TriangleNCT02332980 · OUTCOME
Progression-free Survival of Patients Treated With Combination Therapy
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 progression-free survival will be estimated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Groups in this outcome
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 (Continuation Phase) | 5 |
| Arm C (Continuation Phase) | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Continuation Phase) | 7.6 | Not reported | 1.9 | NA | Not enough events occurred to calculate upper limit |
| Arm C (Continuation Phase) | 5.4 | Not reported | 0.7 | 15.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Not enough events occurred to calculate upper limit
- group Id
- OG000
- lower Limit
- 1.9
- upper Limit
- NA
- value
- 7.6
- group Id
- OG001
- lower Limit
- 0.7
- upper Limit
- 15.0
- value
- 5.4
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 13
- units
- Participants
- description
- The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
- dispersion Type
- 95% Confidence Interval
- groups
- 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
- OG000
- 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
- OG001
- title
- Arm C (Continuation Phase)
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- 5 years
- title
- Progression-free Survival of Patients Treated With Combination Therapy
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice