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    Summary
    EudraCT Number:2019-004380-40
    Sponsor's Protocol Code Number:CA209-76U
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-17
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-004380-40
    A.3Full title of the trial
    A Phase 1/2 Pharmacokinetic Multi-tumor Study of Subcutaneous
    Formulation of Ipilimumab Monotherapy and in Combination with
    Subcutaneous Nivolumab
    Studio farmacocinetico multitumorale di fase 1/2 della formulazione sottocutanea di ipilimumab in monoterapia e in combinazione con nivolumab per via sottocutanea
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study evaluating the drug levels of ipilimumab given under the skin alone
    and in combination with nivolumab in multiple tumor types
    Studio per valutare i livelli di farmaco di Ipilimumab somministrato per via sottocutanea da solo e in combinazione con nivolumab in tipi di tumore multiplo
    A.3.2Name or abbreviated title of the trial where available
    CheckMate 76U: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 76U
    CheckMate 76U: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 76U)
    A.4.1Sponsor's protocol code numberCA209-76U
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1243-0430
    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 SponsorBRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
    B.1.3.4CountryBelgium
    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 supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointGCT-SU
    B.5.3 Address:
    B.5.3.1Street AddressGCT-SU
    B.5.3.2Town/ cityBraine l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.6E-mailclinical.trials@bms.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 Yes
    D.2.1.1.1Trade name Opdivo (100 mg/10 ml)
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    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 nameNivolumab-10 ml vial-COMMERCIAL
    D.3.2Product code [BMS-936558]
    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 INNNIVOLUMAB
    D.3.9.1CAS number 946414-94-4
    D.3.9.2Current sponsor codeBMS-936558
    D.3.9.3Other descriptive nameBMS936558
    D.3.9.4EV Substance CodeSUB32944
    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 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) 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 Yes
    D.2.1.1.1Trade name Yervoy (200 mg/40 ml)
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    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 nameIpilimumab
    D.3.2Product code [BMS-734016]
    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 INNIPILIMUMAB
    D.3.9.1CAS number 477202-00-9
    D.3.9.2Current sponsor codeBMS-734016
    D.3.9.3Other descriptive nameBMS734016; MDX-010
    D.3.9.4EV Substance CodeSUB22577
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product 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 nameIpilimumab Subcutaneous (administered with or without excipient rHuPH20)
    D.3.2Product code [BMS-734016]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIpilimumab
    D.3.9.1CAS number 477202-00-9
    D.3.9.2Current sponsor codena
    D.3.9.3Other descriptive nameBMS734016
    D.3.9.4EV Substance CodeSUB22577
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product 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
    The study population will include participants diagnosed with metastatic
    melanoma, advanced/metastatic urothelial
    carcinoma (mUC), advanced hepatocellular carcinoma (HCC) in Part 1,
    and metastatic squamous or non-squamous non-small cell lung cancer
    (NSCLC), and metastatic renal cell carcinoma (RCC) in Part 2.
    La popolazione dello studio includerà partecipanti con diagnosi di melanoma metastatico, carcinoma uroteliale metastatico (mUC)/in stadio avanzato, carcinoma epatocellulare (HCC) in stadio avanzato nella Parte 1, carcinoma polmonare non a piccole cellule (NSCLC) squamoso o non squamoso metastatico e carcinoma a cellule renali (RCC) metastatico nella Parte 2.
    E.1.1.1Medical condition in easily understood language
    melanoma (skin cancer) , bladder cancer, liver cancer in Part 1, and lung
    cancer, and renal cancer in Part 2.
    melanoma (tumore della pelle) , tumore della vescica, tumore al fegato nella Parte 1, e tumore al polmone e al rene nella Parte 2.
    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 LLT
    E.1.2Classification code 10027481
    E.1.2Term Metastatic melanoma
    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 LLT
    E.1.2Classification code 10064467
    E.1.2Term Urothelial carcinoma
    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 10073071
    E.1.2Term Hepatocellular carcinoma
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10050513
    E.1.2Term Metastatic renal cell 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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - Part 1 Arm A: To describe the pharmacokinetics of ipilimumab with
    rHuPH20 administered subcutaneously as monotherapy
    -Part 2 Arm A: To describe the pharmacokinetics of ipilimumab with
    rHuPH20 administered subcutaneously in combination with SC
    nivolumab
    -Part 2 Arm B: To describe the pharmacokinetics of ipilimumab
    administered subcutaneously with rHuPH20 in combination with SC
    nivolumab with rHuPH20
    - Parte 1 Braccio A: Descrivere la farmacocinetica di ipilimumab con rHuPH20 somministrato per via sottocutanea in monoterapia
    - Parte 2 Braccio A: Descrivere la farmacocinetica di ipilimumab con rHuPH20 somministrato per via sottocutanea in combinazione con nivolumab SC
    - Parte 2 Braccio B: Descrivere la farmacocinetica di ipilimumab somministrato per via sottocutanea con rHuPH20 in combinazione con nivolumab SC con rHuPH20
    E.2.2Secondary objectives of the trial
    - Part 1 Arm B: To describe the pharmacokinetics of ipilimumab without
    rHuPH20 administered subcutaneously as monotherapy
    - Part 1 Arm A: To assess the safety profile of SC ipilimumab with
    rHuPH20 monotherapy followed by ipilimumab and nivolumab IV
    combination
    - Part 1 Arm B: To assess the safety profile of SC ipilimumab without
    rHuPH20 monotherapy followed by ipilimumab and nivolumab IV
    combination
    - Part 2 Arms A/B: To assess the safety profile of SCipilimumab with
    rHuPH20 in combination with SC nivolumab with rHuPH20
    - Part 1 Arms A/B and Part 2 Arms A/B: To evaluate incidence of AEs in
    the broad standardized MedDRA query (SMQ) of Anaphylactic Reaction
    and the select AE hypersensitivity/injection/infusion reaction category
    - Part 1 Arms A/B: To assess the immunogenicity of SC ipilimumab
    - Part 2 Arms A/B: To assess the immunogenicity of SC ipilimumab and
    SC nivolumab
    - Parte 1 Braccio B: Descrivere la farmacocinetica di ipilimumab senza rHuPH20 somministrato per via sottocutanea in monoterapia
    - Parte 1 Braccio A: Valutare il profilo di sicurezza di ipilimumab SC con rHuPH20 in monoterapia seguito dalla combinazione EV con ipilimumab e nivolumab
    - Parte 1 Braccio B: Valutare il profilo di sicurezza di ipilimumab SC senza rHuPH20 in monoterapia seguito dalla combinazione EV con ipilimumab e nivolumab
    - Parte 2 Bracci A/B: Valutare il profilo di sicurezza di ipilimumab SC con rHuPH20 in combinazione con nivolumab SC con rHuPH20
    - Parte 1 Bracci A/B e Parte 2 Bracci A/B: Valutare l’incidenza di EA nell’ambito della ricerca MedDRA ampia standardizzata (SMQ) di reazione anafilattica, nonché nella categoria selezionata di EA del tipo ipersensibilità/reazione da iniezione/infusione
    - Parte 1 Bracci A/B: Valutare l’immunogenicità di ipilimumab SC
    - Parte 2 Bracci A/B: Valutare l’immunogenicità di ipilimumab SC e nivolumab SC
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Pharmacogenetics
    Version: : Protocollo iniziale
    Date: 21/11/2019
    Title: A Phase 1/2 Pharmacokinetic Multi-tumor Study of Subcutaneous Formulation of Ipilimumab Monotherapy and in Combination with Subcutaneous Nivolumab
    Objectives: See section 9.8.1.5 of the protocol: Additional Research Collection

    Pharmacogenomics
    Version: Protocollo iniziale
    Date: 21/11/2019
    Title: A Phase 1/2 Pharmacokinetic Multi-tumor Study of Subcutaneous Formulation of Ipilimumab Monotherapy and in Combination with Subcutaneous Nivolumab
    Objectives: See section 9.8.1.5 of the protocol: Additional Research Collection

    Farmacogenetica
    Versione: : Protocollo iniziale
    Data: 21/11/2019
    Titolo: Studio farmacocinetico multitumorale di fase 1/2 della formulazione sottocutanea di ipilimumab in monoterapia e in combinazione con nivolumab per via sottocutanea – si veda la sezione 9.8.1.5 Additional Research Collection
    Obiettivi: si veda la sezione 9.8.1.5 Additional Research Collection

    Farmacogenomica
    Versione: Protocollo iniziale
    Data: 21/11/2019
    Titolo: Studio farmacocinetico multitumorale di fase 1/2 della formulazione sottocutanea di ipilimumab in monoterapia e in combinazione con nivolumab per via sottocutanea – si veda la sezione 9.8.1.5 Additional Research Collection
    Obiettivi: si veda la sezione 9.8.1.5 Additional Research Collection
    E.3Principal inclusion criteria
    -Men and women must follow methods of contraception as described in
    the protocol
    Part 1 Arms A and B: Metastatic Melanoma
    - Previously untreated, histologically confirmed stage IV melanoma, as
    per American Joint Committee on Cancer (AJCC) staging system v.8.0
    Part 1 Arm A:Advanced/mUC
    - Participants with histologically or cytologically confirmed urothelial
    carcinoma
    Part 1 Arm A: Advanced HCC
    -Participants with histological confirmation of Hepatocellular Cancer
    (HCC)
    Part 2 Arm A: Metastatic NSCLC
    -Participants with histologically confirmed stage IV or recurrent Non
    Small Cell Lung Cancer (NSCLC)
    Part 2 Arm B: Advanced or Metastatic RCC
    - Histological confirmation of Renal Cell Carcinoma (RCC)
    -ECOG Performance Status of 0 or 1 and for RCC (Part 2 Arm B),
    Karnofsky performance status >= 70%
    - Uomini e donne devono seguire i metodi di contraccezione descritti nel protocollo

    Parte 1, Bracci A e B: melanoma metastatico
    - Melanoma allo stadio IV istologicamente confermato precedentemente non trattato, secondo il sistema di stadiazione della Commissione americana congiunta sui tumori (American Joint Committee on Cancer, AJCC), v.8.0

    Parte 1 Braccio A: mUC/avanzato
    - Partecipanti con carcinoma uroteliale confermato istologicamente o citologicamente

    Parte 1 Braccio A: HCC in stadio avanzato
    - Partecipanti con carcinoma epatocellulare confermato istologicamente (HCC)

    Parte 2 Braccio A: NSCLC metastatico
    - Partecipanti affetti da carcinoma polmonare non a piccole cellule (NSCLC) di stadio IV o ricorrente istologicamente confermato

    Parte 2 Braccio B: RCC avanzato o metastatico
    - Conferma istologica di carcinoma a cellule renali (RCC)
    - ECOG performance status di 0 o 1 e per RCC (Parte 2 Braccio B), Karnofsky performance status >= 70%
    E.4Principal exclusion criteria
    - History of allergy or hypersensitivity to study drug components
    Part 1 Arm A: Advanced HCC
    - History of hepatic encephalopathy or evidence of portal hypertension
    - Active co-infection with hepatitis D virus infection in participants with
    HBV
    Part 2 Arm A:Metastatic NSCLC
    -Participants with known ALK translocations and EGFR mutation that are sensitive to available targeted inhibitor therapy
    - Storia di Allergia o ipersensibilità ai componenti del farmaco in studio

    Parte 1 Braccio A: HCC in stadio avanzato
    - Storia di encefalopatia epatica o evidenza di ipertensione portale
    - Infezione concomitante attiva da virus dell’epatite D nei partecipanti con HBV

    Parte 2 Braccio A: NSCLC metastatico
    - Partecipanti con traslocazioni note ALK e mutazione EGFR che sono sensibili alla terapia mirata con inibitori disponibile
    E.5 End points
    E.5.1Primary end point(s)
    1) Part 1 Arm A: Average concentration of ipilimumab (Cavg21d)
    2) Part 1 Arm A: Area under the concentration in ipilimumab AUC(0-21d)
    3) Part 1 Arm A: Maximum observed serum concentration of ipilimumab
    (Cmax)
    4) Part 1 Arm A: Observed concentration of ipilimumab (C21d)
    5) Part 1 Arm A: Time of maximum observed concentration in ipilimumab
    (Tmax)
    6) Part 2 Arm A: Average concentration in ipilimumab (Cavg42d)
    7) Part 2 Arm A: Area under the concentration in ipilimumab AUC(0-42d)
    8) Part 2 Arm A: Maximum observed serum Concentration of Ipilimumab
    (Cmax)
    9) Part 2 Arm A: Observed concentration in ipilimumab (C42d)
    10) Part 2 Arm A: Time of maximum observed concentration in
    ipilimumab (Tmax)
    11) Part 2 Arm B: Average concentration of Ipilimumab (Cavg21d)
    12) Part 2 Arm B: Area Under the Concentration in Ipilimumab AUC(0-
    21d)
    13) Part 2 Arm B: Maximum observed serum Concentration in
    Ipilimumab (Cmax)
    14) Part 2 Arm B: Observed concentration of ipilimumab (C21d)
    15) Part 2 Arm B: Time of maximum observed concentration in
    Ipilimumab (Tmax)
    1) Parte 1 Braccio A: concentrazione media di ipilimumab (Cavg21d)
    2) Parte 1 Braccio A: area sotto la concentrazione in ipilimumab AUC (0-21d)
    3) Parte 1 Braccio A: concentrazione sierica massima osservata di ipilimumab (Cmax)
    4) Parte 1 Braccio A: concentrazione osservata di ipilimumab (C21d)
    5) Parte 1 Braccio A: tempo di massima concentrazione osservata in ipilimumab (Tmax)
    6) Parte 2 Braccio A: concentrazione media in ipilimumab (Cavg42d)
    7) Parte 2 Braccio A: area sotto la concentrazione in AUC di ipilimumab (0-42 d)
    8) Parte 2 Braccio A: Concentrazione sierica massima osservata di Ipilimumab (Cmax)
    9) Parte 2 Braccio A: concentrazione osservata in ipilimumab (C42d)
    10) Parte 2 Braccio A: tempo di massima concentrazione osservata in
    ipilimumab (Tmax)
    11) Parte 2 Braccio B: concentrazione media di Ipilimumab (Cavg21d)
    12) Parte 2 Braccio B: Area sotto la concentrazione nell'AUC di Ipilimumab (0-
    21d)
    13) Parte 2 Braccio B: Concentrazione sierica massima osservata in
    Ipilimumab (Cmax)
    14) Parte 2 Braccio B: concentrazione osservata di ipilimumab (C21d)
    15) Parte 2 Braccio B: tempo di massima concentrazione osservata in
    Ipilimumab (Tmax)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) Giorno 21
    2) Giorno 21
    3) Fino a 21 giorni
    4) Giorno 21
    5) Fino a 21 giorni
    6) Giorno 42
    7) Giorno 42
    8) Fino a 42 giorni
    9) Giorno 42
    10) Fino a 42 giorni
    11) Giorno 21
    12) Giorno 21
    13) Fino a 21 giorni
    14) Giorno 21
    15) Fino a 21 giorni
    1) Day 21
    2) Day 21
    3) Up to 21 days
    4) Day 21
    5) Up to 21 days
    6) Day 42
    7) Day 42
    8) Up to 42 days
    9) Day 42
    10) Up to 42 days
    11) Day 21
    12) Day 21
    13) Up to 21 days
    14) Day 21
    15) Up to 21 days
    E.5.2Secondary end point(s)
    1) Part 1 Arm B: Average concentration of ipilimumab without rHuPH20
    (Cavg21d)
    2) Part 1 Arm B: Area under the concentration in ipilimumab without
    rHuPH20 AUC(0-21d)
    3) Part 1 Arm B: Maximum observed serum concentration of ipilimumab
    without rHuPH20 (Cmax)
    4) Part 1 Arm B: Observed concentration of ipilimumab without rHuPH20
    (C21d)
    5) Part 1 Arm B: Time of maximum observed concentration in ipilimumab
    without rHuPH20 (Tmax)
    6) Incidence of adverse events (AE's)
    7) Incidence of serious adverse events (SAEs)
    8) Incidence of AE's leading to discontinuation
    9) Incidence of death
    10) Incidence of laboratory abnormalities
    11) Instance of Anaphylactic occurring within 2 days of study drug
    administration
    12) Instance of hypersensitivity occurring within 2 days of study drug
    administration
    13) Incidence of hypersensitivity occurring within 2 days of study drug
    administration
    14) Incidence of infusion reactions occurring within 2 days of study drug
    administration
    15) Incidence of injection occurring within 2 days of study drug
    administration
    16) Percentage of participants who develop anti-ipilimumab antibodies
    17) Percentage of participants who develop anti-nivolumab antibodies
    18) Percentage of participants who have developed neutralizing
    antibodies
    1. Parte 1 Braccio B: concentrazione media di ipilimumab senza rHuPH20 (Cavg21d)
    2. Parte 1 Braccio B: area sotto la concentrazione in ipilimumab senza rHuPH20 AUC (0-21d)
    3. Parte 1 Braccio B: concentrazione sierica massima osservata di ipilimumab senza rHuPH20 (Cmax)
    4. Parte 1 Braccio B: concentrazione osservata di ipilimumab senza rHuPH20 (C21d)
    5. Parte 1 Braccio B: tempo di massima concentrazione osservata in ipilimumab senza rHuPH20 (Tmax)
    6. Incidenza di eventi avversi (eventi avversi)
    7. Incidenza di eventi avversi seri (SAE)
    8. Incidenza di AE che determinano interruzione
    9. Incidenza dei decessi
    10. Incidenza di anomalie di laboratorio
    11. Casi di reazioni anafilattiche che si verificano entro 2 giorni dalla somministrazione del farmaco in studio
    12. Casi di reazioni di ipersensibilità che si verificano entro 2 giorni dalla somministrazione del farmaco in studio
    13. Incidenza di ipersensibilità che si verifica entro 2 giorni dal farmaco in studio amministrazione
    14. Incidenza delle reazioni all'infusione che si verificano entro 2 giorni dalla somministrazione del farmaco in studio
    15. Incidenza dell'iniezione che si verifica entro 2 giorni dalla somministrazione del farmaco in studio
    16. Percentuale di partecipanti che sviluppano anticorpi anti-ipilimumab
    17. Percentuale di partecipanti che sviluppano anticorpi anti-nivolumab
    18. Percentuale di partecipanti che hanno sviluppato una neutralizzazione anticorpi
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Day 21
    2) Day 21
    3) Up to 21 days
    4) Day 21
    5) Up to 21 days
    6) Up to 2.5 years
    7) Up to 5 years
    8) Up to 2.5 years
    9) Up to 2.5 years
    10) Up to 2.5 years
    11) Up to 2.5 years
    12) Up to 2.5 years
    13) Up to 2.5 years
    14) Up to 2.5 years
    15) Up to 2.5 years
    16) Up to 2.5 years
    17) Up to 2.5 years
    18) Up to 2.5 years
    1. Giorno 21
    2. Giorno 21
    3. Fino a 21 giorni
    4. Giorno 21
    5. Fino a 21 giorni
    6. Fino a 2,5 anni
    7. Fino a 5 anni
    8. Fino a 2,5 anni
    9. Fino a 2,5 anni
    10. Fino a 2,5 anni
    11. Fino a 2,5 anni
    12. Fino a 2,5 anni
    13. Fino a 2,5 anni
    14. Fino a 2,5 anni
    15. Fino a 2,5 anni
    16. Fino a 2,5 anni
    17. Fino a 2,5 anni
    18. Fino a 2,5 anni
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Patient Experience and Preference Questionnaire
    Questionario sull'esperienza e sulle preferenze del paziente
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    pharmacokinetics, safety, and tolerability of Ipi SC with or without rhuPh20 alone or with nivo SC
    Farmacocinetica, sicurezza e tollerabilità di Ipi SC con o senza rhuPh20 da solo o con nivo SC
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    In aperto
    open
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    New Zealand
    United States
    France
    Italy
    Netherlands
    United Kingdom
    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
    End of trial is defined as last visit or scheduled procedure shown in the
    Schedule of Activities for the last participant
    ongoing on study (=last survival follow-up visit of the last participant)
    La fine della sperimentazione è definita come l’ultima visita o procedura programmata indicata nella schedula delle attività per l'ultimo partecipante in corso nello studio (= ultima visita di follow-up di sopravvivenza dell'ultimo partecipante)
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    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: 65
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects/participants unable to give their written consent may only be
    enrolled in the study with the consent of a legally acceptable
    representative. See Appendix 2 of the protocol.
    I soggetti/partecipanti incapaci di dare il loro consenso scritto possono essere arruolati nello studio con il consenso di un rappresentante legale accettabile. Si veda l'appendice 2 del protocollo.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 44
    F.4.2.2In the whole clinical trial 81
    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)
    At study end, participants who continue to show clinical benefit will be
    eligible to receive BMS-supplied study treatment for a maximum total
    duration of 104 weeks from the start of study drug administration
    (Section 7.1). Study treatment will be provided via an extension of the
    study, a rollover study requiring approval by responsible health
    authority and Ethics Committee or through another mechanism at the
    discretion of BMS. See section 7.8 of the protocol
    A fine studio, i partecipanti che continuano a mostrare beneficio clinico saranno elegibili a ricevere il farmaco di studio fornito da BMS per una durata massima tot. di 104 settimane dall'inizio della somministrazione del farmaco in studio (Sez. 7.1). Il farmaco di studio sarà fornito tramite un'estensione dello studio, uno studio di rollover dopo approvazione dell’autorità competente e del comitato etico o attraverso un altro meccanismo a discrezione di BMS. Si veda la sez. 7.8 del protocollo.
    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 Decision2020-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-20
    P. End of Trial
    P.End of Trial StatusOngoing
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