TriangleNCT02320058 · OUTCOME
Intracranial Progression Free Survival (PFS)
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 66 months
What was measured
Intracranial progression-free survival (PFS) per modified RECIST 1.1 criteria is defined as the time between the date of first dose of study drug and the first date of documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Participant who die without a reported progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die will be censored on the date of first dose of study drug. Participants who started anti-cancer therapy without a prior reported progression will be censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.
Analysis population: All treated participants
Groups in this outcome
Cohort A
Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
Cohort B
Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
| Group | Source count |
|---|---|
| Cohort A | 101 |
| Cohort B | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A | NA | Not reported | 6.87 | NA | Median and Upper Limit not reached per the Kaplan-Meier method, as the probability of survival was still above 50% |
| Cohort B | 1.18 | Not reported | 0.72 | 1.25 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Median and Upper Limit not reached per the Kaplan-Meier method, as the probability of survival was still above 50%
- group Id
- OG000
- lower Limit
- 6.87
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 0.72
- upper Limit
- 1.25
- value
- 1.18
- denoms
- counts
- group Id
- OG000
- value
- 101
- group Id
- OG001
- value
- 18
- units
- Participants
- description
- Intracranial progression-free survival (PFS) per modified RECIST 1.1 criteria is defined as the time between the date of first dose of study drug and the first date of documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Participant who die without a reported progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die will be censored on the date of first dose of study drug. Participants who started anti-cancer therapy without a prior reported progression will be 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
- Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
- id
- OG000
- title
- Cohort A
- description
- Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
- id
- OG001
- title
- Cohort B
- param Type
- MEDIAN
- population Description
- All treated participants
- reporting Status
- POSTED
- time Frame
- Up to 66 months
- title
- Intracranial Progression Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice