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37000

Beschreibung

Phase II Study of MEDI4736 Monotherapy in Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck; ODM derived from: https://clinicaltrials.gov/show/NCT02207530

Link

https://clinicaltrials.gov/show/NCT02207530

Stichworte

Versionen (1)
  1. 27.06.19 27.06.19 -
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See clinicaltrials.gov

Hochgeladen am

27. Juni 2019

DOI

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    Eligibility Recurrent or Metastatic PD-L1-positive Squamous Cell Carcinoma of the Head and Neck (SCCHN) NCT02207530

    Englisch

    Eligibility Recurrent or Metastatic PD-L1-positive Squamous Cell Carcinoma of the Head and Neck (SCCHN) NCT02207530

    1 Formulare  
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    age ≥18 years;
    Beschreibung

    Age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    written informed consent obtained from the patient/legal representative;
    Beschreibung

    Informed Consent | Informed Consent Patient Representative

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    UMLS CUI [2,1]
    C0021430
    UMLS CUI [2,2]
    C0030701
    histologically confirmed recurrent or metastatic scchn;
    Beschreibung

    Recurrent Head and Neck Squamous Cell Carcinoma | Metastatic Head and Neck Squamous Cell Carcinoma

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C4524839
    UMLS CUI [2]
    C0744620
    confirmed pd-l1-positive scchn by a specified ihc assay;
    Beschreibung

    Squamous cell carcinoma of the head and neck PD-L1 Positive Immunohistochemistry

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1168401
    UMLS CUI [1,2]
    C4284303
    UMLS CUI [1,3]
    C0021044
    tumor progression or recurrence during or after treatment with one systemic regimen for recurrent or metastatic disease that must have contained a platinum agent;
    Beschreibung

    Tumor Progression | Recurrent tumor | Systemic therapy Containing Platinum | Recurrent disease | Neoplasm Metastasis

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0178874
    UMLS CUI [2]
    C0521158
    UMLS CUI [3,1]
    C1515119
    UMLS CUI [3,2]
    C0332256
    UMLS CUI [3,3]
    C0032207
    UMLS CUI [4]
    C0277556
    UMLS CUI [5]
    C0027627
    who performance status of 0 or 1;
    Beschreibung

    WHO performance status scale

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1298650
    at least 1 measurable lesion at baseline
    Beschreibung

    Measurable lesion Quantity

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1513041
    UMLS CUI [1,2]
    C1265611
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    any concurrent chemotherapy, ip, biologic, or hormonal therapy for cancer treatment;
    Beschreibung

    Chemotherapy | Therapies, Investigational | Biological treatment | Hormone Therapy | Cancer treatment

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    UMLS CUI [2]
    C0949266
    UMLS CUI [3]
    C1531518
    UMLS CUI [4]
    C0279025
    UMLS CUI [5]
    C0920425
    major surgical procedure within 28 days prior to the first dose of ip;
    Beschreibung

    Major surgery

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0679637
    non-squamous histologies;
    Beschreibung

    Non-squamous cell Histology

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1545484
    UMLS CUI [1,2]
    C0344441
    history of active primary immunodeficiency;
    Beschreibung

    Primary immunodeficiency

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0398686
    active or prior documented autoimmune or inflammatory disorders
    Beschreibung

    Autoimmune Disease | Inflammatory disorder

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0004364
    UMLS CUI [2]
    C1290884
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility Recurrent or Metastatic PD-L1-positive Squamous Cell Carcinoma of the Head and Neck (SCCHN) NCT02207530

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    age ≥18 years;
    boolean
    C0001779 (UMLS CUI [1])
    Informed Consent | Informed Consent Patient Representative
    Item
    written informed consent obtained from the patient/legal representative;
    boolean
    C0021430 (UMLS CUI [1])
    C0021430 (UMLS CUI [2,1])
    C0030701 (UMLS CUI [2,2])
    Recurrent Head and Neck Squamous Cell Carcinoma | Metastatic Head and Neck Squamous Cell Carcinoma
    Item
    histologically confirmed recurrent or metastatic scchn;
    boolean
    C4524839 (UMLS CUI [1])
    C0744620 (UMLS CUI [2])
    Squamous cell carcinoma of the head and neck PD-L1 Positive Immunohistochemistry
    Item
    confirmed pd-l1-positive scchn by a specified ihc assay;
    boolean
    C1168401 (UMLS CUI [1,1])
    C4284303 (UMLS CUI [1,2])
    C0021044 (UMLS CUI [1,3])
    Tumor Progression | Recurrent tumor | Systemic therapy Containing Platinum | Recurrent disease | Neoplasm Metastasis
    Item
    tumor progression or recurrence during or after treatment with one systemic regimen for recurrent or metastatic disease that must have contained a platinum agent;
    boolean
    C0178874 (UMLS CUI [1])
    C0521158 (UMLS CUI [2])
    C1515119 (UMLS CUI [3,1])
    C0332256 (UMLS CUI [3,2])
    C0032207 (UMLS CUI [3,3])
    C0277556 (UMLS CUI [4])
    C0027627 (UMLS CUI [5])
    WHO performance status scale
    Item
    who performance status of 0 or 1;
    boolean
    C1298650 (UMLS CUI [1])
    Measurable lesion Quantity
    Item
    at least 1 measurable lesion at baseline
    boolean
    C1513041 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    Chemotherapy | Therapies, Investigational | Biological treatment | Hormone Therapy | Cancer treatment
    Item
    any concurrent chemotherapy, ip, biologic, or hormonal therapy for cancer treatment;
    boolean
    C0392920 (UMLS CUI [1])
    C0949266 (UMLS CUI [2])
    C1531518 (UMLS CUI [3])
    C0279025 (UMLS CUI [4])
    C0920425 (UMLS CUI [5])
    Major surgery
    Item
    major surgical procedure within 28 days prior to the first dose of ip;
    boolean
    C0679637 (UMLS CUI [1])
    Non-squamous cell Histology
    Item
    non-squamous histologies;
    boolean
    C1545484 (UMLS CUI [1,1])
    C0344441 (UMLS CUI [1,2])
    Primary immunodeficiency
    Item
    history of active primary immunodeficiency;
    boolean
    C0398686 (UMLS CUI [1])
    Autoimmune Disease | Inflammatory disorder
    Item
    active or prior documented autoimmune or inflammatory disorders
    boolean
    C0004364 (UMLS CUI [1])
    C1290884 (UMLS CUI [2])
    Zum Seitenanfang zurückkehren 

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