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NCT03599713 · BASELINE

Baseline characteristics

A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201) · Source last updated 2025-08-05

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
      101
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      107
    units
    Participants
groups
  1. description
    Participants with recurrent, advanced locoregional disease or distant metastatic disease who did not receive any prior chemotherapy received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 60 minutes on Day 1 of each 28-day cycle (Q4W).
    id
    BG000
    title
    Chemotherapy: Naïve
  2. description
    Participants with disease not responding to prior chemotherapy received retifanlimab 500 mg, administered by IV infusion over 60 minutes on Day 1 Q4W.
    id
    BG001
    title
    Chemotherapy: Refractory
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.44
          value
          71.1
        2. group Id
          BG001
          spread
          10.46
          value
          63.8
        3. group Id
          BG002
          spread
          10.52
          value
          70.7
    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
          33
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          34
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          68
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          73
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          75
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          81
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          25
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          78
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          84
        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
          22
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          22
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Baseline data were collected in members of the Safety Evaluable Population, comprised of all enrolled participants who received at least 1 dose of study drug.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      101
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      107
    units
    Participants
groups
  1. description
    Participants with recurrent, advanced locoregional disease or distant metastatic disease who did not receive any prior chemotherapy received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 60 minutes on Day 1 of each 28-day cycle (Q4W).
    id
    BG000
    title
    Chemotherapy: Naïve
  2. description
    Participants with disease not responding to prior chemotherapy received retifanlimab 500 mg, administered by IV infusion over 60 minutes on Day 1 Q4W.
    id
    BG001
    title
    Chemotherapy: Refractory
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.44
          value
          71.1
        2. group Id
          BG001
          spread
          10.46
          value
          63.8
        3. group Id
          BG002
          spread
          10.52
          value
          70.7
    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
          33
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          34
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          68
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          73
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          75
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          81
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          25
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          78
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          84
        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
          22
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          22
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Baseline data were collected in members of the Safety Evaluable Population, comprised of all enrolled participants who received at least 1 dose of study drug.

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Preserved source evidence · Not medical advice