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NCT03553836 · BASELINE

Baseline characteristics

Safety and Efficacy of Pembrolizumab Compared to Placebo in Resected High-risk Stage II Melanoma (MK-3475-716/KEYNOTE-716) · Source last updated 2024-11-29

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
      487
    2. group Id
      BG001
      value
      489
    3. group Id
      BG002
      value
      976
    units
    Participants
groups
  1. description
    Participants received 200 mg pembrolizumab (2 mg/kg for a maximum of 200 mg in pediatric participants) by intravenous (IV) infusion once every 3 weeks (Q3W; 21-day cycles) for up to 17 cycles (up to \~1 year) in Part 1. Participants who completed the initial treatment of 17 cycles of pembrolizumab and experienced disease recurrence may have been eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2.
    id
    BG000
    title
    Pembrolizumab
  2. description
    Participants received saline placebo by IV infusion Q3W (21-day cycles) for up to 17 cycles (up to \~1 year) in Part 1. Participants who completed the initial treatment of 17 cycles of placebo and experienced disease recurrence may have been eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2.
    id
    BG001
    title
    Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.6
          value
          59.0
        2. group Id
          BG001
          spread
          13.3
          value
          59.6
        3. group Id
          BG002
          spread
          12.9
          value
          59.3
    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
          187
        2. group Id
          BG001
          value
          200
        3. group Id
          BG002
          value
          387
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          300
        2. group Id
          BG001
          value
          289
        3. group Id
          BG002
          value
          589
        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
          49
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          79
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          390
        2. group Id
          BG001
          value
          409
        3. group Id
          BG002
          value
          799
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          98
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          435
        2. group Id
          BG001
          value
          439
        3. group Id
          BG002
          value
          874
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          87
        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
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
      title
      T3a
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          200
        2. group Id
          BG001
          value
          201
        3. group Id
          BG002
          value
          401
      title
      T3b
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          113
        2. group Id
          BG001
          value
          116
        3. group Id
          BG002
          value
          229
      title
      T4a
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          172
        2. group Id
          BG001
          value
          172
        3. group Id
          BG002
          value
          344
      title
      T4b
    description
    Participants were stratified into T stages of melanoma, as defined by tumor thickness and ulceration, based on the American Joint Committee on Cancer (AJCC) 8th edition. The T stages were defined as follows: T3a: \>2.0 - 4.0 mm thickness without ulceration; T3b: \>2.0 - 4.0 mm thickness with ulceration; T4a: \>4.0 mm without ulceration; T4b: \>4.0 mm with ulceration.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Melanoma Primary Tumor (T) Stage
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      487
    2. group Id
      BG001
      value
      489
    3. group Id
      BG002
      value
      976
    units
    Participants
groups
  1. description
    Participants received 200 mg pembrolizumab (2 mg/kg for a maximum of 200 mg in pediatric participants) by intravenous (IV) infusion once every 3 weeks (Q3W; 21-day cycles) for up to 17 cycles (up to \~1 year) in Part 1. Participants who completed the initial treatment of 17 cycles of pembrolizumab and experienced disease recurrence may have been eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2.
    id
    BG000
    title
    Pembrolizumab
  2. description
    Participants received saline placebo by IV infusion Q3W (21-day cycles) for up to 17 cycles (up to \~1 year) in Part 1. Participants who completed the initial treatment of 17 cycles of placebo and experienced disease recurrence may have been eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to \~2 years) in Part 2.
    id
    BG001
    title
    Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.6
          value
          59.0
        2. group Id
          BG001
          spread
          13.3
          value
          59.6
        3. group Id
          BG002
          spread
          12.9
          value
          59.3
    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
          187
        2. group Id
          BG001
          value
          200
        3. group Id
          BG002
          value
          387
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          300
        2. group Id
          BG001
          value
          289
        3. group Id
          BG002
          value
          589
        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
          49
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          79
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          390
        2. group Id
          BG001
          value
          409
        3. group Id
          BG002
          value
          799
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          98
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          435
        2. group Id
          BG001
          value
          439
        3. group Id
          BG002
          value
          874
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          87
        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
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
      title
      T3a
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          200
        2. group Id
          BG001
          value
          201
        3. group Id
          BG002
          value
          401
      title
      T3b
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          113
        2. group Id
          BG001
          value
          116
        3. group Id
          BG002
          value
          229
      title
      T4a
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          172
        2. group Id
          BG001
          value
          172
        3. group Id
          BG002
          value
          344
      title
      T4b
    description
    Participants were stratified into T stages of melanoma, as defined by tumor thickness and ulceration, based on the American Joint Committee on Cancer (AJCC) 8th edition. The T stages were defined as follows: T3a: \>2.0 - 4.0 mm thickness without ulceration; T3b: \>2.0 - 4.0 mm thickness with ulceration; T4a: \>4.0 mm without ulceration; T4b: \>4.0 mm with ulceration.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Melanoma Primary Tumor (T) Stage
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice