TriangleNCT01905657 · OUTCOME
Duration of Response (DOR) by RECIST 1.1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Weeks
- Interval / dispersion
- Full Range
- Time frame
- Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)
What was measured
DOR is measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that death or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). Non-responders were not included in the analysis. DOR was analyzed using the Kaplan-Meier method and is reported in weeks. Per protocol, final analysis for this secondary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.
Analysis population: Per protocol, DOR for the first pembrolizumab course and docetaxel treatment arms was analyzed in all randomized participants who demonstrated a CR/PR and had strongly PD-L1 positive and all PD-L1 positive DOR data available and usable. Participants were included in the treatment group to which they were randomized.
Groups in this outcome
Pembrolizumab 2 mg/kg
Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
Pembrolizumab 10 mg/kg
Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
Docetaxel 75 mg/m^2
Participants received docetaxel 75 mg/m\^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
| Group | Source count |
|---|---|
| Pembrolizumab 2 mg/kg | 62 |
| Pembrolizumab 10 mg/kg | 64 |
| Docetaxel 75 mg/m^2 | 32 |
Reported measurements
Strongly PD-L1 Positive
| Group | Source count |
|---|---|
| Pembrolizumab 2 mg/kg | 42 |
| Pembrolizumab 10 mg/kg | 44 |
| Docetaxel 75 mg/m^2 | 12 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab 2 mg/kg | NA | Not reported | 3 | NA | Median DOR and DOR upper limit not reached: No progressive disease by the time of last disease assessment. |
| Pembrolizumab 10 mg/kg | NA | Not reported | 9 | NA | Median DOR and DOR upper limit not reached: No progressive disease by the time of last disease assessment. |
| Docetaxel 75 mg/m^2 | 35 | Not reported | 9 | NA | DOR upper limit not reached: No progressive disease by the time of last disease assessment. |
All PD-L1 Positive
| Group | Source count |
|---|---|
| Pembrolizumab 2 mg/kg | 62 |
| Pembrolizumab 10 mg/kg | 64 |
| Docetaxel 75 mg/m^2 | 32 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab 2 mg/kg | NA | Not reported | 3 | NA | Median DOR and DOR upper limit not reached: No progressive disease by the time of last disease assessment. |
| Pembrolizumab 10 mg/kg | NA | Not reported | 9 | NA | Median DOR and DOR upper limit not reached: No progressive disease by the time of last disease assessment. |
| Docetaxel 75 mg/m^2 | 27 | Not reported | 6 | NA | DOR upper limit not reached: No progressive disease by the time of last disease assessment. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median DOR and DOR upper limit not reached: No progressive disease by the time of last disease assessment.
- group Id
- OG000
- lower Limit
- 3
- upper Limit
- NA
- value
- NA
- comment
- Median DOR and DOR upper limit not reached: No progressive disease by the time of last disease assessment.
- group Id
- OG001
- lower Limit
- 9
- upper Limit
- NA
- value
- NA
- comment
- DOR upper limit not reached: No progressive disease by the time of last disease assessment.
- group Id
- OG002
- lower Limit
- 9
- upper Limit
- NA
- value
- 35
- denoms
- counts
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 44
- group Id
- OG002
- value
- 12
- units
- Participants
- title
- Strongly PD-L1 Positive
- categories
- measurements
- comment
- Median DOR and DOR upper limit not reached: No progressive disease by the time of last disease assessment.
- group Id
- OG000
- lower Limit
- 3
- upper Limit
- NA
- value
- NA
- comment
- Median DOR and DOR upper limit not reached: No progressive disease by the time of last disease assessment.
- group Id
- OG001
- lower Limit
- 9
- upper Limit
- NA
- value
- NA
- comment
- DOR upper limit not reached: No progressive disease by the time of last disease assessment.
- group Id
- OG002
- lower Limit
- 6
- upper Limit
- NA
- value
- 27
- denoms
- counts
- group Id
- OG000
- value
- 62
- group Id
- OG001
- value
- 64
- group Id
- OG002
- value
- 32
- units
- Participants
- title
- All PD-L1 Positive
- denoms
- counts
- group Id
- OG000
- value
- 62
- group Id
- OG001
- value
- 64
- group Id
- OG002
- value
- 32
- units
- Participants
- description
- DOR is measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that death or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). Non-responders were not included in the analysis. DOR was analyzed using the Kaplan-Meier method and is reported in weeks. Per protocol, final analysis for this secondary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.
- dispersion Type
- Full Range
- groups
- description
- Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
- id
- OG000
- title
- Pembrolizumab 2 mg/kg
- description
- Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
- id
- OG001
- title
- Pembrolizumab 10 mg/kg
- description
- Participants received docetaxel 75 mg/m\^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
- id
- OG002
- title
- Docetaxel 75 mg/m^2
- param Type
- MEDIAN
- population Description
- Per protocol, DOR for the first pembrolizumab course and docetaxel treatment arms was analyzed in all randomized participants who demonstrated a CR/PR and had strongly PD-L1 positive and all PD-L1 positive DOR data available and usable. Participants were included in the treatment group to which they were randomized.
- reporting Status
- POSTED
- time Frame
- Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)
- title
- Duration of Response (DOR) by RECIST 1.1
- type
- SECONDARY
- unit Of Measure
- Weeks
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Preserved source evidence · Not medical advice