TriangleNCT02009449 · OUTCOME
Part I: Number of Participants With Overall Response Rate (ORR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From Date of First Dose of Study Drug until Disease Progression or Death (Up to 50 months)
What was measured
Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis.
Analysis population: Participants who received at least one dose of study intervention(s) and had an adequate irRC tumor assessment were included in the analysis.
Groups in this outcome
Part I: Pegilodecakin 0.8/1 mg + Nivolumab
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Nivolumab 3 mg/kg IV infusion over 60 minutes on Day 1 of each 14-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
Part I: Pegilodecakin 1.6/2 mg + Nivolumab
Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC with Nivolumab 3 mg/kg IV infusion over 60 minutes on Day 1 of each 14-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
| Group | Source count |
|---|---|
| Part I: Pegilodecakin 0.8/1 mg + Nivolumab | 1 |
| Part I: Pegilodecakin 1.6/2 mg + Nivolumab | 48 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part I: Pegilodecakin 0.8/1 mg + Nivolumab | 1 | Not reported | Not reported | Not reported | Not reported |
| Part I: Pegilodecakin 1.6/2 mg + Nivolumab | 19 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 19
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 48
- units
- Participants
- description
- Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis.
- groups
- description
- Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Nivolumab 3 mg/kg IV infusion over 60 minutes on Day 1 of each 14-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
- id
- OG000
- title
- Part I: Pegilodecakin 0.8/1 mg + Nivolumab
- description
- Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC with Nivolumab 3 mg/kg IV infusion over 60 minutes on Day 1 of each 14-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
- id
- OG001
- title
- Part I: Pegilodecakin 1.6/2 mg + Nivolumab
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Participants who received at least one dose of study intervention(s) and had an adequate irRC tumor assessment were included in the analysis.
- reporting Status
- POSTED
- time Frame
- From Date of First Dose of Study Drug until Disease Progression or Death (Up to 50 months)
- title
- Part I: Number of Participants With Overall Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice