NCT02554812 · OUTCOME
Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination F
A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley) · Source last updated 2024-07-30
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
- 1-hour post-infusion (i.e. at the end of infusion) on Days 1 and 15 of Cycle 1 (non-dosing); Day 1 of Cycles 2, 4, 6 and Cycle 10
What was measured
Cmax is maximum observed plasma 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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab | 6 |
|---|
| 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 | 6 |
|---|
Reported measurements
Cycle 1/Day1-1 Hour/EOI
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab | 6 |
|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg | 5 |
|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg | 6 |
|---|
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab | 161.2 | 14 | Not reported | Not reported | Not reported |
|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg | 166.1 | 15 | Not reported | Not reported | Not reported |
|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg | 180.7 | 49 | Not reported | Not reported | Not reported |
|---|
Cycle 1/Day15-1 Hour/EOI
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab | 5 |
|---|
| 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 | 5 |
|---|
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab | 182.6 | 11 | Not reported | Not reported | Not reported |
|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg | 171.2 | 27 | Not reported | Not reported | Not reported |
|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg | 151.6 | 16 | Not reported | Not reported | Not reported |
|---|
Cycle 2/Day1-1 Hour/EOI
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab | 5 |
|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg | 5 |
|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg | 4 |
|---|
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab | 165.5 | 10 | Not reported | Not reported | Not reported |
|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg | 176.7 | 22 | Not reported | Not reported | Not reported |
|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg | 171.0 | 26 | Not reported | Not reported | Not reported |
|---|
Cycle 4/Day1-1 Hour/EOI
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab | 2 |
|---|
| 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 |
|---|
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab | 185.0 | 24 | Not reported | Not reported | Not reported |
|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg | 203.9 | 27 | Not reported | Not reported | Not reported |
|---|
Cycle 6/Day1-1 Hour/EOI
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab | 1 |
|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg | 1 |
|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg | 0 |
|---|
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab | 229.0 | NA | Not reported | Not reported | Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed. |
|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg | 174.0 | NA | Not reported | Not reported | Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed. |
|---|
Cycle 10/Day1-1 Hour/EOI
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab | 1 |
|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg | 0 |
|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg | 0 |
|---|
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab | 191.0 | NA | Not reported | Not reported | Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed. |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 14
- value
- 161.2
- group Id
- OG001
- spread
- 15
- value
- 166.1
- group Id
- OG002
- spread
- 49
- value
- 180.7
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 6
- units
- Participants
- title
- Cycle 1/Day1-1 Hour/EOI
- categories
- measurements
- group Id
- OG000
- spread
- 11
- value
- 182.6
- group Id
- OG001
- spread
- 27
- value
- 171.2
- group Id
- OG002
- spread
- 16
- value
- 151.6
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 5
- units
- Participants
- title
- Cycle 1/Day15-1 Hour/EOI
- categories
- measurements
- group Id
- OG000
- spread
- 10
- value
- 165.5
- group Id
- OG001
- spread
- 22
- value
- 176.7
- group Id
- OG002
- spread
- 26
- value
- 171.0
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 4
- units
- Participants
- title
- Cycle 2/Day1-1 Hour/EOI
- categories
- measurements
- group Id
- OG000
- spread
- 24
- value
- 185.0
- group Id
- OG001
- spread
- 27
- value
- 203.9
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- Cycle 4/Day1-1 Hour/EOI
- categories
- measurements
- comment
- Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed.
- group Id
- OG000
- spread
- NA
- value
- 229.0
- comment
- Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed.
- group Id
- OG001
- spread
- NA
- value
- 174.0
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- Cycle 6/Day1-1 Hour/EOI
- categories
- measurements
- comment
- Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed.
- group Id
- OG000
- spread
- NA
- value
- 191.0
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- Cycle 10/Day1-1 Hour/EOI
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 6
- units
- Participants
- description
- Cmax is maximum observed plasma 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
- 1-hour post-infusion (i.e. at the end of infusion) on Days 1 and 15 of Cycle 1 (non-dosing); Day 1 of Cycles 2, 4, 6 and Cycle 10
- title
- Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination F
- type
- SECONDARY
- unit Of Measure
- Nanogram per milliliter
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