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NCT02595866 · BASELINE

Baseline characteristics

Testing the Addition of an Experimental Medication MK-3475 (Pembrolizumab) to Usual Anti-Retroviral Medications in Patients With HIV and Cancer · Source last updated 2024-08-09

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
      34
    2. group Id
      BG001
      value
      24
    3. group Id
      BG002
      value
      58
    units
    Participants
groups
  1. description
    Participants enrolled into 1 of 3 cohorts based on CD4+ T-cell counts, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Per the protocol, participants enrolled into Cohorts 1-3 were combined into one group for analysis. The number of participants enrolled to each cohort (n=12) was not sufficient to perform subgroup analysis based on a CD4 count Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
    id
    BG000
    title
    Cohorts 1-3 (Pembrolizumab and cART)
  2. description
    Participants with HIV associated Kaposi sarcoma enrolled into cohort 4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
    id
    BG001
    title
    Cohort 4 (Pembrolizumab and cART)
  3. description
    Total of all reporting groups
    id
    BG002
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          51
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
        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
          9.3
          value
          56.2
        2. group Id
          BG001
          spread
          10.7
          value
          44.5
        3. group Id
          BG002
          spread
          11.4
          value
          51.3
    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
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          54
        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
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          8
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          49
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          23
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          30
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          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
          34
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          58
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          35
    param Type
    COUNT_OF_PARTICIPANTS
    title
    MK-3475 (Pembrolizumab) as First Systemic Therapy
    unit Of Measure
    Participants
population Description
Participants do not have to complete the study in order to be included in the analysis population for the primary outcome measure.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      34
    2. group Id
      BG001
      value
      24
    3. group Id
      BG002
      value
      58
    units
    Participants
groups
  1. description
    Participants enrolled into 1 of 3 cohorts based on CD4+ T-cell counts, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Per the protocol, participants enrolled into Cohorts 1-3 were combined into one group for analysis. The number of participants enrolled to each cohort (n=12) was not sufficient to perform subgroup analysis based on a CD4 count Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
    id
    BG000
    title
    Cohorts 1-3 (Pembrolizumab and cART)
  2. description
    Participants with HIV associated Kaposi sarcoma enrolled into cohort 4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
    id
    BG001
    title
    Cohort 4 (Pembrolizumab and cART)
  3. description
    Total of all reporting groups
    id
    BG002
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          51
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
        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
          9.3
          value
          56.2
        2. group Id
          BG001
          spread
          10.7
          value
          44.5
        3. group Id
          BG002
          spread
          11.4
          value
          51.3
    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
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          54
        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
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          8
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          49
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          23
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          30
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          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
          34
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          58
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          35
    param Type
    COUNT_OF_PARTICIPANTS
    title
    MK-3475 (Pembrolizumab) as First Systemic Therapy
    unit Of Measure
    Participants
population Description
Participants do not have to complete the study in order to be included in the analysis population for the primary outcome measure.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice