TriangleNCT02231749 · OUTCOME
Progression-Free Survival (PFS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)
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 randomization to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to approximately 125 months and 6 days)
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 IRRC (as per RECIST 1.1 criteria), or death due to any cause, whichever occurred first. Subsequent therapy included anticancer therapy, tumor directed radiotherapy, or tumor directed surgery. Subjects who died without a reported progression were considered to have progressed on the date of their death.
Analysis population: All Randomized
Groups in this outcome
Nivolumab + Ipilimumab
Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Sunitinib
Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
| Group | Source count |
|---|---|
| Nivolumab + Ipilimumab | 550 |
| Sunitinib | 546 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab + Ipilimumab | 12.42 | Not reported | 9.89 | 16.56 | Not reported |
| Sunitinib | 12.32 | Not reported | 9.79 | 15.24 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.89
- upper Limit
- 16.56
- value
- 12.42
- group Id
- OG001
- lower Limit
- 9.79
- upper Limit
- 15.24
- value
- 12.32
- denoms
- counts
- group Id
- OG000
- value
- 550
- group Id
- OG001
- value
- 546
- 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 IRRC (as per RECIST 1.1 criteria), or death due to any cause, whichever occurred first. Subsequent therapy included anticancer therapy, tumor directed radiotherapy, or tumor directed surgery. Subjects who died without a reported progression were considered to have progressed on the date of their death.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
- id
- OG000
- title
- Nivolumab + Ipilimumab
- description
- Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
- id
- OG001
- title
- Sunitinib
- param Type
- MEDIAN
- population Description
- All Randomized
- reporting Status
- POSTED
- time Frame
- From the date of randomization to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to approximately 125 months and 6 days)
- title
- Progression-Free Survival (PFS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice