TriangleNCT03553836 · OUTCOME
Recurrence-free Survival (RFS)
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 ~32.7 months
What was measured
RFS was defined as the time from randomization to any of the following events: recurrence of melanoma at any site (local, in-transit or regional lymph nodes or distant recurrence) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. Per protocol, final analysis for this primary outcome measure was performed using the initial pembrolizumab or placebo treatment with a protocol-specified analysis data cut-off date of June-21-2021.
Analysis population: All randomized participants.
Groups in this outcome
Pembrolizumab
Participants received 200 mg pembrolizumab (2 mg/kg for a maximum of 200 mg in pediatric participants) by intravenous (IV) infusion once every 3 weeks (Q3W; 21-day cycles) for up to 17 cycles (up to \~1 year) in Part 1.
Placebo
Participants received saline placebo by IV infusion Q3W (21-day cycles) for up to 17 cycles (up to \~1 year) in Part 1.
| Group | Source count |
|---|---|
| Pembrolizumab | 487 |
| Placebo | 489 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab | NA | Not reported | NA | NA | Median, Upper limit and lower limit not reached at the time of data cut-off due to insufficient number of participants with recurrence. |
| Placebo | NA | Not reported | 29.9 | NA | Median and Upper limit not reached at the time of data cut-off due to insufficient number of participants with recurrence. |
Source statistical analyses
- ci Lower Limit
- 0.45
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.82
- estimate Comment
- Hazard Ratio based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by melanoma T Stage (T3b, T4a, T4b).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.00046
- p Value Comment
- One-sided p-value based on log-rank test stratified by melanoma T Stage (T3b, T4a, T4b).
- param Type
- Hazard Ratio (HR)
- param Value
- 0.61
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.45
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.82
- estimate Comment
- Hazard Ratio based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by melanoma T Stage (T3b, T4a, T4b).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.00046
- p Value Comment
- One-sided p-value based on log-rank test stratified by melanoma T Stage (T3b, T4a, T4b).
- param Type
- Hazard Ratio (HR)
- param Value
- 0.61
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Median, Upper limit and lower limit not reached at the time of data cut-off due to insufficient number of participants with recurrence.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Median and Upper limit not reached at the time of data cut-off due to insufficient number of participants with recurrence.
- group Id
- OG001
- lower Limit
- 29.9
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 487
- group Id
- OG001
- value
- 489
- units
- Participants
- description
- RFS was defined as the time from randomization to any of the following events: recurrence of melanoma at any site (local, in-transit or regional lymph nodes or distant recurrence) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. Per protocol, final analysis for this primary outcome measure was performed using the initial pembrolizumab or placebo treatment with a protocol-specified analysis data cut-off date of June-21-2021.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 200 mg pembrolizumab (2 mg/kg for a maximum of 200 mg in pediatric participants) by intravenous (IV) infusion once every 3 weeks (Q3W; 21-day cycles) for up to 17 cycles (up to \~1 year) in Part 1.
- id
- OG000
- title
- Pembrolizumab
- description
- Participants received saline placebo by IV infusion Q3W (21-day cycles) for up to 17 cycles (up to \~1 year) in Part 1.
- id
- OG001
- title
- Placebo
- param Type
- MEDIAN
- population Description
- All randomized participants.
- reporting Status
- POSTED
- time Frame
- Up to ~32.7 months
- title
- Recurrence-free Survival (RFS)
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice