{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"20.0"},{"groupId":"OG001","value":"50.0"},{"groupId":"OG002","value":"25.0"},{"groupId":"OG003","value":"20.8"},{"groupId":"OG004","value":"27.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"12"},{"groupId":"OG003","value":"24"},{"groupId":"OG004","value":"58"}],"units":"Participants"}],"description":"This includes the occurrence of grade 2 or higher AEs. Will be graded using CTCAE version 4.0 (version 5.0 beginning April 1, 2018). Any AE of unknown etiology associated with study therapy will be evaluated to determine if it is possibly an ECI of a potentially immunologic etiology or related to combination antiretroviral therapy (cART). All summaries will be presented for each cohort and overall. If the numbers are sufficient, the results may additionally be stratified by tumor type.","groups":[{"description":"Participants enrolled into Cohort 1 (50-199 CD4+ T cells/mcL), 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.\n\nAntiretroviral Therapy: Given PO\n\nBiopsy: Undergo biopsy\n\nBiospecimen Collection: Undergo blood sample collection\n\nComputed Tomography: Undergo CT or PET/CT\n\nPembrolizumab: Given IV\n\nPositron Emission Tomography: Undergo PET/CT","id":"OG000","title":"Cohort 1 (Pembrolizumab and cART)"},{"description":"Participants enrolled into Cohort 2 (200-350 CD4+ cells/mcL), 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.\n\nAntiretroviral Therapy: Given PO\n\nBiopsy: Undergo biopsy\n\nBiospecimen Collection: Undergo blood sample collection\n\nComputed Tomography: Undergo CT or PET/CT\n\nPembrolizumab: Given IV\n\nPositron Emission Tomography: Undergo PET/CT","id":"OG001","title":"Cohort 2 (Pembrolizumab and cART)"},{"description":"Participants enrolled into Cohort 3 (\\> 350 CD4+ cells/mcl), 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.\n\nAntiretroviral Therapy: Given PO\n\nBiopsy: Undergo biopsy\n\nBiospecimen Collection: Undergo blood sample collection\n\nComputed Tomography: Undergo CT or PET/CT\n\nPembrolizumab: Given IV\n\nPositron Emission Tomography: Undergo PET/CT","id":"OG002","title":"Cohort 3 (Pembrolizumab and cART)"},{"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 undergo physical examination and blood sample collection, and may undergo CT or PET/CT. Participants may also undergo biopsies during screening and on study.\n\nAntiretroviral Therapy: Given PO\n\nBiopsy: Undergo biopsy\n\nBiospecimen Collection: Undergo blood sample collection\n\nComputed Tomography: Undergo CT or PET/CT\n\nPembrolizumab: Given IV\n\nPositron Emission Tomography: Undergo PET/CT","id":"OG003","title":"Cohort 4 (Pembrolizumab and cART)"},{"description":"Participants enrolled into Cohorts 1-4, 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 physical examination, CT or PET/CT, and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study.\n\nAntiretroviral 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":"OG004","title":"Total"}],"paramType":"NUMBER","populationDescription":"Participants who received at least 1 dose of the study drug","reportingStatus":"POSTED","timeFrame":"Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment.","title":"Incidence of Immune-related Events of Clinical Interest (irECI)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}