TriangleNCT02741570 · OUTCOME
Duration of Objective Response (DOR)
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 randomization to the first documented response (CR or PR) and progression (up to approximately 65 months)
What was measured
The time between the first documented response (Complete response (CR) or partial response (PR)) and progression or death, per RECIST 1.1 by blinded independent central review (BICR) assessment. (Based on Kaplan-Meier Estimates) Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Analysis population: All randomized participants and randomized PD-L1 CPS \>= 20 participants with a BOR response of CR or PR
Groups in this outcome
Nivolumab + Ipilimumab
Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
EXTREME Regimen
Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.
| Group | Source count |
|---|---|
| Nivolumab + Ipilimumab | 114 |
| EXTREME Regimen | 176 |
Reported measurements
All randomized participants
| Group | Source count |
|---|---|
| Nivolumab + Ipilimumab | 114 |
| EXTREME Regimen | 176 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab + Ipilimumab | 16.59 | Not reported | 9.69 | 29.40 | Not reported |
| EXTREME Regimen | 5.88 | Not reported | 5.45 | 6.97 | Not reported |
Randomized PD-L1 CPS >= 20 participants
| Group | Source count |
|---|---|
| Nivolumab + Ipilimumab | 63 |
| EXTREME Regimen | 63 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab + Ipilimumab | 33.51 | Not reported | 12.12 | NA | Insufficient number of participants with events |
| EXTREME Regimen | 6.97 | Not reported | 5.65 | 10.12 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.69
- upper Limit
- 29.40
- value
- 16.59
- group Id
- OG001
- lower Limit
- 5.45
- upper Limit
- 6.97
- value
- 5.88
- denoms
- counts
- group Id
- OG000
- value
- 114
- group Id
- OG001
- value
- 176
- units
- Participants
- title
- All randomized participants
- categories
- measurements
- comment
- Insufficient number of participants with events
- group Id
- OG000
- lower Limit
- 12.12
- upper Limit
- NA
- value
- 33.51
- group Id
- OG001
- lower Limit
- 5.65
- upper Limit
- 10.12
- value
- 6.97
- denoms
- counts
- group Id
- OG000
- value
- 63
- group Id
- OG001
- value
- 63
- units
- Participants
- title
- Randomized PD-L1 CPS >= 20 participants
- denoms
- counts
- group Id
- OG000
- value
- 114
- group Id
- OG001
- value
- 176
- units
- Participants
- description
- The time between the first documented response (Complete response (CR) or partial response (PR)) and progression or death, per RECIST 1.1 by blinded independent central review (BICR) assessment. (Based on Kaplan-Meier Estimates) Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
- id
- OG000
- title
- Nivolumab + Ipilimumab
- description
- Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.
- id
- OG001
- title
- EXTREME Regimen
- param Type
- MEDIAN
- population Description
- All randomized participants and randomized PD-L1 CPS \>= 20 participants with a BOR response of CR or PR
- reporting Status
- POSTED
- time Frame
- From randomization to the first documented response (CR or PR) and progression (up to approximately 65 months)
- title
- Duration of Objective Response (DOR)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice