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NCT02853331 · BASELINE

Baseline characteristics

Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy in Participants With Renal Cell Carcinoma (MK-3475-426/KEYNOTE-426) · Source last updated 2026-02-02

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
      432
    2. group Id
      BG001
      value
      429
    3. group Id
      BG002
      value
      861
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.
    id
    BG000
    title
    Pembrolizumab + Axitinib
  2. description
    Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
    id
    BG001
    title
    Sunitinib
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.0
          value
          61.2
        2. group Id
          BG001
          spread
          10.2
          value
          60.8
        3. group Id
          BG002
          spread
          10.1
          value
          61.0
    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
          124
        2. group Id
          BG001
          value
          109
        3. group Id
          BG002
          value
          233
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          308
        2. group Id
          BG001
          value
          320
        3. group Id
          BG002
          value
          628
        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
          19
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          37
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          377
        2. group Id
          BG001
          value
          387
        3. group Id
          BG002
          value
          764
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          60
        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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          137
        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
          10
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          18
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          343
        2. group Id
          BG001
          value
          341
        3. group Id
          BG002
          value
          684
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          22
        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
          138
        2. group Id
          BG001
          value
          131
        3. group Id
          BG002
          value
          269
      title
      Favorable
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          238
        2. group Id
          BG001
          value
          246
        3. group Id
          BG002
          value
          484
      title
      Intermediate
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          108
      title
      Poor
    description
    Participants were stratified by IMDC risk group using the following criteria: baseline Karnofsky Performance Status \<80%; interval between initial diagnosis of renal cell carcinoma to start of first-line systemic treatment for advanced disease \<1year; baseline hemoglobin \<lower limit of normal (LLN); baseline platelet count \>upper limit of normal (ULN); baseline corrected calcium1 \>ULN; and baseline neutrophil \>ULN. The category was determined by totaling the risk factors per participant and scored as favorable (no factors); intermediate (1 or 2 factors); and poor (≥3 factors).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Risk Group
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          104
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          207
      title
      North America
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          106
        2. group Id
          BG001
          value
          104
        3. group Id
          BG002
          value
          210
      title
      Western Europe
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          222
        2. group Id
          BG001
          value
          222
        3. group Id
          BG002
          value
          444
      title
      Rest of World
    description
    Participants were stratified by geographic region using the following categories: North America; Western Europe; and Rest of the World.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region
    unit Of Measure
    Participants
population Description
All randomized participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      432
    2. group Id
      BG001
      value
      429
    3. group Id
      BG002
      value
      861
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.
    id
    BG000
    title
    Pembrolizumab + Axitinib
  2. description
    Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
    id
    BG001
    title
    Sunitinib
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.0
          value
          61.2
        2. group Id
          BG001
          spread
          10.2
          value
          60.8
        3. group Id
          BG002
          spread
          10.1
          value
          61.0
    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
          124
        2. group Id
          BG001
          value
          109
        3. group Id
          BG002
          value
          233
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          308
        2. group Id
          BG001
          value
          320
        3. group Id
          BG002
          value
          628
        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
          19
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          37
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          377
        2. group Id
          BG001
          value
          387
        3. group Id
          BG002
          value
          764
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          60
        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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          137
        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
          10
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          18
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          343
        2. group Id
          BG001
          value
          341
        3. group Id
          BG002
          value
          684
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          22
        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
          138
        2. group Id
          BG001
          value
          131
        3. group Id
          BG002
          value
          269
      title
      Favorable
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          238
        2. group Id
          BG001
          value
          246
        3. group Id
          BG002
          value
          484
      title
      Intermediate
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          108
      title
      Poor
    description
    Participants were stratified by IMDC risk group using the following criteria: baseline Karnofsky Performance Status \<80%; interval between initial diagnosis of renal cell carcinoma to start of first-line systemic treatment for advanced disease \<1year; baseline hemoglobin \<lower limit of normal (LLN); baseline platelet count \>upper limit of normal (ULN); baseline corrected calcium1 \>ULN; and baseline neutrophil \>ULN. The category was determined by totaling the risk factors per participant and scored as favorable (no factors); intermediate (1 or 2 factors); and poor (≥3 factors).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Risk Group
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          104
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          207
      title
      North America
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          106
        2. group Id
          BG001
          value
          104
        3. group Id
          BG002
          value
          210
      title
      Western Europe
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          222
        2. group Id
          BG001
          value
          222
        3. group Id
          BG002
          value
          444
      title
      Rest of World
    description
    Participants were stratified by geographic region using the following categories: North America; Western Europe; and Rest of the World.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region
    unit Of Measure
    Participants
population Description
All randomized participants

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

Preserved source evidence · Not medical advice