TriangleNCT01704287 · OUTCOME
Best Overall Response (BOR) - 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
- Not reported
- Time frame
- Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)
What was measured
BOR was assessed by independent radiology review using RECIST 1.1 and was recorded from randomization until the last imaging assessment in this period. Response categories included: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions; and Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. BOR for the Initial Treatment Period was based on IRO. BOR for participants during the Initial Treatment Period is presented.
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
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab 2 mg/kg | 3.3 | Not reported | 16.4 | 29.0 | Not reported |
| Pembrolizumab 10 mg/kg | 7.2 | Not reported | 21.3 | 34.7 | Not reported |
| Investigator-Choice Chemotherapy (ICC) | 0.0 | Not reported | 1.9 | 8.6 | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab 2 mg/kg | 18.9 | Not reported | Not reported | Not reported | Not reported |
| Pembrolizumab 10 mg/kg | 20.4 | Not reported | Not reported | Not reported | Not reported |
| Investigator-Choice Chemotherapy (ICC) | 4.5 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab 2 mg/kg | 16.7 | Not reported | Not reported | Not reported | Not reported |
| Pembrolizumab 10 mg/kg | 14.9 | Not reported | Not reported | Not reported | Not reported |
| Investigator-Choice Chemotherapy (ICC) | 19.0 | Not reported | Not reported | Not reported | Not reported |
Progressive Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab 2 mg/kg | 46.7 | Not reported | Not reported | Not reported | Not reported |
| Pembrolizumab 10 mg/kg | 47.5 | Not reported | Not reported | Not reported | Not reported |
| Investigator-Choice Chemotherapy (ICC) | 61.5 | Not reported | Not reported | Not reported | Not reported |
Not Evaluable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab 2 mg/kg | 13.3 | Not reported | Not reported | Not reported | Not reported |
| Pembrolizumab 10 mg/kg | 9.9 | Not reported | Not reported | Not reported | Not reported |
| Investigator-Choice Chemotherapy (ICC) | 15.1 | Not reported | Not reported | Not reported | Not reported |
No Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab 2 mg/kg | 0.6 | Not reported | Not reported | Not reported | Not reported |
| Pembrolizumab 10 mg/kg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Investigator-Choice Chemotherapy (ICC) | 0.0 | Not reported | Not reported | Not reported | Not reported |
No Assessment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab 2 mg/kg | 0.6 | Not reported | Not reported | Not reported | Not reported |
| Pembrolizumab 10 mg/kg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Investigator-Choice Chemotherapy (ICC) | 0.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 16.4
- upper Limit
- 29.0
- value
- 3.3
- group Id
- OG001
- lower Limit
- 21.3
- upper Limit
- 34.7
- value
- 7.2
- group Id
- OG002
- lower Limit
- 1.9
- upper Limit
- 8.6
- value
- 0.0
- title
- Complete Response
- categories
- measurements
- group Id
- OG000
- value
- 18.9
- group Id
- OG001
- value
- 20.4
- group Id
- OG002
- value
- 4.5
- title
- Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 16.7
- group Id
- OG001
- value
- 14.9
- group Id
- OG002
- value
- 19.0
- title
- Stable Disease
- categories
- measurements
- group Id
- OG000
- value
- 46.7
- group Id
- OG001
- value
- 47.5
- group Id
- OG002
- value
- 61.5
- title
- Progressive Disease
- categories
- measurements
- group Id
- OG000
- value
- 13.3
- group Id
- OG001
- value
- 9.9
- group Id
- OG002
- value
- 15.1
- title
- Not Evaluable
- categories
- measurements
- group Id
- OG000
- value
- 0.6
- group Id
- OG001
- value
- 0.0
- group Id
- OG002
- value
- 0.0
- title
- No Disease
- categories
- measurements
- group Id
- OG000
- value
- 0.6
- group Id
- OG001
- value
- 0.0
- group Id
- OG002
- value
- 0.0
- title
- No Assessment
- denoms
- counts
- group Id
- OG000
- value
- 180
- group Id
- OG001
- value
- 181
- group Id
- OG002
- value
- 179
- units
- Participants
- description
- BOR was assessed by independent radiology review using RECIST 1.1 and was recorded from randomization until the last imaging assessment in this period. Response categories included: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions; and Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. BOR for the Initial Treatment Period was based on IRO. BOR for participants during the Initial Treatment Period is presented.
- 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
- Best Overall Response (BOR) - Initial Treatment Period
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
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Preserved source evidence · Not medical advice