TriangleNCT02181738 · OUTCOME
Objective Response Rate (ORR) Based on IRRC Assessments in Cohorts A, B, and C Extended Collection
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
- From first dose to the date of initial objectively documented progression or the date of subsequent therapy, whichever occurred first (up to approximately 100 months)
What was measured
Represents an updated version of the primary endpoint to include additional data collection that occurred after the primary completion date. (Assessments were made until 30 Nov 2022). Clinical benefit of nivolumab, as measured by ORR per IRRC assessment, and defined as percent of participants achieving either complete remission (CR) or partial remission (PR) according to the 2007 IWG criteria. For cohort A and B, if the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy. For cohort C, no evidence of FDG-avid disease in bone marrow was required in all patients in lieu of bone marrow aspirate/ biopsy. 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. 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.
Analysis population: All treated Cohort A, B and C participants
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 | 63 |
| Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant | 80 |
| Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant | 100 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin | 65.1 | Not reported | 52.0 | 76.7 | Not reported |
| Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant | 71.3 | Not reported | 60.0 | 80.8 | Not reported |
| Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant | 75.0 | Not reported | 65.3 | 83.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 52.0
- upper Limit
- 76.7
- value
- 65.1
- group Id
- OG001
- lower Limit
- 60.0
- upper Limit
- 80.8
- value
- 71.3
- group Id
- OG002
- lower Limit
- 65.3
- upper Limit
- 83.1
- value
- 75.0
- denoms
- counts
- group Id
- OG000
- value
- 63
- group Id
- OG001
- value
- 80
- group Id
- OG002
- value
- 100
- units
- Participants
- description
- Represents an updated version of the primary endpoint to include additional data collection that occurred after the primary completion date. (Assessments were made until 30 Nov 2022). Clinical benefit of nivolumab, as measured by ORR per IRRC assessment, and defined as percent of participants achieving either complete remission (CR) or partial remission (PR) according to the 2007 IWG criteria. For cohort A and B, if the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy. For cohort C, no evidence of FDG-avid disease in bone marrow was required in all patients in lieu of bone marrow aspirate/ biopsy. 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. 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.
- 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
- NUMBER
- population Description
- All treated Cohort A, B and C participants
- reporting Status
- POSTED
- time Frame
- From first dose to the date of initial objectively documented progression or the date of subsequent therapy, whichever occurred first (up to approximately 100 months)
- title
- Objective Response Rate (ORR) Based on IRRC Assessments in Cohorts A, B, and C Extended Collection
- type
- POST_HOC
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice