TriangleNCT01704287 · OUTCOME
Duration of Response (DOR) - Initial Treatment Period
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 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)
What was measured
For participants who demonstrated a confirmed response (Complete Response \[CR\]: disappearance of all target lesions or Partial Response \[PR\]: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. DOR analysis was based on IRO assessment. Analysis of DOR was not planned or analyzed for the switch-to-pembrolizumab treatment groups. Median DOR for participants who demonstrated a confirmed response is presented.
Analysis population: The analysis population consisted of all randomized participants who demonstrated a confirmed response (CR or PR) per RECIST 1.1. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis.
Groups in this outcome
Pembrolizumab 2 mg/kg
Participants were initially randomized to receive pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
Pembrolizumab 10 mg/kg
Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
Investigator-Choice Chemotherapy (ICC)
Participants were initially randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
| Group | Source count |
|---|---|
| Pembrolizumab 2 mg/kg | 40 |
| Pembrolizumab 10 mg/kg | 50 |
| Investigator-Choice Chemotherapy (ICC) | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab 2 mg/kg | 22.8 | Not reported | 1.4 | 25.3 | Not reported |
| Pembrolizumab 10 mg/kg | NA | Not reported | 1.1 | NA | NA=DOR Median not reached NA=DOR Upper Limit not reached: no progressive disease by time of last assessment |
| Investigator-Choice Chemotherapy (ICC) | 6.8 | Not reported | 2.8 | 11.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.4
- upper Limit
- 25.3
- value
- 22.8
- comment
- NA=DOR Median not reached NA=DOR Upper Limit not reached: no progressive disease by time of last assessment
- group Id
- OG001
- lower Limit
- 1.1
- upper Limit
- NA
- value
- NA
- group Id
- OG002
- lower Limit
- 2.8
- upper Limit
- 11.3
- value
- 6.8
- denoms
- counts
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 50
- group Id
- OG002
- value
- 8
- units
- Participants
- description
- For participants who demonstrated a confirmed response (Complete Response \[CR\]: disappearance of all target lesions or Partial Response \[PR\]: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. DOR analysis was based on IRO assessment. Analysis of DOR was not planned or analyzed for the switch-to-pembrolizumab treatment groups. Median DOR for participants who demonstrated a confirmed response is presented.
- dispersion Type
- Full Range
- groups
- description
- Participants were initially randomized to receive pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
- id
- OG000
- title
- Pembrolizumab 2 mg/kg
- description
- Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
- id
- OG001
- title
- Pembrolizumab 10 mg/kg
- description
- Participants were initially randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
- id
- OG002
- title
- Investigator-Choice Chemotherapy (ICC)
- param Type
- MEDIAN
- population Description
- The analysis population consisted of all randomized participants who demonstrated a confirmed response (CR or PR) per RECIST 1.1. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis.
- reporting Status
- POSTED
- time Frame
- Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)
- title
- Duration of Response (DOR) - Initial Treatment Period
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice