TriangleNCT03749460 · OUTCOME
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
- From the date of study enrollment, until disease progression or death, assessed up to 4 years
What was measured
PFS estimate will be calculated using the Kaplan-Meier method. Progression is defined 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 lesion
Groups in this outcome
Treatment (Nivolumab, Ipilimumab, SBRT)
Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for up to 12 courses and then every 4 weeks for an additional 8 courses in the absence of disease progression or unacceptable toxicity. Patients also receive ipilimumab IV over 60 minutes on day 1. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Beginning week 3, patients undergo 3 fractions of stereotactic body radiation therapy every other day in the absence of disease progression or unacceptable toxicity. Nivolumab: Given IV Ipilimumab: Given IV Stereotactic Body Radiation Therapy: Undergo SBRT
| Group | Source count |
|---|---|
| Treatment (Nivolumab, Ipilimumab, SBRT) | 20 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Nivolumab, Ipilimumab, SBRT) | 7.2 | Not reported | 2.52 | 18.24 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.52
- upper Limit
- 18.24
- value
- 7.2
- denoms
- counts
- group Id
- OG000
- value
- 20
- units
- Participants
- description
- PFS estimate will be calculated using the Kaplan-Meier method. Progression is defined 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 lesion
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for up to 12 courses and then every 4 weeks for an additional 8 courses in the absence of disease progression or unacceptable toxicity. Patients also receive ipilimumab IV over 60 minutes on day 1. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Beginning week 3, patients undergo 3 fractions of stereotactic body radiation therapy every other day in the absence of disease progression or unacceptable toxicity. Nivolumab: Given IV Ipilimumab: Given IV Stereotactic Body Radiation Therapy: Undergo SBRT
- id
- OG000
- title
- Treatment (Nivolumab, Ipilimumab, SBRT)
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- From the date of study enrollment, until disease progression or death, assessed up to 4 years
- title
- Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice