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    Summary
    EudraCT Number:2019-004782-40
    Sponsor's Protocol Code Number:PEM-PRO
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-01-21
    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 number2019-004782-40
    A.3Full title of the trial
    An open label, single-arm, phase 2 study of neoadjuvant PEMbrolizumab before radical PROstatectomy (PEM-PRO) in high-risk prostate cancer patients
    Studio di fase 2, open-lable, a braccio singolo sull’uso in neoadiuvante di pembrolizumab prima della prostatectomia radicale nei pazienti con tumore della prostata ad alto rischio (PEM-PRO)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of neoadjuvant PEMbrolizumab before radical PROstatectomy (PEM-PRO) in patients affected by high-risk prostate cancer
    Studio di fase 2 a braccio singolo sull’uso della terapia neoadiuvante con pembrolizumab prima della prostatectomia radicale nei pazienti affetti da tumore della prostata ad alto rischio (PEM-PRO)
    A.3.2Name or abbreviated title of the trial where available
    PEM-PRO
    PEM-PRO
    A.4.1Sponsor's protocol code numberPEM-PRO
    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 SponsorOSPEDALE SAN RAFFAELE
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMERCK SHARP & DOHME CORP
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS Ospedale San Raffaele
    B.5.2Functional name of contact pointUnità Operativa di Urologia
    B.5.3 Address:
    B.5.3.1Street AddressVia Olgettina 58
    B.5.3.2Town/ cityMilan
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.6E-mailgandaglia.giorgio@hsr.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name KEYTRUDA (pembrolizumab, MK 3475)
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme B.V. EU/1/15/1024/002
    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 nameKEYTRUDA (pembrolizumab, MK 3475)
    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 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: 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 name68GA-PSMA-HBED-CC
    D.3.2Product code [68GA-PSMA-HBED-CC]
    D.3.4Pharmaceutical form Solution for injection
    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 INNPSMA-HBED-CC (PSMA-11)
    D.3.9.2Current sponsor code68Ga-PSMA
    D.3.9.3Other descriptive name68Ga-PSMA
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number110 to 210
    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 Yes
    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
    High-risk prostate cancer
    Tumore della prostata ad alto rischio
    E.1.1.1Medical condition in easily understood language
    Prostate cancer at high risk of biochemical recurrence after surgery
    Tumore della prostata considerato ad alto rischio di recidiva biochimica
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10026389
    E.1.2Term Malignant neoplasm of prostate
    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 assess if neoadjuvant therapy with pembrolizumab is associated with pathologic changes at radical prostatectomy and with a reduction in the rate of lymph node invasion in prostate cancer patients at high risk of recurrence after surgery.
    Valutare se la somministrazione di pembrolizumab in neoadiuvante induce una risposta patologica e riduce il rischio di invasione linfonodale nei pazienti con tumore della prostata ad alto rischio candidati a intervento chirurgico
    E.2.2Secondary objectives of the trial
    - To evaluate radiological response in terms of reduction of tumour volume at preoperative mpMRI on those patients with measurable disease at baseline. Radiological response will be defined as a tumour reduction of 30% in the maximum diameter of the index lesion as measured by mpMRI
    - To test the impact of neoadjuvant pembrolizumab on the risk positive surgical margins at final pathology
    - To test the impact of neoadjuvant pembrolizumab on the risk of PSA persistence after surgery
    - To assess the safety and side effects of pembrolizumab in PCa patients undergoing surgery
    - Valutare la risposta radiologica al trattamento con pembrolizumab definita come una riduzione del 30% del volume tumorale alla mpMRI
    - Valutare se la somministrazione di pembrolizumab riduce il rischio di margini chirurgici positivi
    - Valutare se la somministrazione di pembrolizumab riduce il rischio di persistenza di elevati valori di PSA dopo chirurgia
    - Determinare la sicurezza e gli effetti collaterali della somministrazione di pembrolizumab nei pazienti con tumore della prostata
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of prostate cancer
    2. PCa detected at prostate biopsy with a risk of lymph node invasion higher than 5% according to the Briganti nomogram
    3. The participant should be fit and planned for RP and ePLND
    4. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial
    5. Did not start novel therapies within the 4 weeks before the beginning of the study
    1. Pazienti di sesso maschile, di età fra i 18 e gli 80 anni.
    2. Biopsia prostatica per tumore della prostata, con rischio di invasione linfonodale maggiore di 5% secondo il nomogramma di Briganti.
    3. Eleggibilità alla prostatectomia radicale robot-assistita con linfoadenectomia pelvica estesa.
    4. Paziente in grado di intendere e di volere, volontà di firmare il consenso informato.
    5. Se in terapia cronica, dosi stabili da almeno 4 settimane prima dell’ingresso nello studio.
    E.4Principal exclusion criteria
    1. Has received prior systemic anti-cancer therapy including investigational agents prior to allocation.
    2. Unable to complete the diagnostic investigations required per protocol
    3. Evidence of metastases at preoperative imaging
    4. Evidence of lymph node invasion before surgery
    5. Life expectancy shorter than 12 months
    6. History of chemotherapy
    7. History of brachytherapy or EBRT
    8. Cardiovascular diseases not controlled by medical therapy
    9. Hearth failure
    10. Clinically relevant hepatic or renal diseases
    11. Onset of cerebral diseases within 6 months before the study beginning
    12. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject’s participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
    1. Somministrazione di altre terapie neoadiuvanti.
    2. Impossibilità a completare le indagini diagnostico/strumentali richieste dal protocollo.
    3. Malattia metastatica alla diagnosi.
    4. Evidenza di invasione linfonodale alla diagnosi.
    5. Aspettativa di vita inferiore a 12 mesi.
    6. Pregressa chemioterapia.
    7. Pregressa brachiterapia o radioterapia a fasci esterni.
    8. Malattie cardiovascolari non compensate.
    9. Scompenso cardiaco congestizio.
    10. Malattia epatobiliare o renale clinicamente significativa.
    11. Storia di malattia cerebrale nei 6 mesi precedenti.
    12. Qualsiasi altra malattia o disturbo che, all’opinione dell’investigatore, potrebbe o porre il paziente a rischio a causa dello studio, o influenzare il risultato dello studio, o, ancora, la capacità del paziente a partecipare allo studio.
    E.5 End points
    E.5.1Primary end point(s)
    A reduction of 50% in the rate of node positive patients compared to what currently reported in the literature represents the main endpoint of the study (rate of pN0 of 85 vs. 70%)
    La riduzione del rischio di invasione linfonodale è definita come una riduzione del 50% dei pazienti con linfonodi positivi rispetto a quanto riportato attualmente in letteratura nella stessa popolazione (85% di pazienti liberi da malattia linfonodale rispetto al 70% attualmente riportato in letteratura per la stessa popolazione di pazienti).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Pathologic assessment of surgical specimens (within 4 weeks after surgery)
    Analisi istologica della prostatectomia (entro 4 settimane da intervento)
    E.5.2Secondary end point(s)
    Positive margins, PSA persistence after surgery,
    Margini chirurgici positivi, persistenza di PSA dopo l’intervento, riduzione radiologica del volume tumorale, complicanze ed effetti collaterali
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 2 years after radical prostatectomy
    Sino a 2 anni dopo intervento chirurgico
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    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 months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 59
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state59
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 59
    F.4.2.2In the whole clinical trial 59
    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)
    The follow-up will be planned according to clinical international guidelines and will be based on the evaluation of serum PSA levels, imaging in the case of biochemical recurrence and periodic follow-up visits.
    I pazienti verranno seguiti con il follow-up previsto dalle linee guida internazionali per il tumore della prostata basato sul dosaggio dei valori di PSA nel tempo, imaging nel caso di recidiva e visite periodiche.
    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 Decision2020-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-15
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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