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NCT02314169 · BASELINE

Baseline characteristics

Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer · Source last updated 2026-07-31

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      39
    2. group Id
      BG001
      value
      53
    3. group Id
      BG002
      value
      51
    4. group Id
      BG003
      value
      143
    units
    Participants
groups
  1. description
    Patients receive nivolumab IV over 60 minutes once every two weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT scan Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
    id
    BG000
    title
    Part A (Nivolumab)
  2. description
    Patients receive nivolumab once every 8 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT scan Ipilimumab: Given IV Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
    id
    BG001
    title
    Part B1 (Nivolumab)
  3. description
    Patients receive nivolumab +/- ipilimumab once every 8 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT scan Ipilimumab: Given IV Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
    id
    BG002
    title
    Part B2 (Nivolumab + Ipilimumab)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          31
          upper Limit
          71
          value
          56
        2. group Id
          BG001
          lower Limit
          45
          upper Limit
          81
          value
          59
        3. group Id
          BG002
          lower Limit
          36
          upper Limit
          77
          value
          60
        4. group Id
          BG003
          lower Limit
          31
          upper Limit
          81
          value
          59
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          39
        4. group Id
          BG003
          value
          109
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          34
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          47
        4. group Id
          BG003
          value
          137
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          47
        4. group Id
          BG003
          value
          131
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          51
        4. group Id
          BG003
          value
          143
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
The patients included in this baseline analysis were all patients who consented to the study.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      39
    2. group Id
      BG001
      value
      53
    3. group Id
      BG002
      value
      51
    4. group Id
      BG003
      value
      143
    units
    Participants
groups
  1. description
    Patients receive nivolumab IV over 60 minutes once every two weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT scan Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
    id
    BG000
    title
    Part A (Nivolumab)
  2. description
    Patients receive nivolumab once every 8 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT scan Ipilimumab: Given IV Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
    id
    BG001
    title
    Part B1 (Nivolumab)
  3. description
    Patients receive nivolumab +/- ipilimumab once every 8 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study. Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT scan Ipilimumab: Given IV Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
    id
    BG002
    title
    Part B2 (Nivolumab + Ipilimumab)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          31
          upper Limit
          71
          value
          56
        2. group Id
          BG001
          lower Limit
          45
          upper Limit
          81
          value
          59
        3. group Id
          BG002
          lower Limit
          36
          upper Limit
          77
          value
          60
        4. group Id
          BG003
          lower Limit
          31
          upper Limit
          81
          value
          59
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          39
        4. group Id
          BG003
          value
          109
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          34
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          47
        4. group Id
          BG003
          value
          137
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          47
        4. group Id
          BG003
          value
          131
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          51
        4. group Id
          BG003
          value
          143
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
The patients included in this baseline analysis were all patients who consented to the study.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice