TriangleNCT04221945 · OUTCOME
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately 55 months
What was measured
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, or by histopathologic confirmation of suspected disease progression, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD. The Kaplan-Meier nonparametric product limit method for censored data was used to estimate PFS.
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 | 47.6 | Not reported | 47.6 | NA | NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event. |
| Chemoradiotherapy + Placebo for Pembrolizumab | 47.5 | Not reported | 41.0 | NA | NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event. |
Source statistical analyses
- ci Lower Limit
- 0.59
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.87
- estimate Comment
- Based on Cox regression model with Efron's method of tie handling with treatment as a covariate
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0004
- p Value Comment
- One sided p-value
- param Type
- Hazard Ratio (HR)
- param Value
- 0.72
- statistical Comment
- Stratified by planned type of external beam radiation therapy (EBRT), stage at screening, and planned total radiotherapy dose.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.59
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.87
- estimate Comment
- Based on Cox regression model with Efron's method of tie handling with treatment as a covariate
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0004
- p Value Comment
- One sided p-value
- param Type
- Hazard Ratio (HR)
- param Value
- 0.72
- statistical Comment
- Stratified by planned type of external beam radiation therapy (EBRT), stage at screening, and planned total radiotherapy dose.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
- group Id
- OG000
- lower Limit
- 47.6
- upper Limit
- NA
- value
- 47.6
- comment
- NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
- group Id
- OG001
- lower Limit
- 41.0
- upper Limit
- NA
- value
- 47.5
- denoms
- counts
- group Id
- OG000
- value
- 529
- group Id
- OG001
- value
- 531
- units
- Participants
- description
- PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, or by histopathologic confirmation of suspected disease progression, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD. The Kaplan-Meier nonparametric product limit method for censored data was used to estimate PFS.
- 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
- MEDIAN
- population Description
- All randomized participants analyzed in the treatment group to which they were randomized.
- reporting Status
- POSTED
- time Frame
- Up to approximately 55 months
- title
- Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice