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NCT03146650 · BASELINE

Baseline characteristics

Nivolumab and Ipilimumab in Treating Patients With Metastatic/Recurrent ACC of All Sites and Non-ACC Salivary Gland Cancer · Source last updated 2024-01-18

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
      24
    units
    Participants
groups
  1. description
    Nivolumab and ipilimumab combination will be administered intravenously until disease progression or intolerable toxicity. Nivolumab: Given at 240mg over 30 minutes (-5 / +15 minutes) every 2 weeks starting with Cycle 1 Day 1 for the first 16 weeks (1 cycle = 12 weeks). Starting with Cycle 2 Day 29, nivolumab will be given at 480mg IV over 60 minutes (-10 / +15 minutes) every 4 weeks. Ipilimumab: Given at 1mg/Kg every 6 weeks starting with Cycle 1 Day 1 over approximately 90 minutes (-5 / +15 minutes). On days when both nivolumab and ipilimumab are administered, nivolumab should be given first, followed by ipilimumab about 30 minutes after completion of nivolumab. Patients will be assessed for response every 12 weeks (±7 days).
    id
    BG000
    title
    Nivolumab + Ipilimumab
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          18
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          6
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          12
        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
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          22
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          22
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        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
          24
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
      title
      Adenoid Cystic Carcinoma
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Non-Adenoid Cystic Carcinoma
    param Type
    COUNT_OF_PARTICIPANTS
    title
    adenoid cystic carcinoma vs non-adenoid cystic carcinoma
    unit Of Measure
    Participants
population Description
Only patients who received at least one dose of study drug are included in the demographics section.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      24
    units
    Participants
groups
  1. description
    Nivolumab and ipilimumab combination will be administered intravenously until disease progression or intolerable toxicity. Nivolumab: Given at 240mg over 30 minutes (-5 / +15 minutes) every 2 weeks starting with Cycle 1 Day 1 for the first 16 weeks (1 cycle = 12 weeks). Starting with Cycle 2 Day 29, nivolumab will be given at 480mg IV over 60 minutes (-10 / +15 minutes) every 4 weeks. Ipilimumab: Given at 1mg/Kg every 6 weeks starting with Cycle 1 Day 1 over approximately 90 minutes (-5 / +15 minutes). On days when both nivolumab and ipilimumab are administered, nivolumab should be given first, followed by ipilimumab about 30 minutes after completion of nivolumab. Patients will be assessed for response every 12 weeks (±7 days).
    id
    BG000
    title
    Nivolumab + Ipilimumab
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          18
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          6
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          12
        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
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          22
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          22
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        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
          24
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
      title
      Adenoid Cystic Carcinoma
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Non-Adenoid Cystic Carcinoma
    param Type
    COUNT_OF_PARTICIPANTS
    title
    adenoid cystic carcinoma vs non-adenoid cystic carcinoma
    unit Of Measure
    Participants
population Description
Only patients who received at least one dose of study drug are included in the demographics section.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice