TriangleNCT01704287 · OUTCOME
Overall Response Rate (ORR) - Initial Treatment Period
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
- Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)
What was measured
ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. Analysis of ORR was not planned or conducted for the switch-to-pembrolizumab treatment groups. The percentage of participants who experienced a CR or PR is presented. This was the final analysis for ORR.
Analysis population: The analysis population consisted of all randomized participants. 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 | 180 |
| Pembrolizumab 10 mg/kg | 181 |
| Investigator-Choice Chemotherapy (ICC) | 179 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab 2 mg/kg | 22.2 | Not reported | 16.4 | 29.0 | Not reported |
| Pembrolizumab 10 mg/kg | 27.6 | Not reported | 21.3 | 34.7 | Not reported |
| Investigator-Choice Chemotherapy (ICC) | 4.5 | Not reported | 1.9 | 8.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 16.4
- upper Limit
- 29.0
- value
- 22.2
- group Id
- OG001
- lower Limit
- 21.3
- upper Limit
- 34.7
- value
- 27.6
- group Id
- OG002
- lower Limit
- 1.9
- upper Limit
- 8.6
- value
- 4.5
- denoms
- counts
- group Id
- OG000
- value
- 180
- group Id
- OG001
- value
- 181
- group Id
- OG002
- value
- 179
- units
- Participants
- description
- ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. Analysis of ORR was not planned or conducted for the switch-to-pembrolizumab treatment groups. The percentage of participants who experienced a CR or PR is presented. This was the final analysis for ORR.
- dispersion Type
- 95% Confidence Interval
- 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
- NUMBER
- population Description
- The analysis population consisted of all randomized participants. 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
- Overall Response Rate (ORR) - Initial Treatment Period
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice