TriangleNCT01704287 · OUTCOME
Best Overall Response (BOR) - Switch-to-Pembrolizumab 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
The BOR was assessed using RECIST 1.1 and was recorded from the start of the second line of study drug (pembrolizumab) 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. For the switch-to-pembrolizumab treatment groups, BOR was based on independent review committee (IRC) assessment. The BOR for switched-to pembrolizumab treatment groups is presented.
Analysis population: The analysis population consisted of all randomized participants in ICC who switched to receiving pembrolizumab. Participants were included in the treatment group to which they were re-randomized (switched) for this efficacy analysis.
Groups in this outcome
ICC→Pembrolizumab 2 mg/kg
Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received 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 PD, toxicity, or choice. (Up to \~66 months)
ICC→Pembrolizumab 10 mg/kg
Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received 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 PD, toxicity, or choice. (Up to \~66 months)
| Group | Source count |
|---|---|
| ICC→Pembrolizumab 2 mg/kg | 53 |
| ICC→Pembrolizumab 10 mg/kg | 45 |
Reported measurements
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ICC→Pembrolizumab 2 mg/kg | 1.9 | Not reported | Not reported | Not reported | Not reported |
| ICC→Pembrolizumab 10 mg/kg | 4.4 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ICC→Pembrolizumab 2 mg/kg | 17.0 | Not reported | Not reported | Not reported | Not reported |
| ICC→Pembrolizumab 10 mg/kg | 13.3 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ICC→Pembrolizumab 2 mg/kg | 15.1 | Not reported | Not reported | Not reported | Not reported |
| ICC→Pembrolizumab 10 mg/kg | 11.1 | Not reported | Not reported | Not reported | Not reported |
Progressive Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ICC→Pembrolizumab 2 mg/kg | 54.7 | Not reported | Not reported | Not reported | Not reported |
| ICC→Pembrolizumab 10 mg/kg | 55.6 | Not reported | Not reported | Not reported | Not reported |
Not Evaluable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ICC→Pembrolizumab 2 mg/kg | 11.3 | Not reported | Not reported | Not reported | Not reported |
| ICC→Pembrolizumab 10 mg/kg | 13.3 | Not reported | Not reported | Not reported | Not reported |
No Assessment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ICC→Pembrolizumab 2 mg/kg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| ICC→Pembrolizumab 10 mg/kg | 2.2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1.9
- group Id
- OG001
- value
- 4.4
- title
- Complete Response
- categories
- measurements
- group Id
- OG000
- value
- 17.0
- group Id
- OG001
- value
- 13.3
- title
- Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 15.1
- group Id
- OG001
- value
- 11.1
- title
- Stable Disease
- categories
- measurements
- group Id
- OG000
- value
- 54.7
- group Id
- OG001
- value
- 55.6
- title
- Progressive Disease
- categories
- measurements
- group Id
- OG000
- value
- 11.3
- group Id
- OG001
- value
- 13.3
- title
- Not Evaluable
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 2.2
- title
- No Assessment
- denoms
- counts
- group Id
- OG000
- value
- 53
- group Id
- OG001
- value
- 45
- units
- Participants
- description
- The BOR was assessed using RECIST 1.1 and was recorded from the start of the second line of study drug (pembrolizumab) 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. For the switch-to-pembrolizumab treatment groups, BOR was based on independent review committee (IRC) assessment. The BOR for switched-to pembrolizumab treatment groups is presented.
- groups
- description
- Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received 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 PD, toxicity, or choice. (Up to \~66 months)
- id
- OG000
- title
- ICC→Pembrolizumab 2 mg/kg
- description
- Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received 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 PD, toxicity, or choice. (Up to \~66 months)
- id
- OG001
- title
- ICC→Pembrolizumab 10 mg/kg
- param Type
- NUMBER
- population Description
- The analysis population consisted of all randomized participants in ICC who switched to receiving pembrolizumab. Participants were included in the treatment group to which they were re-randomized (switched) for this 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) - Switch-to-Pembrolizumab Treatment Period
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice