TriangleNCT02428192 · OUTCOME
Rate of Progression-free Survival (Cohort B)
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
- Time from start of treatment to time of progression or death, whichever occurs first, assessed at 6 months
What was measured
A null hypothesis of 18% and an alternative hypothesis of 40% at 6 months will be investigated. Patients lost to follow-up or deaths within 6 months will be counted as failures. The overall power for overall progression-free rate at 6 months is 85%, using the exact binomial distribution. The operating characteristics of this design are calculated using a one-sided exact test with 10% type I error.
Analysis population: Progression is defined as using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Groups in this outcome
Cohort B (Nivolumab and Ipilimumab)
Patients receive nivolumab IV over approximately 60 minutes followed by a saline flush and ipilimumab IV over 90 minutes. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Laboratory Biomarker Analysis: Correlative studies
| Group | Source count |
|---|---|
| Cohort B (Nivolumab and Ipilimumab) | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort B (Nivolumab and Ipilimumab) | 2.0 | Not reported | 0.9 | 2.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.9
- upper Limit
- 2.1
- value
- 2.0
- denoms
- counts
- group Id
- OG000
- value
- 8
- units
- Participants
- description
- A null hypothesis of 18% and an alternative hypothesis of 40% at 6 months will be investigated. Patients lost to follow-up or deaths within 6 months will be counted as failures. The overall power for overall progression-free rate at 6 months is 85%, using the exact binomial distribution. The operating characteristics of this design are calculated using a one-sided exact test with 10% type I error.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive nivolumab IV over approximately 60 minutes followed by a saline flush and ipilimumab IV over 90 minutes. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Laboratory Biomarker Analysis: Correlative studies
- id
- OG000
- title
- Cohort B (Nivolumab and Ipilimumab)
- param Type
- MEDIAN
- population Description
- Progression is defined as using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- reporting Status
- POSTED
- time Frame
- Time from start of treatment to time of progression or death, whichever occurs first, assessed at 6 months
- title
- Rate of Progression-free Survival (Cohort B)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice