0 Evaluaciones
ID

35892

Descripción

Study of MK-3475 (Pembrolizumab) in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma After Treatment With Platinum-based and Cetuximab Therapy (MK-3475-055/KEYNOTE-055); ODM derived from: https://clinicaltrials.gov/show/NCT02255097

Link

https://clinicaltrials.gov/show/NCT02255097

Palabras clave

Versiones (1)
  1. 02/04/2019 02/04/2019 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

2 de abril de 2019

DOI

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Licencia

Creative Commons BY 4.0
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    Eligibility Head and Neck Squamous Cell Carcinoma (HNSCC) NCT02255097

    Inglés

    Eligibility Head and Neck Squamous Cell Carcinoma (HNSCC) NCT02255097

    1 formularios  
    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    histologically- or cytologically-confirmed recurrent or metastatic hnscc of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies
    Descripción

    Recurrent Head and Neck Squamous Cell Carcinoma Oral cavity | Squamous cell carcinoma of the head and neck metastatic Oral cavity | Recurrent Head and Neck Squamous Cell Carcinoma Oropharynx | Squamous cell carcinoma of the head and neck metastatic Oropharynx | Recurrent Head and Neck Squamous Cell Carcinoma Hypopharynx | Squamous cell carcinoma of the head and neck metastatic Hypopharynx | Recurrent Head and Neck Squamous Cell Carcinoma Larynx | Squamous cell carcinoma of the head and neck metastatic Larynx | Local Therapy Unsuccessful

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C4524839
    UMLS CUI [1,2]
    C0226896
    UMLS CUI [2,1]
    C1168401
    UMLS CUI [2,2]
    C1522484
    UMLS CUI [2,3]
    C0226896
    UMLS CUI [3,1]
    C4524839
    UMLS CUI [3,2]
    C0521367
    UMLS CUI [4,1]
    C1168401
    UMLS CUI [4,2]
    C1522484
    UMLS CUI [4,3]
    C0521367
    UMLS CUI [5,1]
    C4524839
    UMLS CUI [5,2]
    C0020629
    UMLS CUI [6,1]
    C1168401
    UMLS CUI [6,2]
    C1522484
    UMLS CUI [6,3]
    C0020629
    UMLS CUI [7,1]
    C4524839
    UMLS CUI [7,2]
    C0023078
    UMLS CUI [8,1]
    C1168401
    UMLS CUI [8,2]
    C1522484
    UMLS CUI [8,3]
    C0023078
    UMLS CUI [9,1]
    C1517925
    UMLS CUI [9,2]
    C1272705
    tumor progression or recurrence within 6 months of the last dose of any number of platinum-based and cetuximab therapy lines in the adjuvant, primary, recurrent, or metastatic setting; must be resistant (not responding) to both platinum and cetuximab
    Descripción

    Tumor Progression | Recurrent tumor | Therapeutic procedure Platinum-Based | cetuximab | Adjuvant therapy | Primary tumor | Recurrent disease | Neoplasm Metastasis | Refractory cancer

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0178874
    UMLS CUI [2]
    C0521158
    UMLS CUI [3,1]
    C0087111
    UMLS CUI [3,2]
    C1514162
    UMLS CUI [4]
    C0995188
    UMLS CUI [5]
    C0677850
    UMLS CUI [6]
    C0677930
    UMLS CUI [7]
    C0277556
    UMLS CUI [8]
    C0027627
    UMLS CUI [9]
    C0677936
    available tissue for biomarker analysis
    Descripción

    Availability of Tissue Biomarker Analysis

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0470187
    UMLS CUI [1,2]
    C0040300
    UMLS CUI [1,3]
    C1879847
    measurable disease based on recist 1.1 as determined by central review
    Descripción

    Measurable Disease

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    eastern cooperative oncology group (ecog) performance status of 0 or 1
    Descripción

    ECOG performance status

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    adequate organ function
    Descripción

    Organ function

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0678852
    female participants of childbearing potential must have a negative urine or serum pregnancy test and must be willing to use 2 adequate methods of contraception starting with the screening visit through 120 days after the last dose of pembrolizumab
    Descripción

    Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods Quantity | pembrolizumab

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0430057
    UMLS CUI [2,1]
    C3831118
    UMLS CUI [2,2]
    C0430061
    UMLS CUI [3,1]
    C3831118
    UMLS CUI [3,2]
    C0700589
    UMLS CUI [3,3]
    C1265611
    UMLS CUI [4]
    C3658706
    male participants with a female partner(s) of childbearing potential must be willing to use 2 adequate methods of contraception from screening through 120 days after the last dose of pembrolizumab
    Descripción

    Gender Partner Childbearing Potential Contraceptive methods | pembrolizumab

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0079399
    UMLS CUI [1,2]
    C0682323
    UMLS CUI [1,3]
    C3831118
    UMLS CUI [1,4]
    C0700589
    UMLS CUI [2]
    C3658706
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    disease that is suitable for local therapy administered with curative intent
    Descripción

    Disease Suitable Local Therapy Curative

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C3900053
    UMLS CUI [1,3]
    C1517925
    UMLS CUI [1,4]
    C1276305
    currently receiving treatment in a study of an investigational agent or using an investigational device <= 4 weeks prior to the first dose of trial medication
    Descripción

    Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    UMLS CUI [2]
    C0013230
    UMLS CUI [3]
    C2346570
    diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial medication
    Descripción

    Immunodeficiency | Steroid therapy Systemic | Therapeutic immunosuppression

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0021051
    UMLS CUI [2,1]
    C0149783
    UMLS CUI [2,2]
    C0205373
    UMLS CUI [3]
    C0021079
    not recovered from aes due to a previously administered therapy
    Descripción

    Adverse event Due to Prior Therapy | Recovery Lacking

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0678226
    UMLS CUI [1,3]
    C1514463
    UMLS CUI [2,1]
    C2004454
    UMLS CUI [2,2]
    C0332268
    known additional malignancy that is progressing or requires active treatment excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cancer
    Descripción

    Cancer Other Progressing | Cancer Other Treatment required for | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin | Exception Carcinoma in Situ

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1707251
    UMLS CUI [1,2]
    C0205329
    UMLS CUI [2,1]
    C1707251
    UMLS CUI [2,2]
    C0332121
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C1273390
    UMLS CUI [3,3]
    C0007117
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C1273390
    UMLS CUI [4,3]
    C0553723
    UMLS CUI [5,1]
    C1705847
    UMLS CUI [5,2]
    C0007099
    known active central nervous system (cns) metastases and/or carcinomatous meningitis
    Descripción

    CNS metastases | Meningeal Carcinomatosis

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0686377
    UMLS CUI [2]
    C0220654
    active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
    Descripción

    Autoimmune Disease Requirement Systemic therapy | Autoimmune Disease Severe | Syndrome Requirement Systemic steroids | Syndrome Requirement Immunosuppressive Agents

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0004364
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C1515119
    UMLS CUI [2,1]
    C0004364
    UMLS CUI [2,2]
    C0205082
    UMLS CUI [3,1]
    C0039082
    UMLS CUI [3,2]
    C1514873
    UMLS CUI [3,3]
    C2825233
    UMLS CUI [4,1]
    C0039082
    UMLS CUI [4,2]
    C1514873
    UMLS CUI [4,3]
    C0021081
    active, non-infectious pneumonitis
    Descripción

    Pneumonitis | Communicable Disease Absent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C3714636
    UMLS CUI [2,1]
    C0009450
    UMLS CUI [2,2]
    C0332197
    active infection requiring systemic therapy
    Descripción

    Communicable Disease Requirement Systemic therapy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C1515119
    pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial medication
    Descripción

    Pregnancy | Breast Feeding | Pregnancy Expected | Conception Expected

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3,1]
    C0032961
    UMLS CUI [3,2]
    C1517001
    UMLS CUI [4,1]
    C0009637
    UMLS CUI [4,2]
    C1517001
    human immunodeficiency virus (hiv)
    Descripción

    HIV Infection

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    hepatitis b or c
    Descripción

    Hepatitis B | Hepatitis C

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0019163
    UMLS CUI [2]
    C0019196
    received live vaccine within 30 days of planned start of study therapy
    Descripción

    Vaccines, Attenuated

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0042211
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    Similar models

    Eligibility Head and Neck Squamous Cell Carcinoma (HNSCC) NCT02255097

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Recurrent Head and Neck Squamous Cell Carcinoma Oral cavity | Squamous cell carcinoma of the head and neck metastatic Oral cavity | Recurrent Head and Neck Squamous Cell Carcinoma Oropharynx | Squamous cell carcinoma of the head and neck metastatic Oropharynx | Recurrent Head and Neck Squamous Cell Carcinoma Hypopharynx | Squamous cell carcinoma of the head and neck metastatic Hypopharynx | Recurrent Head and Neck Squamous Cell Carcinoma Larynx | Squamous cell carcinoma of the head and neck metastatic Larynx | Local Therapy Unsuccessful
    Item
    histologically- or cytologically-confirmed recurrent or metastatic hnscc of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies
    boolean
    C4524839 (UMLS CUI [1,1])
    C0226896 (UMLS CUI [1,2])
    C1168401 (UMLS CUI [2,1])
    C1522484 (UMLS CUI [2,2])
    C0226896 (UMLS CUI [2,3])
    C4524839 (UMLS CUI [3,1])
    C0521367 (UMLS CUI [3,2])
    C1168401 (UMLS CUI [4,1])
    C1522484 (UMLS CUI [4,2])
    C0521367 (UMLS CUI [4,3])
    C4524839 (UMLS CUI [5,1])
    C0020629 (UMLS CUI [5,2])
    C1168401 (UMLS CUI [6,1])
    C1522484 (UMLS CUI [6,2])
    C0020629 (UMLS CUI [6,3])
    C4524839 (UMLS CUI [7,1])
    C0023078 (UMLS CUI [7,2])
    C1168401 (UMLS CUI [8,1])
    C1522484 (UMLS CUI [8,2])
    C0023078 (UMLS CUI [8,3])
    C1517925 (UMLS CUI [9,1])
    C1272705 (UMLS CUI [9,2])
    Tumor Progression | Recurrent tumor | Therapeutic procedure Platinum-Based | cetuximab | Adjuvant therapy | Primary tumor | Recurrent disease | Neoplasm Metastasis | Refractory cancer
    Item
    tumor progression or recurrence within 6 months of the last dose of any number of platinum-based and cetuximab therapy lines in the adjuvant, primary, recurrent, or metastatic setting; must be resistant (not responding) to both platinum and cetuximab
    boolean
    C0178874 (UMLS CUI [1])
    C0521158 (UMLS CUI [2])
    C0087111 (UMLS CUI [3,1])
    C1514162 (UMLS CUI [3,2])
    C0995188 (UMLS CUI [4])
    C0677850 (UMLS CUI [5])
    C0677930 (UMLS CUI [6])
    C0277556 (UMLS CUI [7])
    C0027627 (UMLS CUI [8])
    C0677936 (UMLS CUI [9])
    Availability of Tissue Biomarker Analysis
    Item
    available tissue for biomarker analysis
    boolean
    C0470187 (UMLS CUI [1,1])
    C0040300 (UMLS CUI [1,2])
    C1879847 (UMLS CUI [1,3])
    Measurable Disease
    Item
    measurable disease based on recist 1.1 as determined by central review
    boolean
    C1513041 (UMLS CUI [1])
    ECOG performance status
    Item
    eastern cooperative oncology group (ecog) performance status of 0 or 1
    boolean
    C1520224 (UMLS CUI [1])
    Organ function
    Item
    adequate organ function
    boolean
    C0678852 (UMLS CUI [1])
    Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Contraceptive methods Quantity | pembrolizumab
    Item
    female participants of childbearing potential must have a negative urine or serum pregnancy test and must be willing to use 2 adequate methods of contraception starting with the screening visit through 120 days after the last dose of pembrolizumab
    boolean
    C3831118 (UMLS CUI [1,1])
    C0430057 (UMLS CUI [1,2])
    C3831118 (UMLS CUI [2,1])
    C0430061 (UMLS CUI [2,2])
    C3831118 (UMLS CUI [3,1])
    C0700589 (UMLS CUI [3,2])
    C1265611 (UMLS CUI [3,3])
    C3658706 (UMLS CUI [4])
    Gender Partner Childbearing Potential Contraceptive methods | pembrolizumab
    Item
    male participants with a female partner(s) of childbearing potential must be willing to use 2 adequate methods of contraception from screening through 120 days after the last dose of pembrolizumab
    boolean
    C0079399 (UMLS CUI [1,1])
    C0682323 (UMLS CUI [1,2])
    C3831118 (UMLS CUI [1,3])
    C0700589 (UMLS CUI [1,4])
    C3658706 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    Disease Suitable Local Therapy Curative
    Item
    disease that is suitable for local therapy administered with curative intent
    boolean
    C0012634 (UMLS CUI [1,1])
    C3900053 (UMLS CUI [1,2])
    C1517925 (UMLS CUI [1,3])
    C1276305 (UMLS CUI [1,4])
    Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
    Item
    currently receiving treatment in a study of an investigational agent or using an investigational device <= 4 weeks prior to the first dose of trial medication
    boolean
    C2348568 (UMLS CUI [1])
    C0013230 (UMLS CUI [2])
    C2346570 (UMLS CUI [3])
    Immunodeficiency | Steroid therapy Systemic | Therapeutic immunosuppression
    Item
    diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial medication
    boolean
    C0021051 (UMLS CUI [1])
    C0149783 (UMLS CUI [2,1])
    C0205373 (UMLS CUI [2,2])
    C0021079 (UMLS CUI [3])
    Adverse event Due to Prior Therapy | Recovery Lacking
    Item
    not recovered from aes due to a previously administered therapy
    boolean
    C0877248 (UMLS CUI [1,1])
    C0678226 (UMLS CUI [1,2])
    C1514463 (UMLS CUI [1,3])
    C2004454 (UMLS CUI [2,1])
    C0332268 (UMLS CUI [2,2])
    Cancer Other Progressing | Cancer Other Treatment required for | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin | Exception Carcinoma in Situ
    Item
    known additional malignancy that is progressing or requires active treatment excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cancer
    boolean
    C1707251 (UMLS CUI [1,1])
    C0205329 (UMLS CUI [1,2])
    C1707251 (UMLS CUI [2,1])
    C0332121 (UMLS CUI [2,2])
    C1705847 (UMLS CUI [3,1])
    C1273390 (UMLS CUI [3,2])
    C0007117 (UMLS CUI [3,3])
    C1705847 (UMLS CUI [4,1])
    C1273390 (UMLS CUI [4,2])
    C0553723 (UMLS CUI [4,3])
    C1705847 (UMLS CUI [5,1])
    C0007099 (UMLS CUI [5,2])
    CNS metastases | Meningeal Carcinomatosis
    Item
    known active central nervous system (cns) metastases and/or carcinomatous meningitis
    boolean
    C0686377 (UMLS CUI [1])
    C0220654 (UMLS CUI [2])
    Autoimmune Disease Requirement Systemic therapy | Autoimmune Disease Severe | Syndrome Requirement Systemic steroids | Syndrome Requirement Immunosuppressive Agents
    Item
    active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
    boolean
    C0004364 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C1515119 (UMLS CUI [1,3])
    C0004364 (UMLS CUI [2,1])
    C0205082 (UMLS CUI [2,2])
    C0039082 (UMLS CUI [3,1])
    C1514873 (UMLS CUI [3,2])
    C2825233 (UMLS CUI [3,3])
    C0039082 (UMLS CUI [4,1])
    C1514873 (UMLS CUI [4,2])
    C0021081 (UMLS CUI [4,3])
    Pneumonitis | Communicable Disease Absent
    Item
    active, non-infectious pneumonitis
    boolean
    C3714636 (UMLS CUI [1])
    C0009450 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    Communicable Disease Requirement Systemic therapy
    Item
    active infection requiring systemic therapy
    boolean
    C0009450 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C1515119 (UMLS CUI [1,3])
    Pregnancy | Breast Feeding | Pregnancy Expected | Conception Expected
    Item
    pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial medication
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C0032961 (UMLS CUI [3,1])
    C1517001 (UMLS CUI [3,2])
    C0009637 (UMLS CUI [4,1])
    C1517001 (UMLS CUI [4,2])
    HIV Infection
    Item
    human immunodeficiency virus (hiv)
    boolean
    C0019693 (UMLS CUI [1])
    Hepatitis B | Hepatitis C
    Item
    hepatitis b or c
    boolean
    C0019163 (UMLS CUI [1])
    C0019196 (UMLS CUI [2])
    Vaccines, Attenuated
    Item
    received live vaccine within 30 days of planned start of study therapy
    boolean
    C0042211 (UMLS CUI [1])
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