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NCT02595866 · OUTCOME

Duration of Response (Kaposi Sarcoma Cohort)

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.

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Interval between the date of first response (CR/PR) and the date of progression, assessed up to 2 years

What was measured

Assessed using ACTG criteria. Summarized statistically using Kaplan-Meier method.

Analysis population: Analysis is based on all participants who received at least one dose of study drug. Participants without documented progression were censored at the last disease assessment date.

Groups in this outcome

Kaposi Sarcoma Cohort (Pembrolizumab and cART)

Participants enrolled into Cohort 4 and participants with evaluable HIV associated Kaposi sarcoma enrolled into Cohorts 1-3, 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 undergo physical examination and blood sample collection, and may undergo CT or PET/CT. 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

Treatment Naïve Kaposi Sarcoma Cohort (Pembrolizumab and cART)

Treatment naïve participants enrolled into Cohort 4 and treatment naïve participants with evaluable HIV associated Kaposi sarcoma enrolled into Cohorts 1-3, 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 undergo physical examination and blood sample collection, and may undergo CT or PET/CT. 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

Previously Treated Kaposi Sarcoma Cohort (Pembrolizumab and cART)

Previously treated participants enrolled into Cohort 4 and previously treated participants with evaluable HIV associated Kaposi sarcoma enrolled into Cohorts 1-3, 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 undergo physical examination and blood sample collection, and may undergo CT or PET/CT. 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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Kaposi Sarcoma Cohort (Pembrolizumab and cART)29
Treatment Naïve Kaposi Sarcoma Cohort (Pembrolizumab and cART)8
Previously Treated Kaposi Sarcoma Cohort (Pembrolizumab and cART)21

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Kaposi Sarcoma Cohort (Pembrolizumab and cART)NANot reportedNANAMedian for duration of response (DOR) was not calculated. Lower and upper confidence intervals for DOR were not obtained based on the Kaplan-Meier estimates. Insufficient number of participants with events.
Treatment Naïve Kaposi Sarcoma Cohort (Pembrolizumab and cART)NANot reported3.5NAMedian for duration of response (DOR) was not calculated. Upper confidence interval for DOR were not obtained based on the Kaplan-Meier estimates. Insufficient number of participants with events.
Previously Treated Kaposi Sarcoma Cohort (Pembrolizumab and cART)NANot reportedNANAMedian for duration of response was not calculated. Lower and upper confidence intervals for DOR were not obtained based on the Kaplan-Meier estimates. Insufficient number of participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median for duration of response (DOR) was not calculated. Lower and upper confidence intervals for DOR were not obtained based on the Kaplan-Meier estimates. Insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Median for duration of response (DOR) was not calculated. Upper confidence interval for DOR were not obtained based on the Kaplan-Meier estimates. Insufficient number of participants with events.
        group Id
        OG001
        lower Limit
        3.5
        upper Limit
        NA
        value
        NA
      3. comment
        Median for duration of response was not calculated. Lower and upper confidence intervals for DOR were not obtained based on the Kaplan-Meier estimates. Insufficient number of participants with events.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      29
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      21
    units
    Participants
description
Assessed using ACTG criteria. Summarized statistically using Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants enrolled into Cohort 4 and participants with evaluable HIV associated Kaposi sarcoma enrolled into Cohorts 1-3, 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 undergo physical examination and blood sample collection, and may undergo CT or PET/CT. 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
    OG000
    title
    Kaposi Sarcoma Cohort (Pembrolizumab and cART)
  2. description
    Treatment naïve participants enrolled into Cohort 4 and treatment naïve participants with evaluable HIV associated Kaposi sarcoma enrolled into Cohorts 1-3, 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 undergo physical examination and blood sample collection, and may undergo CT or PET/CT. 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
    OG001
    title
    Treatment Naïve Kaposi Sarcoma Cohort (Pembrolizumab and cART)
  3. description
    Previously treated participants enrolled into Cohort 4 and previously treated participants with evaluable HIV associated Kaposi sarcoma enrolled into Cohorts 1-3, 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 undergo physical examination and blood sample collection, and may undergo CT or PET/CT. 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
    OG002
    title
    Previously Treated Kaposi Sarcoma Cohort (Pembrolizumab and cART)
param Type
MEDIAN
population Description
Analysis is based on all participants who received at least one dose of study drug. Participants without documented progression were censored at the last disease assessment date.
reporting Status
POSTED
time Frame
Interval between the date of first response (CR/PR) and the date of progression, assessed up to 2 years
title
Duration of Response (Kaposi Sarcoma Cohort)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice