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    Summary
    EudraCT Number:2022-000494-91
    Sponsor's Protocol Code Number:PEMBR-01
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-05-17
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2022-000494-91
    A.3Full title of the trial
    A multicentre, open-label phase 2 study to evaluate the efficacy and safety of pembrolizumab in the treatment of advanced, progressive adrenocortical carcinoma.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pembrolizumab in the treatment of advanced, progressive adrenocortical carcinoma.
    A.3.2Name or abbreviated title of the trial where available
    Pembrolizumab in the treatment of advanced, progressive adrenocortical carcinoma.
    A.4.1Sponsor's protocol code numberPEMBR-01
    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 SponsorNarodowy Instytut Onkologii im. Marii Skłodowskiej-Curie, Państwowy Instytut Badawczy
    B.1.3.4CountryPoland
    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 supportABM - competition for research and development activities in the field of non-commercial clinical trials ABM/2020/1
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNarodowy Instytut Onkologii im. Marii Skłodowskiej-Curie, Państwowy Instytut Badawczy
    B.5.2Functional name of contact pointBarbara Ewa Ziółkowska
    B.5.3 Address:
    B.5.3.1Street Addressul. W. K. Roentgena 5, (Oddział w Gliwicach) ul. Wybrzeże Armii Krajowej 15
    B.5.3.2Town/ cityWarszawa/Gliwice
    B.5.3.3Post code05-077/44-102
    B.5.3.4CountryPoland
    B.5.4Telephone number+4832278 8822
    B.5.6E-mailbarbara.ziolkowska@gliwice.nio.gov.pl
    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 25 mg/ml concentrate for solution infusion
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme B.V. Waarderweg 39 2031 BN Haarlem Holandia
    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
    D.3.4Pharmaceutical form Concentrate for 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.3.9.4EV 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.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
    carcinoma
    nowotwór
    E.1.1.1Medical condition in easily understood language
    adrenocortical carcinoma
    rak kory nadnerczy
    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 10001388
    E.1.2Term Adrenocortical carcinoma
    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
    Evaluation of the effectiveness of the drug pembrolizumab in the treatment of advanced, progressive adrenocortical carcinoma
    Ocena skuteczności leku pembrolizumab w terapii zaawansowanego, progresującego raka kory nadnerczy
    E.2.2Secondary objectives of the trial
    - To evaluate the safety of pembrolizumab in the treatment of advanced, progressive adrenal cortex carcinoma
    - To assess the impact of therapy on the quality of life

    Exploratory:
    -To identify potential markers such as tumor tissue infiltration (TIL), PD-L1 expression, microsatellite instability (MSI) and closely related tumor tissue mutation (TMB) count) influencing and / or conditioning the clinical response to pembrolizumab
    - Ocena bezpieczeństwa leku pembrolizumab w terapii zaawansowanego, progresującego raka kory nadnerczy
    - Ocena wpływu terapii na jakość życia pacjenta

    Cele eksploracyjne:
    - Określenie potencjalnych markerów (ocenę nacieczenia limfocytami tkanki nowotworu (TIL), ekspresję PD-L1, niestabilność mikrosatelitarną (MSI) i ściśle z nią związana ilość mutacji w tkance guza (TMB)) wpływających i/lub warunkujących odpowiedź kliniczną na lek pembrolizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1- Signing the informed consent form to participate in the study
    2- Age over 18 years of age
    3- Histopathologically confirmed adrenocortical carcinoma
    4- The general condition of the patient was assessed according to the Eastern Cooperative Oncology Group (ECOG) scale <2
    5- Measurable disease according to RECIST 1.1
    6- Confirmed progression according to RECIST 1.1 within the last 6 months in patients, who received at least one line chemotherapy according to the EDP or EDP-M
    7- Adequate function of the marrow and internal organs:
    a.hemoglobin ≥ 9g%, neutrophils> 1500 / mm3, platelets> 100 thousand / mm3
    bilirubin ≤ 2 x upper limit of normal (UNL), Alat, Aspat ≤ 3 x UNL (if liver metastases are present ≤ 5 x UNL)
    c. creatinine clearance> 40 ml / min
    d. coagulation parameters: INR, PT, APTT <1.5 x UNL (exception: patients undergoing anticoagulation therapy, where INR, PT, APTT remain within the therapeutic range recommended for the patient)
    8- For women of reproductive age : confirmed negative pregnancy test result, and the requirement of dual barrier contraception
    9- For men of reproductive age: the requirement of dual barrier contraception
    1- Podpisanie formularza świadomej zgody na udział w badaniu
    2- Wiek powyżej 18 roku życia
    3- Potwierdzony histopatologicznie rak kory nadnercza
    4- Stan ogólny pacjenta oceniony wg skali Eastern Cooperative Oncology Group (ECOG) < 2
    5- Mierzalna choroba wg RECIST 1.1
    6- Potwierdzona progresja wg RECIST 1.1 w ciągu ostatnich 6 miesięcy u pacjentów, którzy otrzymali minimum 1 linię leczenia z zastosowaniem schematu EDP lub EDP-M
    7- Adekwatna funkcja szpiku i narządów wewnętrznych:
    a. hemoglobina ≥ 9g%, neutrofile > 1500 /mm3, płytki krwi > 100 tyś/mm3
    b. bilirubina ≤ 2 x górna granica normy (GGN), Alat, Aspat ≤ 3 x GGN (w przypadku obecności przerzutów do wątroby ≤ 5 x GGN)
    c. klirens kreatyniny > 40ml/min
    parametry krzepnięcia: INR, PT, APTT < 1,5 x GGN (wyjątek: pacjenci w trakcie leczenia antykoagulacyjnego, gdzie INR, PT, APTT pozostają w zakresie wartości terapeutycznych zalecanych dla danego pacjenta)
    8 -W przypadku kobiet w wieku reprodukcyjnym: potwierdzony ujemny wynik testu ciążowego oraz konieczność stosowania podwójnej antykoncepcji barierowej
    9 - W przypadku mężczyzn w wieku reprodukcyjnym: konieczność stosowania podwójnej antykoncepcji barierowej
    E.4Principal exclusion criteria
    1- Pre-treatment with an immune checkpoint inhibitor
    2- Any cancer therapy within the last 7 days (including mitotane)
    3- Persistent side effects of previous anti-cancer therapy in the> G1 stage or after surgical treatment (exception: alopecia)
    4- Immunosuppressive therapy present or conducted within the last 4 weeks
    5- Glucocorticoid therapy in a dose higher than the replacement dose (subject to the permitted use: inhaled or topical steroids, single administration of a steroid, e.g. in case of an allergic reaction to contrast, use of mineralocorticosteroids, steroids in the course of asthma or COPD)
    6- Previous allograft marrow or organ transplant
    7- Current or diagnosed in the last 2 years autoimmune disease with the exception of vitiligo, psoriasis not requiring systemic treatment, autoimmune disease of the thyroid gland
    8- Active or previously documented inflammatory disease of the large intestine
    9- Previous non-infectious pneumonia requiring steroid therapy
    10- Hepatitis B or C
    11- Active tuberculosis
    12- Current active infection requiring systemic treatment
    13- Symptomatic, untreated central nervous system (CNS) metastases (exception: patients with asymptomatic CNS metastases with prior surgery or radiotherapy and no history of intracranial bleeding)
    14- Circulatory failure NYHA ≥3
    15- Corrected QT interval> 500 ms
    16- Significant coexisting disease, including neoplastic, except for basal cell carcinoma of the skin, carcinoma in situ: prostate, cervix, breast
    17- Other significant comorbid disease that, in the investigator's opinion, would pose risks to the patient during therapy
    18- Pregnancy or breastfeeding
    19- Patients requiring dialysis
    20- The patient's inability to meet the requirements specified in the study protocol
    21- Vaccination with live vaccine within 3 months before starting treatment
    1- Poprzedzające leczenie inhibitorem punktów kontroli immunologicznej
    2- Jakakolwiek terapia przeciwnowotworowa w ciągu ostatnich 7 dni ( w tym stosowanie mitotanu)
    3- Utrzymujące się objawy niepożądane poprzednio stosowanej terapii przeciwnowotworowej w stadium > G1 lub po przebytym leczeniu chirurgicznym (wyjątek łysienie)
    4- Obecna lub prowadzona w ciągu ostatnich 4 tygodni terapia immunosupresyjna
    5- Terapia glikokortykosteroidami w dawce wyższej niż substytucyjna (z zastrzeżeniem dopuszczalnego stosowania: steroidy stosowane wziewnie lub miejscowo, jednorazowe podanie steroidu np. w przypadku reakcji alergicznej na kontrast, stosowanie mineralokortykosteroidów, steroidów w przebiegu astmy lub POChP)
    6- Przebyty przeszczep allogeniczny szpiku lub przeszczep narządowy
    7- Obecna lub rozpoznawana w ciągu ostatnich 2 lat choroba autoimmunizacyjna z wyjątkiem bielactwa, łuszczycy niewymagającej leczenia ogólnoustrojowego, choroby autoimmunizacyjnej tarczycy
    8- Aktywna lub poprzednio udokumentowana choroba zapalna jelita grubego
    9- Przebyte nieinfekcyjne zapalenie płuc wymagające steroidoterapii
    10- Wirusowe zapalenie wątroby typu B lub C
    11- Aktywna gruźlica
    12- Obecna aktywna infekcja wymagająca leczenia systemowego
    13- Objawowe, nieleczone przerzuty do OUN (wyjątek: pacjenci z bezobjawowymi przerzutami do OUN, po wcześniejszym leczeniu chirurgicznym lub radioterapii oraz bez epizodu krwawienia wewnątrzczaszkowego w wywiadzie
    14- Niewydolność krążenia NYHA ≥3
    15- Skorygowany odstęp QT > 500 ms
    16- Istotna choroba współistniejąca w tym nowotworowa z wyjątkiem raka podstawnokomórkowego skóry, rak in situ: prostaty, szyjki macicy, piersi
    17- Inna istotna choroba współistniejąca, która w opinii badacza, stanowiłaby zagrożenia dla pacjenta w trakcie terapii
    18- Ciąża lub karmienie piersią
    19- Pacjenci wymagający dializoterapii
    20- Niemożność spełnienia przez pacjenta wymagań określonych w protokole badania
    21- Szczepienie żywą szczepionką w ciągu 3 miesięcy przed rozpoczęciem leczenia
    E.5 End points
    E.5.1Primary end point(s)
    The purpose of the study is to assess response to treatment, defined by the following endpoints:
    - Objective Response Rate –
    percentage of patients who achieved a partial (PR) or complete (CR) response to treatment
    - Progression-Free Survival (PFS) – time from first dose of treatment until disease progression or death from any cause
    - Duration of Response (DoR) – duration of response to treatment (from the start of CR or PR) until disease progression or death from any cause
    - Overall Survival (OS) – time from initiating treatment to death from any cause
    Celem badania jest ocena odpowiedzi na leczenie, definiowana w oparciu o poniższe punkty końcowe:
    - Objective Response Rate (ORR)– procent pacjentów, którzy uzyskali częściową (PR) lub całkowitą (CR) odpowiedź na leczenie
    - Progression-Free Survival (PFS) – czas od otrzymania pierwszej dawki leczenia do progresji choroby lub śmierci z dowolnego powodu
    - Duration of Response (DoR) – czas trwania odpowiedzi na leczenie do progresji choroby lub śmierci z dowolnego powodu
    - Overall Survival (OS) – czas od rozpoczęcia leczenia do śmierci z jakiegokolwiek powodu
    E.5.1.1Timepoint(s) of evaluation of this end point
    will be formally summarized upon completion of the study
    zostanie formalnie podsumowane po zakończeniu badania
    E.5.2Secondary end point(s)
    - Number of Adverse Events and Serious Adverse Events (AE and SAE) related and not related to treatment according to CTCAE
    - Quality of life assessed based on the QLQ-C30 questionnaire
    - Ilość Zdarzeń Niepożądanych i Ciężkich Zdarzeń Niepożądanych (AE i SAE) powiązanych oraz niepowiązanych z leczeniem wg CTCAE
    - Jakość życia oceniana na podstawie kwestionariusza QLQ-C30.
    E.5.2.1Timepoint(s) of evaluation of this end point
    will be formally summarized upon completion of the study
    zostanie formalnie podsumowane po zakończeniu badania
    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 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 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 concerned5
    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 No
    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 (Last Visit Last Subject)
    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 months8
    E.8.9.1In the Member State concerned days19
    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: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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)
    Decisions on anticancer treatment after completion of study treatment will be made by the attending physician in the primary Oncology Center
    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 Decision2022-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-01
    P. End of Trial
    P.End of Trial StatusOngoing
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