TriangleNCT02105636 · OUTCOME
Investigator-Assessed Objective Response Rate (ORR)
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
- From date of randomization to date of disease progression or study drug is discontinued, whichever occurs first (Up to approximately 87 months)
What was measured
ORR was defined as the percentage of randomized participants who achieved a best response of complete response (CR) or partial response (PR) using the RECIST1.1 criteria as per investigator assessment. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.
Analysis population: All randomized participants
Groups in this outcome
Nivolumab 3mg/kg
Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
Investigators Choice
Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligrams per square meter (mg/m\^2) for the first dose followed that a doses of 250 mg/m\^2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m\^2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m\^2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice
| Group | Source count |
|---|---|
| Nivolumab 3mg/kg | 240 |
| Investigators Choice | 121 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab 3mg/kg | 13.3 | Not reported | 9.3 | 18.3 | Not reported |
| Investigators Choice | 5.8 | Not reported | 2.4 | 11.6 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 13.6
- estimate Comment
- Stratum adjusted difference in response rates (Nivolumab - Investigators Choice) based on the Cochran-Mantel-Haenszel method of weighting.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Difference in ORR
- param Value
- 7.6
- ci Lower Limit
- 1.07
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.82
- estimate Comment
- Stratified by Prior Cetuximab (yes, no) as recorded in the IVRS. Stratum adjusted odds ratio (Nivolumab - Investigators Choice) using Mantel-Haenszel Method.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- CMH Estimate of Common Odds Ratio
- param Value
- 2.49
Complete source fields
- analyses
- ci Lower Limit
- 1.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 13.6
- estimate Comment
- Stratum adjusted difference in response rates (Nivolumab - Investigators Choice) based on the Cochran-Mantel-Haenszel method of weighting.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Difference in ORR
- param Value
- 7.6
- ci Lower Limit
- 1.07
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.82
- estimate Comment
- Stratified by Prior Cetuximab (yes, no) as recorded in the IVRS. Stratum adjusted odds ratio (Nivolumab - Investigators Choice) using Mantel-Haenszel Method.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- CMH Estimate of Common Odds Ratio
- param Value
- 2.49
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.3
- upper Limit
- 18.3
- value
- 13.3
- group Id
- OG001
- lower Limit
- 2.4
- upper Limit
- 11.6
- value
- 5.8
- denoms
- counts
- group Id
- OG000
- value
- 240
- group Id
- OG001
- value
- 121
- units
- Participants
- description
- ORR was defined as the percentage of randomized participants who achieved a best response of complete response (CR) or partial response (PR) using the RECIST1.1 criteria as per investigator assessment. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
- id
- OG000
- title
- Nivolumab 3mg/kg
- description
- Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligrams per square meter (mg/m\^2) for the first dose followed that a doses of 250 mg/m\^2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m\^2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m\^2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice
- id
- OG001
- title
- Investigators Choice
- param Type
- NUMBER
- population Description
- All randomized participants
- reporting Status
- POSTED
- time Frame
- From date of randomization to date of disease progression or study drug is discontinued, whichever occurs first (Up to approximately 87 months)
- title
- Investigator-Assessed Objective Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice