TriangleNCT02105636 · OUTCOME
Investigator-Assessed Progression-Free Survival (PFS)
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
- From date of randomization to date of disease progression or death, whichever occurs first (Up to approximately 87 months)
What was measured
PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the investigator (as per Response Evaluation Criteria In Solid Tumors (RECIST1.1)), or death due to any cause, whichever occurs first. Progressive Disease: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must demonstrate an absolute increase of at least 5mm. Participants who: * Die without a reported progression were considered to have progressed on the date of their death. * Did not progress or die were censored on the date of their last evaluable tumor assessment. * Without any on study tumor assessments and did not die were censored on their date of randomization. * Received subsequent systemic anti-cancer therapy prior to documented progression were censored at the date of the last tumor assessment prior to the initiation of the new therapy.
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 | 2.04 | Not reported | 1.91 | 2.14 | Not reported |
| Investigators Choice | 2.33 | Not reported | 1.94 | 3.06 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.68
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.10
- estimate Comment
- Number of responders (CR +PR) over number of participants
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 0.86
Complete source fields
- analyses
- ci Lower Limit
- 0.68
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.10
- estimate Comment
- Number of responders (CR +PR) over number of participants
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 0.86
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.91
- upper Limit
- 2.14
- value
- 2.04
- group Id
- OG001
- lower Limit
- 1.94
- upper Limit
- 3.06
- value
- 2.33
- denoms
- counts
- group Id
- OG000
- value
- 240
- group Id
- OG001
- value
- 121
- units
- Participants
- description
- PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the investigator (as per Response Evaluation Criteria In Solid Tumors (RECIST1.1)), or death due to any cause, whichever occurs first. Progressive Disease: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must demonstrate an absolute increase of at least 5mm. Participants who: * Die without a reported progression were considered to have progressed on the date of their death. * Did not progress or die were censored on the date of their last evaluable tumor assessment. * Without any on study tumor assessments and did not die were censored on their date of randomization. * Received subsequent systemic anti-cancer therapy prior to documented progression were censored at the date of the last tumor assessment prior to the initiation of the new therapy.
- 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
- MEDIAN
- population Description
- All randomized participants
- reporting Status
- POSTED
- time Frame
- From date of randomization to date of disease progression or death, whichever occurs first (Up to approximately 87 months)
- title
- Investigator-Assessed Progression-Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice