Participant flow

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.

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 (cART) 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

   FG000

   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 (cART) 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

   FG001

   title

   Cohort 4 (Pembrolizumab and cART)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         5

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Complicating Disease/Intercurrent Illness

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Incarceration

   5. reasons

      1. group Id

         FG000

         num Subjects

         17

      2. group Id

         FG001

         num Subjects

         7

      type

      Lack of Efficacy

   6. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         3

      type

      Physician Decision

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Switched to Alternative Treatment

   8. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         4

      type

      Study Terminated

   9. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         1

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         34

      2. group Id

         FG001

         num Subjects

         24

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      comment

      Participants who completed 2 years or 35 cycles of study treatment.

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         32

      2. group Id

         FG001

         num Subjects

         22

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Per the protocol, participants enrolled into Cohorts 1-3 were combined into one group for analysis. The number of participants enrolled to each cohort was not sufficient to perform subgroup analysis based on a CD4 count.

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

Preserved source evidence · Not medical advice