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NCT02595866 · OUTCOME

Objective Response Rate (Partial Response + Completion 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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 2 years

What was measured

Defined as the proportion of participants who achieved the best objective response rate (complete response (CR) + partial response (PR)) as determined by modified Acquired Immunodeficiency Syndrome Clinical Trials Group (ACTG) criteria Analyzed using Clopper-Pearson 95% confidence intervals.

Analysis population: Analysis is based on all participants who have received at least one dose of study treatment. Participants with missing outcomes considered nonresponders. Participants without 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 percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Kaposi Sarcoma Cohort (Pembrolizumab and cART)62.1Not reported42.379.3Not reported
Treatment Naïve Kaposi Sarcoma Cohort (Pembrolizumab and cART)87.5Not reported47.399.7Not reported
Previously Treated Kaposi Sarcoma Cohort (Pembrolizumab and cART)52.4Not reported29.874.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        42.3
        upper Limit
        79.3
        value
        62.1
      2. group Id
        OG001
        lower Limit
        47.3
        upper Limit
        99.7
        value
        87.5
      3. group Id
        OG002
        lower Limit
        29.8
        upper Limit
        74.3
        value
        52.4
denoms
  1. counts
    1. group Id
      OG000
      value
      29
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      21
    units
    Participants
description
Defined as the proportion of participants who achieved the best objective response rate (complete response (CR) + partial response (PR)) as determined by modified Acquired Immunodeficiency Syndrome Clinical Trials Group (ACTG) criteria Analyzed using Clopper-Pearson 95% confidence intervals.
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
NUMBER
population Description
Analysis is based on all participants who have received at least one dose of study treatment. Participants with missing outcomes considered nonresponders. Participants without progression were censored at the last disease assessment date.
reporting Status
POSTED
time Frame
Up to 2 years
title
Objective Response Rate (Partial Response + Completion Response)(Kaposi Sarcoma Cohort)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice