TriangleNCT04221945 · OUTCOME
Overall Survival (OS) at Month 36
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
- 36 months
What was measured
OS is the time from randomization to death due to any cause. The analysis was performed via Kaplan-Meier approach to estimate the OS rate at Month 36. The percentage of participants with OS at Month 36 is presented.
Analysis population: All randomized participants analyzed in the treatment group to which they were randomized.
Groups in this outcome
Chemoradiotherapy + Pembrolizumab
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of pembrolizumab, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).
Chemoradiotherapy + Placebo for Pembrolizumab
Participants received placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).
| Group | Source count |
|---|---|
| Chemoradiotherapy + Pembrolizumab | 529 |
| Chemoradiotherapy + Placebo for Pembrolizumab | 531 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Chemoradiotherapy + Pembrolizumab | 81.8 | Not reported | 78.1 | 84.9 | Not reported |
| Chemoradiotherapy + Placebo for Pembrolizumab | 74.4 | Not reported | 70.3 | 78.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 2.3
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 12.5
- estimate Comment
- Pembrolizumab minus Placebo
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- param Type
- Difference in Survival Rate
- param Value
- 7.4
Complete source fields
- analyses
- ci Lower Limit
- 2.3
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 12.5
- estimate Comment
- Pembrolizumab minus Placebo
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- param Type
- Difference in Survival Rate
- param Value
- 7.4
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 78.1
- upper Limit
- 84.9
- value
- 81.8
- group Id
- OG001
- lower Limit
- 70.3
- upper Limit
- 78.0
- value
- 74.4
- denoms
- counts
- group Id
- OG000
- value
- 529
- group Id
- OG001
- value
- 531
- units
- Participants
- description
- OS is the time from randomization to death due to any cause. The analysis was performed via Kaplan-Meier approach to estimate the OS rate at Month 36. The percentage of participants with OS at Month 36 is presented.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of pembrolizumab, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).
- id
- OG000
- title
- Chemoradiotherapy + Pembrolizumab
- description
- Participants received placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).
- id
- OG001
- title
- Chemoradiotherapy + Placebo for Pembrolizumab
- param Type
- NUMBER
- population Description
- All randomized participants analyzed in the treatment group to which they were randomized.
- reporting Status
- POSTED
- time Frame
- 36 months
- title
- Overall Survival (OS) at Month 36
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
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Preserved source evidence · Not medical advice