TriangleNCT02684006 · OUTCOME
PFS as Assessed by BICR in Participants Irrespective of PD-L1 Expression
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 date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months)
What was measured
PFS: time from the date of randomization to the date of the first documentation of PD or death due to any cause, whichever occurred first as assessed by BICR. PFS data was censored on date of last adequate tumor assessment for participants who did not have an event (PD or death), who started new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. PD was defined as at least a 20% increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20 %, sum must have also demonstrated an absolute \> of at least 5 mm. The appearance of one or more new lesions was also considered progression.
Analysis population: FAS included all randomized participants.
Groups in this outcome
Avelumab + Axitinib
Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.
Sunitinib
Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
| Group | Source count |
|---|---|
| Avelumab + Axitinib | 442 |
| Sunitinib | 444 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Avelumab + Axitinib | 13.8 | Not reported | 11.1 | NA | The upper limit of 95% CI was not estimable due to insufficient number of participants with event. |
| Sunitinib | 8.4 | Not reported | 6.9 | 11.1 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.563
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.840
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0002
- p Value Comment
- 2-sided p-value
- param Type
- Hazard Ratio (HR)
- param Value
- 0.69
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.563
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.840
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0002
- p Value Comment
- 2-sided p-value
- param Type
- Hazard Ratio (HR)
- param Value
- 0.69
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- The upper limit of 95% CI was not estimable due to insufficient number of participants with event.
- group Id
- OG000
- lower Limit
- 11.1
- upper Limit
- NA
- value
- 13.8
- group Id
- OG001
- lower Limit
- 6.9
- upper Limit
- 11.1
- value
- 8.4
- denoms
- counts
- group Id
- OG000
- value
- 442
- group Id
- OG001
- value
- 444
- units
- Participants
- description
- PFS: time from the date of randomization to the date of the first documentation of PD or death due to any cause, whichever occurred first as assessed by BICR. PFS data was censored on date of last adequate tumor assessment for participants who did not have an event (PD or death), who started new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. PD was defined as at least a 20% increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20 %, sum must have also demonstrated an absolute \> of at least 5 mm. The appearance of one or more new lesions was also considered progression.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.
- id
- OG000
- title
- Avelumab + Axitinib
- description
- Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
- id
- OG001
- title
- Sunitinib
- param Type
- MEDIAN
- population Description
- FAS included all randomized participants.
- reporting Status
- POSTED
- time Frame
- From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months)
- title
- PFS as Assessed by BICR in Participants Irrespective of PD-L1 Expression
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice