TriangleNCT02009449 · OUTCOME
Part H: 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 48 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 H: Pegilodecakin 0.8/1 mg + Pembrolizumab
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
Part H: Pegilodecakin 1.6/2 mg + Pembrolizumab
Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
Part H: Pegilodecakin 3.2/4 mg + Pembrolizumab
Participants received 3.2 or 4 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
| Group | Source count |
|---|---|
| Part H: Pegilodecakin 0.8/1 mg + Pembrolizumab | 14 |
| Part H: Pegilodecakin 1.6/2 mg + Pembrolizumab | 28 |
| Part H: Pegilodecakin 3.2/4 mg + Pembrolizumab | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part H: Pegilodecakin 0.8/1 mg + Pembrolizumab | 5 | Not reported | Not reported | Not reported | Not reported |
| Part H: Pegilodecakin 1.6/2 mg + Pembrolizumab | 3 | Not reported | Not reported | Not reported | Not reported |
| Part H: Pegilodecakin 3.2/4 mg + Pembrolizumab | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 28
- group Id
- OG002
- value
- 5
- 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 Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
- id
- OG000
- title
- Part H: Pegilodecakin 0.8/1 mg + Pembrolizumab
- description
- Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
- id
- OG001
- title
- Part H: Pegilodecakin 1.6/2 mg + Pembrolizumab
- description
- Participants received 3.2 or 4 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
- id
- OG002
- title
- Part H: Pegilodecakin 3.2/4 mg + Pembrolizumab
- 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 48 months)
- title
- Part H: 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