NCT02554812 · OUTCOME
Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination D
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-dose (at end of infusion) on Days 1 and 15 of Cycle 1; Day 8 of Cycle 1 (non-dosing); Pre-dose and 1 hour post-dose on Day 1 of Cycle 2, 4, 6, 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 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 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 D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab | 11 |
|---|
| 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 | 9 |
|---|
| 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 | 10 |
|---|
Reported measurements
Cycle 1/Day1-1 Hour/EOI
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab | 10 |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab | 11 |
|---|
| 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 | 8 |
|---|
| 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 | 10 |
|---|
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab | 158.3 | 26 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab | 188.2 | 26 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab | 200.8 | 22 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab | 185.1 | 38 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab | 187.4 | 18 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab | 174.2 | 32 | Not reported | Not reported | Not reported |
|---|
Cycle 1/Day8-168 Hour
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab | 11 |
|---|
| 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 | 9 |
|---|
| 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 | 9 |
|---|
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab | 46.74 | 46 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab | 37.71 | 20 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab | 39.14 | 24 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab | 41.96 | 24 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab | 41.32 | 24 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab | 36.07 | 36 | Not reported | Not reported | Not reported |
|---|
Cycle 1/Day15-1 Hour/EOI
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab | 11 |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab | 9 |
|---|
| 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 | 5 |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab | 11 |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab | 7 |
|---|
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab | 201.8 | 20 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab | 124.1 | 136 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab | 150.8 | 91 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab | 167.3 | 17 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab | 217.2 | 20 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab | 80.14 | 1114 | Not reported | Not reported | Not reported |
|---|
Cycle 2/Day1-1 Hour/EOI
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab | 11 |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab | 7 |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab | 11 |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab | 5 |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab | 9 |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab | 7 |
|---|
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab | 200.4 | 18 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab | 190.9 | 23 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab | 149.2 | 143 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab | 142.9 | 42 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab | 228.5 | 18 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab | 175.1 | 24 | Not reported | Not reported | Not reported |
|---|
Cycle 4/Day1-1 Hour/EOI
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab | 3 |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab | 4 |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab | 6 |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab | 3 |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab | 5 |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab | 3 |
|---|
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab | 188.9 | 30 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab | 210.0 | 23 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab | 193.9 | 29 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab | 192.8 | 6 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab | 223.2 | 16 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab | 178.7 | 25 | Not reported | Not reported | Not reported |
|---|
Cycle 6/Day1-1 Hour/EOI
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab | 4 |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab | 4 |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab | 4 |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab | 2 |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab | 2 |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab | 3 |
|---|
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab | 216.7 | 25 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab | 198.8 | 34 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab | 208.2 | 13 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab | 161.0 | 4 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab | 217.1 | 8 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab | 193.3 | 19 | Not reported | Not reported | Not reported |
|---|
Cycle 10/Day1-1 Hour/EOI
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab | 3 |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab | 3 |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab | 3 |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab | 2 |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab | 1 |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab | 2 |
|---|
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab | 203.7 | 10 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab | 196.0 | 53 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab | 194.5 | 26 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab | 182.0 | 2 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab | 268.0 | NA | Not reported | Not reported | Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed. |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab | 229.1 | 34 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 26
- value
- 158.3
- group Id
- OG001
- spread
- 26
- value
- 188.2
- group Id
- OG002
- spread
- 22
- value
- 200.8
- group Id
- OG003
- spread
- 38
- value
- 185.1
- group Id
- OG004
- spread
- 18
- value
- 187.4
- group Id
- OG005
- spread
- 32
- value
- 174.2
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 12
- group Id
- OG005
- value
- 10
- units
- Participants
- title
- Cycle 1/Day1-1 Hour/EOI
- categories
- measurements
- group Id
- OG000
- spread
- 46
- value
- 46.74
- group Id
- OG001
- spread
- 20
- value
- 37.71
- group Id
- OG002
- spread
- 24
- value
- 39.14
- group Id
- OG003
- spread
- 24
- value
- 41.96
- group Id
- OG004
- spread
- 24
- value
- 41.32
- group Id
- OG005
- spread
- 36
- value
- 36.07
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 12
- group Id
- OG005
- value
- 9
- units
- Participants
- title
- Cycle 1/Day8-168 Hour
- categories
- measurements
- group Id
- OG000
- spread
- 20
- value
- 201.8
- group Id
- OG001
- spread
- 136
- value
- 124.1
- group Id
- OG002
- spread
- 91
- value
- 150.8
- group Id
- OG003
- spread
- 17
- value
- 167.3
- group Id
- OG004
- spread
- 20
- value
- 217.2
- group Id
- OG005
- spread
- 1114
- value
- 80.14
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 11
- group Id
- OG005
- value
- 7
- units
- Participants
- title
- Cycle 1/Day15-1 Hour/EOI
- categories
- measurements
- group Id
- OG000
- spread
- 18
- value
- 200.4
- group Id
- OG001
- spread
- 23
- value
- 190.9
- group Id
- OG002
- spread
- 143
- value
- 149.2
- group Id
- OG003
- spread
- 42
- value
- 142.9
- group Id
- OG004
- spread
- 18
- value
- 228.5
- group Id
- OG005
- spread
- 24
- value
- 175.1
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 9
- group Id
- OG005
- value
- 7
- units
- Participants
- title
- Cycle 2/Day1-1 Hour/EOI
- categories
- measurements
- group Id
- OG000
- spread
- 30
- value
- 188.9
- group Id
- OG001
- spread
- 23
- value
- 210.0
- group Id
- OG002
- spread
- 29
- value
- 193.9
- group Id
- OG003
- spread
- 6
- value
- 192.8
- group Id
- OG004
- spread
- 16
- value
- 223.2
- group Id
- OG005
- spread
- 25
- value
- 178.7
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 3
- units
- Participants
- title
- Cycle 4/Day1-1 Hour/EOI
- categories
- measurements
- group Id
- OG000
- spread
- 25
- value
- 216.7
- group Id
- OG001
- spread
- 34
- value
- 198.8
- group Id
- OG002
- spread
- 13
- value
- 208.2
- group Id
- OG003
- spread
- 4
- value
- 161.0
- group Id
- OG004
- spread
- 8
- value
- 217.1
- group Id
- OG005
- spread
- 19
- value
- 193.3
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 3
- units
- Participants
- title
- Cycle 6/Day1-1 Hour/EOI
- categories
- measurements
- group Id
- OG000
- spread
- 10
- value
- 203.7
- group Id
- OG001
- spread
- 53
- value
- 196.0
- group Id
- OG002
- spread
- 26
- value
- 194.5
- group Id
- OG003
- spread
- 2
- value
- 182.0
- comment
- Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed.
- group Id
- OG004
- spread
- NA
- value
- 268.0
- group Id
- OG005
- spread
- 34
- value
- 229.1
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 2
- units
- Participants
- title
- Cycle 10/Day1-1 Hour/EOI
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 12
- group Id
- OG005
- value
- 10
- units
- Participants
- description
- Cmax is maximum observed plasma concentration.
- dispersion Type
- Geometric Coefficient of Variation
- 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
- 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-dose (at end of infusion) on Days 1 and 15 of Cycle 1; Day 8 of Cycle 1 (non-dosing); Pre-dose and 1 hour post-dose on Day 1 of Cycle 2, 4, 6, 10
- title
- Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination D
- type
- SECONDARY
- unit Of Measure
- Nanogram per milliliter
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Preserved source evidence · Not medical advice
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