NCT02554812 · OUTCOME
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PF-04518600 in Combination B
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 Days 1 and 15 of Cycle 1 (non-dosing); Day 1 of Cycles 2, 4, 6 and Cycle 10
What was measured
Ctrough is steady-state pre-dose concentration.
Analysis population: Pharmacokinetic (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 B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab
During Phase 1b participants received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab
During Phase 1b participants received PF-04518600 1.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab
During Phase 1b participants received PF-04518600 3.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab
During Phase 2 participants with NSCLC received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab
During Phase 2 participants with SCCHN received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.
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 B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 12 |
|---|
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 12 |
|---|
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 8 |
|---|
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 14 |
|---|
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 25 |
|---|
Reported measurements
Avelumab Cycle 1/Day1-0 Hour
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 12 |
|---|
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 12 |
|---|
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 8 |
|---|
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 14 |
|---|
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 25 |
|---|
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination B Phase 1b: 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 B Phase 1b: 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 B Phase 1b: PF-04518600 3.0 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 B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 228.0 | 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 B Phase 2 SCCHN: 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. |
|---|
Avelumab Cycle 1/Day15-0 Hour
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 10 |
|---|
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 11 |
|---|
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 6 |
|---|
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 13 |
|---|
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 22 |
|---|
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 19.05 | 69 | Not reported | Not reported | Not reported |
|---|
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 16.83 | 63 | Not reported | Not reported | Not reported |
|---|
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 19.88 | 50 | Not reported | Not reported | Not reported |
|---|
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 21.72 | 54 | Not reported | Not reported | Not reported |
|---|
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 17.00 | 63 | Not reported | Not reported | Not reported |
|---|
Avelumab Cycle 2/Day1-0 Hour
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 10 |
|---|
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 8 |
|---|
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 6 |
|---|
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 12 |
|---|
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 18 |
|---|
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 21.10 | 84 | Not reported | Not reported | Not reported |
|---|
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 21.27 | 47 | Not reported | Not reported | Not reported |
|---|
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 22.04 | 70 | Not reported | Not reported | Not reported |
|---|
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 25.32 | 59 | Not reported | Not reported | Not reported |
|---|
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 18.77 | 92 | Not reported | Not reported | Not reported |
|---|
Avelumab Cycle 4/Day1-0 Hour
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 2 |
|---|
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 2 |
|---|
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 2 |
|---|
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 10 |
|---|
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 13 |
|---|
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 15.72 | 179 | Not reported | Not reported | Not reported |
|---|
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 21.16 | 13 | Not reported | Not reported | Not reported |
|---|
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 22.37 | 91 | Not reported | Not reported | Not reported |
|---|
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 22.69 | 46 | Not reported | Not reported | Not reported |
|---|
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 17.95 | 90 | Not reported | Not reported | Not reported |
|---|
Avelumab Cycle 6/Day1-0 Hour
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 0 |
|---|
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 1 |
|---|
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 0 |
|---|
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 5 |
|---|
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 6 |
|---|
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 16.00 | 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 B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 29.83 | 34 | Not reported | Not reported | Not reported |
|---|
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 25.82 | 37 | Not reported | Not reported | Not reported |
|---|
Avelumab Cycle 10/Day1-0 Hour
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 0 |
|---|
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 0 |
|---|
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 0 |
|---|
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 1 |
|---|
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 3 |
|---|
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 26.30 | 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 B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 23.70 | 24 | Not reported | Not reported | Not reported |
|---|
PF-04518600 Cycle 1/Day1-0 Hour
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 12 |
|---|
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 12 |
|---|
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 8 |
|---|
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 13 |
|---|
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 25 |
|---|
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination B Phase 1b: 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 B Phase 1b: 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 B Phase 1b: PF-04518600 3.0 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 B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 5750 | 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 B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 23.10 | 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. |
|---|
PF-04518600 Cycle 1/Day15-0 Hour
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 10 |
|---|
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 11 |
|---|
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 6 |
|---|
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 13 |
|---|
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 22 |
|---|
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 1497 | 55 | Not reported | Not reported | Not reported |
|---|
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 6234 | 50 | Not reported | Not reported | Not reported |
|---|
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 25320 | 29 | Not reported | Not reported | Not reported |
|---|
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 1758 | 59 | Not reported | Not reported | Not reported |
|---|
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 1702 | 50 | Not reported | Not reported | Not reported |
|---|
PF-04518600 Cycle 2/Day1-0 Hour
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 11 |
|---|
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 8 |
|---|
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 7 |
|---|
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 13 |
|---|
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 23 |
|---|
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 1826 | 176 | Not reported | Not reported | Not reported |
|---|
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 11000 | 23 | Not reported | Not reported | Not reported |
|---|
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 31830 | 99 | Not reported | Not reported | Not reported |
|---|
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 2928 | 39 | Not reported | Not reported | Not reported |
|---|
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 2327 | 58 | Not reported | Not reported | Not reported |
|---|
PF-04518600 Cycle 4/Day1-0 Hour
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 3 |
|---|
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 0 |
|---|
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 3 |
|---|
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 10 |
|---|
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 13 |
|---|
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 2324 | 235 | Not reported | Not reported | Not reported |
|---|
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 79790 | 28 | Not reported | Not reported | Not reported |
|---|
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 4799 | 47 | Not reported | Not reported | Not reported |
|---|
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 5129 | 43 | Not reported | Not reported | Not reported |
|---|
PF-04518600 Cycle 6/Day1-0 Hour
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 0 |
|---|
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 1 |
|---|
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 0 |
|---|
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 6 |
|---|
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 6 |
|---|
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 17200 | 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 B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 6577 | 37 | Not reported | Not reported | Not reported |
|---|
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 6508 | 23 | Not reported | Not reported | Not reported |
|---|
PF-04518600 Cycle 10/Day1-0 Hour
Analysis denominator · Participants
| Group | Source count |
|---|
| Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 0 |
|---|
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 0 |
|---|
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 0 |
|---|
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 2 |
|---|
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 4 |
|---|
Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 8097 | 59 | Not reported | Not reported | Not reported |
|---|
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 5484 | 16 | Not reported | Not reported | Not reported |
|---|
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
- 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
- 228.0
- 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
- OG004
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 14
- group Id
- OG004
- value
- 25
- units
- Participants
- title
- Avelumab Cycle 1/Day1-0 Hour
- categories
- measurements
- group Id
- OG000
- spread
- 69
- value
- 19.05
- group Id
- OG001
- spread
- 63
- value
- 16.83
- group Id
- OG002
- spread
- 50
- value
- 19.88
- group Id
- OG003
- spread
- 54
- value
- 21.72
- group Id
- OG004
- spread
- 63
- value
- 17.00
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 22
- units
- Participants
- title
- Avelumab Cycle 1/Day15-0 Hour
- categories
- measurements
- group Id
- OG000
- spread
- 84
- value
- 21.10
- group Id
- OG001
- spread
- 47
- value
- 21.27
- group Id
- OG002
- spread
- 70
- value
- 22.04
- group Id
- OG003
- spread
- 59
- value
- 25.32
- group Id
- OG004
- spread
- 92
- value
- 18.77
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 12
- group Id
- OG004
- value
- 18
- units
- Participants
- title
- Avelumab Cycle 2/Day1-0 Hour
- categories
- measurements
- group Id
- OG000
- spread
- 179
- value
- 15.72
- group Id
- OG001
- spread
- 13
- value
- 21.16
- group Id
- OG002
- spread
- 91
- value
- 22.37
- group Id
- OG003
- spread
- 46
- value
- 22.69
- group Id
- OG004
- spread
- 90
- value
- 17.95
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 13
- units
- Participants
- title
- Avelumab Cycle 4/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
- 16.00
- group Id
- OG003
- spread
- 34
- value
- 29.83
- group Id
- OG004
- spread
- 37
- value
- 25.82
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 6
- units
- Participants
- title
- Avelumab Cycle 6/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
- OG003
- spread
- NA
- value
- 26.30
- group Id
- OG004
- spread
- 24
- value
- 23.70
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 3
- units
- Participants
- title
- Avelumab Cycle 10/Day1-0 Hour
- 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
- 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
- 5750
- 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
- 23.10
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 25
- units
- Participants
- title
- PF-04518600 Cycle 1/Day1-0 Hour
- categories
- measurements
- group Id
- OG000
- spread
- 55
- value
- 1497
- group Id
- OG001
- spread
- 50
- value
- 6234
- group Id
- OG002
- spread
- 29
- value
- 25320
- group Id
- OG003
- spread
- 59
- value
- 1758
- group Id
- OG004
- spread
- 50
- value
- 1702
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 22
- units
- Participants
- title
- PF-04518600 Cycle 1/Day15-0 Hour
- categories
- measurements
- group Id
- OG000
- spread
- 176
- value
- 1826
- group Id
- OG001
- spread
- 23
- value
- 11000
- group Id
- OG002
- spread
- 99
- value
- 31830
- group Id
- OG003
- spread
- 39
- value
- 2928
- group Id
- OG004
- spread
- 58
- value
- 2327
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 23
- units
- Participants
- title
- PF-04518600 Cycle 2/Day1-0 Hour
- categories
- measurements
- group Id
- OG000
- spread
- 235
- value
- 2324
- group Id
- OG002
- spread
- 28
- value
- 79790
- group Id
- OG003
- spread
- 47
- value
- 4799
- group Id
- OG004
- spread
- 43
- value
- 5129
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 13
- units
- Participants
- title
- PF-04518600 Cycle 4/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
- 17200
- group Id
- OG003
- spread
- 37
- value
- 6577
- group Id
- OG004
- spread
- 23
- value
- 6508
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- units
- Participants
- title
- PF-04518600 Cycle 6/Day1-0 Hour
- categories
- measurements
- group Id
- OG003
- spread
- 59
- value
- 8097
- group Id
- OG004
- spread
- 16
- value
- 5484
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 4
- units
- Participants
- title
- PF-04518600 Cycle 10/Day1-0 Hour
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 14
- group Id
- OG004
- value
- 25
- units
- Participants
- description
- Ctrough is steady-state pre-dose concentration.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- During Phase 1b participants received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
- id
- OG000
- title
- Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab
- description
- During Phase 1b participants received PF-04518600 1.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
- id
- OG001
- title
- Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab
- description
- During Phase 1b participants received PF-04518600 3.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
- id
- OG002
- title
- Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab
- description
- During Phase 2 participants with NSCLC received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.
- id
- OG003
- title
- Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab
- description
- During Phase 2 participants with SCCHN received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.
- id
- OG004
- title
- Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab
- param Type
- GEOMETRIC_MEAN
- population Description
- Pharmacokinetic (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 Days 1 and 15 of Cycle 1 (non-dosing); Day 1 of Cycles 2, 4, 6 and Cycle 10
- title
- Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PF-04518600 in Combination B
- type
- SECONDARY
- unit Of Measure
- Nanogram per milliliter
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle