TriangleNCT02554812 · OUTCOME
PFS for Combination D
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 D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 0.1 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.1 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
| Group | Source count |
|---|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab | 12 |
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab | 12 |
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab | 12 |
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab | 12 |
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab | 12 |
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab | 11 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab | 1.8 | Not reported | 1.1 | 9.2 | Not reported |
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab | 1.8 | Not reported | 1.3 | NA | Upper limit of 95% CI was not estimable as there were less number of participants with an event. |
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab | 3.7 | Not reported | 1.0 | 23.8 | Not reported |
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab | 1.8 | Not reported | 1.2 | NA | Upper limit of 95% CI was not estimable as there were less number of participants with an event. |
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab | 1.8 | Not reported | 1.4 | 3.1 | Not reported |
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab | 1.8 | Not reported | 0.6 | 1.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.1
- upper Limit
- 9.2
- value
- 1.8
- comment
- Upper limit of 95% CI was not estimable as there were less number of participants with an event.
- group Id
- OG001
- lower Limit
- 1.3
- upper Limit
- NA
- value
- 1.8
- group Id
- OG002
- lower Limit
- 1.0
- upper Limit
- 23.8
- value
- 3.7
- comment
- Upper limit of 95% CI was not estimable as there were less number of participants with an event.
- group Id
- OG003
- lower Limit
- 1.2
- upper Limit
- NA
- value
- 1.8
- group Id
- OG004
- lower Limit
- 1.4
- upper Limit
- 3.1
- value
- 1.8
- group Id
- OG005
- lower Limit
- 0.6
- upper Limit
- 1.9
- value
- 1.8
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 12
- group Id
- OG005
- value
- 11
- 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 utomilumab 20 mg IV Q4W along with PF-04518600 0.1 mg/kg IV Q2W and 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 D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab
- description
- During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.1 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
- id
- OG001
- title
- Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab
- description
- During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
- id
- OG002
- title
- Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab
- description
- During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
- id
- OG003
- title
- Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
- description
- During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
- id
- OG004
- title
- Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
- description
- During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
- id
- OG005
- title
- Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + 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 D
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice