NCT02399371 · OUTCOME
Disease Control Rate (CR + PR + SD)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 1 year
What was measured
The disease control rate (CR+PR+SD) and 90% confidence interval will also be determined. Per Response Evaluation Criteria In Solid Tumors Criteria modified for immunotherapy (iRECIST) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD), \>=120% increase in the sum of the longest diameter of target lesions; Stable disease (SD), not meeting criteria for either CR, PR, or PD. Per iRECIST, if criteria indicate PD, tumor assessment should be repeated 4 weeks later in order to confirm PD.
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) | 64 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Pembrolizumab) | 62.5 | Not reported | 50.6 | 74.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 50.6
- upper Limit
- 74.4
- value
- 62.5
- denoms
- counts
- group Id
- OG000
- value
- 64
- units
- Participants
- description
- The disease control rate (CR+PR+SD) and 90% confidence interval will also be determined. Per Response Evaluation Criteria In Solid Tumors Criteria modified for immunotherapy (iRECIST) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD), \>=120% increase in the sum of the longest diameter of target lesions; Stable disease (SD), not meeting criteria for either CR, PR, or PD. Per iRECIST, if criteria indicate PD, tumor assessment should be repeated 4 weeks later in order to confirm PD.
- 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
- reporting Status
- POSTED
- time Frame
- Up to 1 year
- title
- Disease Control Rate (CR + PR + SD)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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