NCT02332980 · OUTCOME
Overall Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 5 years
What was measured
The distribution of overall survival will be estimated using the method of Kaplan-Meier.
Groups in this outcome
Arm A (CLL)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
Arm B (NHL)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
Arm C (CLL With Richters)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
Arm A (Continuation Phase)
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
Arm C (Continuation Phase)
CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
| Group | Source count |
|---|---|
| Arm A (CLL) | 25 |
| Arm B (NHL) | 23 |
| Arm C (CLL With Richters) | 17 |
| Arm A (Continuation Phase) | 5 |
| Arm C (Continuation Phase) | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (CLL) | 10.6 | Not reported | 5.4 | 34.4 | Not reported |
| Arm B (NHL) | 48.6 | Not reported | 13.0 | NA | Not enough events to estimate upper confidence limit |
| Arm C (CLL With Richters) | 11.5 | Not reported | 4.1 | 17.6 | Not reported |
| Arm A (Continuation Phase) | 11.7 | Not reported | 1.9 | NA | Not enough events to estimate upper confidence limit |
| Arm C (Continuation Phase) | 13.3 | Not reported | 5.8 | NA | Not enough events to estimate upper confidence limit |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.4
- upper Limit
- 34.4
- value
- 10.6
- comment
- Not enough events to estimate upper confidence limit
- group Id
- OG001
- lower Limit
- 13.0
- upper Limit
- NA
- value
- 48.6
- group Id
- OG002
- lower Limit
- 4.1
- upper Limit
- 17.6
- value
- 11.5
- comment
- Not enough events to estimate upper confidence limit
- group Id
- OG003
- lower Limit
- 1.9
- upper Limit
- NA
- value
- 11.7
- comment
- Not enough events to estimate upper confidence limit
- group Id
- OG004
- lower Limit
- 5.8
- upper Limit
- NA
- value
- 13.3
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 23
- group Id
- OG002
- value
- 17
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 13
- units
- Participants
- description
- The distribution of overall survival will be estimated using the method of Kaplan-Meier.
- 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 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
- id
- OG000
- title
- Arm A (CLL)
- description
- Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
- id
- OG001
- title
- Arm B (NHL)
- description
- Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
- id
- OG002
- title
- Arm C (CLL With Richters)
- description
- CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
- id
- OG003
- title
- Arm A (Continuation Phase)
- description
- CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
- id
- OG004
- title
- Arm C (Continuation Phase)
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- 5 years
- title
- Overall Survival
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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