TriangleNCT02554812 · OUTCOME
Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab 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 Day 1 of Cycles 1,3,5,8, and Cycle 12; Day 15 of Cycle 1 (non-dosing). For ''Phase 2 1L NSCLC: Avelumab then Utomilumab + Avelumab'' reporting group: Day 1 of Cycles 3,5,8 and 12
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 participants of ''Phase 2 1L NSCLC: Avelumab then Utomilumab + Avelumab'' reporting group PK sampling started from Cycle 3 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 | 28 |
| 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 | 28 |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 33 |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 21 |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 10 |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 20 |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 10 |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 8 |
Reported measurements
Cycle 1/Day1-0 Hour
| Group | Source count |
|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 28 |
| 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 | 28 |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 33 |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 21 |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 10 |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 20 |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 10 |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 619.0 | 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 A Phase 1b NSCLC: 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 1b NSCLC: Utomilumab 20 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 Melanoma: Utomilumab 100 mg + Avelumab | 1430 | 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 SCCHN: Utomilumab 100 mg + Avelumab | 931.0 | 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 2 TNBC: Utomilumab 100 mg + Avelumab | 24400 | 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 SCLC: Utomilumab 100 mg + Avelumab | 20500 | 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 | 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: 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. |
Cycle 1/Day15-0 Hour
| Group | Source count |
|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 26 |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 22 |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 29 |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 26 |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 32 |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 21 |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 8 |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 18 |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 9 |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 2723 | 28 | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 1536 | 26 | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 779.3 | 25 | Not reported | Not reported | Not reported |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 1443 | 20 | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 1688 | 23 | Not reported | Not reported | Not reported |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 2323 | 30 | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 2509 | 28 | Not reported | Not reported | Not reported |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 2529 | 49 | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 4283 | 42 | Not reported | Not reported | Not reported |
Cycle 3/Day1-0 Hour
| Group | Source count |
|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 17 |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 12 |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 21 |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 14 |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 18 |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 10 |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 3 |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 10 |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 8 |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 2114 | 30 | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 982.3 | 29 | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 743.2 | 26 | Not reported | Not reported | Not reported |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 1627 | 145 | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 1547 | 72 | Not reported | Not reported | Not reported |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 1351 | 38 | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 693.5 | 29 | Not reported | Not reported | Not reported |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 1114 | 38 | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 928.0 | 69 | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 780.4 | 48 | Not reported | Not reported | Not reported |
Cycle 5/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 | 6 |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 7 |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 8 |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 15 |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 8 |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 3 |
| 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 | 7 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 2259 | 53 | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 1059 | 63 | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 931.9 | 97 | Not reported | Not reported | Not reported |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 1281 | 33 | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 1366 | 37 | Not reported | Not reported | Not reported |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 1417 | 25 | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 855.1 | 14 | Not reported | Not reported | Not reported |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 1046 | 30 | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 906.7 | 67 | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 671.9 | 38 | Not reported | Not reported | Not reported |
Cycle 8/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 | 5 |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 4 |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 5 |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 6 |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 5 |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 2 |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 2 |
| 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 | 1840 | 54 | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 1726 | 21 | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 839.9 | 38 | Not reported | Not reported | Not reported |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 1747 | 19 | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 2300 | 138 | Not reported | Not reported | Not reported |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 1196 | 29 | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 1030 | 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 | 1070 | 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 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 669.0 | 27 | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 851.8 | 30 | Not reported | Not reported | Not reported |
Cycle 12/Day1-0 Hour
| Group | Source count |
|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 6 |
| 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 | 5 |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 2 |
| 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 | 1 |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 3 |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 1814 | 52 | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 1171 | 24 | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 690.2 | 35 | Not reported | Not reported | Not reported |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 1172 | 39 | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 610.0 | 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 A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 1359 | 5 | Not reported | Not reported | Not reported |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + 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 A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 655.4 | 64 | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 653.9 | 23 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- 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
- 619.0
- 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
- 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
- 1430
- 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
- OG004
- spread
- NA
- value
- 931.0
- 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
- OG005
- spread
- NA
- value
- 24400
- 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
- 20500
- 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
- OG007
- 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
- OG008
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 27
- group Id
- OG002
- value
- 29
- group Id
- OG003
- value
- 28
- group Id
- OG004
- value
- 33
- group Id
- OG005
- value
- 21
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 20
- group Id
- OG008
- value
- 10
- group Id
- OG009
- value
- 0
- units
- Participants
- title
- Cycle 1/Day1-0 Hour
- categories
- measurements
- group Id
- OG000
- spread
- 28
- value
- 2723
- group Id
- OG001
- spread
- 26
- value
- 1536
- group Id
- OG002
- spread
- 25
- value
- 779.3
- group Id
- OG003
- spread
- 20
- value
- 1443
- group Id
- OG004
- spread
- 23
- value
- 1688
- group Id
- OG005
- spread
- 30
- value
- 2323
- group Id
- OG006
- spread
- 28
- value
- 2509
- group Id
- OG007
- spread
- 49
- value
- 2529
- group Id
- OG008
- spread
- 42
- value
- 4283
- denoms
- counts
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 22
- group Id
- OG002
- value
- 29
- group Id
- OG003
- value
- 26
- group Id
- OG004
- value
- 32
- group Id
- OG005
- value
- 21
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 18
- group Id
- OG008
- value
- 9
- group Id
- OG009
- value
- 0
- units
- Participants
- title
- Cycle 1/Day15-0 Hour
- categories
- measurements
- group Id
- OG000
- spread
- 30
- value
- 2114
- group Id
- OG001
- spread
- 29
- value
- 982.3
- group Id
- OG002
- spread
- 26
- value
- 743.2
- group Id
- OG003
- spread
- 145
- value
- 1627
- group Id
- OG004
- spread
- 72
- value
- 1547
- group Id
- OG005
- spread
- 38
- value
- 1351
- group Id
- OG006
- spread
- 29
- value
- 693.5
- group Id
- OG007
- spread
- 38
- value
- 1114
- group Id
- OG008
- spread
- 69
- value
- 928.0
- group Id
- OG009
- spread
- 48
- value
- 780.4
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 21
- group Id
- OG003
- value
- 14
- group Id
- OG004
- value
- 18
- group Id
- OG005
- value
- 10
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 10
- group Id
- OG008
- value
- 8
- group Id
- OG009
- value
- 8
- units
- Participants
- title
- Cycle 3/Day1-0 Hour
- categories
- measurements
- group Id
- OG000
- spread
- 53
- value
- 2259
- group Id
- OG001
- spread
- 63
- value
- 1059
- group Id
- OG002
- spread
- 97
- value
- 931.9
- group Id
- OG003
- spread
- 33
- value
- 1281
- group Id
- OG004
- spread
- 37
- value
- 1366
- group Id
- OG005
- spread
- 25
- value
- 1417
- group Id
- OG006
- spread
- 14
- value
- 855.1
- group Id
- OG007
- spread
- 30
- value
- 1046
- group Id
- OG008
- spread
- 67
- value
- 906.7
- group Id
- OG009
- spread
- 38
- value
- 671.9
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 15
- group Id
- OG005
- value
- 8
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 7
- units
- Participants
- title
- Cycle 5/Day1-0 Hour
- categories
- measurements
- group Id
- OG000
- spread
- 54
- value
- 1840
- group Id
- OG001
- spread
- 21
- value
- 1726
- group Id
- OG002
- spread
- 38
- value
- 839.9
- group Id
- OG003
- spread
- 19
- value
- 1747
- group Id
- OG004
- spread
- 138
- value
- 2300
- group Id
- OG005
- spread
- 29
- value
- 1196
- 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
- 1030
- 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
- OG007
- spread
- NA
- value
- 1070
- group Id
- OG008
- spread
- 27
- value
- 669.0
- group Id
- OG009
- spread
- 30
- value
- 851.8
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 6
- units
- Participants
- title
- Cycle 8/Day1-0 Hour
- categories
- measurements
- group Id
- OG000
- spread
- 52
- value
- 1814
- group Id
- OG001
- spread
- 24
- value
- 1171
- group Id
- OG002
- spread
- 35
- value
- 690.2
- group Id
- OG003
- spread
- 39
- value
- 1172
- 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
- 610.0
- group Id
- OG005
- spread
- 5
- value
- 1359
- 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
- OG007
- spread
- NA
- value
- NA
- group Id
- OG008
- spread
- 64
- value
- 655.4
- group Id
- OG009
- spread
- 23
- value
- 653.9
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 3
- units
- Participants
- title
- Cycle 12/Day1-0 Hour
- denoms
- counts
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 27
- group Id
- OG002
- value
- 29
- group Id
- OG003
- value
- 28
- group Id
- OG004
- value
- 33
- group Id
- OG005
- value
- 21
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 20
- group Id
- OG008
- value
- 10
- group Id
- OG009
- value
- 8
- 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 participants of ''Phase 2 1L NSCLC: Avelumab then Utomilumab + Avelumab'' reporting group PK sampling started from Cycle 3 Day 1.
- reporting Status
- POSTED
- time Frame
- Pre-dose on Day 1 of Cycles 1,3,5,8, and Cycle 12; Day 15 of Cycle 1 (non-dosing). For ''Phase 2 1L NSCLC: Avelumab then Utomilumab + Avelumab'' reporting group: Day 1 of Cycles 3,5,8 and 12
- title
- Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab in Combination A
- type
- SECONDARY
- unit Of Measure
- Nanogram per milliliter
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice