TriangleNCT02554812 · OUTCOME
PFS for Combination C
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 first dose of study drug until first documentation of PD or death due to any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)
What was measured
PFS as assessed by investigator per RECIST v1.1, was defined as time (in months) from date of first dose of study drug to date of first documentation of PD or death due to any cause or data censoring date, whichever occurred first. PD: \>= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on study treatment (this included baseline sum if that was smallest on study treatment). The sum must also demonstrate absolute increase of \>=5 mm, or appearance of \>=1 new lesions. PFS was analyzed by Kaplan-Meier method. PFS data was censored on the date the last adequate tumor assessment for participants without an event (PD or death), for participants who started new anti-cancer treatment prior to PFS event, for participants with a PFS event after \>=2 missing tumor assessments.
Analysis population: Full analysis set included all enrolled participants who received at least one dose of study drug.
Groups in this outcome
Combination C Phase 1b: PD 0360324 50 mg + Avelumab
During Phase 1b participants received PD 0360324 50 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
Combination C Phase 1b: PD 0360324 100 mg + Avelumab
During Phase 1b participants received PD 0360324 100 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
Combination C Phase 1b: PD 0360324 150 mg + Avelumab
During Phase 1b participants received PD 0360324 150 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
| Group | Source count |
|---|---|
| Combination C Phase 1b: PD 0360324 50 mg + Avelumab | 10 |
| Combination C Phase 1b: PD 0360324 100 mg + Avelumab | 8 |
| Combination C Phase 1b: PD 0360324 150 mg + Avelumab | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination C Phase 1b: PD 0360324 50 mg + Avelumab | 1.9 | Not reported | 0.5 | NA | Upper limit of 95% CI was not estimable as there were less number of participants with an event. |
| Combination C Phase 1b: PD 0360324 100 mg + Avelumab | 9.0 | Not reported | 1.1 | NA | Upper limit of 95% CI was not estimable as there were less number of participants with an event. |
| Combination C Phase 1b: PD 0360324 150 mg + Avelumab | 12.2 | Not reported | 1.7 | NA | Upper limit of 95% CI was not estimable as there were less number of participants with an event. |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit of 95% CI was not estimable as there were less number of participants with an event.
- group Id
- OG000
- lower Limit
- 0.5
- upper Limit
- NA
- value
- 1.9
- comment
- Upper limit of 95% CI was not estimable as there were less number of participants with an event.
- group Id
- OG001
- lower Limit
- 1.1
- upper Limit
- NA
- value
- 9.0
- comment
- Upper limit of 95% CI was not estimable as there were less number of participants with an event.
- group Id
- OG002
- lower Limit
- 1.7
- upper Limit
- NA
- value
- 12.2
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 6
- units
- Participants
- description
- PFS as assessed by investigator per RECIST v1.1, was defined as time (in months) from date of first dose of study drug to date of first documentation of PD or death due to any cause or data censoring date, whichever occurred first. PD: \>= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on study treatment (this included baseline sum if that was smallest on study treatment). The sum must also demonstrate absolute increase of \>=5 mm, or appearance of \>=1 new lesions. PFS was analyzed by Kaplan-Meier method. PFS data was censored on the date the last adequate tumor assessment for participants without an event (PD or death), for participants who started new anti-cancer treatment prior to PFS event, for participants with a PFS event after \>=2 missing tumor assessments.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- During Phase 1b participants received PD 0360324 50 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
- id
- OG000
- title
- Combination C Phase 1b: PD 0360324 50 mg + Avelumab
- description
- During Phase 1b participants received PD 0360324 100 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
- id
- OG001
- title
- Combination C Phase 1b: PD 0360324 100 mg + Avelumab
- description
- During Phase 1b participants received PD 0360324 150 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
- id
- OG002
- title
- Combination C Phase 1b: PD 0360324 150 mg + Avelumab
- param Type
- MEDIAN
- population Description
- Full analysis set included all enrolled participants who received at least one dose of study drug.
- reporting Status
- POSTED
- time Frame
- From first dose of study drug until first documentation of PD or death due to any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)
- title
- PFS for Combination C
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice