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NCT05116189 · BASELINE

Baseline characteristics

Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65). · Source last updated 2026-03-09

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
      322
    2. group Id
      BG001
      value
      321
    3. group Id
      BG002
      value
      643
    units
    Participants
groups
  1. description
    Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
    id
    BG000
    title
    Pembrolizumab + Paclitaxel ± Bevacizumab
  2. description
    Participants receive placebo via IV infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
    id
    BG001
    title
    Placebo + Paclitaxel ± Bevacizumab
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.7
          value
          61.6
        2. group Id
          BG001
          spread
          9.9
          value
          60.6
        3. group Id
          BG002
          spread
          10.3
          value
          60.8
    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
          322
        2. group Id
          BG001
          value
          321
        3. group Id
          BG002
          value
          643
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          46
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          98
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          261
        2. group Id
          BG001
          value
          255
        3. group Id
          BG002
          value
          516
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          29
        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
          72
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          130
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          14
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          207
        2. group Id
          BG001
          value
          217
        3. group Id
          BG002
          value
          424
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          29
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          44
        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
          235
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          471
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          87
        2. group Id
          BG001
          value
          85
        3. group Id
          BG002
          value
          172
        title
        No
    description
    For the participant to receive bevacizumab in the study (yes versus no).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Investigator Choice to Use Bevacizumab
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          88
        2. group Id
          BG001
          value
          89
        3. group Id
          BG002
          value
          177
        title
        CPS <1
      2. measurements
        1. group Id
          BG000
          value
          133
        2. group Id
          BG001
          value
          132
        3. group Id
          BG002
          value
          265
        title
        CPS 1 to <10
      3. measurements
        1. group Id
          BG000
          value
          101
        2. group Id
          BG001
          value
          100
        3. group Id
          BG002
          value
          201
        title
        CPS ≥10
    description
    The Programmed Cell Death-Ligand 1(PD-L1) Combined Positive Score (CPS) status indicates tumor PD-L1 positivity using both tumor cells and inflammatory cells that are positive for PD-L1 by immunohistochemistry (IHC). The number of participants with CPS \<1, CPS 1 to \<10, and CPS ≥10 at baseline is presented. Participants with a CPS \<1 were classified as PD-L1 negative and participants with a CPS≥1 were classified as PD-L1 positive.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) Status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          59
        title
        United States (US)
      2. measurements
        1. group Id
          BG000
          value
          149
        2. group Id
          BG001
          value
          151
        3. group Id
          BG002
          value
          300
        title
        European Union (EU)
      3. measurements
        1. group Id
          BG000
          value
          143
        2. group Id
          BG001
          value
          141
        3. group Id
          BG002
          value
          284
        title
        Rest of World (ROW)
    description
    Participants were stratified by region of enrollment; United States (US), versus European Union, versus Rest of World (ROW).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      322
    2. group Id
      BG001
      value
      321
    3. group Id
      BG002
      value
      643
    units
    Participants
groups
  1. description
    Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
    id
    BG000
    title
    Pembrolizumab + Paclitaxel ± Bevacizumab
  2. description
    Participants receive placebo via IV infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
    id
    BG001
    title
    Placebo + Paclitaxel ± Bevacizumab
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.7
          value
          61.6
        2. group Id
          BG001
          spread
          9.9
          value
          60.6
        3. group Id
          BG002
          spread
          10.3
          value
          60.8
    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
          322
        2. group Id
          BG001
          value
          321
        3. group Id
          BG002
          value
          643
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          46
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          98
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          261
        2. group Id
          BG001
          value
          255
        3. group Id
          BG002
          value
          516
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          29
        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
          72
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          130
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          14
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          207
        2. group Id
          BG001
          value
          217
        3. group Id
          BG002
          value
          424
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          29
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          44
        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
          235
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          471
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          87
        2. group Id
          BG001
          value
          85
        3. group Id
          BG002
          value
          172
        title
        No
    description
    For the participant to receive bevacizumab in the study (yes versus no).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Investigator Choice to Use Bevacizumab
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          88
        2. group Id
          BG001
          value
          89
        3. group Id
          BG002
          value
          177
        title
        CPS <1
      2. measurements
        1. group Id
          BG000
          value
          133
        2. group Id
          BG001
          value
          132
        3. group Id
          BG002
          value
          265
        title
        CPS 1 to <10
      3. measurements
        1. group Id
          BG000
          value
          101
        2. group Id
          BG001
          value
          100
        3. group Id
          BG002
          value
          201
        title
        CPS ≥10
    description
    The Programmed Cell Death-Ligand 1(PD-L1) Combined Positive Score (CPS) status indicates tumor PD-L1 positivity using both tumor cells and inflammatory cells that are positive for PD-L1 by immunohistochemistry (IHC). The number of participants with CPS \<1, CPS 1 to \<10, and CPS ≥10 at baseline is presented. Participants with a CPS \<1 were classified as PD-L1 negative and participants with a CPS≥1 were classified as PD-L1 positive.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) Status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          59
        title
        United States (US)
      2. measurements
        1. group Id
          BG000
          value
          149
        2. group Id
          BG001
          value
          151
        3. group Id
          BG002
          value
          300
        title
        European Union (EU)
      3. measurements
        1. group Id
          BG000
          value
          143
        2. group Id
          BG001
          value
          141
        3. group Id
          BG002
          value
          284
        title
        Rest of World (ROW)
    description
    Participants were stratified by region of enrollment; United States (US), versus European Union, versus Rest of World (ROW).
    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