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NCT03924895 · BASELINE

Baseline characteristics

Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303) · Source last updated 2026-06-30

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
      166
    2. group Id
      BG001
      value
      259
    3. group Id
      BG002
      value
      170
    4. group Id
      BG003
      value
      595
    units
    Participants
groups
  1. description
    Participants receive 3 preoperative cycles of pembrolizumab, followed by standard of care surgery, followed by 14 cycles of postoperative pembrolizumab. Each cycle is 21 days.
    id
    BG000
    title
    Arm A: Pembrolizumab + Surgery
  2. description
    Participants receive standard of care surgery alone.
    id
    BG001
    title
    Arm B: Surgery Alone
  3. description
    Participants receive 3 preoperative cycles of EV + pembrolizumab, followed by standard of care surgery, followed by 6 cycles of postoperative EV + pembrolizumab, followed by 8 cycles of pembrolizumab alone. Each cycle is 21 days.
    id
    BG002
    title
    Arm C: Enfortumab Vedotin (EV) + Pembrolizumab + Surgery
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.9
          value
          71.8
        2. group Id
          BG001
          spread
          7.7
          value
          71.9
        3. group Id
          BG002
          spread
          7.9
          value
          72.1
        4. group Id
          BG003
          spread
          7.8
          value
          71.9
    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
          36
        2. group Id
          BG001
          value
          66
        3. group Id
          BG002
          value
          33
        4. group Id
          BG003
          value
          135
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          130
        2. group Id
          BG001
          value
          193
        3. group Id
          BG002
          value
          137
        4. group Id
          BG003
          value
          460
        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
          3
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          26
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          155
        2. group Id
          BG001
          value
          231
        3. group Id
          BG002
          value
          160
        4. group Id
          BG003
          value
          546
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          23
        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
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          31
        4. group Id
          BG003
          value
          85
        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
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          148
        2. group Id
          BG001
          value
          205
        3. group Id
          BG002
          value
          132
        4. group Id
          BG003
          value
          485
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          11
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          6
        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
          163
        2. group Id
          BG001
          value
          223
        3. group Id
          BG002
          value
          142
        4. group Id
          BG003
          value
          528
        title
        Cisplatin-Ineligible
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          67
        title
        Cisplatin-Eligible but Declined
    description
    Particpants were categorized according to their cisplatin status: ineligible for cisplatin-based chemotherapy or eligible for but declined cisplatin-based chemotherapy
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cisplatin Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          82
        title
        T2N0
      2. measurements
        1. group Id
          BG000
          value
          150
        2. group Id
          BG001
          value
          209
        3. group Id
          BG002
          value
          133
        4. group Id
          BG003
          value
          492
        title
        T3/T4aN0
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          21
        title
        T1-4aN1
    description
    Imaging of the chest, abdomen, and pelvis was performed within ≤28 days before randomization to assess tumor status as follows: T2N0: Stage II; tumor invades muscularis propria, no regional nodes, and generally has better outcomes. T3/T4aN0: Stage III; extends into perivesical tissue or adjacent organs, no regional nodes, and has worse outcomes. T1-4aN1: Stage III; tumor with one regional lymph node metastasis, generally associated with the worst outcomes. Disease staging was assessed centrally after review of the pathology and imaging results.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Tumor Clinical Stage
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          73
        title
        United States (US)
      2. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          110
        3. group Id
          BG002
          value
          78
        4. group Id
          BG003
          value
          261
        title
        European Union (EU)
      3. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          116
        3. group Id
          BG002
          value
          71
        4. group Id
          BG003
          value
          261
        title
        Most of World (MOW)
    description
    Participants were categorized according to their geographic region (United States, European Union, or Most of World)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      166
    2. group Id
      BG001
      value
      259
    3. group Id
      BG002
      value
      170
    4. group Id
      BG003
      value
      595
    units
    Participants
groups
  1. description
    Participants receive 3 preoperative cycles of pembrolizumab, followed by standard of care surgery, followed by 14 cycles of postoperative pembrolizumab. Each cycle is 21 days.
    id
    BG000
    title
    Arm A: Pembrolizumab + Surgery
  2. description
    Participants receive standard of care surgery alone.
    id
    BG001
    title
    Arm B: Surgery Alone
  3. description
    Participants receive 3 preoperative cycles of EV + pembrolizumab, followed by standard of care surgery, followed by 6 cycles of postoperative EV + pembrolizumab, followed by 8 cycles of pembrolizumab alone. Each cycle is 21 days.
    id
    BG002
    title
    Arm C: Enfortumab Vedotin (EV) + Pembrolizumab + Surgery
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.9
          value
          71.8
        2. group Id
          BG001
          spread
          7.7
          value
          71.9
        3. group Id
          BG002
          spread
          7.9
          value
          72.1
        4. group Id
          BG003
          spread
          7.8
          value
          71.9
    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
          36
        2. group Id
          BG001
          value
          66
        3. group Id
          BG002
          value
          33
        4. group Id
          BG003
          value
          135
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          130
        2. group Id
          BG001
          value
          193
        3. group Id
          BG002
          value
          137
        4. group Id
          BG003
          value
          460
        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
          3
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          26
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          155
        2. group Id
          BG001
          value
          231
        3. group Id
          BG002
          value
          160
        4. group Id
          BG003
          value
          546
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          23
        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
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          31
        4. group Id
          BG003
          value
          85
        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
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          148
        2. group Id
          BG001
          value
          205
        3. group Id
          BG002
          value
          132
        4. group Id
          BG003
          value
          485
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          11
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          6
        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
          163
        2. group Id
          BG001
          value
          223
        3. group Id
          BG002
          value
          142
        4. group Id
          BG003
          value
          528
        title
        Cisplatin-Ineligible
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          67
        title
        Cisplatin-Eligible but Declined
    description
    Particpants were categorized according to their cisplatin status: ineligible for cisplatin-based chemotherapy or eligible for but declined cisplatin-based chemotherapy
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cisplatin Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          82
        title
        T2N0
      2. measurements
        1. group Id
          BG000
          value
          150
        2. group Id
          BG001
          value
          209
        3. group Id
          BG002
          value
          133
        4. group Id
          BG003
          value
          492
        title
        T3/T4aN0
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          21
        title
        T1-4aN1
    description
    Imaging of the chest, abdomen, and pelvis was performed within ≤28 days before randomization to assess tumor status as follows: T2N0: Stage II; tumor invades muscularis propria, no regional nodes, and generally has better outcomes. T3/T4aN0: Stage III; extends into perivesical tissue or adjacent organs, no regional nodes, and has worse outcomes. T1-4aN1: Stage III; tumor with one regional lymph node metastasis, generally associated with the worst outcomes. Disease staging was assessed centrally after review of the pathology and imaging results.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Tumor Clinical Stage
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          73
        title
        United States (US)
      2. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          110
        3. group Id
          BG002
          value
          78
        4. group Id
          BG003
          value
          261
        title
        European Union (EU)
      3. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          116
        3. group Id
          BG002
          value
          71
        4. group Id
          BG003
          value
          261
        title
        Most of World (MOW)
    description
    Participants were categorized according to their geographic region (United States, European Union, or Most of World)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice