TriangleNCT02500797 · OUTCOME
6-Month Clinical Benefit Rate [Expansion LPS and UPS/MFH Cohorts 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
- 85% 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 LPS and UPS/MFH Cohorts Participants who received treatment Only
Groups in this outcome
LPS Single
Dedifferentiated liposarcoma (LPS) 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.
LPS Dual
Dedifferentiated liposarcoma (LPS) 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.
UPS/MFH Single
Undifferentiated Pleomorphic Sarcoma \& Malignant Fibrous Histiocytoma (UPS/MFH) 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.
UPS/MFH Dual
Undifferentiated Pleomorphic Sarcoma \& Malignant Fibrous Histiocytoma (UPS/MFH) 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 |
|---|---|
| LPS Single | 15 |
| LPS Dual | 14 |
| UPS/MFH Single | 13 |
| UPS/MFH Dual | 14 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| LPS Single | 6.7 | Not reported | NA | 21 | 1-sided Upper Confidence Limit |
| LPS Dual | 35.7 | Not reported | NA | 53.1 | 1-sided Upper Confidence Limit |
| UPS/MFH Single | 15.4 | Not reported | NA | 32.7 | 1-sided Upper Confidence Limit |
| UPS/MFH Dual | 35.7 | Not reported | NA | 53.1 | 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
- 21
- value
- 6.7
- comment
- 1-sided Upper Confidence Limit
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- 53.1
- value
- 35.7
- comment
- 1-sided Upper Confidence Limit
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- 32.7
- value
- 15.4
- comment
- 1-sided Upper Confidence Limit
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- 53.1
- value
- 35.7
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 13
- group Id
- OG003
- value
- 14
- 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
- 85% Confidence Interval
- groups
- description
- Dedifferentiated liposarcoma (LPS) 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
- LPS Single
- description
- Dedifferentiated liposarcoma (LPS) 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
- LPS Dual
- description
- Undifferentiated Pleomorphic Sarcoma \& Malignant Fibrous Histiocytoma (UPS/MFH) 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
- OG002
- title
- UPS/MFH Single
- description
- Undifferentiated Pleomorphic Sarcoma \& Malignant Fibrous Histiocytoma (UPS/MFH) 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
- OG003
- title
- UPS/MFH Dual
- param Type
- NUMBER
- population Description
- Randomized Expansion LPS and UPS/MFH Cohorts Participants who received treatment Only
- reporting Status
- POSTED
- time Frame
- At 6 months
- title
- 6-Month Clinical Benefit Rate [Expansion LPS and UPS/MFH Cohorts Only]
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice