NCT02554812 · OUTCOME
Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab 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
- Pre-dose on Day 1 of Cycle 1, 3, 5, 8 and Cycle 12; Day 15 of Cycle 1 (non-dosing)
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 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 | 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 | 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
Cycle 1/Day1-0 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 | 11 |
|---|
| 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 | 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 |
|---|
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 | 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. |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab | 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. |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab | 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. |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab | 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. |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab | 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. |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab | 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 1/Day15-0 Hour
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab | 9 |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab | 10 |
|---|
| 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 | 616.5 | 41 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab | 1353 | 24 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab | 726.4 | 19 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab | 1649 | 34 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab | 595.2 | 23 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab | 1752 | 16 | Not reported | Not reported | Not reported |
|---|
Cycle 3/Day1-0 Hour
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab | 5 |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab | 5 |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab | 8 |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab | 6 |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab | 6 |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab | 5 |
|---|
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 | 561.0 | 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. |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab | 846.0 | 54 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab | 516.6 | 31 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab | 602.2 | 38 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab | 813.3 | 28 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab | 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 5/Day1-0 Hour
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 | 5 |
|---|
| 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 | 2 |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab | 4 |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab | 4 |
|---|
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 | 712.3 | 11 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab | 718.1 | 34 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab | 505.0 | 23 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab | 422.0 | 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. |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab | 763.0 | 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. |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab | 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 8/Day1-0 Hour
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab | 2 |
|---|
| 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 | 3 |
|---|
| 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 | NA | NA | Not reported | Not reported | There were \<=2 participants, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated. |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab | 730.5 | 23 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab | 674.3 | 41 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab | 1440 | 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. |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab | 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. |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab | NA | NA | Not reported | Not reported | There were \<=2 participants, and no observation was equal or above LLoQ . Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated. |
|---|
Cycle 12/Day1-0 Hour
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab | 2 |
|---|
| 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 | 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 | 0 |
|---|
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 | 407.0 | 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. |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab | 720.9 | 25 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab | 794.2 | 105 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab | 985.6 | 81 | Not reported | Not reported | Not reported |
|---|
| Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab | NA | NA | Not reported | Not reported | There were \<=2 participants, and no observation was equal or above LLoQ . Therefore, both Geometric Mean 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
- OG000
- spread
- NA
- value
- NA
- 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
- 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
- OG002
- spread
- NA
- value
- NA
- 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
- OG003
- spread
- NA
- value
- NA
- 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
- OG004
- spread
- NA
- value
- NA
- 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
- OG005
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 12
- group Id
- OG005
- value
- 11
- units
- Participants
- title
- Cycle 1/Day1-0 Hour
- categories
- measurements
- group Id
- OG000
- spread
- 41
- value
- 616.5
- group Id
- OG001
- spread
- 24
- value
- 1353
- group Id
- OG002
- spread
- 19
- value
- 726.4
- group Id
- OG003
- spread
- 34
- value
- 1649
- group Id
- OG004
- spread
- 23
- value
- 595.2
- group Id
- OG005
- spread
- 16
- value
- 1752
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 10
- 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/Day15-0 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
- OG000
- spread
- NA
- value
- 561.0
- group Id
- OG001
- spread
- 54
- value
- 846.0
- group Id
- OG002
- spread
- 31
- value
- 516.6
- group Id
- OG003
- spread
- 38
- value
- 602.2
- group Id
- OG004
- spread
- 28
- value
- 813.3
- 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
- OG005
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 5
- units
- Participants
- title
- Cycle 3/Day1-0 Hour
- categories
- measurements
- group Id
- OG000
- spread
- 11
- value
- 712.3
- group Id
- OG001
- spread
- 34
- value
- 718.1
- group Id
- OG002
- spread
- 23
- value
- 505.0
- 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
- OG003
- spread
- NA
- value
- 422.0
- 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
- OG004
- spread
- NA
- value
- 763.0
- 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
- OG005
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 4
- units
- Participants
- title
- Cycle 5/Day1-0 Hour
- categories
- measurements
- comment
- There were \<=2 participants, and no observation was equal or above LLoQ. Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
- group Id
- OG000
- spread
- NA
- value
- NA
- group Id
- OG001
- spread
- 23
- value
- 730.5
- group Id
- OG002
- spread
- 41
- value
- 674.3
- 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
- OG003
- spread
- NA
- value
- 1440
- 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
- OG004
- spread
- NA
- value
- NA
- comment
- There were \<=2 participants, and no observation was equal or above LLoQ . Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
- group Id
- OG005
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 2
- units
- Participants
- title
- Cycle 8/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
- OG000
- spread
- NA
- value
- 407.0
- group Id
- OG001
- spread
- 25
- value
- 720.9
- group Id
- OG002
- spread
- 105
- value
- 794.2
- group Id
- OG003
- spread
- 81
- value
- 985.6
- comment
- There were \<=2 participants, and no observation was equal or above LLoQ . Therefore, both Geometric Mean and Geometric Coefficient of Variation could not be calculated.
- group Id
- OG004
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- units
- Participants
- title
- Cycle 12/Day1-0 Hour
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 12
- group Id
- OG005
- value
- 11
- units
- Participants
- description
- Ctrough is steady-state pre-dose 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
- Pre-dose on Day 1 of Cycle 1, 3, 5, 8 and Cycle 12; Day 15 of Cycle 1 (non-dosing)
- title
- Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab in Combination D
- type
- SECONDARY
- unit Of Measure
- Nanogram per milliliter
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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