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    Summary
    EudraCT Number:2015-003589-10
    Sponsor's Protocol Code Number:D419LC00001
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-01-13
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2015-003589-10
    A.3Full title of the trial
    A Phase III Randomized, Open-label, Multi-center, Global Study of MEDI4736 Alone or in Combination with Tremelimumab versus Standard of Care in the Treatment of First-line Recurrent or Metastatic Squamous Cell Head and Neck Cancer Patients
    Randomizowane, wieloośrodkowe o zasięgu światowym, prowadzone metodą otwartej próby badanie fazy III MEDI4736 w monoterapii lub w połączeniu z Tremelimumabem w porównaniu do leczenia standardowego pierwszego rzutu wznowy lub przerzutów komórek raka płaskonabłonkowego głowy i szyi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of First Line MEDI4736 with or without Tremelimumab Versus standard of
    care chemotherapy in Recurrent or Metastatic Head and Neck cancer
    Badanie leczenia z zastosowaniem MEDI4736 z lub bez Tremelimumabu w porównaniu do leczenia standardowego pierwszego rzutu chemioterapii wznowy lub przerzutów raka głowy i szyi
    A.3.2Name or abbreviated title of the trial where available
    KESTREL
    A.4.1Sponsor's protocol code numberD419LC00001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02551159
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointClinical Trial Transparency
    B.5.3 Address:
    B.5.3.1Street AddressKarlebyhus, Astraallén
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post codeSE 151 85
    B.5.3.4CountrySweden
    B.5.6E-mailClinicalTrialTransparency@astrazeneca.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 nameMEDI4736
    D.3.2Product code MEDI4736
    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 INNdurvalumab
    D.3.9.1CAS number 1428935-60-7
    D.3.9.2Current sponsor codeMEDI4736
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 nametremelimumab
    D.3.2Product code MEDI1123
    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 INNTremelimumab
    D.3.9.1CAS number 745013-19-6
    D.3.9.2Current sponsor codeMEDI1123
    D.3.9.3Other descriptive nameMEDI1123
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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 RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Erbitux
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Europe 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 namecetuximab
    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 INNCetuximab
    D.3.9.1CAS number 205923-56-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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: 4
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The 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 nameCarboplatin
    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 INNCarboplatin
    D.3.9.1CAS number 41575-94-4
    D.3.9.3Other descriptive nameCARBOPLATIN
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 5
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The 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 name5-fluorouracil (5FU)
    D.3.4Pharmaceutical form Solution for injection/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 INNFLUOROURACIL
    D.3.9.1CAS number 54-21-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 6
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The 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 nameCisplatin
    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 INNCisplatin
    D.3.9.1CAS number 15663-27-1
    D.3.9.3Other descriptive nameCISPLATIN
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) who have not received prior systemic chemotherapy.
    Nawracający lub przerzutowy płaskonabłonkowy rak głowy i szyi u
    dorosłych pacjentów, u których nie stosowano wcześniejszego leczenia
    E.1.1.1Medical condition in easily understood language
    Specific type of cancer of head and neck called "squamous cell carcinoma of the head and neck" (SCCHN)
    Określony typ raka głowy i szyi nazywany „płaskonabłonkowym rakiem
    głowy i szyi "SCCHN"
    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 PT
    E.1.2Classification code 10067821
    E.1.2Term Head and neck cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 the efficacy of MEDI4736 monotherapy versus SoC (EXTREME)
    in PD-L1 TC/IC high subgroup in terms of OS.
    Ocena skuteczności stosowania MEDI4736 w monoterapii względem postępowania standardowego (SoC) w schemacie EXTREME u pacjentów w podgrupie o wysokiej ekspresji PD-L1 TC/IC (pacjenci, u których ekspresja białka PD-L1 występuje na powierzchni ≥50% komórek rakowych lub ≥25% komórek układu odpornościowego infiltrujących nowotwór) w odniesieniu do przeżycia całkowitego (OS).
    E.2.2Secondary objectives of the trial
    Assess efficacy of MEDI4736 monotherapy compared to SoC in terms of
    OS, PFS, ORR, DoR, BoR, TTR, TFST, TSST, APF6, APF12, PFS2, OS12,
    OS18 & OS24
    Assess efficacy of MEDI4736 +tremelimumab combination therapy
    compared to SoC in terms of OS, PFS, ORR, DoR, BoR, TTR, TFST, TSST,
    APF6, APF12, PFS2, OS12, OS18 & OS24
    Assess efficacy of MEDI4736+ tremelimumab combination therapy
    compared to MEDI4736 monotherapy in terms of PFS, ORR & OS
    Assess disease-related symptoms and health-related quality of life in
    patients treated with MEDI4736 + tremelimumab combination therapy
    and MEDI4736 monotherapy compared to SoC using the EORTC 30-item
    Core QLQ-C30 & QLQ H&N35 modules
    Assess PK of MEDI4736 + tremelimumab combination therapy &
    MEDI4736 monotherapy
    Investigate immunogenicity of MEDI4736 & tremelimumab
    Assess safety & tolerability profile of MEDI4736 + tremelimumab
    combination therapy & MEDI4736 monotherapy compared to SoC in the
    first-line setting for treatment of SCCHN
    Ocena skuteczności monoterapii MEDI4736 vs SoC na podstawie: OS, PFS, ORR, DoR, BoR, TTR, TFST, TSS, APF6, APF12, PFS2, OS12, OS18, OS24

    Ocena skuteczności monoterapii MEDI4736 vs SoC na podstawie: PFS, ORR, DoR, BoR, TTR, TFST, TSST, APF5, APF12, PFS2, OS, OS12, OS18 i OS24

    Ocena skuteczności MEDI4736 w skojarzeniu z tremelimumabem vs monoterapii MEDI4736 na podstawie PFS, ORR, OS

    Ocena objawów związanych z chorobą i jakości życia pacjentów otrzymujących MEDI4736 w skojarzeniu z tremelimumabem i monoterapii MEDI476 vs SoC wg 30-elementowy kwestionariusz oceny jakości życia (Core QLQ-C30) i 35-elementowy kwestionariusz jakość życia pacjentów z nowotworami głowy i szyi (moduł QLQ-H&N35)

    Ocena PK MEDI4736 stosowanego w skojarzeniu z tremelimumabem i monoterapii MEDI4736

    Ocena immunogenności MEDI4736 i tremelimumabu;

    Ocena profilu bezpieczeństwa i tolerancji MEDI4736 w skojarzeniu z tremelimumabem i monoterapii MEDI4736 vs SoC w terapii I linii SCCHN
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥18 years at the time of screening
    2. Documented evidence of recurrent or metastatic SCCHN (oral cavity, oropharynx, hypopharynx, or larynx) ).
    3. A fresh tumor biopsy for the purpose of screening or an available archival tumor sample.
    4. No prior systemic therapy for recurrent/metastatic disease. Systemic therapy given as part of multimodality treatment for locally advanced or locally recurrent disease is allowed.
    5. World Health Organization (WHO)/ECOG performance status of 0 or 1 at enrollment
    6. No prior exposure to immune-mediated therapy
    1.Wiek ≥18 lat podczas oceny przesiewowej
    2.Potwierdzony nawrotowy lub przerzutowy SCCHN (jama ustna, ustna część gardła, krtaniowa część gardła lub krtań)
    3.Wykonanie biopsji guza dla potrzeb oceny przesiewowej dla tego badania klinicznego lub dostarczenia archiwalnej próbki tkanki guza
    4.Brak wcześniejszego leczenia układowego z powodu nawrotowego SCCHN lub SCCHN z przerzutami. Terapia układowa podawana jako składowa multimodalnego leczenia lokalnie zaawansowanej lub nawracającej choroby, jest dozwolona.
    5.Stan sprawności w momencie włączenia do badania wynoszący 0 lub 1 według Światowej Organizacji Zdrowia (WHO)/ECOG
    6.Pacjenci nie mogą być wcześniej poddani terapii immunologicznej
    E.4Principal exclusion criteria
    1. Histologically or cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including patients with SCCHN of unknown primary or non-squamous histologies (eg, nasopharynx or salivary gland)
    2. Tumor progression or recurrence within 6 months of last dose of platinum therapy in the primary treatment setting
    3. Receipt of any radiotherapy or hormonal therapy for cancer treatment within 30 days prior to first dose of study treatment
    4. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis, Crohn’s disease], diverticulitis
    1.Histologicznie lub cytologicznie potwierdzony rak głowy i szyi o jakiejkolwiek innej pierwotnej anatomicznej lokalizacji w głowie lub szyi nie wymieniony w kryteriach włączenia chorych z SCCHN o nieznanej pierwotnej lub niepłaskonabłonkowej histologii (np.: jama nosowo-gardłowa, gruczoł ślinowy)
    2.Progresja guza lub nawrót w okresie 6 miesięcy od podania ostatniej dawki platyny w leczeniu pierwotnym
    3.Przebyte radioterapia lub leczenie hormonalne raka w okresie 30 dni poprzedzających podanie pierwszej dawki leczenia badanego
    4.Aktywna lub udokumentowana wcześniej choroba autoimmunologiczna lub zapalna (w tym choroba zapalna jelita [np. zapalenie jelita grubego, choroba Leśniowskiego-Crohna], zapalenie uchyłków
    E.5 End points
    E.5.1Primary end point(s)
    OS in the PD-L1 TC/IC subgroup
    OS w populacji PD-l1 TC/IC
    E.5.1.1Timepoint(s) of evaluation of this end point
    Assessments for survival must be made every 3 months following
    treatment discontinuation and/or upon disease progression.
    Ocena pod kątem przeżycia musi być dokonywana co 3 miesiące po zakończeniu leczenia i/lub od wystąpieniu progresji.
    E.5.2Secondary end point(s)
    OS in low risk of early mortality (EM) subgroup, ctDNA TMB high
    subgroup and all-comers
    OS12, OS18, OS24 in the PD-L1 TC/IC subgroup, low risk of EM
    subgroup, and ctDNA TMB high subgroup and all-comers
    PFS, ORR, APF6 and APF12 in the PD-L1 TC/IC subgroup, low risk of EM
    subgroup, ctDNA TMB high subgroup and all-comers using site
    investigator assessments according to RECIST 1.1
    DoR, BoR and TTR using site investigator assessments according to
    RECIST 1.1 in the PD-L1 TC/IC subgroup and all-comers
    PFS2 using local standard clinical practice in the PD-L1 TC/IC subgroup
    and all-comers
    TFST and TSST in the PD-L1 TC/IC subgroup and all-comers
    EORTC QLQ-C30 - global health QoL, functioning (physical) and
    symptoms (fatigue) in the PD-L1 TC/IC subgroup and all-comers
    EORTC QLQ-H&N35 - symptoms (pain, swallowing) in the PD-L1 TC/IC
    subgroup and all-comers
    Changes in World Health Organization/Eastern Cooperative Oncology
    Group performance status in the PD-L1 TC/IC subgroup and all-comers
    Concentration of MEDI4736 and tremelimumab in blood and PK
    parameters, such as peak concentration and trough
    Presence of ADAs for MEDI4736 and tremelimumab
    OS w podgrupie o niskim ryzyku wczesnej śmiertelności (early mortality, EM), u pacjentów w podgrupie wysokiego obciążenia mutacją guza ctDNA (TMB) i u wszystkich uczestników

    OS12, OS18 i OS24 w podgrupie PD-L1 TC/IC, w podgrupie o niskim ryzyku EM, podgrupie wysokiego obciążenia ctDNA TMB i u wszystkich uczestników

    PFS, ORR, APF6 i APF12 w podgrupie PD-L1 TC/IC, w podgrupie o niskim ryzyku EM, podgrupie wysokiego obciążenia ctDNA TMB i u wszystkich uczestników według oceny badacza na podstawie kryteriów RECIST 1.1;

    DoR, BoR i TTR według oceny badacza na podstawie kryteriów RECIST 1.1 w podgrupie PD-L1 TC/IC i u wszystkich uczestników;

    PFS2 w oparciu o standardową, lokalną praktykę kliniczną w podgrupie PD-L1 TC/IC i u wszystkich uczestników;

    TFST i TSS w podgrupie PD-L1 TC/IC i u wszystkich uczestników;

    Kwestionariusz EORTC QLQ C30 – ogólny stan zdrowia związny z jakością życia, wydolnością (fizyczną) i objawami (zmęczenie) w podgrupie PD-L1 TC/IC i u wszystkich uczestników;

    Kwestionariusz EORTC QLQ-H&N35 – objawy (ból, problemy z przełykaniem w podgrupie PD-L1 TC/IC i u wszystkich uczestników;

    Zmiany w stanie sprawności wg Światowej Organizacji Zdrowia (WHO)/ Wschodniej Grupy Współpracy Onkologicznej (Eastern Cooperative Oncology Group) w podgrupie PD-L1 TC/IC i u wszystkich uczestników;

    Stężenie MEDI4736 i tremelimumabu we krwi i parametry farmakokinetyczne, takie jak maksymalne i minimalne stężenie;

    Obecność ADA dla MEDI4736 i tremelimumabu.
    E.5.2.1Timepoint(s) of evaluation of this end point
    PFS - At baseline, after that every 6 weeks for the first 24 weeks relative to
    the date of randomization, and then every 8 weeks until progression.
    Assessments for survival must be made every 3 months following treatment
    discontinuation and/or upon disease progression.
    EORTC QLQ-C30- Every 8 weeks (±3 days) relative to the date of Cycle 1 Day 1
    EORTC QLQ-H&N35-Every 4 weeks (±3 days) relative to the date of Cycle 1 Day 1
    WHO/ECOG Every cycle until PD
    MEDI4736 and tremelimumab PK - Cycles 1, 2, 4 and 7
    ADAs for MEDI4736 and tremelimumab - Cycles 1, 4 and 7
    PFS – dane wyjściowe następnie, co 6 tygodni przez pierwsze 24 tygodnie zależnie od daty randomizacji, i następnie co 8 tygodni aż do wystąpienia progresji;
    Ocena pod kątem przeżycia musi być przeprowadzana co 3 miesiące po zakończeniu leczenia i/lub wystąpieniu progresji choroby;
    EORTC QLQ C30 - co 8 tygodni (± 3 dni) począwszy od daty pierwszego dnia
    Cyklu 1;
    EORTC QLQ-H&N35 - co 4 tygodnie (± 3 dni) począwszy od daty pierwszego dnia Cyklu 1;
    (WHO/ECOG) Zmiany w stanie sprawności wg Światowej Organizacji Zdrowia (WHO)/ Wschodniej Grupy Współpracy Onkologicznej (Eastern Cooperative Oncology Group) – przy każdym cyklu aż do wystąpienia progresji;
    Ocena PK MEDI4736 i tremelimumabu – cykle 1, 2, 4 i 7;
    Obecność ADA dla MEDI4736 i tremelimumabu – cykle 1, 4 i 7.
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Cetuksymab + Platyna (cysplatyna lub karboplatyna) + 5FU
    Cetuximab + Platinum (Cisplatin or Carboplatin) + 5FU
    E.8.2.4Number of treatment arms in the trial3
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA131
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belgium
    Brazil
    Bulgaria
    Canada
    France
    Germany
    Greece
    India
    Italy
    Japan
    Korea, Democratic People's Republic of
    Philippines
    Poland
    Portugal
    Romania
    Russian Federation
    Slovakia
    Spain
    Taiwan
    Thailand
    Ukraine
    United Kingdom
    United States
    Vietnam
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    „LVLS” (Last Visit Last Subject)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    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: 456
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 304
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 425
    F.4.2.2In the whole clinical trial 760
    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)
    After end of treatment with study drug, patients should be managed according to local standard of care.
    Po zakończeniu leczenia badanymi produktami, pacjenci powinni zostać
    objęci leczeniem zgodnie z lokalnym standardem opieki.
    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 Decision2016-01-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-04
    P. End of Trial
    P.End of Trial StatusCompleted
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