TriangleNCT02580058 · OUTCOME
Number of Participants With CD8 Expression for PFS (Based on BICR Assessment) and for OS
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
- Biomarkers are measured only at screening.
What was measured
Tumor infiltrating CD8 positive (CD8+) T lymphocytes was assessed by immunohistochemistry. Participants were considered positive for CD8 T cells if their baseline tissue sample demonstrated presence of \>=1% CD8+ cells across the area of the tumor.
Analysis population: The biomarker analysis set included participants who had at least 1 screening biomarker assessment. 'Number of Participants Analyzed' is based on number of participants in the biomarker analysis set within each treatment group with reported CD8 status.
Groups in this outcome
Avelumab
Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
Avelumab + PLD
Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
Pegylated Liposomal Doxorubicin (PLD)
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
| Group | Source count |
|---|---|
| Avelumab | 165 |
| Avelumab + PLD | 171 |
| Pegylated Liposomal Doxorubicin (PLD) | 164 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Avelumab | 76 | Not reported | Not reported | Not reported | Not reported |
| Avelumab + PLD | 80 | Not reported | Not reported | Not reported | Not reported |
| Pegylated Liposomal Doxorubicin (PLD) | 72 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 76
- group Id
- OG001
- value
- 80
- group Id
- OG002
- value
- 72
- denoms
- counts
- group Id
- OG000
- value
- 165
- group Id
- OG001
- value
- 171
- group Id
- OG002
- value
- 164
- units
- Participants
- description
- Tumor infiltrating CD8 positive (CD8+) T lymphocytes was assessed by immunohistochemistry. Participants were considered positive for CD8 T cells if their baseline tissue sample demonstrated presence of \>=1% CD8+ cells across the area of the tumor.
- groups
- description
- Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
- id
- OG000
- title
- Avelumab
- description
- Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
- id
- OG001
- title
- Avelumab + PLD
- description
- PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
- id
- OG002
- title
- Pegylated Liposomal Doxorubicin (PLD)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The biomarker analysis set included participants who had at least 1 screening biomarker assessment. 'Number of Participants Analyzed' is based on number of participants in the biomarker analysis set within each treatment group with reported CD8 status.
- reporting Status
- POSTED
- time Frame
- Biomarkers are measured only at screening.
- title
- Number of Participants With CD8 Expression for PFS (Based on BICR Assessment) and for OS
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice