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    Summary
    EudraCT Number:2019-001745-40
    Sponsor's Protocol Code Number:MK-7339-007
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-22
    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 ConcernedItaly - Italian Medicines Agency
    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
    Studio di Fase II con Olaparib in combinazione con Pembrolizumab in Soggetti con Mutazione nel Sistema di Riparo di Ricombinazione Omologa (HRRm) e/o Deficitari (HRD), con Tumore in Stato Avanzato e Precedentemente Trattato
    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 HRD positive cancer
    Olaparib in combinazione con Pembrolizumab nel tumore HRRm e HRD positivo
    A.3.2Name or abbreviated title of the trial where available
    Olaparib in combination with pembrolizumab in HRRm and HRD positive cancer
    Olaparib in combinazione con Pembrolizumab nel tumore HRRm e HRD positivo
    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. UNA SUSSIDIARIA DI 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., una sussidiaria di 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 organisationMSD Italia Srl
    B.5.2Functional name of contact pointDivisione Ricerca Clinica
    B.5.3 Address:
    B.5.3.1Street AddressVia Vitorchiano, 151
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00189
    B.5.3.4CountryItaly
    B.5.4Telephone number00390636191371
    B.5.5Fax number0390636380371
    B.5.6E-mailgcto.italy@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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.3.1Product name-
    D.3.2Product code [-]
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.3.9.4EV 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.3.9.4EV 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Tumore HRRm e/o HRD positivo
    E.1.1.1Medical condition in easily understood language
    Second line and beyond HHRm and HRD pan tumor cancers
    Tutti i tumori solidi HHRm e HRD di seconda linea e oltre
    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
    Valutare il Tasso di Risposta Obiettiva (ORR) mediante i Criteri RECIST v. 1.1 o i Criteri RECIST 1.1 modificati dal Prostate Cancer Working Group (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 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 cancer
    1. Valutare la Durata della Risposta (DOR) mediante i Criteri RECIST 1.1 o i Criteri RECIST 1.1 modificati dal PCWG
    2. Valutare la Sopravvivenza Libera da Progressione (PFS) mediante i Criteri RECIST 1.1 o i Criteri RECIST 1.1 modificati dal PCWG
    3. Valutare la Sopravvivenza Complessiva (OS)
    4. Valutare la sicurezza e tollerabilità del trattamento di studio
    5. Valutare ORR, DOR e PFS mediante i Criteri RECIST 1.1 o i Criteri RECIST 1.1 modificati dal PCWG e OS in base allo stato del biomarcatore tumorale
    6. Valutare il tempo alla prima progressione dall’antigene tumorale 125 (CA-125) nelle partecipanti affette da tumore ovarico
    7. Valutare la percentuale di risposta dell’antigene prostatico specifico (PSA) nei partecipanti affetti da tumore prostatico
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative 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.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Merck condurrà una Ricerca Biomedica Futura su campioni di DNA (estratti dal sangue, plasma, siero, urina e tessuto) raccolti nel corso di questo studio clinico. Tale ricerca ha lo scopo di esaminare vari biomarcatori per rispondere a domande che stanno emergendo e che non sono descritte in altre parti del protocollo (nell’ambito dello studio principale), e verrà condotta solo su campioni di soggetti che abbiano rilasciato apposito consenso. L'obiettivo della raccolta dei campioni per la Ricerca Biomedica Futura è quello di esplorare e identificare biomarcatori che contribuiscano scientificamente alla comprensione delle malattie e/o delle relative terapie. L'obiettivo ultimo è quello di utilizzare tali informazioni per sviluppare farmaci più sicuri e più efficaci, e/o per garantire che i soggetti ricevano la dose giusta del giusto farmaco al momento giusto.
    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. Presentare una diagnosi confermata istologicamente o citologicamente di tumore solido (metastatico e / o non resecabile) (ad eccezione dei tumori mammari o ovarici il cui tumore ha una linea germinale o una mutazione BRCA somatica) che non è elegibile per trattamenti curativi e per il quale la terapia standard di cura non funziona. I partecipanti devono aver progredito o essere intolleranti alle terapie standard di cura che sono note per fornire benefici clinici. Non vi è alcun limite al numero di precedenti regimi di trattamento.
    2. Ha mutazioni deleterie confermate centralmente o sospette in almeno 1 dei 15 geni specificati coinvolti nell'HRR (ad es. BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C , RAD51D e RAD54L) o HRD confermato centralmente in base al test HRR-HRD di Lynparza.
    3. Ha una malattia misurabile secondo RECIST 1.1, valutata dallo sperimentatore / dalla radiologia del sito locale e confermata in tempo reale dal BICR. Il BICR deve confermare la presenza di malattia misurabile radiologicamente secondo RECIST 1.1 affinché il partecipante sia ammissibile allo studio. Le lesioni situate in un'area precedentemente irradiata sono considerate misurabili se la progressione è stata dimostrata in tali lesioni.
    4. Ha un’aspettativa di vita di almeno 3 mesi.
    5. E’ uomo o donna con almento 18 anni di età compiuti al momento della firma del consenso informato.
    6. Ha uno stato di prestazione ECOG pari a 0 o 1, valutato entro 3 giorni dall'inizio del trattamento.
    7. Un partecipante di sesso maschile deve acconsentire ad utilizzare la contraccezione come indicato nel protocollo durante il periodo di trattamento e per almeno 120 giorni (4 mesi), corrispondenti al tempo necessario per eliminare qualsiasi intervento (i) di studio e astenersi dal donare sperma durante questo periodo.
    8. Una partecipante donna è ammessa se non è incinta, non sta allattando e adotta almeno 1 delle seguenti condizioni:
    - Non è una donna in età fertile (WOCBP)
    O
    - E’ una donna in età fertile che accetta di seguire le indicazioni contraccettive contenute nel Protocollo durante il periodo di trattamento e per almeno 180 giorni (6 mesi) dopo l'ultima dose dell'intervento di studio, corrispondente al tempo necessario per eliminare qualsiasi intervento di studio.
    9. Il partecipante (o il rappresentante legalmente accettabile se applicabile) fornisce il consenso informato scritto per lo studio. Il partecipante può anche fornire il consenso per FBR. Tuttavia, il partecipante può partecipare allo studio principale senza partecipare a FBR.
    10. Ha un'adeguata funzionalità d'organi; tutti i test di laboratorio di screening devono essere eseguiti entro 10 giorni prima della prima dose dell'intervento di studio.
    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 colony-stimulating 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 a gastrointestinal 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-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory 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)

    ...for the following points (from 26 to 33) please refer to the Protocol.
    1. Ha un’ulteriore neoplasia nota che sta progredendo o che ha richiesto trattamento attivo negli ultimi 3 anni
    2. Ha una storia di polmonite non infettiva che ha richiesto il trattamento con steroidi o attualmente ha una polmonite
    3. Ha la sindrome mielodisplastica (MDS) / leucemia mieloide acuta (LMA) o con caratteristiche suggestive di MDS / AML
    4. Ha una metastasi riconosciuta del sistema nervoso centrale (CNS) e / o una meningite carcinomatosa
    5. Ha un'infezione attiva che richiede una terapia sistemica
    6. Ha una tubercolosi attiva
    7. Ha una diagnosi di immunodeficienza o sta ricevendo una terapia cronica sistemica steroidea (dosaggio nel protocollo) o qualsiasi altra forma di terapia immunosoppressiva entro 7 giorni prima della prima dose di intervento di studio
    8. Ha una malattia autoimmune attiva che ha richiesto trattamento sistemico negli ultimi 2 anni
    9. Ha una storia o prove recenti di qualsiasi condizione (fare riferimento al Protocollo), terapia o anomalie di laboratorio che potrebbero confondere i risultati dello studio, interferire con il coinvolgimento del partecipante per l’intera durata dello studio, o non è nel migliore interesse del partecipante essere coinvolto, secondo l'opinione dello sperimentatore
    10. Ha ricevuto fattori stimolanti delle colonie (ad es. Stimolazione delle colonie di granulociti fattore [G-CSF], stimolante le colonie di granulociti-macrofagi fattore [GM-CSF] o eritropoietina ricombinante) entro 28 giorni prima della prima dose di intervento in studio
    11. È considerato di scarso rischio medico a causa di un grave, incontrollato disturbo medico, malattia sistemica non maligna o infezione attiva, incontrollata.
    12. Ha un riconosciuto disturbo psichiatrico o di abuso di sostanze che lo farebbero interferire con la cooperazione con i requisiti dello studio
    13. Ha una storia nota di infezione da virus dell'immunodeficienza umana (HIV). Il test per l'HIV allo screening è richiesto solo se obbligatorio secondo l’autorità sanitaria locale
    14. Ha un’epatite attiva (cioè epatite B o C)
    15. Non è in grado di deglutire i farmaci somministrati per via orale o ha a disturbo gastrointestinale che influenza l'assorbimento
    16. E’ una donna in età fertile che ha un test di gravidanza sulle urine positivo entro 72 ore prima della prima dose di intervento in studio. Se il test delle urine è positivo o non può essere confermato come negativo, sarà necessario un test sierico di gravidanza
    17. Ha ricevuto una terapia precedente con un anti-PD-1, anti-PD-L1 o anti-PDL2 agente o con un agente diretto ad un altro stimolante o coinibitorio Recettore delle cellule T (ad es. CTLA-4, OX 40, CD137)
    18. Ha ricevuto una precedente terapia con olaparib o con qualsiasi altro PARP inibitore
    19. Sono stati refrattari alla precedente terapia con platino per terapia avanzata di tumore solido (metastatico e / o non resecabile)
    20. Ha ricevuto una precedente terapia anticancro sistemica incluso agenti sperimentali entro 4 settimane prima della somministrazione dell’intervento di studio
    21. Deve essersi ripreso da tutti gli eventi avversi a causa di terapie precedenti, esclusa l'alopecia, a = Grado 1 o basale
    22. Ha una nota ipersensibilità ai trattamenti in studio e / o ad uno qualsiasi dei loro eccipienti
    23. Attualmente sta ricevendo forti o moderati inibitori di citocromo P450 (CYP) 3A4 che non può essere interrotto per la durata dello studio. Il periodo di washout richiesto prima di iniziare olaparib è di 2 settimane
    24. Attualmente sta ricevendo induttori forti o moderati del CYP3A4 che non può essere interrotto per la durata dello studio. La richiesta il periodo di washout prima di iniziare olaparib è di 5 settimane per il fenobarbital e 3 settimane per altri agenti
    25. Ha ricevuto un precedente trapianto allogenico di midollo osseo o doppio trapianto di cordone ombelicale (DUCBT)

    ...per i successivi punti (da 26 a 33) fare riferimento al Protocollo.
    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. Tasso di Risposta Obiettivo (ORR) come definito dai Criteri di Valutazione della Risposta nei Tumori Solidi Versione 1.1 (RECIST 1.1) o dai RECIST 1.1 modificati dal Gruppo di Lavoro sul Cancro alla prostata (PCWG) nei sottogruppi di Biomarker
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to ~3 years
    1. Fino a circa 3 anni
    E.5.2Secondary end point(s)
    1. Duration of Response (DOR) as Assessed by RECIST 1.1 or PCWG-modified RECIST 1.1 in Biomarker Subgroups
    2. Progression-Free Survival (PFS) as Assessed by RECIST 1.1 or PCWG-modified 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. Durata della risposta (DOR) valutata mediante RECIST 1.1 o RECIST 1.1 modificati dal PCWG nei sottogruppi di biomarcatori
    2. Sopravvivenza libera da progressione (PFS) valutata mediante RECIST 1.1 o RECIST 1.1 modificati da PCWG nei sottogruppi di biomarcatori
    3. Sopravvivenza complessiva (OS) nei sottogruppi di biomarcatori
    4. Numero di partecipanti che sperimentano un evento avverso (AE)
    5. Numero di partecipanti che interrompono il trattamento di studio a causa di un Evento avverso (AE)
    6. Tasso di risposta obiettiva (ORR) basato sullo stato del biomarcatore tumorale valutato secondo RECIST 1.1 o RECIST 1.1 modificato da PCWG in sottopopolazioni aggiuntive di biomarcatori
    7. Durata della risposta (DOR) in base allo stato del biomarcatore tumorale valutato secondo RECIST 1.1 o RECIST 1.1 modificati da PCWG in Sottopopolazioni aggiuntive di biomarcatori
    8. Sopravvivenza libera da progressione (PFS) basata sullo stato del biomarcatore tumorale valutato secondo RECIST 1.1 o RECIST 1.1 modificati da PCWG in Sottopopolazioni aggiuntive di biomarcatori
    9. Sopravvivenza globale (OS) nelle sottopopolazioni di biomarcatori aggiuntivi
    10. Numero di partecipanti con Livello di Antigene tumorale-125 (CA-125) = 2 × Upper Limit of Normal (ULN) tra le partecipanti con tumore ovarico
    11. Numero di partecipanti con Cancer Antigen-125 (CA-125) Livello =2 × Valore Nadir (più basso) tra le partecipanti con tumore ovarico con livelli elevati di CA-125 =ULN al basale
    12. Numero di partecipanti con una variazione rispetto al basale del Livello di antigene specifico per la prostata (PSA) =50% tra i partecipanti con cancro alla prostata
    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. Fino a circa 3 anni
    2. Fino a circa 3 anni
    3. Fino a circa 3 anni
    4. Fino a circa 3 anni
    5. Fino a circa 3 anni
    6. UFino a circa 3 anni
    7. Fino a circa 3 anni
    8. Fino a circa 3 anni
    9. Fino a circa 3 anni
    10. Fino a circa 3 anni
    11. Fino a circa 3 anni
    12. Fino a circa 3 anni
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    in aperto
    open
    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 concerned4
    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 Information not present in EudraCT
    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
    Guatemala
    Israel
    Korea, Republic of
    Mexico
    Peru
    Puerto Rico
    South Africa
    Turkey
    Ukraine
    United States
    France
    Germany
    Italy
    Latvia
    Poland
    Romania
    Spain
    Sweden
    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
    LSLV
    LSLV
    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 days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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: 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 state12
    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
    Nessuno
    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 Decision2019-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-23
    P. End of Trial
    P.End of Trial StatusOngoing
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