NCT02399371 · OUTCOME
Ability of PD-L1 to Predict Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Youden index
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 1 year
What was measured
The Youden Index will be used to determine the optimal threshold for PD-L1 expression in correlation with tumor response. Youden Index ranges from 0-1 with higher scores meaning greater accuracy/sensitivity/specificity calculated from an ROC AUC (sensitivity + specificity - 1 = Youden Index).
Analysis population: Two patients had missing PD-L1 expression data.
Groups in this outcome
Treatment (Pembrolizumab)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients may be eligible for up to 1 year of additional pembrolizumab therapy if they progress after stopping pembrolizumab. Pembrolizumab: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacogenomic Study: Correlative studies
| Group | Source count |
|---|---|
| Treatment (Pembrolizumab) | 62 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Pembrolizumab) | 0.377 | Not reported | 0.136 | 0.618 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.136
- upper Limit
- 0.618
- value
- 0.377
- denoms
- counts
- group Id
- OG000
- value
- 62
- units
- Participants
- description
- The Youden Index will be used to determine the optimal threshold for PD-L1 expression in correlation with tumor response. Youden Index ranges from 0-1 with higher scores meaning greater accuracy/sensitivity/specificity calculated from an ROC AUC (sensitivity + specificity - 1 = Youden Index).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients may be eligible for up to 1 year of additional pembrolizumab therapy if they progress after stopping pembrolizumab. Pembrolizumab: Given IV Laboratory Biomarker Analysis: Correlative studies Pharmacogenomic Study: Correlative studies
- id
- OG000
- title
- Treatment (Pembrolizumab)
- param Type
- NUMBER
- population Description
- Two patients had missing PD-L1 expression data.
- reporting Status
- POSTED
- time Frame
- Up to 1 year
- title
- Ability of PD-L1 to Predict Response
- type
- PRIMARY
- unit Of Measure
- Youden index
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Preserved source evidence · Not medical advice
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