TriangleNCT02554812 · OUTCOME
Number of Participants With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression and Tumor Infiltrating Cluster of Differentiation 8 (CD8+) Lymphocytes at Baseline for Combination A
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline (Day 1)
What was measured
PD-L1 protein expression is determined by using Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. The specimen is considered to have PD-L1 expression if TPS \>=1% and high PD-L1 expression if TPS \>= 50%. Tumor infiltrating CD8+ lymphocytes is defined as the number of CD8+ cells per unit area and the percent of counted cells. Positive is defined as \>=1% and negative is defined as \<1%.
Analysis population: The analysis population was a subset of the safety analysis set (all participants who received at least one dose of study drug) and included participants who had at least one biomarker parameter of PD-L1 and CD8+ lymphocytes from the corresponding assay sample with at least one baseline biomarker measurement. Here, ''Number Analyzed'' signifies number of participants evaluable for each specified row.
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 | 24 |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 24 |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 22 |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 22 |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 24 |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 18 |
| 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 | 8 |
Reported measurements
PD-L1
| Group | Source count |
|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 24 |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 24 |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 22 |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 22 |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 24 |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 18 |
| 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 | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 24 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 24 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 22 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 22 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 24 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 18 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 8 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 18 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 9 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 8 | Not reported | Not reported | Not reported | Not reported |
CD8+
| Group | Source count |
|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 24 |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 24 |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 22 |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 21 |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 24 |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 18 |
| 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 | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 24 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 24 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 22 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 21 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 24 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 18 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 8 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 18 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 9 | Not reported | Not reported | Not reported | Not reported |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 8 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 22
- group Id
- OG003
- value
- 22
- group Id
- OG004
- value
- 24
- group Id
- OG005
- value
- 18
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 18
- group Id
- OG008
- value
- 9
- group Id
- OG009
- value
- 8
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 22
- group Id
- OG003
- value
- 22
- group Id
- OG004
- value
- 24
- group Id
- OG005
- value
- 18
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 18
- group Id
- OG008
- value
- 9
- group Id
- OG009
- value
- 8
- units
- Participants
- title
- PD-L1
- categories
- measurements
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 22
- group Id
- OG003
- value
- 21
- group Id
- OG004
- value
- 24
- group Id
- OG005
- value
- 18
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 18
- group Id
- OG008
- value
- 9
- group Id
- OG009
- value
- 8
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 22
- group Id
- OG003
- value
- 21
- group Id
- OG004
- value
- 24
- group Id
- OG005
- value
- 18
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 18
- group Id
- OG008
- value
- 9
- group Id
- OG009
- value
- 8
- units
- Participants
- title
- CD8+
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 22
- group Id
- OG003
- value
- 22
- group Id
- OG004
- value
- 24
- group Id
- OG005
- value
- 18
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 18
- group Id
- OG008
- value
- 9
- group Id
- OG009
- value
- 8
- units
- Participants
- description
- PD-L1 protein expression is determined by using Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. The specimen is considered to have PD-L1 expression if TPS \>=1% and high PD-L1 expression if TPS \>= 50%. Tumor infiltrating CD8+ lymphocytes is defined as the number of CD8+ cells per unit area and the percent of counted cells. Positive is defined as \>=1% and negative is defined as \<1%.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- The analysis population was a subset of the safety analysis set (all participants who received at least one dose of study drug) and included participants who had at least one biomarker parameter of PD-L1 and CD8+ lymphocytes from the corresponding assay sample with at least one baseline biomarker measurement. Here, ''Number Analyzed'' signifies number of participants evaluable for each specified row.
- reporting Status
- POSTED
- time Frame
- Baseline (Day 1)
- title
- Number of Participants With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression and Tumor Infiltrating Cluster of Differentiation 8 (CD8+) Lymphocytes at Baseline for Combination A
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice