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    Summary
    EudraCT Number:2016-001676-29
    Sponsor's Protocol Code Number:MK3475_PROMO
    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:2018-02-27
    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 number2016-001676-29
    A.3Full title of the trial
    PROMO: A phase II study of Pembrolizumab in patients with Relapsed Or Metastatic Osteosarcoma not eligible for curative surgery
    Studio di fase 2 di Pembrolizumab in pazienti con osteosarcoma in ricaduta o metastatici non suscettibile di trattamento chirurgico con intento curativo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PROMO: A phase II study of Pembrolizumab in patients with Relapsed Or Metastatic Osteosarcoma not eligible for curative surgery
    Studio con immunoterapico nell'osteosarcoma in ricaduta o metastatico che non può essere operato
    A.3.2Name or abbreviated title of the trial where available
    PROMO
    PROMO
    A.4.1Sponsor's protocol code numberMK3475_PROMO
    A.5.4Other Identifiers
    Name:PROMONumber:PROMO
    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 SponsorOSLO UNIVERSITETSSYKEHUS HF
    B.1.3.4CountryNorway
    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 supportAzienda Farmaceutica: MSD
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Oslo
    B.5.2Functional name of contact pointDepartment of Oncology Norwegian R
    B.5.3 Address:
    B.5.3.1Street AddressOslo University Hospital PO Box 4953 Nydalen, NO
    B.5.3.2Town/ cityOSLO
    B.5.3.3Post codeNO-0424
    B.5.3.4CountryNorway
    B.5.4Telephone number004722781852
    B.5.5Fax number004722781852
    B.5.6E-mailkjetil.boye@rr-research.no
    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 - 50 MG- POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE- USO ENDOVENOSO- FLACONCINO (VETRO) 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SHARP & DOHME LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Powder for 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 INNPEMBROLIZUMAB
    D.3.9.1CAS number 1374853-91-4
    D.3.9.2Current sponsor codeMK3475
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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) 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
    Osteosarcoma, not eligible for curative surgery
    Osteosarcoma metastatico o in ricaduta non candidato a chirurgia
    E.1.1.1Medical condition in easily understood language
    Osteosarcoma
    Osteosarcoma in fase avanzata, non operabile
    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 PT
    E.1.2Classification code 10031291
    E.1.2Term Osteosarcoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10031294
    E.1.2Term Osteosarcoma metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the percentage of patients who achieve clinical response; complete response (CR), partial response (PR), or stable disease (SD) at 18 weeks
    Valutare la percentuale di pazienti che raggiunge la risposta clinica; la risposta completa, parziale o stabilità di malattia a 18 settimane valutata secondo RECIST 1.1
    E.2.2Secondary objectives of the trial
    •Overall response rate (ORR), clinical benefit rate (CBR), duration of response (DOR), and progression-free survival (PFS), assessed by the Investigator using RECIST v1.1.
    •To evaluate the percentage of patients who have achieved clinical response; CR, PR, or SD at 18 weeks , ORR, CBR, DOR, and PFS assessed by the Investigator using immune-related response criteria, irRC.
    •To evaluate the percentage of patients who achieve response by 18F-FDG PET/CT measured by changes in maximum standardized uptake value (SUVmax), metabolic tumor volume (MTV) and/or total lesion glycolosis (TLG).
    •To evaluate overall survival (OS).
    •To evaluate the safety and tolerability of pembrolizumab in patients with osteosarcoma.
    •To evaluate health-related quality of life changes from baseline in patients with osteosarcoma, receiving pembrolizumab, using EORTC QLQ-C30.
    •Valutare il tasso di risposta globale, tasso di beneficio clinico durata della risposta, and sopravvivenza libera da progressione, valuata in accordo ai criteri RECIST 1.1
    •Valutare la percentuale di pazienti che raggiunge risposta clinica, risposta completa, parziale o stabilità di malattia a 18 settimane in accordo agli immune-related response criteria, irRC.
    • Valutare la percentuale di pazienti che raggiunge risposta valuatata mediante PET (variazioni del maximum standardized uptake value (SUVmax), del volume metabolico del (MTV) e/o la glicolisi totale della lesione (TLG).
    •Valutare la sopravivvenza globale (OS)
    •Valutare la sicurezza e la tollerabilità di pembrolizumab in pazienti con osteosarcoma
    •Valutare i cambiamenti correlati alla qualità di vita rispetto al basale mediante il questionario EORTC QLQ-C30, in pazienti con osteosarcoma che hanno ricevuto pembolizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically confirmed osteosarcoma.
    2. Disease relapse or progression after at least one line of systemic treatment.
    3. Surgical resection with curative intent not possible.
    4. Be willing and able to provide written informed consent/assent for the trial.
    5. Be 18 years of age on day of signing informed consent.
    6. Have measurable disease based on RECIST, version 1.1.
    7. Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion.
    8. Have a performance status of 0 or 1 on the ECOG Performance Scale.
    9. Demonstrate adequate organ function as defined in Table 1.
    1. Osteosarcoma istologicamente confermato.
    2. Ricaduta o progressione di malattia dopo almeno 1 linea di trattamento sistemico
    3. Impossibilità di resezione chirurgica con intento curativo o chirurgia non fattibile
    E.4Principal exclusion criteria
    1. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
    2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
    3. Has a known history of active TB (Bacillus Tuberculosis)
    4. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.Hypersensitivity to pembrolizumab or any of its excipients.
    5. Hypersensitivity to pembrolizumab or any of its excipients.
    6. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
    7. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
    8. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
    9. Has known active central nervous system (CNS) metastases and/or sarcomatous meningitis.
    10. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
    11. Has known history of, or any evidence of active, non-infectious pneumonitis.
    12. Has an active infection requiring systemic therapy.
    13. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.
    14. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
    15. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
    16. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
    17. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
    18. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
    19. Has received a live vaccine within 30 days of planned start of study therapy.
    1. Pazienti che ricevono altri farmaci sperimentali o che hanno terminato il trattamento sperimentale entro le 4 settimane.
    2. Diagnosi di immunodeficienza o che prendono steroidi o altri agenti immunosopressivi nei 7 giorni prima della prima dose di IMP.
    3. Storia di tubercolosi attiva
    4. Storia di polmonite non infettiva che richiede l'uso di steroidi o polmonite in corso
    5. Ipersensibilità al pembrolizumab e/o ai suoi eccipienti .
    6. Precedente terapia antitumorale con anticorpi monoclonali nelle 4 settimane prima dell'inizio trattamento o con tossicità superiore al grado 1.
    7. Precedente chemioterapia con farmaci target, radioterapia entro le 2 settimane o con tossità non risolta
    8. Concomitante patologia maligna con eccezione del cacrinoma delle cellule basali della pelle o del carcinoma squamoso che è stato trattato con intento curativo o carcinoma della cervice in sito.
    9. Metastasi a livello del SNC.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the percentage of patients who achieve clinical response; complete response (CR), partial response (PR), or stable disease (SD) at 18 weeks as assessed by the Investigator, using RECIST v1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Clinical response at 18 weeks: The percentage of patients with unresectable osteosarcoma who have achieved clinical response; complete response (CR), partial response (PR), or stable disease (SD) at 18 weeks as assessed using RECIST v1.1
    E.5.2Secondary end point(s)
    • Overall response rate (ORR), clinical benefit rate (CBR), duration of response (DOR), and progression-free survival (PFS), assessed by the Investigator using RECIST v1.1. • To evaluate the percentage of patients who have achieved clinical response; CR, PR, or SD at 18 weeks , ORR, CBR, DOR, and PFS assessed by the Investigator using immune-related response criteria, irRC. • To evaluate the percentage of patients who achieve response by 18F-FDG PET/CT measured by changes in maximum standardized uptake value (SUVmax), metabolic tumor volume (MTV) and/or total lesion glycolosis (TLG). • To evaluate overall survival (OS). • To evaluate the safety and tolerability of pembrolizumab in patients with osteosarcoma. • To evaluate health-related quality of life changes from baseline in patients with osteosarcoma, receiving pembrolizumab, using EORTC QLQ-C30.
    E.5.2.1Timepoint(s) of evaluation of this end point
    OS will be calculated from the date of first dose of pembro until death. Patients alive at the time of data analysis 24 M after last enrolled patient will be treated as censored. OS will be estimated by Kaplan Meier method. PFS will be measured as the time from first dose of pembrolizumab to the first progression recorded, or Death. If patients undergo curative surgical resection after start of treatment, PFS will be measured as time from first dose of pembro to disease recurrence after surgery, or death. Patients who have not yet progressed or died at the time of data analysis 24 M after last enrolled patient will be treated as censored. PFS will be estimated by Kaplan Meier Method. Safety Endpoints Safety will be assessed by reporting adverse experiences using CTCAE v4.0
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 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 Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 No
    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
    The overall trial ends when the last subject completes the last study related phone call or visit, discontinues from the trial or is lost to follow-up (i.e. the subject is unable to be contacted by the investigator)
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    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 years7
    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: 25
    F.1.3Elderly (>=65 years) No
    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 Yes
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 25
    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)
    Patients will be treated in accordance to the Osteosarcoma Guidelines
    I pazienti verranno trattati secondo le linee guida per l'Osteosarcoma
    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 Decision2017-05-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-15
    P. End of Trial
    P.End of Trial StatusOngoing
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