TriangleNCT01844505 · OUTCOME
Rate of Progression-Free Survival
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
- 24 months
What was measured
PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the Investigator, or death due to any cause, whichever occurred first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. Participants treated beyond progression were considered to have progressive disease at the time of the initial progression event regardless of subsequent tumor response. Participants who started anti-cancer therapy without a prior reported progression were censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.
Analysis population: All randomized participants
Groups in this outcome
Nivolumab
Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
Nivolumab + Ipilimumab
Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
Ipilimumab
Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
| Group | Source count |
|---|---|
| Nivolumab | 316 |
| Nivolumab + Ipilimumab | 314 |
| Ipilimumab | 315 |
Reported measurements
Rate at 6 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 0.52 | Not reported | 0.46 | 0.58 | Not reported |
| Nivolumab + Ipilimumab | 0.63 | Not reported | 0.57 | 0.68 | Not reported |
| Ipilimumab | 0.28 | Not reported | 0.23 | 0.33 | Not reported |
Rate at 12 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 0.43 | Not reported | 0.37 | 0.49 | Not reported |
| Nivolumab + Ipilimumab | 0.50 | Not reported | 0.44 | 0.55 | Not reported |
| Ipilimumab | 0.18 | Not reported | 0.14 | 0.22 | Not reported |
Rate at 24 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 0.37 | Not reported | 0.31 | 0.43 | Not reported |
| Nivolumab + Ipilimumab | 0.43 | Not reported | 0.37 | 0.48 | Not reported |
| Ipilimumab | 0.12 | Not reported | 0.09 | 0.17 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.46
- upper Limit
- 0.58
- value
- 0.52
- group Id
- OG001
- lower Limit
- 0.57
- upper Limit
- 0.68
- value
- 0.63
- group Id
- OG002
- lower Limit
- 0.23
- upper Limit
- 0.33
- value
- 0.28
- title
- Rate at 6 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.37
- upper Limit
- 0.49
- value
- 0.43
- group Id
- OG001
- lower Limit
- 0.44
- upper Limit
- 0.55
- value
- 0.50
- group Id
- OG002
- lower Limit
- 0.14
- upper Limit
- 0.22
- value
- 0.18
- title
- Rate at 12 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.31
- upper Limit
- 0.43
- value
- 0.37
- group Id
- OG001
- lower Limit
- 0.37
- upper Limit
- 0.48
- value
- 0.43
- group Id
- OG002
- lower Limit
- 0.09
- upper Limit
- 0.17
- value
- 0.12
- title
- Rate at 24 months
- denoms
- counts
- group Id
- OG000
- value
- 316
- group Id
- OG001
- value
- 314
- group Id
- OG002
- value
- 315
- units
- Participants
- description
- PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the Investigator, or death due to any cause, whichever occurred first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. Participants treated beyond progression were considered to have progressive disease at the time of the initial progression event regardless of subsequent tumor response. Participants who started anti-cancer therapy without a prior reported progression were censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
- id
- OG000
- title
- Nivolumab
- description
- Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
- id
- OG001
- title
- Nivolumab + Ipilimumab
- description
- Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
- id
- OG002
- title
- Ipilimumab
- param Type
- NUMBER
- population Description
- All randomized participants
- reporting Status
- POSTED
- time Frame
- 24 months
- title
- Rate of Progression-Free Survival
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice