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    Summary
    EudraCT Number:2019-001745-40
    Sponsor's Protocol Code Number:MK-7339-007
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2019-11-06
    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 number2019-001745-40
    A.3Full title of the trial
    A Phase 2 Study of Olaparib in Combination with Pembrolizumab in Participants with Previously Treated, Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer
    Estudio de fase 2 de olaparib en combinación con pembrolizumab en participantes con cáncer avanzado con mutación en el sistema de reparación por recombinación homóloga (mRRH) y/o deficiencia en el sistema de recombinación homóloga (DRH) tratado previamente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Olaparib in combination with pembrolizumab in HRRm and/or HRD positive
    cancer
    Olaparib en combinación con pembrolizumab en el cáncer con mRRH y/o DRH
    A.3.2Name or abbreviated title of the trial where available
    Olaparib in combination with pembrolizumab in HRRm and/or HRD positive
    Olaparib en combinación con pembrolizumab en el cáncer con mRRH y/o DRH
    A.4.1Sponsor's protocol code numberMK-7339-007
    A.5.4Other Identifiers
    Name:INDNumber:142968
    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 SA
    B.5.2Functional name of contact pointInvestigación clínica
    B.5.3 Address:
    B.5.3.1Street AddressCalle Josefa valcárcel, 38
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28027
    B.5.3.4CountrySpain
    B.5.4Telephone number+3491321 06 00
    B.5.5Fax number+3491321 05 90
    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 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 namePEMBROLIZUMAB
    D.3.2Product code MK-3475
    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 INNPEMBROLIZUMAB
    D.3.9.1CAS number 1374853-91-4
    D.3.9.2Current sponsor codeMK-3475
    D.3.9.4EV Substance CodeSUB167136
    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) 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.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 Yes
    D.2.1.1.1Trade name KEYTRUDA (pembrolizumab, MK-3475)
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme B.V.
    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.3.4Pharmaceutical 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 INNPEMBROLIZUMAB
    D.3.9.1CAS number 1374853-91-4
    D.3.9.2Current sponsor codeMK-3475
    D.3.9.4EV Substance CodeSUB167136
    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) 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.IMP: 3
    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 nameOlaparib
    D.3.2Product code MK-7339
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOLAPARIB
    D.3.9.1CAS number 763113-22-0
    D.3.9.2Current sponsor codeMK-7339
    D.3.9.3Other descriptive nameOLAPARIB
    D.3.9.4EV Substance CodeSUB32234
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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 nameOlaparib
    D.3.2Product code MK-7339
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOLAPARIB
    D.3.9.1CAS number 763113-22-0
    D.3.9.2Current sponsor codeMK-7339
    D.3.9.3Other descriptive nameOLAPARIB
    D.3.9.4EV Substance CodeSUB32234
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    HRRm and/or HRD-positive cancer
    Cáncer con mRRH y/o DRH
    E.1.1.1Medical condition in easily understood language
    Second line and beyond HHRm and HRD pan tumor cancers
    Segunda línea y posteriores en el conjunto de cánceres tumorales con mRRH y DRH
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10065252
    E.1.2Term Solid tumor
    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
    1. To evaluate the Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or Prostate Cancer Working Group (PCWG)-modified RECIST 1.1
    1. Evaluar la Tasa de Respuesta Objetiva (TRO) conforme a los Criterios de Evaluación de la Respuesta en Tumores Sólidos, versión 1.1 (RECIST 1.1) o los criterios RECIST 1.1 modificados por el Grupo de Trabajo sobre el Cáncer de Próstata (PCWG).
    E.2.2Secondary objectives of the trial
    1. To evaluate Duration of Response (DOR) as assessed by RECIST 1.1 or PCWG-modified RECIST 1.1
    2. To evaluate Progression-Free Survival (PFS) as assessed by modified RECIST 1.1 or PCWG-modified RECIST 1.1
    3. To evaluate Overall Survival (OS)
    4. To evaluate the safety and tolerability of study treatment
    5. To evaluate ORR, DOR and PFS as assessed by RECIST 1.1 or PCWG modified
    RECIST 1.1 and OS based on tumor biomarker status
    6. To evaluate the time to earliest progression by cancer antigen-125 (CA-125) in participants with ovarian cancer
    7. To evaluate the prostate-specific antigen (PSA) response rate in participants with prostate cáncer.
    1.Evaluar la Duración de la Respuesta (DR) conforme a los criterios RECIST 1.1 o los criterios RECIST 1.1 modificados por el PCWG.
    2.Evaluar la Supervivencia Sin Progresión (SSP) conforme a los criterios RECIST 1.1 o los criterios RECIST 1.1 modificados por el PCWG.
    3.Evaluar la Supervivencia Global (SG).
    4.Evaluar la seguridad y la tolerabilidad del tratamiento en el estudio.
    5.Evaluar la TRO, la DR y la SSP conforme a los criterios RECIST 1.1 o los criterios RECIST 1.1 modificados por el PCWG y SG basado en el estado de biomarcadores tumorales.
    6.Evaluar el tiempo hasta la progresión más temprana según el antígeno tumoral-125 (CA-125) en participantes con cáncer de ovario.
    7.Evaluar la tasa de respuesta por el antígeno prostático específico (PSA) en participantes con cáncer de próstata,
    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 and tissue - tumor specimen) 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 (sangre y tejido - muestra tumoral) 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
    1. Has a histologically- or cytologically-confirmed advanced (metastatic
    and/or unresectable) solid tumor (except breast or ovarian cancers
    whose tumor has a germline or somatic BRCA mutation) that is not
    eligible for curative treatment and for which standard of care therapy
    has failed. Participants must have progressed on or be intolerant to
    standard of care therapies that are known to provide clinical benefit.
    There is no limit on the number of prior treatment regimens.
    2. Has either centrally-confirmed known or suspected deleterious
    mutations in at least 1 of the specified 15 genes involved in HRR (ie,
    BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL,
    PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, and RAD54L) or centrally confirmed HRD based on the Lynparza HRR-HRD assay.
    3. Has measurable disease per RECIST 1.1 as assessed by the local site
    investigator/radiology and confirmed in real time by BICR. BICR must
    confirm the presence of radiologically measurable disease per RECIST
    1.1 for the participant to be eligible for the study. Lesions situated in a
    previously irradiated area are considered measurable if progression has
    been demonstrated in such lesions.
    4. Has a life expectancy of at least 3 months.
    5. Is male or female, who is at least 18 years of age at the time of
    signing the informed consent.
    6. Has an Eastern Cooperative Oncology Group (ECOG) performance
    status of either 0 or 1, as assessed within 3 days of treatment initiation.
    7. A male participant must agree to use contraception as detailed in the
    protocol during the treatment period and for at least 120 days (4
    months), corresponding to time needed to eliminate any study
    intervention(s) and refrain from donating sperm during this period.
    8. A female participant is eligible to participate if she is not pregnant,
    not breastfeeding, and at least 1 of the following conditions applies:
    - Not a woman of childbearing potential (WOCBP)
    OR
    - A WOCBP who agrees to follow the contraceptive guidance in the
    Protocol during the treatment period and for at least 180 days (6
    months) after the last dose of study intervention, corresponding to time
    needed to eliminate any study intervention(s).
    9. The participant (or legally acceptable representative if applicable)
    provides written informed consent for the study. The participant may
    also provide consent for FBR.
    However, the participant may participate in the main study without
    participating in FBR.
    10. Has adequate organ function; all screening laboratory tests should
    be performed within 10 days prior to the first dose of study intervention.
    1. Presencia de un tumor sólido avanzado (metastásico y/o irresecable) confirmado mediante estudio histológico o citológico (excepto cánceres de mama u ovario con una mutación somática o en la línea germinal de BRCA) que no es apto para tratamiento curativo y en el que ha fracasado el tratamiento de referencia. Los participantes deberán haber presentado progresión con los tratamientos de referencia que aportan beneficios clínicos conocidos o haber mostrado intolerancia a ellos. No hay límite en el número de pautas de tratamiento previas
    2. Presencia de mutaciones deletéreas conocidas o sospechadas, confirmada de manera centralizada, en al menos uno de los 15 genes especificados que se han implicado en el sistema de RRH (es decir, BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D y RAD54L) o DRH confirmada por el laboratorio central mediante el análisis HRR-HRD de Lynparza.
    3. Presencia de enfermedad mensurable conforme a los criterios RECIST 1.1, según la evaluación del investigador o radiólogo del centro y confirmada en tiempo real mediante una RCIE. La RCIE deberá confirmar la presencia de enfermedad mensurable radiológicamente conforme a los criterios RECIST 1.1 para que el paciente pueda participar en el estudio. Las lesiones ubicadas en una zona previamente irradiada se considerarán mensurables siempre que se haya constatado progresión en dichas lesiones.
    4. Esperanza de vida mínima de tres meses.
    5. Varón o mujer de al menos 18 años de edad en el momento de firmar el consentimiento informado.
    6. Estado funcional del Eastern Cooperative Oncology Group (ECOG) de 0 o 1, evaluado en los tres días previos al inicio del tratamiento.
    7. Los varones deben comprometerse a utilizar métodos anticonceptivos tal y como se detalla en el protocolo durante el período de tratamiento y hasta, como mínimo, 120 días (4 meses) tras la última dosis de la intervención del estudio, lo que corresponde al tiempo necesario para eliminar cualquier intervención del estudio, así como a abstenerse de donar semen durante este período.
    8. Podrán participar en el estudio mujeres que no estén embarazadas ni dando el pecho y que cumplan al menos una de las siguientes condiciones:
    • No es una mujer en edad fértil (MEF)
    O BIEN
    • Es una MEF que se compromete a seguir las normas relativas a métodos anticonceptivos que se recogen en el protocolo durante el período de tratamiento y hasta, como mínimo, 180 días (6 meses) tras la última dosis de la intervención del estudio, lo que corresponde al tiempo necesario para eliminar la intervención del estudio.
    9. El participante (o su representante legal cuando proceda) otorga su consentimiento informado por escrito para el estudio. El participante también podrá otorgar su consentimiento para investigaciones biomédicas futuras. No obstante, podrá participar en el estudio principal sin necesidad de hacerlo en las investigaciones biomédicas futuras.
    10. Presencia de una función orgánica adecuada, todas las pruebas analíticas de selección deberán realizarse en los 10 días previos a la primera dosis de la intervención del estudio.
    E.4Principal exclusion criteria
    1. Has a known additional malignancy that is progressing or has required
    active treatment in the last 3 years
    2. Has a history of non-infectious pneumonitis that required treatment
    with steroids or currently has pneumonitis
    3. Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
    or with features suggestive of MDS/AML
    4. Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
    5. Has an active infection requiring systemic therapy
    6. Has active tuberculosis
    7. Has a diagnosis of immunodeficiency or is receiving chronic systemic
    steroid therapy (dosing in the Protocol) or any other form of
    immunosuppressive therapy within 7 days prior to the first dose of study
    intervention
    8. Has an active autoimmune disease that has required systemic treatment in the past 2 years
    9. Has a history or current evidence of any condition (please refer to the
    Protocol), therapy, or laboratory abnormality that might confound the
    results of the study, interfere with the participant's involvement for the
    full duration of the study, or is not in the best interest of the participant
    to be involved, in the opinion of the treating investigator
    10. Received colony-stimulating factors (eg, granulocyte colonystimulating
    factor [G-CSF], granulocyte-macrophage colony-stimulating
    factor [GM-CSF] or recombinant erythropoietin) within 28 days prior to
    the first dose of study intervention
    11. Is considered a poor medical risk due to a serious, uncontrolled
    medical disorder, nonmalignant systemic disease or active, uncontrolled
    infection.
    12. Has a known psychiatric or substance abuse disorder that would
    interfere with cooperation with the requirements of the study
    13. Has a known history of human immunodeficiency virus (HIV)
    infection. Testing for HIV at screening is only required if mandated by
    local health authority
    14. Has known active hepatitis (ie, Hepatitis B or C)
    15. Is unable to swallow orally administered medication or has agastrointestinal disorder affecting absorption
    16. A WOCBP who has a positive urine pregnancy test within 72 hours
    before the first dose of study intervention. If the urine test is positive or
    cannot be confirmed as negative, a serum pregnancy test will be
    required.
    17. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PDL2
    agent or with an agent directed to another stimulatory or coinhibitory
    T-cell receptor (eg, CTLA-4, OX 40, CD137)
    18. Has received prior therapy with olaparib or with any other PARP
    Inhibitor
    19. Were refractory to prior platinum therapy for advanced (metastatic
    and/or unresectable) solid tumor
    20. Has received prior systemic anti-cancer therapy including
    investigational agents within 4 weeks prior to administration of study
    intervention
    21. Must have recovered from all AEs due to previous therapies,
    excluding alopecia, to ≤Grade 1 or baseline
    22. Has a known hypersensitivity to the study treatments and/or any of
    their excipients
    23. Is currently receiving either strong or moderate inhibitors of
    cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration
    of the study. The required washout period prior to starting olaparib is 2
    weeks
    24. Is currently receiving either strong or moderate inducers of CYP3A4
    that cannot be discontinued for the duration of the study. The required
    washout period prior to starting olaparib is 5 weeks for phenobarbital
    and 3 weeks for other agents
    25. Has received previous allogenic bone-marrow transplant or double
    umbilical cord transplantation (dUCBT)
    26. Has received a whole blood transfusion in the last 120 days prior to
    entry to the study. Packed red blood cells and platelet transfusions are
    acceptable if not performed within 28 days of the first dose of study
    intervention
    27. Has received prior radiotherapy within 2 weeks of start of study
    intervention. Participants must have recovered from all radiation-related
    toxicities, not require corticosteroids, and not have had radiation
    pneumonitis. A 1-week washout is permitted for palliative radiation (≤2
    weeks of radiotherapy) to non-CNS disease

    Read rest in the protocol
    1. Presencia de otra neoplasia maligna conocida que está en progresión o ha precisado tratamiento activo en los últimos tres años
    2. Antecedentes de neumonitis no infecciosa que precisó tratamiento con esteroides o presencia de una neumonitis activa.
    3. Presencia de un síndrome mielodisplásico (SMD)/leucemia mielógena aguda (LMA) o signos indicativos de SMD/LMA.
    4. Presencia de metástasis conocidas en el sistema nervioso central (SNC) y/o de meningitis carcinomatosa.
    5. Infección activa con necesidad de tratamiento sistémico.
    6. Tuberculosis activa
    7.Diagnóstico de inmunodeficiencia o recepción de tratamiento sistémico crónico con esteroides (dosificación en el Protocolo) o cualquier otra forma de tratamiento inmunodepresor en los siete días previos a la primera dosis de la intervención del estudio.
    8. Presencia de una enfermedad autoinmune activa que ha precisado tratamiento sistémico en los dos últimos años.
    9. Antecedentes o datos presentes de cualquier proceso (consulte el Protocolo), tratamiento o anomalía analítica que, en opinión del investigador responsable del tratamiento, podría confundir los resultados del estudio, dificultar la participación durante la totalidad del estudio o motivar que la participación no sea lo más conveniente para el posible participante.
    10. Recepción de factores estimuladores de colonias (p. ej., factor estimulador de las colonias de granulocitos [G-CSF], factor estimulador de las colonias de granulocitos y macrófagos [GM-CSF] o eritropoyetina recombinante) en los 28 días previos a la primera dosis de la intervención del estudio.
    11. Se considera que el participante tiene un riesgo médico elevado debido a un trastorno médico grave y no controlado, una enfermedad sistémica no maligna o una infección activa no controlada
    12. Trastorno psiquiátrico o por abuso de sustancias que pueda dificultar el cumplimiento de los requisitos del estudio.
    13. Antecedentes de infección por el virus de la inmunodeficiencia humana (VIH). Sólo será necesaria una prueba del VIH en la fase de selección si así lo exigen las autoridades sanitarias locales.

    14. Hepatitis activa conocida (es decir, hepatitis B o C).

    15. Incapacidad de tragar medicación administrada por vía oral o presencia de un trastorno digestivo que afecta a la absorción.
    16. Mujer en edad fértil que da positivo en una prueba de embarazo en orina realizada en las 72 horas previas a la primera dosis de la intervención del estudio. Si el resultado de la prueba en orina es positivo o si no puede confirmarse que sea negativo, será necesario hacer una prueba de embarazo en suero.
    17. Recepción de un tratamiento previo con un fármaco anti-PD-1, anti-PD-L1 o anti-PD-L2 o con un fármaco dirigido contra otro receptor de los linfocitos T estimulador o coinhibidor (como CTLA-4, OX-40 o CD137).
    18. Recepción de tratamiento previo con olaparib o cualquier otro inhibidor de la PARP.
    19. Resistencia al tratamiento previo con platino por un tumor sólido avanzado (metastásico y/o irresecable).
    20. Recepción de un tratamiento antineoplásico sistémico previo, incluidos fármacos experimentales, en las cuatro semanas previas a la administración de la intervención del estudio.
    21. Los participantes deberán haberse recuperado a un grado ≤ 1 o a la situación basal de todos los acontecimientos adversos debidos a tratamientos previos, excluyendo la alopecia.
    22. Hipersensibilidad conocida a los tratamientos del estudio y/o a cualquiera de sus excipientes
    23. Recepción activa de inhibidores potentes o moderados del citocromo P450 (CYP) 3A4 que no pueden suspenderse durante el estudio. El período de lavado necesario antes de comenzar el tratamiento con olaparib es de dos semanas.

    24. Recepción activa de inductores potentes o moderados de la enzima CYP3A4 que no puedan suspenderse durante el estudio. El período de lavado necesario antes de comenzar el tratamiento con olaparib es de cinco semanas en el caso de fenobarbital y de tres semanas en el de otros fármacos .
    25. Recepción de un alotrasplante de médula ósea o un doble trasplante de sangre de cordón umbilical (dTSCU) previo.
    26. Recepción de una transfusión de sangre completa en los 120 días previos a la incorporación al estudio. Los concentrados de eritrocitos y las transfusiones de plaquetas se consideran aceptables si no se han realizado en los 28 días previos a la primera dosis de la intervención del estudio.
    27. Recepción de radioterapia en las dos semanas previas al comienzo de la intervención del estudio. Los participantes deberán haberse recuperado de toda la toxicidad relacionada con la radioterapia, no precisar corticoides y no haber sufrido neumonitis por radiación. Se permite un reposo farmacológico de una semana en caso de radioterapia paliativa (≤ 2 semanas de radioterapia) por enfermedad que no afecta al sistema nervioso central (SNC).
    Leer resto en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    1. Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or Prostate Cancer Working Group (PCWG)-modified RECIST 1.1 in Biomarker Subgroups
    1. Tasa de Respuesta Objetiva (TRO) conforme a los Criterios de Evaluación de la Respuesta en Tumores Sólidos, versión 1.1 (RECIST 1.1) o los criterios RECIST 1.1 modificados por el Grupo de Trabajo sobre el Cáncer de Próstata (PCWG) en subgrupos de biomarcadores.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to ~3 years
    1. Hasta ~ 3 años
    E.5.2Secondary end point(s)
    1. Duration of Response (DOR) as Assessed by RECIST 1.1 or PCWGmodified RECIST 1.1 in Biomarker Subgroups
    2. Progression-Free Survival (PFS) as Assessed by RECIST 1.1 or PCWGmodified RECIST 1.1 in Biomarker Subgroups
    3. Overall Survival (OS) in Biomarker Subgroups
    4. Number of Participants Who Experience an Adverse Event (AE)
    5. Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
    6. Objective Response Rate (ORR) Based on Tumor Biomarker Status as Assessed by RECIST 1.1 or PCWG-modified RECIST 1.1 in Additional Biomarker Subpopulations.
    7. Duration of Response (DOR) Based on Tumor Biomarker Status as Assessed by RECIST 1.1 or PCWG-modified RECIST 1.1 in Additional Biomarker Subpopulations
    8. Progression-Free Survival (PFS) Based on Tumor Biomarker Status as Assessed by RECIST 1.1 or PCWG-modified RECIST 1.1 in Additional Biomarker Subpopulations
    9. Overall Survival (OS) in Additional Biomarker Subpopulations
    10. Number of Participants with Cancer Antigen-125 (CA-125) Level of ≥ 2 × Upper Limit of Normal (ULN) Among Participants with Ovarian Cancer.
    11. Number of Participants with Cancer Antigen-125 (CA-125) Level ≥2 × Nadir (Lowest) Value Among Participants with Ovarian Cancer Who Had Elevated CA-125 Levels ≥ULN at Baseline
    12. Number of Participants with a Change from Baseline in Prostate-Specific Antigen (PSA) Level of ≥50% Among Participants with Prostate Cancer.
    1.Duración de la Respuesta (DR) conforme a los criterios RECIST 1.1 o criterios RECIST 1.1. modificados por el PCWG en subgrupos de biomarcadores.
    2.Supervivencia Sin Progresión (SSP) conforme a los criterios RECIST 1.1 o criterios RECIST 1.1. modificados por el PCWG en subgrupos de biomarcadores.
    3. Supervivencia Global (SG) en subgrupos de biomarcadores.
    4. Número de participantes que experimenta un acontecimiento adverso (AA).
    5. Número de participantes que abandona el tratamiento de estudio debido a un acontecimiento adverso (AA).
    6. Tasa de Respuesta Objetiva (TRO) basada en el estado de biomarcadores tumorales conforme a RECIST 1.1 o RECIST 1.1 modificado por PCWG en subpoblaciones de biomarcadores adicionales.
    7. Duración de la Respuesta (DR) basada en el estado de biomarcadores tumorales conforme a RECIST 1.1 o RECIST 1.1 modificado por PCWG en subpoblaciones de biomarcadores adicionales.
    8. Supervivencia Sin Progresión (SSP) basada en el estado de biomarcadores tumorales conforme a RECIST 1.1 o RECIST 1.1 modificado por PCWG en subpoblaciones de biomarcadores adicionales.
    9. Supervivencia Global (SG) en subpoblaciones de biomarcadores adicionales.
    10. Número de participantes con niveles de antígeno tumoral-125 (CA-125) dos o más veces superior al límite superior de la normalidad (LSN). Entre los participantes con cáncer de ovario
    11. Número de participantes con niveles de antígeno tumoral-125 (CA-125) dos o más veces superior al valor nadir más bajo entre los participantes con cáncer de ovarios con niveles de CA-125 elevados por encima del LSN en el momento basal.
    12. Número de participantes con cambio respecto al momento basal en los niveles de antígeno prostático específico (PSA) mayor o igual a 50 %, en participantes con cáncer de próstata.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Up to ~3 years
    2. Up to ~3 years
    3. Up to ~3 years
    4. Up to ~3 years
    5. Up to ~3 years
    6. Up to ~3 years
    7. Up to ~3 years
    8. Up to ~3 years
    9. Up to ~3 years
    10. Up to ~3 years
    11. Up to ~3 years
    12. Up to ~3 years
    1. Hasta ~ 3 años
    2. Hasta ~ 3 años
    3. Hasta ~ 3 años
    4. Hasta ~ 3 años
    5. Hasta ~ 3 años
    6. Hasta ~ 3 años
    7. Hasta ~ 3 años
    8. Hasta ~ 3 años
    9. Hasta ~ 3 años
    10. Hasta ~ 3 años
    11. Hasta ~ 3 años
    12. Hasta ~ 3 años
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 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.8.2.4Number of treatment arms in the trial1
    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 EEA30
    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
    Argentina
    Australia
    Canada
    Colombia
    France
    Germany
    Guatemala
    Israel
    Italy
    Korea, Republic of
    Latvia
    Mexico
    Peru
    Poland
    Puerto Rico
    Romania
    South Africa
    Spain
    Sweden
    Turkey
    Ukraine
    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 years4
    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 years4
    E.8.9.2In all countries concerned by the trial months6
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 98
    F.4.2.2In the whole clinical trial 300
    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
    Ninguno
    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 Decision2019-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-09
    P. End of Trial
    P.End of Trial StatusRestarted
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