TriangleNCT02554812 · OUTCOME
Number of Participants With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression and Tumor Infiltrating CD8+ Lymphocytes at Baseline for Combination B
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 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.
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 | Source count |
|---|---|
| Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 4 |
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 8 |
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 4 |
| 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 | 19 |
Reported measurements
PD-L1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 4 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 8 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 4 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 10 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 19 | Not reported | Not reported | Not reported | Not reported |
CD8+
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab | 3 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab | 8 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab | 4 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 10 | Not reported | Not reported | Not reported | Not reported |
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 18 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 19
- title
- PD-L1
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 18
- title
- CD8+
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 19
- units
- Participants
- description
- PD-L1 protein expression is determined by using 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 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
- 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.
- 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 CD8+ Lymphocytes at Baseline for Combination B
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice