TriangleNCT02362594 · OUTCOME
Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among Participants With PD-L1-positive Tumor Expression
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
- 6 months
What was measured
RFS was defined as the time between the date of randomization and the date of first melanoma recurrence (local, regional, distant metastasis) or death (whatever the cause), whichever occurred first. For participants who remained alive and whose disease had not recurred, RFS was censored on the date of last visit/contact with disease assessments. The percentage of participants with RFS at Month 6 was reported for all participants with PD-L1-positive tumors in both treatment arms of Part 1.
Analysis population: All randomized participants in Part 1 with PD-L1-positive tumors.
Groups in this outcome
Pembrolizumab
In Part 1, participants received pembrolizumab 200 mg IV as post-surgery therapy Q3W for up to 1 year.
Placebo
In Part 1, participants received placebo IV as post-surgery therapy Q3W.
| Group | Source count |
|---|---|
| Pembrolizumab | 428 |
| Placebo | 425 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab | 83.8 | Not reported | 80.0 | 87.0 | Not reported |
| Placebo | 75.4 | Not reported | 71.0 | 79.2 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.42
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95.0
- ci Upper Limit
- 0.69
- group Description
- Comparison of RFS time-to-event distribution between the 2 treatment arms (PD-L1-positive participants) was based on Cox regression model with treatment as a covariate stratified by stage (IIIA \[\>1 mm metastasis\] vs. IIIB vs. IIIC 1-3 nodes vs. IIIC ≥4 nodes) as indicated at randomization.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- One-sided p-value based on log-rank test.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.54
- statistical Method
- Regression, Cox
Complete source fields
- analyses
- ci Lower Limit
- 0.42
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95.0
- ci Upper Limit
- 0.69
- group Description
- Comparison of RFS time-to-event distribution between the 2 treatment arms (PD-L1-positive participants) was based on Cox regression model with treatment as a covariate stratified by stage (IIIA \[\>1 mm metastasis\] vs. IIIB vs. IIIC 1-3 nodes vs. IIIC ≥4 nodes) as indicated at randomization.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- One-sided p-value based on log-rank test.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.54
- statistical Method
- Regression, Cox
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 80.0
- upper Limit
- 87.0
- value
- 83.8
- group Id
- OG001
- lower Limit
- 71.0
- upper Limit
- 79.2
- value
- 75.4
- denoms
- counts
- group Id
- OG000
- value
- 428
- group Id
- OG001
- value
- 425
- units
- Participants
- description
- RFS was defined as the time between the date of randomization and the date of first melanoma recurrence (local, regional, distant metastasis) or death (whatever the cause), whichever occurred first. For participants who remained alive and whose disease had not recurred, RFS was censored on the date of last visit/contact with disease assessments. The percentage of participants with RFS at Month 6 was reported for all participants with PD-L1-positive tumors in both treatment arms of Part 1.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- In Part 1, participants received pembrolizumab 200 mg IV as post-surgery therapy Q3W for up to 1 year.
- id
- OG000
- title
- Pembrolizumab
- description
- In Part 1, participants received placebo IV as post-surgery therapy Q3W.
- id
- OG001
- title
- Placebo
- param Type
- NUMBER
- population Description
- All randomized participants in Part 1 with PD-L1-positive tumors.
- reporting Status
- POSTED
- time Frame
- 6 months
- title
- Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among Participants With PD-L1-positive Tumor Expression
- type
- PRIMARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice