TriangleNCT02494583 · OUTCOME
Pembro Mono vs SOC: DOR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)
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 42 months
What was measured
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based upon BICR, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. DOR is reported here for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants) and had CR or PR. Per protocol, DOR was compared separately between CPS ≥1 responders of the pembro combo arm and SOC arm and is presented earlier in the record.
Analysis population: All CPS ≥1 participants in the ITT population randomized to the pembro mono arm and SOC arm and who demonstrated a confirmed CR or PR were analyzed. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis.
Groups in this outcome
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg IV Q3W.
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
Placebo + SOC Chemotherapy (SOC)
Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
| Group | Source count |
|---|---|
| Pembrolizumab Monotherapy (Pembro Mono) | 38 |
| Pembrolizumab + SOC Chemotherapy (Pembro Combo) | 0 |
| Placebo + SOC Chemotherapy (SOC) | 93 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab Monotherapy (Pembro Mono) | NA | Not reported | NA | NA | NA=Median DOR and DOR range lower and upper limit not reached (no progressive disease by time of last disease assessment) |
| Placebo + SOC Chemotherapy (SOC) | NA | Not reported | NA | NA | NA=Median DOR and DOR range lower and upper limit not reached (no progressive disease by time of last disease assessment) |
Complete source fields
- classes
- categories
- measurements
- comment
- NA=Median DOR and DOR range lower and upper limit not reached (no progressive disease by time of last disease assessment)
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- NA=Median DOR and DOR range lower and upper limit not reached (no progressive disease by time of last disease assessment)
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 38
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 93
- units
- Participants
- description
- For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based upon BICR, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. DOR is reported here for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants) and had CR or PR. Per protocol, DOR was compared separately between CPS ≥1 responders of the pembro combo arm and SOC arm and is presented earlier in the record.
- dispersion Type
- Full Range
- groups
- description
- Participants received pembrolizumab 200 mg IV Q3W.
- id
- OG000
- title
- Pembrolizumab Monotherapy (Pembro Mono)
- description
- Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
- id
- OG001
- title
- Pembrolizumab + SOC Chemotherapy (Pembro Combo)
- description
- Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
- id
- OG002
- title
- Placebo + SOC Chemotherapy (SOC)
- param Type
- MEDIAN
- population Description
- All CPS ≥1 participants in the ITT population randomized to the pembro mono arm and SOC arm and who demonstrated a confirmed CR or PR were analyzed. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis.
- reporting Status
- POSTED
- time Frame
- Up to approximately 42 months
- title
- Pembro Mono vs SOC: DOR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice