TriangleNCT02595866 · OUTCOME
Duration of Response (Cohorts 1-3)
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
Defined in participants experiencing CR or PR using RECIST 1.1, "Lugano Criteria" for malignant lymphoma or other tumor-specific 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. 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.
Groups in this outcome
Cohorts 1-3 (Pembrolizumab and cART)
Patients enrolled into 1 of 3 cohorts based on CD4+ T-cell counts, who receive pembrolizumab IV over 30 minutes on day 1. Patients 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. Patients also undergo CT or PET/CT and blood sample collection throughout the trial. Patients 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 | Source count |
|---|---|
| Cohorts 1-3 (Pembrolizumab and cART) | 34 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohorts 1-3 (Pembrolizumab and cART) | NA | Not reported | NA | NA | Median duration of response (DOR) could not be calculated. Upper and lower confidence interval for DOR could not be obtained using Kaplan-Meier estimates. Insufficient number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median duration of response (DOR) could not be calculated. Upper and lower confidence interval for DOR could not be obtained using Kaplan-Meier estimates. Insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 34
- units
- Participants
- description
- Defined in participants experiencing CR or PR using RECIST 1.1, "Lugano Criteria" for malignant lymphoma or other tumor-specific criteria. Summarized statistically using Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients enrolled into 1 of 3 cohorts based on CD4+ T-cell counts, who receive pembrolizumab IV over 30 minutes on day 1. Patients 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. Patients also undergo CT or PET/CT and blood sample collection throughout the trial. Patients 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
- Cohorts 1-3 (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. 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.
- 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 (Cohorts 1-3)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice