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NCT04640623 · BASELINE

Baseline characteristics

A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy · Source last updated 2026-08-28

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
      55
    2. group Id
      BG001
      value
      85
    3. group Id
      BG002
      value
      28
    4. group Id
      BG003
      value
      52
    5. group Id
      BG004
      value
      220
    units
    Participants
groups
  1. description
    Participants with CIS with or without papillary disease, received TAR-200 intravesically every 3 weeks (Q3W) from Week 0 for the first 24 weeks, followed by every 12 weeks (Q12W) dosing through Week 99 in combination with cetrelimab 360 milligrams (mg) intravenously (IV) Q3W from Week 0 through Week 78. TAR-200 was inserted intravesically via the urinary placement catheter (UPC).
    id
    BG000
    title
    Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)
  2. description
    Participants with CIS with or without papillary disease received TAR-200 intravesically Q3W from Week 0 for the first 24 weeks, followed by Q12W dosing through Week 99. TAR-200 was inserted intravesically via UPC.
    id
    BG001
    title
    2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)
  3. description
    Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
    id
    BG002
    title
    Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
  4. description
    Participants with papillary disease only, received TAR-200 intravesically Q3W from Week 0 for the first 24 weeks, followed by Q12W dosing through Week 99. TAR-200 was inserted intravesically via UPC.
    id
    BG003
    title
    Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. 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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          54
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          61
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          41
        5. group Id
          BG004
          value
          166
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.87
          value
          72
        2. group Id
          BG001
          spread
          9.46
          value
          69.7
        3. group Id
          BG002
          spread
          8.73
          value
          68.6
        4. group Id
          BG003
          spread
          9.64
          value
          70.1
        5. group Id
          BG004
          spread
          9.52
          value
          70.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          48
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          37
        5. group Id
          BG004
          value
          172
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          14
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          48
        5. group Id
          BG004
          value
          204
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. 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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          22
        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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          74
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          45
        5. group Id
          BG004
          value
          191
        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
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
      title
      AUSTRALIA
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          19
      title
      BELGIUM
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          7
      title
      CANADA
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          38
      title
      FRANCE
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          18
      title
      GERMANY
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          4
      title
      GREECE
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          24
      title
      ITALY
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          5
      title
      JAPAN
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          8
      title
      NETHERLANDS
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          6
      title
      PORTUGAL
    11. 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
          4
      title
      RUSSIAN FEDERATION
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          16
      title
      SOUTH KOREA
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      55
    2. group Id
      BG001
      value
      85
    3. group Id
      BG002
      value
      28
    4. group Id
      BG003
      value
      52
    5. group Id
      BG004
      value
      220
    units
    Participants
groups
  1. description
    Participants with CIS with or without papillary disease, received TAR-200 intravesically every 3 weeks (Q3W) from Week 0 for the first 24 weeks, followed by every 12 weeks (Q12W) dosing through Week 99 in combination with cetrelimab 360 milligrams (mg) intravenously (IV) Q3W from Week 0 through Week 78. TAR-200 was inserted intravesically via the urinary placement catheter (UPC).
    id
    BG000
    title
    Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)
  2. description
    Participants with CIS with or without papillary disease received TAR-200 intravesically Q3W from Week 0 for the first 24 weeks, followed by Q12W dosing through Week 99. TAR-200 was inserted intravesically via UPC.
    id
    BG001
    title
    2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)
  3. description
    Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
    id
    BG002
    title
    Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
  4. description
    Participants with papillary disease only, received TAR-200 intravesically Q3W from Week 0 for the first 24 weeks, followed by Q12W dosing through Week 99. TAR-200 was inserted intravesically via UPC.
    id
    BG003
    title
    Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. 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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          54
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          61
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          41
        5. group Id
          BG004
          value
          166
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.87
          value
          72
        2. group Id
          BG001
          spread
          9.46
          value
          69.7
        3. group Id
          BG002
          spread
          8.73
          value
          68.6
        4. group Id
          BG003
          spread
          9.64
          value
          70.1
        5. group Id
          BG004
          spread
          9.52
          value
          70.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          48
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          37
        5. group Id
          BG004
          value
          172
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          14
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          48
        5. group Id
          BG004
          value
          204
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. 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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          22
        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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          74
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          45
        5. group Id
          BG004
          value
          191
        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
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
      title
      AUSTRALIA
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          19
      title
      BELGIUM
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          7
      title
      CANADA
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          38
      title
      FRANCE
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          18
      title
      GERMANY
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          4
      title
      GREECE
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          24
      title
      ITALY
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          5
      title
      JAPAN
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          8
      title
      NETHERLANDS
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          6
      title
      PORTUGAL
    11. 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
          4
      title
      RUSSIAN FEDERATION
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          16
      title
      SOUTH KOREA
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants

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

Preserved source evidence · Independent clinical review pending · Not medical advice