TriangleNCT02453594 · OUTCOME
Duration of Response (DOR) Assessed by the Investigator
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Full Range
- Time frame
- Up to approximately 99 months
What was measured
DOR for the subgroup of participants who achieved a CR or PR by independent central review, is the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of PD or to death due to any cause, whichever comes first assessed by the investigator based on the IWG criteria. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. The analysis used the Kaplan-Meier method, with participants with response censored at their last assessment, and there was no progressive disease at the time of the last disease assessment.
Analysis population: All allocated participants who received at least 1 dose of study treatment and had a CR or PR response.
Groups in this outcome
Cohort 1
Participants with RRcHL who failed to achieve a response or progressed after auto-SCT and have relapsed after treatment with or failed to respond to BV post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.
Cohort 2
Participants with RRcHL who were unable to achieve Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.
Cohort 3
Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle, up to 35 cycles for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment.
| Group | Source count |
|---|---|
| Cohort 1 | 50 |
| Cohort 2 | 54 |
| Cohort 3 | 43 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 25.0 | Not reported | 0.0 | 88.8 | Not reported |
| Cohort 2 | 16.4 | Not reported | 0.0 | 86.1 | Not reported |
| Cohort 3 | 24.7 | Not reported | 2.8 | 91.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 88.8
- value
- 25.0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 86.1
- value
- 16.4
- group Id
- OG002
- lower Limit
- 2.8
- upper Limit
- 91.2
- value
- 24.7
- denoms
- counts
- group Id
- OG000
- value
- 50
- group Id
- OG001
- value
- 54
- group Id
- OG002
- value
- 43
- units
- Participants
- description
- DOR for the subgroup of participants who achieved a CR or PR by independent central review, is the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of PD or to death due to any cause, whichever comes first assessed by the investigator based on the IWG criteria. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. The analysis used the Kaplan-Meier method, with participants with response censored at their last assessment, and there was no progressive disease at the time of the last disease assessment.
- dispersion Type
- Full Range
- groups
- description
- Participants with RRcHL who failed to achieve a response or progressed after auto-SCT and have relapsed after treatment with or failed to respond to BV post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.
- id
- OG000
- title
- Cohort 1
- description
- Participants with RRcHL who were unable to achieve Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months.
- id
- OG001
- title
- Cohort 2
- description
- Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle, up to 35 cycles for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment.
- id
- OG002
- title
- Cohort 3
- param Type
- MEDIAN
- population Description
- All allocated participants who received at least 1 dose of study treatment and had a CR or PR response.
- reporting Status
- POSTED
- time Frame
- Up to approximately 99 months
- title
- Duration of Response (DOR) Assessed by the Investigator
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice