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    Summary
    EudraCT Number:2015-002406-37
    Sponsor's Protocol Code Number:3475-170
    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:2016-01-13
    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 number2015-002406-37
    A.3Full title of the trial
    A Phase 2 Study of Pembrolizumab (MK 3475) in Subjects with Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)
    Estudio de fase II de pembrolizumab (MK-3475) en sujetos con linfoma mediastínico primario de linfocitos B grandes recidivante o resistente (LMPLBrr)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial investigating how well pembrolizumab works in treating patients with relapsed or refractory Primary Mediastinal Large B-Cell Lymphoma
    Un ensayo de investigación de como funciona el pembrolizumab en el tratamiento de pacientes con linfoma mediastínico primario de linfocitos B grandes recidivante o resistente
    A.3.2Name or abbreviated title of the trial where available
    A phase II study of pembrolizumab in subjects with relapsed or refractory PMBCL
    Estudio de fase II de pembrolizumab en sujetos con LMPLB recidivante o resistente
    A.4.1Sponsor's protocol code number3475-170
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00118064
    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 SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck Co., 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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme de España S.A.
    B.5.2Functional name of contact pointInvestigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Josefa Valcárcel, 38
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28027
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913210600
    B.5.5Fax number+34913210590
    B.5.6E-mailensayos_clinicos@merck.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 Yes
    D.2.1.1.1Trade name Keytruda
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp and Dohme, Ltd
    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.3.1Product namePembrolizumab
    D.3.2Product code MK-3475
    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 INNPEMBROLIZUMAB
    D.3.9.1CAS number 1374853-91-4
    D.3.9.2Current sponsor codeMK-3475
    D.3.9.3Other descriptive nameAnti-PD-1 monoclonal antibody
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) Yes
    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
    relapsed or refractory Primary Mediastinal Large B-Cell Lymphoma
    Linfoma mediastínico primario de linfocitos B grandes recidivante o resistente
    E.1.1.1Medical condition in easily understood language
    relapsed or refractory Primary Mediastinal Large B-Cell Lymphoma
    Linfoma mediastínico primario de linfocitos B grandes recidivante o resistente
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the Overall Response Rate (ORR) of pembrolizumab by independent central review according to the International Working Group (IWG) response criteria (Cheson, 2007)
    Evaluar la tasa de respuesta global (TRG) del pembrolizumab mediante una revisión central independiente, según los criterios de respuesta del Grupo de Trabajo Internacional (IWG) (Cheson, 2007 [1]).
    E.2.2Secondary objectives of the trial
    Evaluate Overall Response Rate, Progression Free Survival, Duration of Response, Disease Control Rate, Overall Survival and safety and tolerability of pembrolizumab.
    Evaluar la tasa de respuesta global, la supervivencia sin progresión, la duración de la respuesta, la tasa de control de la enfermedad, la supervivencia global , y la seguridad y tolerabilidad del pembrolizumab.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Merck will conduct future Biomedical Research on DNA (blood) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.
    Merck realizará investigaciones biomédicas futuras con las muestras obtenidas para tal finalidad durante este ensayo clínico. Estas investigaciones tendrán por objeto el análisis de biomarcadores con el fin de abordar aspectos nuevos que no se describen en otras partes del protocolo (como parte del ensayo principal) y solo se llevarán a cabo en muestras de los pacientes que hayan otorgado el consentimiento correspondiente. El objetivo de la obtención de muestras para investigaciones biomédicas futuras es estudiar e identificar biomarcadores que proporcionen información a los científicos sobre las enfermedades y sus tratamientos. El objetivo último es utilizar tal información para desarrollar fármacos más seguros y eficaces o para garantizar que los sujetos reciban la dosis correcta del fármaco en el momento preciso.
    E.3Principal inclusion criteria
    - Confirmed diagnosis of Primary Mediastinal Large B-cell lymphoma by independent central review, according to the WHO classification of neoplasms of the hematopoietic and lymphoid tissues (WHO Criteria 2008 [52].
    - Subject must be able to provide an evaluable core or excisional lymph node biopsy for confirmation of PMBCL diagnosis from an archival or newly obtained biopsy at Screening. In addition subjects may be asked to provide additional biopsy samples, if possible, at Week 12 and at the time of discontinuation due to progression for biomarker analysis.
    - Have relapsed*a or refractory*b Primary Mediastinal Large B-cell lymphoma and:
    - Have relapsed after auto-SCT or have failed to achieve a Complete Response within 60 days of auto-SCT. Subjects may have received intervening therapy after auto-SCT for relapsed or refractory disease, in which case they must have relapsed after or be refractory to their last treatment.
    OR
    - For subjects who are ineligible for auto-SCT, have received at least ? 2 lines of prior therapy and have failed to respond to or relapsed after their last line of treatment. For subjects who received consolidative local radiotherapy after systemic therapy, local radiotherapy will not be considered as a separate line of treatment.
    - Must have been previously exposed to rituximab as part of prior lines of treatment.
    - Have radiographically measureable disease by independent central review, defined as at least one lesion that can be accurately measured in at least two dimensions with spiral computed tomography (CT) scan. Minimum measurement must be > 15 mm in the longest diameter.
    - Must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
    - Diagnóstico de linfoma mediastínico primario de linfocitos B grandes confirmado mediante revisión centralizada independiente según la clasificación de la OMS de neoplasias de los tejidos hematopoyético y linfoide (WHO Criteria, 2008 [52]).
    - El sujeto debe poder proporcionar una muestra de biopsia de ganglios linfáticos evaluable para confirmar el diagnóstico de LMPLB, en concreto, una biopsia con aguja gruesa o por escisión, de archivo u obtenida recientemente en la selección. Además, se puede pedir a los sujetos que proporcionen más muestras de biopsia para análisis de biomarcadores, si es posible, en la semana 12 y en el momento de la retirada por progresión.
    - Presentar linfoma mediastínico primario de linfocitos B grandes recidivante o resistente y:
    -Haber recidivado después de TCM autólogo o no haber alcanzado una respuesta completa durante los 60 días siguientes al TCM autólogo. Los sujetos pueden haber recibido tratamiento de la enfermedad recidivante o resistente después del TCM autólogo, y en tal caso deben haber recidivado después de dicho tratamiento o haber mostrado resistencia a éste.
    O BIEN
    - En el caso de sujetos no candidatos al TCM autólogo, haber recibido al menos 2 líneas de tratamiento previo y no haber respondido o haber recidivado después de la última línea de tratamiento. En el caso de los sujetos que hayan recibido radioterapia local de consolidación después de un tratamiento sistémico, dicha radioterapia no se considerará una línea de tratamiento distinta.
    - Exposición previa a rituximab como parte de líneas de tratamiento anteriores.
    - Presentar enfermedad mensurable radiológicamente según una revisión centralizada independiente, definida como al menos una lesión que puede medirse con precisión en dos dimensiones como mínimo mediante tomografía computarizada (TC) helicoidal. La lesión deberá medir como mínimo >15 mm en su diámetro mayor.
    - Presentar un estado funcional del Eastern Cooperative Oncology Group (ECOG) de 0 o 1.
    E.4Principal exclusion criteria
    - Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
    - Has a known history of immunosuppression or is receiving systemic steroid therapy or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of trial treatment. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.
    - Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e. < or = Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
    - Has had prior chemotherapy or targeted small molecule therapy within 2 weeks prior to study Day 1 or has had prior radiation therapy within 4 weeks prior to study Day 1 or who has not recovered (i.e. < or = Grade 1 or at baseline) from adverse events due to a previously administered agent.
    - Has undergone prior allogeneic hematopoetic stem cell transplantation within the last 5 years. (Subjects who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of Graft versus Host Disease (GVHD).
    - Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
    - Has known active CNS involvement. Subjects with prior CNS involvement are eligible if their CNS disease is in radiographic, cytological (for CSF disease) and clinical remission.
    - Has active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
    - Has evidence of active, non-infectious pneumonitis.
    - Has an active infection requiring intravenous systemic therapy.
    - Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
    - Has a known Human Immunodeficiency Virus (HIV), Hepatitis B (HBV), or Hepatitis C (HCV) infection.
    - Has received a live vaccine within 30 days prior to first dose.
    - Está participando o ha participado en un estudio de un fármaco en investigación y está recibiendo o ha recibido el tratamiento o ha utilizado un producto sanitario en investigación en las 4 semanas previas a la administración de la primera dosis del tratamiento.
    - Tiene antecedentes documentados de inmunodepresión o está reciviendo esteroides sistémicos o algún otro tipo de tratamiento inmunodepresor sistémico en los 7 días anteriores a la administración de la primera dosis del tratamiento del ensayo. El uso de dosis fisiológicas de corticosteroides podrá autorizarse previa consulta con el promotor.
    - Ha recibido un anticuerpo monoclonal en las 4 semanas previas al día 1 del estudio o no se ha recuperado (a un grado < o = 1 o al nivel basal) de acontecimientos adversos provocados por fármacos administrados más de 4 semanas antes.
    - Ha recibido quimioterapia previa o un tratamiento dirigido con moléculas pequeñas durante las 2 semanas anteriores al día 1 del estudio o radioterapia en las 4 semanas anteriores al día 1 del estudio o no se ha recuperado (a un grado < o = 1 o al valor basal) de acontecimientos adversos provocados por un fármaco administrado anteriormente.
    - Ha recibido un alotrasplante de células madre hematopoyéticas en los 5 años precedentes. (Si el trasplante se realizó más de 5 años antes, el paciente podrá participar siempre que no presente síntomas de enfermedad de injerto contra huésped [EICH].)
    - Presenta otro tumor maligno conocido que esté en progresión o necesite tratamiento activo. Son excepciones el carcinoma basocelular de piel, el carcinoma espinocelular de piel y el cáncer de cuello uterino in situ que haya recibido un tratamiento potencialmente curativo.
    - Presenta afectación demostrada activa del SNC. Los sujetos que han presentado en el pasado afectación del SNC pueden incluirse si está en remisión radiológica, citológica (para enfermedad del LCR) y clínica.
    - Presenta enfermedad autoinmunitaria activa que ha necesitado tratamiento sistémico en los dos años precedentes (con medicamentos modificadores de la enfermedad, corticosteroides o inmunodepresores). El tratamiento de sustitución (p. ej., tiroxina, insulina o corticosteroides en dosis fisiológicas para una insuficiencia suprarrenal o hipofisaria, etc.) no se considera una forma de tratamiento sistémico.
    - Tener indicios de neumonitis no infecciosa activa.
    - Presentar una infección activa con necesidad de tratamiento sistémico por vía intravenosa.
    - Ha recibido tratamiento previo con un anticuerpo anti PD 1, anti PD L1, anti PD L2, anti CD137 o anti CTLA 4 (antígeno asociado a los linfocitos T citotóxicos 4) (como ipilimumab o cualquier otro anticuerpo o fármaco dirigido específicamente contra la coestimulación de linfocitos T o contra vías que actúen de punto de control).
    - Tener antecedentes de infección por el virus de la inmunodeficiencia humana (VIH), Hepatitis B (VHB) o infección por Hepatitis C (VHC).
    - Haber recibido una vacuna de microbios atenuados en los 30 días anteriores a la administración de la primera dosis.
    E.5 End points
    E.5.1Primary end point(s)
    - Confirm efficacy of pembrolizumab monotherapy in subjects relapsed or refractory primary mediastinal large B-cell lymphoma (rrPMBCL)
    - To evaluate the Overall Response Rate (ORR) of pembrolizumab by independent central review according to the International Working Group (IWG) response criteria (Cheson, 2007)
    -Confirmar la eficacia del pembrolizumab en monoterapia en sujetos con Linfoma mediastínico primario de linfocitos B grandes recidivante o resistente.
    - Evaluar la tasa de respuesta global (TRG) de pembrolizumab evaluada mediante una revisión central independiente, según los criterios de respuesta del Grupo de Trabajo Internacional (IWG) (Cheson, 2007).
    E.5.1.1Timepoint(s) of evaluation of this end point
    up to 2 years
    hasta los 2 años
    E.5.2Secondary end point(s)
    None
    Ninguno
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    N/A
    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 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) 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 No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    Colombia
    France
    Germany
    Italy
    Netherlands
    New Zealand
    Russian Federation
    Switzerland
    United Kingdom
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 53
    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)
    Subjects will be followed 30 days after last dose of treatment or before the initiation of a new antineoplastic treatment,whichever occurs first. If discontinue trial treatment for a reason other than confirmed disease progression will move into the Follow-Up Phase and should be assessed every 12 weeks to monitor disease status. Once a subject experiences confirmed disease progression or starts a new antineoplastic therapy,the subject moves into the survival follow-up phase.
    Sujetos se seguirán 30 días después de la última dosis de tratamiento o antes del comienzo de un nuevo antineoplásico, lo que ocurra antes. Si suspenden tratamiento por un motivo distinto de progresión de enfermedad confirmada, se incorporarán a la fase de seguimiento y se evaluarán cada 12 semanas para controlar la enfermedad. Una vez presente progresión confirmada de la enfermedad o empiece a recibir un nuevo tratamiento antineoplásico, se incorporará a la fase de seguimiento de supervivencia
    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 Decision2016-02-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-04
    P. End of Trial
    P.End of Trial StatusCompleted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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