TriangleNCT02009449 · OUTCOME
Part A: 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 54 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 Immune-related Complete Response (irCR) or Immune-related Partial Response (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 A: Pegilodecakin 0.08/0.1 mg
Participants received 0.08 or 0.1 mg of Pegilodecakin once daily (QD) administered subcutaneously (SC). Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
Part A: Pegilodecakin 0.2/0.25 mg
Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
Part A: Pegilodecakin 0.4/0.5 mg
Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
Part A: Pegilodecakin 0.8/1 mg
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
Part A: Pegilodecakin 1.6/2 mg
Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
Part A: Pegilodecakin 3.2/4 mg
Participants received 3.2 or 4 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
| Group | Source count |
|---|---|
| Part A: Pegilodecakin 0.08/0.1 mg | 4 |
| Part A: Pegilodecakin 0.2/0.25 mg | 5 |
| Part A: Pegilodecakin 0.4/0.5 mg | 6 |
| Part A: Pegilodecakin 0.8/1 mg | 5 |
| Part A: Pegilodecakin 1.6/2 mg | 95 |
| Part A: Pegilodecakin 3.2/4 mg | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: Pegilodecakin 0.08/0.1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A: Pegilodecakin 0.2/0.25 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A: Pegilodecakin 0.4/0.5 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A: Pegilodecakin 0.8/1 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part A: Pegilodecakin 1.6/2 mg | 6 | Not reported | Not reported | Not reported | Not reported |
| Part A: Pegilodecakin 3.2/4 mg | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 95
- group Id
- OG005
- 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 Immune-related Complete Response (irCR) or Immune-related Partial Response (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 0.08 or 0.1 mg of Pegilodecakin once daily (QD) administered subcutaneously (SC). Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
- id
- OG000
- title
- Part A: Pegilodecakin 0.08/0.1 mg
- description
- Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
- id
- OG001
- title
- Part A: Pegilodecakin 0.2/0.25 mg
- description
- Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
- id
- OG002
- title
- Part A: Pegilodecakin 0.4/0.5 mg
- description
- Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
- id
- OG003
- title
- Part A: Pegilodecakin 0.8/1 mg
- description
- Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
- id
- OG004
- title
- Part A: Pegilodecakin 1.6/2 mg
- description
- Participants received 3.2 or 4 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
- id
- OG005
- title
- Part A: Pegilodecakin 3.2/4 mg
- 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 54 months)
- title
- Part A: 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