TriangleNCT02181738 · OUTCOME
Duration of Objective Response Based on IRRC Assessments in Cohorts A, B, and C
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
- From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months).
What was measured
DOR is the time from first response (complete remission (CR) or partial remission (PR)) to the date of initial objectively documented progression as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. For participants who neither progressed nor died, the DOR was censored on the date of their last tumor assessment. Participants who started subsequent therapy without a prior reported progression were censored at the last tumor assessments prior to initiation of the subsequent anticancer therapy. CR is the percent of participants with a best overall response (BOR) of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment. PR is the percent of participants with a best overall response (BOR) of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment. Computed using Kaplan-Meier method.
Analysis population: All treated Cohort A, B and C participants with objective response of CR or PR.
Groups in this outcome
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
| Group | Source count |
|---|---|
| Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin | 41 |
| Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant | 57 |
| Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant | 75 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin | 26.18 | Not reported | 15.21 | NA | The upper 95% confidence interval was not reached due to Insufficient number of participants with events to reach the threshold according to Kaplan-Meier methodology. |
| Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant | 16.59 | Not reported | 9.26 | 25.72 | Not reported |
| Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant | 18.17 | Not reported | 11.63 | 30.85 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- The upper 95% confidence interval was not reached due to Insufficient number of participants with events to reach the threshold according to Kaplan-Meier methodology.
- group Id
- OG000
- lower Limit
- 15.21
- upper Limit
- NA
- value
- 26.18
- group Id
- OG001
- lower Limit
- 9.26
- upper Limit
- 25.72
- value
- 16.59
- group Id
- OG002
- lower Limit
- 11.63
- upper Limit
- 30.85
- value
- 18.17
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 57
- group Id
- OG002
- value
- 75
- units
- Participants
- description
- DOR is the time from first response (complete remission (CR) or partial remission (PR)) to the date of initial objectively documented progression as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. For participants who neither progressed nor died, the DOR was censored on the date of their last tumor assessment. Participants who started subsequent therapy without a prior reported progression were censored at the last tumor assessments prior to initiation of the subsequent anticancer therapy. CR is the percent of participants with a best overall response (BOR) of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment. PR is the percent of participants with a best overall response (BOR) of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment. Computed using Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
- id
- OG000
- title
- Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
- description
- Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
- id
- OG001
- title
- Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
- description
- Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
- id
- OG002
- title
- Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
- param Type
- MEDIAN
- population Description
- All treated Cohort A, B and C participants with objective response of CR or PR.
- reporting Status
- POSTED
- time Frame
- From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months).
- title
- Duration of Objective Response Based on IRRC Assessments in Cohorts A, B, and C
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice