TriangleNCT02554812 · OUTCOME
Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab in Combination F
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- Nanogram per milliliter
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Pre-dose on Day 1 of Cycle 1 (non-dosing); Pre-dose on Day 1 of Cycle 2 and 4
What was measured
Ctrough is steady-state pre-dose concentration.
Analysis population: PK analysis set included all participants who had received at least one dose of study drug and who had at least one of the PK concentrations of interest for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure, where "Number Analyzed" signifies number of participants evaluable for specified time points.
Groups in this outcome
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab
During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 sub-cutaneous \[SC\] administered at weekly intervals, followed by 5 intra tumoral \[IT\] administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W. Phase 2 was not planned.
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg
During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus utomilumab 100 mg administered IV Q4W. Phase 2 was not planned.
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg
During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus PF-04518600 at 0.3 mg/kg administered IV Q2W. Phase 2 was not planned.
| Group | Source count |
|---|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab | 0 |
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg | 7 |
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg | 0 |
Reported measurements
Cycle 1/Day1-0 Hour
| Group | Source count |
|---|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab | 0 |
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg | 7 |
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg | NA | NA | Not reported | Not reported | There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated. |
Cycle 2/Day1-0 Hour
| Group | Source count |
|---|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab | 0 |
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg | 6 |
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg | 748.9 | 25 | Not reported | Not reported | Not reported |
Cycle 4/Day1-0 Hour
| Group | Source count |
|---|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab | 0 |
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg | 3 |
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg | 866.0 | NA | Not reported | Not reported | Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated. |
Complete source fields
- classes
- categories
- measurements
- comment
- There were \>2 observations, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
- group Id
- OG001
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- Cycle 1/Day1-0 Hour
- categories
- measurements
- group Id
- OG001
- spread
- 25
- value
- 748.9
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- Cycle 2/Day1-0 Hour
- categories
- measurements
- comment
- Only 1 observation was equal or above LLoQ. Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
- group Id
- OG001
- spread
- NA
- value
- 866.0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- Cycle 4/Day1-0 Hour
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 0
- units
- Participants
- description
- Ctrough is steady-state pre-dose concentration.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 sub-cutaneous \[SC\] administered at weekly intervals, followed by 5 intra tumoral \[IT\] administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W. Phase 2 was not planned.
- id
- OG000
- title
- Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab
- description
- During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus utomilumab 100 mg administered IV Q4W. Phase 2 was not planned.
- id
- OG001
- title
- Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg
- description
- During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus PF-04518600 at 0.3 mg/kg administered IV Q2W. Phase 2 was not planned.
- id
- OG002
- title
- Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg
- param Type
- GEOMETRIC_MEAN
- population Description
- PK analysis set included all participants who had received at least one dose of study drug and who had at least one of the PK concentrations of interest for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure, where "Number Analyzed" signifies number of participants evaluable for specified time points.
- reporting Status
- POSTED
- time Frame
- Pre-dose on Day 1 of Cycle 1 (non-dosing); Pre-dose on Day 1 of Cycle 2 and 4
- title
- Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab in Combination F
- type
- SECONDARY
- unit Of Measure
- Nanogram per milliliter
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice