Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02488759 · BASELINE

Baseline characteristics

An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors · Source last updated 2023-11-13

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
      113
    2. group Id
      BG001
      value
      195
    3. group Id
      BG002
      value
      133
    4. group Id
      BG003
      value
      8
    5. group Id
      BG004
      value
      6
    6. group Id
      BG005
      value
      123
    7. group Id
      BG006
      value
      578
    units
    Participants
groups
  1. description
    Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
    id
    BG000
    title
    Metastatic Monotherapy
  2. description
    Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
    id
    BG001
    title
    Metastatic Combo A
  3. description
    Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
    id
    BG002
    title
    Metastatic Combo B
  4. description
    Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 months, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
    id
    BG003
    title
    Metastatic Combo C
  5. description
    Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
    id
    BG004
    title
    Metastatic Combo D
  6. description
    Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
    id
    BG005
    title
    Neoadjuvant
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.5
          value
          57.4
        2. group Id
          BG001
          spread
          13.2
          value
          57.5
        3. group Id
          BG002
          spread
          12.3
          value
          48.2
        4. group Id
          BG003
          spread
          7.6
          value
          59.0
        5. group Id
          BG004
          spread
          15.3
          value
          66.5
        6. group Id
          BG005
          spread
          12.7
          value
          62.0
        7. group Id
          BG006
          spread
          13.8
          value
          56.4
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          85
        3. group Id
          BG002
          value
          129
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          59
        7. group Id
          BG006
          value
          316
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          110
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          64
        7. group Id
          BG006
          value
          262
        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
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          6
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          56
        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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          17
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          86
        2. group Id
          BG001
          value
          147
        3. group Id
          BG002
          value
          115
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          113
        7. group Id
          BG006
          value
          475
        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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          24
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      113
    2. group Id
      BG001
      value
      195
    3. group Id
      BG002
      value
      133
    4. group Id
      BG003
      value
      8
    5. group Id
      BG004
      value
      6
    6. group Id
      BG005
      value
      123
    7. group Id
      BG006
      value
      578
    units
    Participants
groups
  1. description
    Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
    id
    BG000
    title
    Metastatic Monotherapy
  2. description
    Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
    id
    BG001
    title
    Metastatic Combo A
  3. description
    Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
    id
    BG002
    title
    Metastatic Combo B
  4. description
    Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 months, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
    id
    BG003
    title
    Metastatic Combo C
  5. description
    Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
    id
    BG004
    title
    Metastatic Combo D
  6. description
    Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
    id
    BG005
    title
    Neoadjuvant
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.5
          value
          57.4
        2. group Id
          BG001
          spread
          13.2
          value
          57.5
        3. group Id
          BG002
          spread
          12.3
          value
          48.2
        4. group Id
          BG003
          spread
          7.6
          value
          59.0
        5. group Id
          BG004
          spread
          15.3
          value
          66.5
        6. group Id
          BG005
          spread
          12.7
          value
          62.0
        7. group Id
          BG006
          spread
          13.8
          value
          56.4
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          85
        3. group Id
          BG002
          value
          129
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          59
        7. group Id
          BG006
          value
          316
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          110
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          64
        7. group Id
          BG006
          value
          262
        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
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          6
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          56
        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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          17
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          86
        2. group Id
          BG001
          value
          147
        3. group Id
          BG002
          value
          115
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          113
        7. group Id
          BG006
          value
          475
        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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          24
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice