios siguientes:
    - LLA de precursores B CD20+ comprobada (definida por una expresión de CD20 mediante citometría de flujo en al menos el 20 % de linfoblastos leucémicos) tras la quimioterapia de inducción y un ciclo de consolidación.
    a. Los pacientes con LLA positiva para el cromosoma Filadelfia deben haber presentado fracaso o intolerancia a un inhibidor de la tirosina cinasa de segunda generación.
    - Edad ? 18 años.
    - Ausencia de afectación del SNC, confirmada mediante punción lumbar en los 28 días anteriores a la primera dosis del fármaco del ensayo.
    - Función adecuada de la médula ósea, confirmada mediante:
    a. Recuento de plaquetas ? 10 x 109/l
    b. Concentración de hemoglobina ? 7 g/dl
    c. Recuento absoluto de fagocitos ? 0,5 x 109/l (fagocitos: neutrófilos, cayados y monocitos).
    - Función hepática adecuada:
    a. Bilirrubina total ? 1,5 x LSN (?3 x LSN en caso de afectación hepática)
    b. Transaminasas ? 2,5 x LSN (?5 x LSN en caso de afectación hepática)
    c. Fosfatasa alcalina ? 2,5 x LSN (?5 x LSN en caso de afectación hepática)
    E.4Principal exclusion criteria
    Principal Exclusion Criteria for B-cell NHL and HL Treatment Arms

    Primary central nervous system (CNS) lymphoma, or known or suspected CNS involvement by non-primary CNS NHL

    History of or current relevant CNS pathology

    Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments

    Standard anti-lymphoma chemotherapy (non-biologic) or radiotherapy within 28 days prior to first administration of study drug(s)

    Treatment with an investigational non-biologic agent within 28 days prior to first administration of study drug(s).

    Treatment with rituximab, alemtuzumab, immune-modulating agents or other investigational or commercial biologic agent within 28 days prior to first administration of study drug(s).

    Prior Allogeneic stem cell transplantation

    Prior treatment with an agent that blocks the PD-1/PD-L1 pathway, unless the patient demonstrated benefit (applicable only for patients in single-agent REGN2810 therapy).

    Principal Exclusion Criteria for Acute Lymphoblastic Leukemia Treatment Arms

    History of or current relevant CNS pathology

    Ongoing or recent (within 2 years) evidence of significant autoimmune disease (with the exception of GvHD) that required treatment with systemic immunosuppressive treatments

    Standard anti-leukemia chemotherapy (non-biologic) or radiotherapy within 14 days prior to first administration of study drug(s)

    Treatment with an investigational non-biologic agent within 14 days prior to first administration of study drug(s).

    Treatment with rituximab, immune modulating agents or other investigational or commercial biologic agent within 14 days prior to first administration of study drug.

    Treatment with alemtuzumab, within 12 weeks

    Prior Allogeneic stem cell transplantation within 3 months of treatment
    Criterios de exclusión para los grupos de tratamiento con LNH de linfocitos B y LH

    - Linfoma primario del sistema nervioso central (SNC), o afectación presunta o confirmada del SNC por un LNH no primario.
    - Antecedentes o presencia de un trastorno importante del SNC
    - Pruebas actuales o recientes (en los dos últimos años) de enfermedad autoinmunitaria importante que exigió tratamiento inmunodepresor por vía sistémica, lo que indica un riesgo de AAi.
    - Quimioterapia clásica (no biológica) o radioterapia contra el linfoma en los 28 días anteriores a la primera dosis del fármaco o fármacos del ensayo.
    - Tratamiento con un producto no biológico experimental en los 28 días anteriores a la primera dosis del fármaco o fármacos del ensayo.
    - Tratamiento con rituximab, alemtuzumab, inmunomoduladores u otro producto biológico experimental o comercial en los 28 días anteriores a la primera dosis del fármaco o fármacos del ensayo.
    - Antecedentes de alotrasplante de células progenitoras.
    - Antecedentes de tratamiento con un fármaco que bloquee la vía de PD 1/PD L1, a menos que el paciente obtuviera efectos beneficiosos confirmados (aplicable solo a los pacientes de los grupos de REGN2810 en monoterapia)

    Criterios de exclusión para los grupos de tratamiento con leucemia linfoblástica aguda

    - Pruebas actuales o recientes (en los dos últimos años) de enfermedad autoinmunitaria importante (a excepción de la EICH) que exigió tratamiento inmunodepresor por vía sistémica
    - Quimioterapia clásica (no biológica) o radioterapia contra la leucemia en los 14 días anteriores a la primera dosis del fármaco o fármacos del ensayo.
    - Tratamiento con un producto no biológico experimental en los 14 días anteriores a la primera dosis del fármaco o fármacos del ensayo.
    - Tratamiento con rituximab, inmunomoduladores u otro producto biológico experimental o comercial en los 14 días anteriores a la primera dosis del fármaco o fármacos del ensayo.
    - Tratamiento con alemtuzumab en las 12 semanas anteriores a la primera dosis del fármaco o fármacos del ensayo.
    - Alotrasplante de células progenitoras en los tres meses anteriores al tratamiento.
    E.5 End points
    E.5.1Primary end point(s)
    Safety
    Seguridad
    E.5.1.1Timepoint(s) of evaluation of this end point
    From informed consent form signature until 30 day post last dose of study drug
    Desde la firma del Consentimiento Informado, hasta 30 días después de la última dosis del fármaco del estudio
    E.5.2Secondary end point(s)
    ? Pharmacokinetics of REGN1979 and REGN2810 when given alone and in combination

    ? Immunogenicity: anti-REGN1979 and/or anti-REGN2810 antibodies

    ? Antitumor activity:

    - Overall response rate (ORR) as per applicable response criteria for the indication

    - Duration of response, and PFS at 6 and 12 months

    - Minimal residual disease (MRD) for patients with bone marrow involvement at baseline

    ? Pharmacodynamic measures including:

    - Cytokine profiling

    - Peripheral blood B-cell and T-cell subsets and immune phenotyping

    - Analysis of PD-1 receptor occupancy of circulating T-cells

    - Changes in gene expression in peripheral blood

    - Serum immunoglobulin
    ? Farmacocinética del REGN1979 y el REGN2810 en monoterapia y en politerapia.

    ? Inmunogenicidad: anticuerpos anti-REGN1979 y / o anti-REGN2810

    ? Actividad antitumoral:

    - Tasa de respuesta global (TRG) conforme a los criterios de respuesta pertinentes para cada indicación
    - Duración de la respuesta, y la Superviviencia sin progresión a los 6 y 12 meses

    - enfermedad residual mínima (ERM) para los pacientes con afectación de la médula ósea al inicio del estudio

    ? Las variables farmacodinámicas incluyen:

    - Determinación del perfil de citocinas
    - Inmunofenotipificación de subpoblaciones de linfocitos B y T de sangre periférica
    - Análisis de ocupación del receptor PD 1 (proteína de muerte celular programada 1) en linfocitos T circulantes.
    - Cambios de la expresión génica en sangre periférica.
    - Inmunoglobulina sérica
    E.5.2.1Timepoint(s) of evaluation of this end point
    each of the secondary endpoints is being assessed at specific time points as outlined in protocol
    cada uno de los objetivos secundarios es evaluado en momentos específicos como se indica en el protocolo
    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 Yes
    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
    combination study
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    Germany
    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
    The end of the study is defined as the date on which the last subject
    completes the last visit (includes the follow-up visit).
    El final del estudio será considerado la fecha en la que el último paciente complete la última visita (incluida la visita de seguimiento)
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months9
    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: 214
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 106
    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 state81
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 306
    F.4.2.2In the whole clinical trial 318
    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 Decision2015-12-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-06
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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