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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2018-004118-16
    Sponsor's Protocol Code Number:MK-7339-010
    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:2019-05-17
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2018-004118-16
    A.3Full title of the trial
    A Phase 3, Randomized Open-label Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Participants with Metastatic Castrationresistant Prostate Cancer (mCRPC) Who are Unselected for Homologous Recombination Repair Defects and Have Failed Prior Treatment with One Next generation Hormonal Agent (NHA) and Chemotherapy (KEYLYNK-010)
    Estudio de fase 3, aleatorizado y abierto de pembrolizumab (MK-3475) más olaparib frente a acetato de abiraterona o enzalutamida en participantes con cáncer de próstata resistente a la castración metastásico (CPRCm) que no son seleccionados por defectos en la reparación por recombinación homóloga y que han mostrado fracaso con el tratamiento previo con un fármaco hormonal de última generación (FHUG) y quimioterapia (KEYLYNK-010)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 Study of Pembrolizumab Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in mCRPC
    Estudio de fase 3 de pembrolizumab más olaparib frente a acetato de abiraterona o enzalutamida en el CPRCm
    A.4.1Sponsor's protocol code numberMK-7339-010
    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 RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Zytiga (Abiraterone)
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag Pty Ltd, Australia
    D.2.1.2Country which granted the Marketing AuthorisationAustralia
    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 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 INNABIRATERONE ACETATE
    D.3.9.1CAS number 154229-18-2
    D.3.9.3Other descriptive nameABIRATERONE ACETATE
    D.3.9.4EV Substance CodeSUB31647
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 5
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Zytiga (Abiraterone)
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag Pty Ltd, Australia
    D.2.1.2Country which granted the Marketing AuthorisationAustralia
    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 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 INNABIRATERONE ACETATE
    D.3.9.1CAS number 154229-18-2
    D.3.9.3Other descriptive nameABIRATERONE ACETATE
    D.3.9.4EV Substance CodeSUB31647
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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: 6
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Zytiga (Abiraterone)
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV, Belgium
    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 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 INNABIRATERONE ACETATE
    D.3.9.1CAS number 154229-18-2
    D.3.9.3Other descriptive nameABIRATERONE ACETATE
    D.3.9.4EV Substance CodeSUB31647
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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: 7
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Xtandi (Enzalutamide)
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Australia Pty Ltd
    D.2.1.2Country which granted the Marketing AuthorisationAustralia
    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 Capsule
    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 INNENZALUTAMIDE
    D.3.9.1CAS number 915087-33-1
    D.3.9.3Other descriptive nameENZALUTAMIDE
    D.3.9.4EV Substance CodeSUB77412
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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: 8
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Xtandi (Enzalutamide)
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe B.V., Netherlands
    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 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 INNENZALUTAMIDE
    D.3.9.1CAS number 915087-33-1
    D.3.9.3Other descriptive nameENZALUTAMIDE
    D.3.9.4EV Substance CodeSUB77412
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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: 9
    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.IMP: 10
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Xtandi (Enzalutamide)
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe B.V., Netherlands
    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 Capsule
    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 INNENZALUTAMIDE
    D.3.9.1CAS number 915087-33-1
    D.3.9.3Other descriptive nameENZALUTAMIDE
    D.3.9.4EV Substance CodeSUB77412
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    Metastatic Castration resistant Prostate Cancer (mCRPC)
    cáncer de próstata resistente a la castración metastásico (CPRCm)
    E.1.1.1Medical condition in easily understood language
    Metastatic Castration-Resistant Prostate Cancer
    cáncer de próstata resistente a la castración metastásico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10076506
    E.1.2Term Castration-resistant prostate cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    -To compare pembrolizumab plus olaparib to abiraterone acetate or enzalutamide with respect to overall survival (OS)
    -To compare pembrolizumab plus olaparib to abiraterone acetate or enzalutamide with respect to radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR)
    Comparar pembrolizumab más olaparib con acetato de abiraterona o enzalutamida en lo que respecta a la supervivencia global (SG).
    2-Comparar pembrolizumab más olaparib con acetato de abiraterona o enzalutamida en lo que respecta a la supervivencia sin progresión radiológica (SSPr) conforme a los Criterios de evaluación de la respuesta en tumores sólidos, versión 1.1 (RECIST 1.1) modificados por el Grupo de trabajo sobre el cáncer de próstata (PCWG), según lo evaluado mediante una revisión central independiente y enmascarada (RCIE).
    E.2.2Secondary objectives of the trial
    -To compare pembrolizumab + olaparib to abiraterone acetate or enzalutamide with respect to time to initiation of the first subsequent anticancer therapy or death
    -To evaluate pembrolizumab + olaparib vs abiraterone acetate or enzalutamide with respect to the objective response rate and duration of response per Prostate Cancer Working Group-modified Response Evaluation Criteria in Solid Tumors Version 1.1 as assessed by blinded independent central review
    -To compare pembrolizumab + olaparib to abiraterone acetate or enzalutamide with respect to time to PSA progression; time to first symptomatic skeletal related event; time to radiographic soft tissue progression per soft tissue rules of PCWG- RECIST 1.1 as assessed by BICR and time to pain progression as determined by Item 3 of the Brief Pain Inventory-Short Form and by the Analgesic Quantification Algorithm score
    -To evaluate the safety and tolerability of pembrolizumab + olaparib vs abiraterone acetate or enzalutamide
    -Comparar pembrolizumab más olaparib con acetato de abiraterona o enzalutamida en lo que respecta al tiempo transcurrido hasta el inicio del primer tratamiento antineoplásico posterior o la muerte (TPTP).
    -Evaluar pembrolizumab más olaparib en comparación con acetato de abiraterona o enzalutamida en lo que respecta a la tasa de respuestas objetivas (TRO) y la duración de la respuesta (DR) conforme a los criterios RECIST 1.1 modificados por el PCWG, según lo evaluado mediante una RCIE.
    -Comparar pembrolizumab más olaparib con acetato de abiraterona o enzalutamida en lo que respecta a:
    Tiempo transcurrido hasta la progresión del antígeno prostático específico (PSA). Tiempo transcurrido hasta el primer episodio óseo sintomático (EOS). Tiempo transcurrido hasta la progresión radiológica en las partes blandas conforme a las normas sobre partes blandas de los criterios RECIST 1.1 modificados por el PCWG, según lo evaluado mediante una RCIE. Leer el resto en Protocolo
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Exploratory Biomarker Research, Genetic (DNA) analyses from tumor, Tumor and blood RNA analyses, Proteomics and immunohistochemistry (IHC) using blood or tumor, Other biomarkers, Future Biomedical Research.
    Investigación exploratoria de biomarcadores, análisis genéticos (ADN) de tumor, análisis de ARN en sangre y tumor, Proteómica e inmunohistoquímica (IHC) con sangre o tumor, otros biomarcadores, nvestigaciones biomédicas futuras.
    E.3Principal inclusion criteria
    1.Have histologically or cytologically confirmed (if acceptable according to local health authority regulations) adenocarcinoma of the prostate without small cell histology. The diagnosis must be stated in a pathology report and confirmed by the investigator
    2. Have prostate cancer progression while receiving androgen deprivation therapy (or post bilateral orchiectomy) within 6 months prior to screening, as determined by the investigator through 1 of the following:
    -PSA progression shown by local laboratory values, as defined by a minimum of 2 consecutive rising PSA levels with an interval of ≥1 week between each assessment, where PSA at screening should be ≥1 ng/mL.
    -Radiographic disease progression in soft tissue based on RECIST 1.1, with or without PSA progression.
    -Radiographic disease progression in bone per PCWG, defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression
    3.Have disease progression under the following conditions if the participant received anti-androgen therapy prior to enrollment:
    -Evidence of progression >4 weeks since the last flutamide treatment.
    -Evidence of progression >6 weeks since the last bicalutamide or nilutamide treatment.
    4.Have current evidence of metastatic disease documented by bone lesions on bone scan and/or soft tissue disease shown by CT/MRI.
    5.Have received prior treatment with abiraterone acetate OR enzalutamide, but not both
    -Have disease that progressed through treatment with abiraterone acetate or
    enzalutamide for mCRPC for at least 8 weeks (at least 14 weeks for participants with bone progression).
    6.Have received no more than 1 previous chemotherapy regimen for mCRPC and have had PD during treatment. If docetaxel chemotherapy has been used more than once, it will be considered as 1 therapy. Prior docetaxel for mCRPC is allowed if ≥4 weeks have elapsed from the last dose of docetaxel prior to Day 1 of Cycle 1.
    7.Have ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM). If the participant is currently being treated with luteinizing hormone-releasing hormone agonists or antagonists (in participants who have not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to the date of randomization, and treatment must be continued hroughout the study.
    8.If receiving bone resorptive therapy, including but not limited to bisphosphonates or denosumab, have been receiving stable doses for ≥4 weeks prior to the date of randomization.
    9.Have adequate organ function; all screening laboratory tests should be performed by the central laboratory within 10 days of the first dose of study intervention
    10.Be male
    11.Be ≥18 years of age on the day of signing the informed consent.Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
    12.Agree to the following during the intervention period and for at least 180 days,corresponding to the time needed to eliminate study intervention:
    -Refrain from donating sperm.
    PLUS either:
    -Be abstinent from heterosexual intercourse as their preferred and usual lifestyle(abstinent on a long-term and persistent basis) and agree to remain abstinent
    OR:
    -Agree to use contraception unless confirmed to be azoospermic
    or
    -Secondary to medical cause as detailed: Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penilevaginal intercourse or use a male condom during each episode of penilevaginal penetration.
    13.Also agree to use a male condom when engaging in any activity that allows passage of ejaculate to another person of any sex.
    14.The participant (or legally acceptable representative if applicable) provides written informed consent/assent for the study. The participant may also provide consent/assent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research.
    15.Have provided tumor tissue from a fresh core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated. Samples from tumors progressing at a prior site of radiation are allowed; other exceptions may be considered after Sponsor consultation. Participants with bone-only or bone-predominant disease may provide a bone biopsy sample. However, if obtaining a fresh biopsy is not feasible, participants may provide an archival tumor tissue sample after Sponsor consultation. Formalin-fixed, paraffin embedded tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
    16.Have an Eastern Cooperative Oncology Group performance status of 0 or 1, assessed within 7 days of randomization.
    1. Tener un adenocarcinoma de próstata confirmado por métodos histológicos o citológicos (siempre que sea aceptable conforme a la normativa de las autoridades sanitarias locales), sin histología microcítica. El diagnóstico debe estar consignado en un informe anatomopatológico y ser confirmado por el investigador.
    2. Haber mostrado progresión del cáncer de próstata durante el tratamiento de privación androgénica (o después de una orquiectomía bilateral) en los seis meses previos a la selección, según lo determinado por el investigador, definida por una de las circunstancias siguientes:
    • Progresión por PSA, según los valores del laboratorio local, definida como un mínimo de dos concentraciones crecientes de PSA con un intervalo de al menos una semana entre cada determinación; el valor de PSA de selección debe ser ≥ 1 ng/ml. En la sección 8.2.2 se ofrecen más detalles.
    • Progresión radiológica de la enfermedad en las partes blandas conforme a los criterios RECIST 1.1, con o sin progresión por PSA.
    • Progresión radiológica de la enfermedad en el hueso, según los criterios del PCWG, definida como la aparición de dos o más lesiones óseas nuevas en la gammagrafía ósea, con o sin progresión por PSA.
    3. Mostrar progresión de la enfermedad en las circunstancias siguientes si el participante ha recibido tratamiento antiandrogénico antes de su reclutamiento:
    • Signos de progresión más de cuatro semanas después del último tratamiento con flutamida.
    • Signos de progresión más de seis semanas después del último tratamiento con bicalutamida o nilutamida.
    4. Presentar signos actuales de enfermedad metastásica, documentada por la existencia de lesiones óseas en la gammagrafía ósea y/o de afectación de partes blandas en la TC/RM.
    5. Haber recibido tratamiento previo con acetato de abiraterona O enzalutamida, pero no con ambos.
    • Presentar enfermedad que haya progresado durante el tratamiento con acetato de abiraterona o enzalutamida por CPRCm durante al menos 8 semanas (al menos 14 semanas en los participantes con progresión ósea).
    6. Haber recibido no más de una pauta previa de quimioterapia contra el CPRCm y haber presentado progresión de la enfermedad durante el tratamiento. De haberse utilizado quimioterapia con docetaxel más de una vez (por ejemplo, una vez por cáncer de próstata hormonosensible metastásico y otra por CPRCm), se considerará un solo tratamiento. Se permitirá el tratamiento previo con docetaxel por CPRCm siempre que hayan transcurrido más de cuatro semanas desde la última dosis de docetaxel antes del día 1 del ciclo 1.
    7. Estar en situación de privación androgénica persistente con una concentración sérica de testosterona < 50 ng/dl (< 2,0 nM). Si el participante está recibiendo agonistas o antagonistas de la gonadoliberina (LHRH) (en los participantes que no se hayan sometido a una orquiectomía), este tratamiento deberá haberse empezado al menos cuatro semanas antes de la fecha de aleatorización y el tratamiento deberá mantenerse durante todo el estudio.
    8. Los participantes que se encuentren en tratamiento antirresortivo óseo (con bisfosfonatos o denosumab, entre otros) deberán haber recibido dosis estables durante al menos cuatro semanas antes de la fecha de aleatorización.
    9. Presentar una función orgánica adecuada, según se define en la Tabla 1; todos los análisis de selección deberán realizarse en el laboratorio central en los 10 días previos a la primera dosis de la intervención del estudio.
    10. Ser varón.
    11. Edad mínima de 18 años el día de firma del consentimiento informado.
    12. Comprometerse a lo siguiente durante el período de intervención y durante al menos 180 días, correspondiente al tiempo necesario para eliminar la intervención del estudio:
    • Abstenerse de donar semen.
    MÁS:
    • Abstenerse de mantener relaciones heterosexuales como modo de vida habitual y preferido (abstinencia a largo plazo y persistente) y compromiso de mantener dicha abstinencia sexual.
    O
    • Comprometerse a utilizar métodos anticonceptivos a menos que se confirme que presentan azoospermia (por vasectomía o secundaria a una causa médica [apéndice 5]) tal como se detalla a continuación:
    • Comprometerse a utilizar preservativo masculino más uso por parte de la pareja de un método anticonceptivo adicional cuando mantengan relaciones sexuales con penetración vaginal con mujeres en edad fértil que no estén embarazadas. Nota: Los varones con una pareja embarazada o en período de lactancia deberán comprometerse a mantener la abstinencia de relaciones sexuales con penetración vaginal o a utilizar preservativo masculino durante cada episodio de penetración vaginal.
    13. También deberán comprometerse a utilizar preservativo masculino en cualquier actividad que permita el paso de eyaculado a otra persona de cualquier sexo.
    14. El participante (o su representante legal cuando proceda) otorga su consentimiento/asentimiento informado por escrito para el estudio. Resto Leer en Protocolo
    E.4Principal exclusion criteria
    - Has a known additional malignancy that is progressing or has required active treatment in the last 3 years
    - Has an active autoimmune disease that has required systemic treatment in the past 2 years
    - Has a history of (noninfectious) pneumonitis requiring steroids, or has current pneumonitis
    - Has known active human immunodeficiency virus (HIV), hepatitis B virus (e.g., hepatitis B surface antigen reactive) or hepatitis C virus (HCV) infection (e.g., HCV RNA [qualitative] is detected)
    - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
    - Has a history of seizure or any condition that may predispose to seizure
    - Has a history of loss of consciousness within 12 months of screening
    - Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML
    - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
    - Has severe (Grade >3) hypersensitivity to pembrolizumab and/or any of its excipients
    - Has known hypersensitivity to the components or excipients in olaparib, abiraterone acetate, prednisone or prednisolone, or enzalutamide
    - Has symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease)
    - Has received an anticancer monoclonal antibody (mAb) prior to randomization
    - Has received prior treatment with olaparib or any other PARP inhibitor
    - Has received prior treatment with apalutamide or darolutamide
    - Has used herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA (e.g., saw palmetto) prior to the date of randomization
    - Has received prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer
    - Has received prior treatment with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor(e.g., CTLA-4, OX-40, or CD137)
    - Is currently receiving either strong or moderate inhibitors of cytochrome P450
    [CYP] (CYP3A4) that cannot be discontinued for the duration of the study
    - Has received a previous allogenic bone marrow transplant or double umbilical cord transplantation (dUCBT)
    - Has received a live vaccine within 30 days prior to the date of randomization
    - Is currently participating in or has participated in a study of an investigational agent, or has used an investigational device, within 4 weeks prior to the date of randomization
    - Has a bone “superscan”
    - Is expecting to father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of study intervention
    1. Presencia de otra neoplasia maligna conocida que está en progresión o ha precisado tratamiento activo en los últimos tres años. No se excluirá a los participantes con carcinoma basocelular o espinocelular de piel o carcinoma in situ que se hayan sometido a un tratamiento potencialmente curativo.
    2. Presencia de un síndrome mielodisplásico (SMD)/leucemia mieloide aguda (LMA) o signos indicativos de SMD/LMA.
    3. Presencia de toxicidad persistente (grado > 2 de los CTCAE) causada por un tratamiento antineoplásico previo, excepto alopecia y neuropatía.
    4. Recepción de factores estimulantes de colonias (p. ej., factor estimulante de las colonias de granulocitos [G-CSF], factor estimulante de las colonias de granulocitos y macrófagos [GMCSF] o eritropoyetina recombinante) en los 28 días previos a la fecha de aleatorización.
    5. 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. Algunos ejemplos son, entre otros, arritmia ventricular no controlada,infarto de miocardio reciente (en los últimos 3 meses), trastorno convulsivo importante no controlado, compresión medular inestable, síndrome de la vena cava superior, neumopatía intersticial bilateral extensa en una tomografía computarizada de alta resolución o cualquier trastorno psiquiátrico que impida obtener el consentimiento informado.
    6. Trastorno psiquiátrico o por abuso de sustancias que pueda dificultar el cumplimiento de los requisitos del estudio.
    7. Presencia de una enfermedad autoinmunitaria activa que ha precisado tratamiento sistémico (es decir, fármacos modificadores de la enfermedad, corticoides o inmunodepresores) en los dos últimos años. El tratamiento de reposición (es decir, tiroxina, insulina o corticoides en dosis fisiológicas por insuficiencia suprarrenal o hipofisaria, etc.) no se considera una forma de tratamiento sistémico.
    8. Presencia de un trastorno digestivo que afecte a la absorción (por ejemplo, gastrectomía o úlcera péptica activa en los tres últimos meses).
    9. Incapacidad de tragar comprimidos o cápsulas.
    10. Antecedentes de neumonitis (no infecciosa) que precisó la administración de esteroides o presencia de una neumonitis activa.
    11. Presencia de una infección activa (incluida la tuberculosis) con necesidad de tratamiento sistémico.
    12. Antecedentes o datos presentes de cualquier proceso, tratamiento o anomalía analítica que, en opinión del investigador responsable del tratamiento, podrían confundir los resultados del estudio, dificultar la participación durante la totalidad del estudio o indicar que la participación en el estudio no sea lo más conveniente para el posible participante.
    13. Presencia de infección activa conocida por el virus de la inmunodeficiencia humana (VIH), el virus de la hepatitis B (por ejemplo, reactividad del antígeno de superficie del virus de la hepatitis B) o el virus de la hepatitis C (VHC) (por ejemplo, detección [cualitativa] de ARN del VHC). Análisis no obligatorio a menos que lo exijan las autoridades sanitarias locales. Véanse en el Apéndice 7 los requisitos de análisis específicos de cada país.
    14. Presencia de metástasis activas conocidas en el sistema nervioso central (SNC) o meningitis carcinomatosa. Los posibles participantes con metástasis cerebrales tratadas con anterioridad podrán participar siempre que se encuentren estables (sin signos de progresión en los estudios de imagen durante al menos 28 días antes de la fecha de aleatorización y con regreso de todos los síntomas neurológicos a la situación basal), no presenten indicios de metástasis cerebrales nuevas o que estén aumentando de tamaño y no utilicen esteroides durante al menos 7 días antes de la fecha de aleatorización. Esta excepción no se aplica a la meningitis carcinomatosa, que será motivo de exclusión con independencia de la estabilidad clínica.
    15. Diagnóstico de inmunodeficiencia o recepción de tratamiento sistémico crónico con esteroides (en dosis superiores a 10 mg diarios de prednisona o un equivalente) o cualquier otra forma de tratamiento inmunodepresor en los siete días previos a la fecha de aleatorización.
    16. Presencia de hipersensibilidad grave (grado > 3) a pembrolizumab y/o a cualquiera de sus excipientes.
    17. Hipersensibilidad conocida a los componentes o excipientes de olaparib, acetato de abiraterona, prednisona o prednisolona o enzalutamida.
    18. Presencia de neuropatía periférica de grado ≥ 2 según los criterios CTCAE, excepto cuando se deba a un traumatismo.
    19. Presencia de ascitis o derrame pleural clínicamente significativo.
    20. Antecedentes de convulsiones en los 6 meses previos a la firma del consentimiento informado o presencia de cualquier trastorno que pueda predisponer a sufrirlas (entre otros, accidente cerebrovascular, accidente isquémico transitorio o malformación arteriovenosa cerebral previos o masas intracraneales..RESTO LEER Protocolo
    E.5 End points
    E.5.1Primary end point(s)
    1. Overall survival (OS)
    2. Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR)
    1-supervivencia global (SG).
    2-supervivencia sin progresión radiológica (SSPr) conforme a los Criterios de evaluación de la respuesta en tumores sólidos, versión 1.1 (RECIST 1.1) modificados por el Grupo de trabajo sobre el cáncer de próstata
    (PCWG), según lo evaluado mediante una revisión central independiente y enmascarada (RCIE).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to approximately 29 months
    1. Up to approximately 29 months
    1-hasta 29 meses aproximadamente
    1-hasta 29 meses aproximadamente
    E.5.2Secondary end point(s)
    1.Time to initiation of the first subsequent anticancer therapy or death (TFST)
    2.Objective response per Prostate Cancer Working Group (PCWG)- modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR)
    3.Duration of response (DOR) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR)
    4.Time to prostate-specific antigen (PSA)progression
    5.Time to first symptomatic skeletal-related event (SSRE)
    6.Time to radiographic soft tissue progression per soft tissue rules of Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR)
    7.Time to pain progression (TTPP)
    8.Number of Participants with One or More Adverse Events (AEs)
    9.Number of Participants with Study Discontinuations Due to Adverse Events (AEs)
    1-Tiempo transcurrido hasta el inicio del primer tratamiento antineoplásico posterior o la muerte (TPTP)
    2-Tasa de respuestas objetivas (TRO) (criterios RECIST 1.1 modificados por el PCWG, según lo evaluado mediante una RCIE)
    3.Duración de la respuesta (DR) (criterios RECIST 1.1 modificados por el PCWG, según lo evaluado mediante una RCIE)
    4.Tiempo transcurrido hasta la progresión del PSA
    5.Tiempo transcurrido hasta el primer episodio óseo sintomático
    6.Tiempo transcurrido hasta la progresión radiológica en las partes blandas (normas sobre partes blandas de los criterios RECIST 1.1 modificados por el PCWG, según lo evaluado mediante una RCIE)
    7.Tiempo transcurrido hasta la progresión del dolor (THPD)
    8.Numero de sujetos con uno o más eventos adversos (EAs)
    9.Número de sujetos discontinuados del estudio debido a eventos adversos
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.Up to approximately 29 months
    2.Up to approximately 29 months
    3.Up to approximately 29 months
    4.Up to approximately 29 months
    5.Up to approximately 29 months
    6.Up to approximately 29 months
    7.Up to approximately 29 months
    8.Up to approximately 29 months
    9.Up to approximately 29 months
    1-hasta 29 meses aproximadamente
    2-hasta 29 meses aproximadamente
    3-hasta 29 meses aproximadamente
    4-hasta 29 meses aproximadamente
    5-hasta 29 meses aproximadamente
    6-hasta 29 meses aproximadamente
    7-hasta 29 meses aproximadamente
    8-hasta 29 meses aproximadamente
    9-hasta 29 meses aproximadamente
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA83
    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
    Austria
    Brazil
    Canada
    Chile
    Colombia
    France
    Germany
    Israel
    Italy
    Japan
    Korea, Republic of
    Netherlands
    New Zealand
    Poland
    Russian Federation
    Spain
    Taiwan
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 years2
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    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: 312
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 468
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 390
    F.4.2.2In the whole clinical trial 780
    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 Decision2019-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-12
    P. End of Trial
    P.End of Trial StatusCompleted
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