TriangleNCT02554812 · OUTCOME
Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination A
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, Day 8 of Cycle 1 (non-dosing) and then Day 1 of Cycles 2,4,6 and Cycle 10. For ''Phase 2 1L NSCLC: Utomilumab then Utomilumab + Avelumab'' reporting group: Day 1 of Cycles 2,4,6,10
What was measured
Ctrough is steady-state pre-dose concentration.
Analysis population: All participants who received at least one dose of study drug and who had at least one of the PK concentrations 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. For ''Phase 2 1L NSCLC: Utomilumab then Utomilumab + Avelumab'' reporting group PK sampling started from Cycle 2 Day 1.
Groups in this outcome
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab
During Phase 2 participants with melanoma received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab
During Phase 2 participants with Squamous Cell Carcinoma of the Head and Neck (SCCHN) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with Triple Negative Breast Cancer (TNBC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with Squamous cell lung cancer (SCLC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
| Group | Source count |
|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 27 |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 27 |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 29 |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 27 |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 33 |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 20 |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 9 |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 20 |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 9 |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 11 |
Reported measurements
Cycle 1/Day1-0 Hour
| Group | Source count |
|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 27 |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 26 |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 29 |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 27 |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 33 |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 20 |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 9 |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 20 |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 0 |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 11 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 9.510 | NA | Not reported | Not reported | Only 1 observation was equal or above lower limit of quantification (LLoQ). Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated. |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 5.532 | 540 | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 16.24 | 19873078 | Not reported | Not reported | Not reported |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 64.96 | 162 | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 93.02 | 190 | Not reported | Not reported | Not reported |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + 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 A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 9.440 | 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 A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 3.082 | 80 | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + 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
| Group | Source count |
|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 23 |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 24 |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 28 |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 26 |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 29 |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 19 |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 8 |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 17 |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 0 |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 11 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 22.13 | 106 | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 17.85 | 135 | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 19.92 | 102 | Not reported | Not reported | Not reported |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 22.02 | 138 | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 23.03 | 74 | Not reported | Not reported | Not reported |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 25.53 | 38 | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 18.37 | 53 | Not reported | Not reported | Not reported |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 13.15 | 45 | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 9.781 | 84 | Not reported | Not reported | Not reported |
Cycle 2/Day1-0 Hour
| Group | Source count |
|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 22 |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 22 |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 22 |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 24 |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 29 |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 17 |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 5 |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 17 |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 9 |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 10 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 23.14 | 84 | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 20.69 | 115 | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 22.67 | 105 | Not reported | Not reported | Not reported |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 25.45 | 224 | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 23.35 | 77 | Not reported | Not reported | Not reported |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 27.94 | 43 | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 21.61 | 76 | Not reported | Not reported | Not reported |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 12.52 | 80 | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + 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 A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 10.96 | 110 | Not reported | Not reported | Not reported |
Cycle 4/Day1-0 Hour
| Group | Source count |
|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 14 |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 8 |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 11 |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 10 |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 15 |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 9 |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 3 |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 6 |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 8 |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 18.79 | 132 | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 21.53 | 103 | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 32.46 | 74 | Not reported | Not reported | Not reported |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 49.20 | 259 | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 23.30 | 59 | Not reported | Not reported | Not reported |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 26.82 | 55 | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 20.21 | 86 | Not reported | Not reported | Not reported |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 26.50 | 85 | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 10.52 | 140 | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 15.38 | 81 | Not reported | Not reported | Not reported |
Cycle 6/Day1-0 Hour
| Group | Source count |
|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 10 |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 4 |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 6 |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 5 |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 11 |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 7 |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 2 |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 5 |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 6 |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 24.80 | 52 | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 27.33 | 99 | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 33.45 | 40 | Not reported | Not reported | Not reported |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 59.47 | 105 | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 24.28 | 65 | Not reported | Not reported | Not reported |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 26.17 | 57 | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 20.66 | 9 | Not reported | Not reported | Not reported |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 27.62 | 73 | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 22.16 | 43 | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 21.05 | 45 | Not reported | Not reported | Not reported |
Cycle 10/Day1-0 Hour
| Group | Source count |
|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 7 |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 3 |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 4 |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 4 |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 5 |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 3 |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 0 |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 3 |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 2 |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 27.56 | 46 | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 26.87 | 100 | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 40.42 | 66 | Not reported | Not reported | Not reported |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 39.89 | 24 | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 34.09 | 52 | Not reported | Not reported | Not reported |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 25.31 | 101 | Not reported | Not reported | Not reported |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 34.90 | 47 | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 19.04 | 117 | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 19.41 | 24 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Only 1 observation was equal or above lower limit of quantification (LLoQ). Only Geometric Mean was reported, and Geometric Coefficient of Variation could not be calculated.
- group Id
- OG000
- spread
- NA
- value
- 9.510
- group Id
- OG001
- spread
- 540
- value
- 5.532
- group Id
- OG002
- spread
- 19873078
- value
- 16.24
- group Id
- OG003
- spread
- 162
- value
- 64.96
- group Id
- OG004
- spread
- 190
- value
- 93.02
- 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
- 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
- OG006
- spread
- NA
- value
- 9.440
- group Id
- OG007
- spread
- 80
- value
- 3.082
- 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
- OG009
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 26
- group Id
- OG002
- value
- 29
- group Id
- OG003
- value
- 27
- group Id
- OG004
- value
- 33
- group Id
- OG005
- value
- 20
- group Id
- OG006
- value
- 9
- group Id
- OG007
- value
- 20
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 11
- units
- Participants
- title
- Cycle 1/Day1-0 Hour
- categories
- measurements
- group Id
- OG000
- spread
- 106
- value
- 22.13
- group Id
- OG001
- spread
- 135
- value
- 17.85
- group Id
- OG002
- spread
- 102
- value
- 19.92
- group Id
- OG003
- spread
- 138
- value
- 22.02
- group Id
- OG004
- spread
- 74
- value
- 23.03
- group Id
- OG005
- spread
- 38
- value
- 25.53
- group Id
- OG006
- spread
- 53
- value
- 18.37
- group Id
- OG007
- spread
- 45
- value
- 13.15
- group Id
- OG009
- spread
- 84
- value
- 9.781
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 28
- group Id
- OG003
- value
- 26
- group Id
- OG004
- value
- 29
- group Id
- OG005
- value
- 19
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 17
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 11
- units
- Participants
- title
- Cycle 1/Day15-0 Hour
- categories
- measurements
- group Id
- OG000
- spread
- 84
- value
- 23.14
- group Id
- OG001
- spread
- 115
- value
- 20.69
- group Id
- OG002
- spread
- 105
- value
- 22.67
- group Id
- OG003
- spread
- 224
- value
- 25.45
- group Id
- OG004
- spread
- 77
- value
- 23.35
- group Id
- OG005
- spread
- 43
- value
- 27.94
- group Id
- OG006
- spread
- 76
- value
- 21.61
- group Id
- OG007
- spread
- 80
- value
- 12.52
- 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
- OG008
- spread
- NA
- value
- NA
- group Id
- OG009
- spread
- 110
- value
- 10.96
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 22
- group Id
- OG002
- value
- 22
- group Id
- OG003
- value
- 24
- group Id
- OG004
- value
- 29
- group Id
- OG005
- value
- 17
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 17
- group Id
- OG008
- value
- 9
- group Id
- OG009
- value
- 10
- units
- Participants
- title
- Cycle 2/Day1-0 Hour
- categories
- measurements
- group Id
- OG000
- spread
- 132
- value
- 18.79
- group Id
- OG001
- spread
- 103
- value
- 21.53
- group Id
- OG002
- spread
- 74
- value
- 32.46
- group Id
- OG003
- spread
- 259
- value
- 49.20
- group Id
- OG004
- spread
- 59
- value
- 23.30
- group Id
- OG005
- spread
- 55
- value
- 26.82
- group Id
- OG006
- spread
- 86
- value
- 20.21
- group Id
- OG007
- spread
- 85
- value
- 26.50
- group Id
- OG008
- spread
- 140
- value
- 10.52
- group Id
- OG009
- spread
- 81
- value
- 15.38
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 15
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 8
- group Id
- OG009
- value
- 6
- units
- Participants
- title
- Cycle 4/Day1-0 Hour
- categories
- measurements
- group Id
- OG000
- spread
- 52
- value
- 24.80
- group Id
- OG001
- spread
- 99
- value
- 27.33
- group Id
- OG002
- spread
- 40
- value
- 33.45
- group Id
- OG003
- spread
- 105
- value
- 59.47
- group Id
- OG004
- spread
- 65
- value
- 24.28
- group Id
- OG005
- spread
- 57
- value
- 26.17
- group Id
- OG006
- spread
- 9
- value
- 20.66
- group Id
- OG007
- spread
- 73
- value
- 27.62
- group Id
- OG008
- spread
- 43
- value
- 22.16
- group Id
- OG009
- spread
- 45
- value
- 21.05
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 11
- group Id
- OG005
- value
- 7
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 6
- units
- Participants
- title
- Cycle 6/Day1-0 Hour
- categories
- measurements
- group Id
- OG000
- spread
- 46
- value
- 27.56
- group Id
- OG001
- spread
- 100
- value
- 26.87
- group Id
- OG002
- spread
- 66
- value
- 40.42
- group Id
- OG003
- spread
- 24
- value
- 39.89
- group Id
- OG004
- spread
- 52
- value
- 34.09
- group Id
- OG005
- spread
- 101
- value
- 25.31
- group Id
- OG007
- spread
- 47
- value
- 34.90
- group Id
- OG008
- spread
- 117
- value
- 19.04
- group Id
- OG009
- spread
- 24
- value
- 19.41
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 4
- units
- Participants
- title
- Cycle 10/Day1-0 Hour
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 27
- group Id
- OG002
- value
- 29
- group Id
- OG003
- value
- 27
- group Id
- OG004
- value
- 33
- group Id
- OG005
- value
- 20
- group Id
- OG006
- value
- 9
- group Id
- OG007
- value
- 20
- group Id
- OG008
- value
- 9
- group Id
- OG009
- value
- 11
- units
- Participants
- description
- Ctrough is steady-state pre-dose concentration.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
- id
- OG000
- title
- Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
- description
- During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
- id
- OG001
- title
- Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
- description
- During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
- id
- OG002
- title
- Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
- description
- During Phase 2 participants with melanoma received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
- id
- OG003
- title
- Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab
- description
- During Phase 2 participants with Squamous Cell Carcinoma of the Head and Neck (SCCHN) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
- id
- OG004
- title
- Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab
- description
- During Phase 2 participants with Triple Negative Breast Cancer (TNBC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
- id
- OG005
- title
- Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab
- description
- During Phase 2 participants with Squamous cell lung cancer (SCLC) received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
- id
- OG006
- title
- Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab
- description
- During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
- id
- OG007
- title
- Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
- description
- During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
- id
- OG008
- title
- Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
- description
- During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
- id
- OG009
- title
- Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
- param Type
- GEOMETRIC_MEAN
- population Description
- All participants who received at least one dose of study drug and who had at least one of the PK concentrations 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. For ''Phase 2 1L NSCLC: Utomilumab then Utomilumab + Avelumab'' reporting group PK sampling started from Cycle 2 Day 1.
- reporting Status
- POSTED
- time Frame
- Pre-dose on Days 1 and 15 of Cycle 1, Day 8 of Cycle 1 (non-dosing) and then Day 1 of Cycles 2,4,6 and Cycle 10. For ''Phase 2 1L NSCLC: Utomilumab then Utomilumab + Avelumab'' reporting group: Day 1 of Cycles 2,4,6,10
- title
- Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination A
- type
- SECONDARY
- unit Of Measure
- Nanogram per milliliter
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Preserved source evidence · Not medical advice