TriangleNCT03635567 · OUTCOME
PFS Per RECIST 1.1 as Assessed by Investigator in 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
- 95% Confidence Interval
- Time frame
- Up to approximately 46 months
What was measured
PFS was 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, PD was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator for all randomized participants is presented.
Analysis population: All randomized participants based on the treatment group to which they were randomized.
Groups in this outcome
Pembrolizumab+Chemotherapy
On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
Placebo+Chemotherapy
On Day 1 of each 21-day cycle, participants received an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity.
| Group | Source count |
|---|---|
| Pembrolizumab+Chemotherapy | 308 |
| Placebo+Chemotherapy | 309 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab+Chemotherapy | 10.4 | Not reported | 9.1 | 12.2 | Not reported |
| Placebo+Chemotherapy | 8.2 | Not reported | 6.4 | 8.4 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.50
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.74
- group Description
- Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- <0.0001
- p Value Comment
- No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.61
- statistical Comment
- Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.
- statistical Method
- Stratified Log-Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.50
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.74
- group Description
- Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- <0.0001
- p Value Comment
- No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.61
- statistical Comment
- Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.
- statistical Method
- Stratified Log-Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.1
- upper Limit
- 12.2
- value
- 10.4
- group Id
- OG001
- lower Limit
- 6.4
- upper Limit
- 8.4
- value
- 8.2
- denoms
- counts
- group Id
- OG000
- value
- 308
- group Id
- OG001
- value
- 309
- units
- Participants
- description
- PFS was 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, PD was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator for all randomized participants is presented.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
- id
- OG000
- title
- Pembrolizumab+Chemotherapy
- description
- On Day 1 of each 21-day cycle, participants received an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity.
- id
- OG001
- title
- Placebo+Chemotherapy
- param Type
- MEDIAN
- population Description
- All randomized participants based on the treatment group to which they were randomized.
- reporting Status
- POSTED
- time Frame
- Up to approximately 46 months
- title
- PFS Per RECIST 1.1 as Assessed by Investigator in All Participants
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice