TriangleNCT02603432 · OUTCOME
Number of Participants With Programmed Death Receptor-1 Ligand 1 (PD-L1) Biomarker Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC)
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
- Up to 41 months at the time of the analysis
What was measured
PD-L1 assessment was performed using immunohistochemistry on pre-treatment tumor tissue samples. Participants were classified as having PD-L1 -positive status if at least one of the following three criteria were met: at least 25% of tumor cells stained for PD-L1, at least 25% of immune cells stained for PD-L1 if more than 1% of the tumor area contained immune cells, or 100% of immune cells stained for PD-L1 if no more than 1% of the tumor area contained immune cells.
Analysis population: The full analysis set included all randomized participants.
Groups in this outcome
Avelumab + Best Supportive Care (BSC)
Participants received an intravenous (IV) infusion of 10 milligrams per kilograms (mg/kg) of Avelumab along with BSC, on Day 1 and 15 of each 28 days treatment cycle, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. BSC was administered as per the treating physician. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
Best Supportive Care
As prescribed by the treating physician, participants received BSC which included treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
| Group | Source count |
|---|---|
| Avelumab + Best Supportive Care (BSC) | 350 |
| Best Supportive Care | 350 |
Reported measurements
Source class 1
Positive
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Avelumab + Best Supportive Care (BSC) | 189 | Not reported | Not reported | Not reported | Not reported |
| Best Supportive Care | 169 | Not reported | Not reported | Not reported | Not reported |
Negative
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Avelumab + Best Supportive Care (BSC) | 139 | Not reported | Not reported | Not reported | Not reported |
| Best Supportive Care | 131 | Not reported | Not reported | Not reported | Not reported |
Unknown
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Avelumab + Best Supportive Care (BSC) | 22 | Not reported | Not reported | Not reported | Not reported |
| Best Supportive Care | 50 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 189
- group Id
- OG001
- value
- 169
- title
- Positive
- measurements
- group Id
- OG000
- value
- 139
- group Id
- OG001
- value
- 131
- title
- Negative
- measurements
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 50
- title
- Unknown
- denoms
- counts
- group Id
- OG000
- value
- 350
- group Id
- OG001
- value
- 350
- units
- Participants
- description
- PD-L1 assessment was performed using immunohistochemistry on pre-treatment tumor tissue samples. Participants were classified as having PD-L1 -positive status if at least one of the following three criteria were met: at least 25% of tumor cells stained for PD-L1, at least 25% of immune cells stained for PD-L1 if more than 1% of the tumor area contained immune cells, or 100% of immune cells stained for PD-L1 if no more than 1% of the tumor area contained immune cells.
- groups
- description
- Participants received an intravenous (IV) infusion of 10 milligrams per kilograms (mg/kg) of Avelumab along with BSC, on Day 1 and 15 of each 28 days treatment cycle, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. BSC was administered as per the treating physician. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
- id
- OG000
- title
- Avelumab + Best Supportive Care (BSC)
- description
- As prescribed by the treating physician, participants received BSC which included treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
- id
- OG001
- title
- Best Supportive Care
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The full analysis set included all randomized participants.
- reporting Status
- POSTED
- time Frame
- Up to 41 months at the time of the analysis
- title
- Number of Participants With Programmed Death Receptor-1 Ligand 1 (PD-L1) Biomarker Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice