TriangleNCT02009449 · OUTCOME
Number of Participants With Anti-Pegilodecakin Antibody Formation
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
- Up to 63 Months
What was measured
Number of participants with treatment-emergent anti-Pegilodecakin antibodies, defined as participants with at least one postbaseline anti-drug antibody (ADA) titer ≥4-fold increase from baseline (treatment-boosted) or ADA present with titer ≥1:20 if baseline ADA was negative (treatment-induced), analyses were conducted in the TE ADA-evaluable population. A participant is TE ADA evaluable if at least one non-missing ADA result is available at both baseline and postbaseline.
Analysis population: Participants who received at least one dose of study intervention and had evaluable data for this specified outcome.
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.
Part B: Pegilodecakin 0.2/0.25 mg + Platinum/Taxane
Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
Part B: Pegilodecakin 0.4/0.5 mg + Platinum/Taxane
Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
Part B: Pegilodecakin 0.8/1 mg + Platinum/Taxane
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
Part C: Pegilodecakin 0.2/0.25 mg + FOLFOX
Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
Part C: Pegilodecakin 0.4/0.5 mg + FOLFOX
Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
Part C: Pegilodecakin 0.8/1 mg + FOLFOX
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
Part D: Pegilodecakin 0.4/ 0.5 mg + Gemcitabine/Nab-Paclitaxel
Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC with Gemcitabine 1000 mg/m2 IV over 30 minutes plus nab-paclitaxel 125 mg/m2 IV over 30 to 40 minutes on Days 1, 8, and 15 of every 28-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
Part E: Pegilodecakin 0.8/1 mg + Capecitabine
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Capecitabine 1000 mg/m² orally twice daily (BID) on Days 1 through 14 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
Part F: Pegilodecakin 0.8/ 1 mg + Paclitaxel
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Paclitaxel 80 mg/m2 IV over 3 hours on Days 1, 8, and 15 of every 28-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
Part G: Pegilodecakin 0.8/1 mg + Pazopanib
Participants received a 0.8 or 1 mg of Pegilodecakin QD administered SC with Pazopanib 800 mg orally QD. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
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.
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.
Part J: Pegilodecakin 0.4/0.5 mg + Gemcitabine/Carboplatin
Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC with gemcitabine 500 mg/m2 IV over 30 minutes followed by carboplatin targeting an AUC2 IV over 60 minutes on Days 1 and 8 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
Part J: Pegilodecakin 0.8/1 mg + Gemcitabine/Carboplatin
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with gemcitabine 500 mg/m2 IV over 30 minutes followed by carboplatin targeting an AUC2 IV over 60 minutes on Days 1 and 8 of each 21-day cycle. 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 | 6 |
| Part A: Pegilodecakin 0.4/0.5 mg | 6 |
| Part A: Pegilodecakin 0.8/1 mg | 6 |
| Part A: Pegilodecakin 1.6/2 mg | 105 |
| Part A: Pegilodecakin 3.2/4 mg | 5 |
| Part B: Pegilodecakin 0.2/0.25 mg + Platinum/Taxane | 4 |
| Part B: Pegilodecakin 0.4/0.5 mg + Platinum/Taxane | 2 |
| Part B: Pegilodecakin 0.8/1 mg + Platinum/Taxane | 16 |
| Part C: Pegilodecakin 0.2/0.25 mg + FOLFOX | 3 |
| Part C: Pegilodecakin 0.4/0.5 mg + FOLFOX | 28 |
| Part C: Pegilodecakin 0.8/1 mg + FOLFOX | 6 |
| Part D: Pegilodecakin 0.4/ 0.5 mg + Gemcitabine/Nab-Paclitaxel | 5 |
| Part E: Pegilodecakin 0.8/1 mg + Capecitabine | 6 |
| Part F: Pegilodecakin 0.8/ 1 mg + Paclitaxel | 6 |
| Part G: Pegilodecakin 0.8/1 mg + Pazopanib | 6 |
| Part H: Pegilodecakin 0.8/1 mg + Pembrolizumab | 13 |
| Part H: Pegilodecakin 1.6/2 mg + Pembrolizumab | 33 |
| Part H: Pegilodecakin 3.2/4 mg + Pembrolizumab | 5 |
| Part I: Pegilodecakin 0.8/1 mg + Nivolumab | 1 |
| Part I: Pegilodecakin 1.6/2 mg + Nivolumab | 46 |
| Part J: Pegilodecakin 0.4/0.5 mg + Gemcitabine/Carboplatin | 5 |
| Part J: Pegilodecakin 0.8/1 mg + Gemcitabine/Carboplatin | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: Pegilodecakin 0.08/0.1 mg | 3 | Not reported | Not reported | Not reported | Not reported |
| Part A: Pegilodecakin 0.2/0.25 mg | 3 | Not reported | Not reported | Not reported | Not reported |
| Part A: Pegilodecakin 0.4/0.5 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Part A: Pegilodecakin 0.8/1 mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Part A: Pegilodecakin 1.6/2 mg | 22 | Not reported | Not reported | Not reported | Not reported |
| Part A: Pegilodecakin 3.2/4 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B: Pegilodecakin 0.2/0.25 mg + Platinum/Taxane | 2 | Not reported | Not reported | Not reported | Not reported |
| Part B: Pegilodecakin 0.4/0.5 mg + Platinum/Taxane | 1 | Not reported | Not reported | Not reported | Not reported |
| Part B: Pegilodecakin 0.8/1 mg + Platinum/Taxane | 2 | Not reported | Not reported | Not reported | Not reported |
| Part C: Pegilodecakin 0.2/0.25 mg + FOLFOX | 0 | Not reported | Not reported | Not reported | Not reported |
| Part C: Pegilodecakin 0.4/0.5 mg + FOLFOX | 5 | Not reported | Not reported | Not reported | Not reported |
| Part C: Pegilodecakin 0.8/1 mg + FOLFOX | 1 | Not reported | Not reported | Not reported | Not reported |
| Part D: Pegilodecakin 0.4/ 0.5 mg + Gemcitabine/Nab-Paclitaxel | 1 | Not reported | Not reported | Not reported | Not reported |
| Part E: Pegilodecakin 0.8/1 mg + Capecitabine | 1 | Not reported | Not reported | Not reported | Not reported |
| Part F: Pegilodecakin 0.8/ 1 mg + Paclitaxel | 0 | Not reported | Not reported | Not reported | Not reported |
| Part G: Pegilodecakin 0.8/1 mg + Pazopanib | 0 | Not reported | Not reported | Not reported | Not reported |
| Part H: Pegilodecakin 0.8/1 mg + Pembrolizumab | 7 | Not reported | Not reported | Not reported | Not reported |
| Part H: Pegilodecakin 1.6/2 mg + Pembrolizumab | 12 | Not reported | Not reported | Not reported | Not reported |
| Part H: Pegilodecakin 3.2/4 mg + Pembrolizumab | 3 | Not reported | Not reported | Not reported | Not reported |
| 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 | 14 | Not reported | Not reported | Not reported | Not reported |
| Part J: Pegilodecakin 0.4/0.5 mg + Gemcitabine/Carboplatin | 0 | Not reported | Not reported | Not reported | Not reported |
| Part J: Pegilodecakin 0.8/1 mg + Gemcitabine/Carboplatin | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 22
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 5
- group Id
- OG011
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 105
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 16
- group Id
- OG009
- value
- 3
- group Id
- OG010
- value
- 28
- group Id
- OG011
- value
- 6
- units
- Participants
- description
- Number of participants with treatment-emergent anti-Pegilodecakin antibodies, defined as participants with at least one postbaseline anti-drug antibody (ADA) titer ≥4-fold increase from baseline (treatment-boosted) or ADA present with titer ≥1:20 if baseline ADA was negative (treatment-induced), analyses were conducted in the TE ADA-evaluable population. A participant is TE ADA evaluable if at least one non-missing ADA result is available at both baseline and postbaseline.
- 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
- description
- Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
- id
- OG006
- title
- Part B: Pegilodecakin 0.2/0.25 mg + Platinum/Taxane
- description
- Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
- id
- OG007
- title
- Part B: Pegilodecakin 0.4/0.5 mg + Platinum/Taxane
- description
- Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
- id
- OG008
- title
- Part B: Pegilodecakin 0.8/1 mg + Platinum/Taxane
- description
- Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
- id
- OG009
- title
- Part C: Pegilodecakin 0.2/0.25 mg + FOLFOX
- description
- Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
- id
- OG010
- title
- Part C: Pegilodecakin 0.4/0.5 mg + FOLFOX
- description
- Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
- id
- OG011
- title
- Part C: Pegilodecakin 0.8/1 mg + FOLFOX
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Participants who received at least one dose of study intervention and had evaluable data for this specified outcome.
- reporting Status
- POSTED
- time Frame
- Up to 63 Months
- title
- Number of Participants With Anti-Pegilodecakin Antibody Formation
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice