TriangleNCT02500797 · OUTCOME
6-Month Clinical Benefit Rate [Expansion GIST Cohort Only]
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
- 80% Confidence Interval
- Time frame
- At 6 months
What was measured
The 6-month clinical benefit rate is defined as the percentage of participants with a response or stable disease (CR, PR, or SD) at 6 months. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by \>= 50% of previously involved sites from nadir, SD: Not CR/PR or PD).
Analysis population: Randomized Expansion GIST Cohort Participants who received treatment Only.
Groups in this outcome
GIST Single
Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
GIST Dual
Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
| Group | Source count |
|---|---|
| GIST Single | 10 |
| GIST Dual | 11 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| GIST Single | 10 | Not reported | NA | 27.1 | 1-sided Upper Confidence Limit |
| GIST Dual | 54.5 | Not reported | NA | 70.1 | 1-sided Upper Confidence Limit |
Complete source fields
- classes
- categories
- measurements
- comment
- 1-sided Upper Confidence Limit
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- 27.1
- value
- 10
- comment
- 1-sided Upper Confidence Limit
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- 70.1
- value
- 54.5
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 11
- units
- Participants
- description
- The 6-month clinical benefit rate is defined as the percentage of participants with a response or stable disease (CR, PR, or SD) at 6 months. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by \>= 50% of previously involved sites from nadir, SD: Not CR/PR or PD).
- dispersion Type
- 80% Confidence Interval
- groups
- description
- Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- GIST Single
- description
- Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
- id
- OG001
- title
- GIST Dual
- param Type
- NUMBER
- population Description
- Randomized Expansion GIST Cohort Participants who received treatment Only.
- reporting Status
- POSTED
- time Frame
- At 6 months
- title
- 6-Month Clinical Benefit Rate [Expansion GIST Cohort Only]
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice