TriangleNCT02009449 · STUDY IN CONTEXT
A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
The number of participants who experienced treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) during the study.
Serum concentration of Pegilodecakin is reported.
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.
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.
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.
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- trial label
- A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 23
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- outcome key
- om-0000
- source section id
- NCT02009449-om-0000
- source outcome index
- 0
- endpoint
- Number of Participants With TEAEs and SAEs Observed During the Study of Pegilodecakin
- endpoint definition
- The number of participants who experienced treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) during the study.
- time origin
- From first dose of study drug through 30 days after the last dose of study drug (Up to 63 Months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who received at least one dose of study intervention.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- outcome key
- om-0001
- source section id
- NCT02009449-om-0001
- source outcome index
- 1
- endpoint
- Pharmacokinetic (PK): Serum Concentration of Pegilodecakin
- endpoint definition
- Serum concentration of Pegilodecakin is reported.
- time origin
- Day 29
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who received at least one dose of the study intervention and had evaluable PK data. Per protocol, PK data was pre-specified to be analyzed by Pegilodecakin dose levels across all parts.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- outcome key
- om-0002
- source section id
- NCT02009449-om-0002
- source outcome index
- 2
- endpoint
- Number of Participants With Anti-Pegilodecakin Antibody Formation
- endpoint definition
- 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.
- time origin
- Up to 63 Months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who received at least one dose of study intervention and had evaluable data for this specified outcome.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- outcome key
- om-0003
- source section id
- NCT02009449-om-0003
- source outcome index
- 3
- endpoint
- Part A: Number of Participants With Overall Response Rate (ORR)
- endpoint definition
- 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.
- time origin
- From Date of First Dose of study drug until Disease Progression or Death (Up to 54 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who received at least one dose of study intervention(s) and had an adequate irRC tumor assessment were included in the analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- outcome key
- om-0004
- source section id
- NCT02009449-om-0004
- source outcome index
- 4
- endpoint
- Part B: Number of Participants With Overall Response Rate (ORR)
- endpoint definition
- 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.
- time origin
- From Date of First Dose of Study Drug until Disease Progression or Death (Up to 11 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who received at least one dose of study intervention(s) and had an adequate irRC tumor assessment were included in the analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- outcome key
- om-0005
- source section id
- NCT02009449-om-0005
- source outcome index
- 5
- endpoint
- Part C: Number of Participants With Overall Response Rate (ORR)
- endpoint definition
- 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.
- time origin
- From Date of First Dose of Study drug until Disease Progression or Death (Upto 23 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who received at least one dose of study intervention(s) and had an adequate irRC tumor assessment were included in the analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Part A: Pegilodecakin 0.08/0.1 mg
- regimen
- 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.
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02009449-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Part A: Pegilodecakin 0.2/0.25 mg
- regimen
- 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.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02009449-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Part A: Pegilodecakin 0.4/0.5 mg
- regimen
- 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.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02009449-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- outcome key
- om-0000
- arm key
- OG003
- arm label
- Part A: Pegilodecakin 0.8/1 mg
- regimen
- 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.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02009449-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- outcome key
- om-0000
- arm key
- OG004
- arm label
- Part A: Pegilodecakin 1.6/2 mg
- regimen
- 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.
- analyzed count
- 117
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02009449-om-0000#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- outcome key
- om-0000
- arm key
- OG005
- arm label
- Part A: Pegilodecakin 3.2/4 mg
- regimen
- 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.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02009449-om-0000#groups/OG005
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- outcome key
- om-0000
- arm key
- OG006
- arm label
- Part B: Pegilodecakin 0.2/0.25 mg + Platinum/Taxane
- regimen
- 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.
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02009449-om-0000#groups/OG006
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- outcome key
- om-0000
- arm key
- OG007
- arm label
- Part B: Pegilodecakin 0.4/0.5 mg + Platinum/Taxane
- regimen
- 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.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02009449-om-0000#groups/OG007
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- outcome key
- om-0000
- arm key
- OG008
- arm label
- Part B: Pegilodecakin 0.8/1 mg + Platinum/Taxane
- regimen
- 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.
- analyzed count
- 18
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02009449-om-0000#groups/OG008
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- outcome key
- om-0000
- arm key
- OG009
- arm label
- Part C: Pegilodecakin 0.2/0.25 mg + FOLFOX
- regimen
- 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.
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02009449-om-0000#groups/OG009
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- outcome key
- om-0000
- arm key
- OG010
- arm label
- Part C: Pegilodecakin 0.4/0.5 mg + FOLFOX
- regimen
- 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.
- analyzed count
- 29
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02009449-om-0000#groups/OG010
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- outcome key
- om-0000
- arm key
- OG011
- arm label
- Part C: Pegilodecakin 0.8/1 mg + FOLFOX
- regimen
- 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.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02009449-om-0000#groups/OG011
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- harm key
- EG000
- source section id
- NCT02009449-ae
- event group key
- EG000
- event group label
- Part A: Pegilodecakin 0.08/0.1 mg
- serious affected
- 3
- serious at risk
- 4
- other affected
- 4
- other at risk
- 4
- frequency threshold
- 0
- collection period
- From first dose of study drug through 30 days after the last dose of study drug (Up to 116 Months)
- event definition
- Participants who received at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected and reported by treatment regimen. Gender specific events only occurring in male or female participants have had the number of participants "At Risk" adjusted accordingly.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- harm key
- EG001
- source section id
- NCT02009449-ae
- event group key
- EG001
- event group label
- Part A: Pegilodecakin 0.2/0.25 mg
- serious affected
- 2
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 0
- collection period
- From first dose of study drug through 30 days after the last dose of study drug (Up to 116 Months)
- event definition
- Participants who received at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected and reported by treatment regimen. Gender specific events only occurring in male or female participants have had the number of participants "At Risk" adjusted accordingly.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- harm key
- EG002
- source section id
- NCT02009449-ae
- event group key
- EG002
- event group label
- Part A: Pegilodecakin 0.4/0.5 mg
- serious affected
- 2
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 0
- collection period
- From first dose of study drug through 30 days after the last dose of study drug (Up to 116 Months)
- event definition
- Participants who received at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected and reported by treatment regimen. Gender specific events only occurring in male or female participants have had the number of participants "At Risk" adjusted accordingly.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- harm key
- EG003
- source section id
- NCT02009449-ae
- event group key
- EG003
- event group label
- Part A: Pegilodecakin 0.8/1 mg
- serious affected
- 2
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 0
- collection period
- From first dose of study drug through 30 days after the last dose of study drug (Up to 116 Months)
- event definition
- Participants who received at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected and reported by treatment regimen. Gender specific events only occurring in male or female participants have had the number of participants "At Risk" adjusted accordingly.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- harm key
- EG004
- source section id
- NCT02009449-ae
- event group key
- EG004
- event group label
- Part A: Pegilodecakin 1.6/2 mg
- serious affected
- 60
- serious at risk
- 117
- other affected
- 116
- other at risk
- 117
- frequency threshold
- 0
- collection period
- From first dose of study drug through 30 days after the last dose of study drug (Up to 116 Months)
- event definition
- Participants who received at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected and reported by treatment regimen. Gender specific events only occurring in male or female participants have had the number of participants "At Risk" adjusted accordingly.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- harm key
- EG005
- source section id
- NCT02009449-ae
- event group key
- EG005
- event group label
- Part A: Pegilodecakin 3.2/4 mg
- serious affected
- 2
- serious at risk
- 5
- other affected
- 5
- other at risk
- 5
- frequency threshold
- 0
- collection period
- From first dose of study drug through 30 days after the last dose of study drug (Up to 116 Months)
- event definition
- Participants who received at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected and reported by treatment regimen. Gender specific events only occurring in male or female participants have had the number of participants "At Risk" adjusted accordingly.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- harm key
- EG006
- source section id
- NCT02009449-ae
- event group key
- EG006
- event group label
- Part B: Pegilodecakin 0.2/0.25 mg + Platinum/Taxane
- serious affected
- 0
- serious at risk
- 4
- other affected
- 4
- other at risk
- 4
- frequency threshold
- 0
- collection period
- From first dose of study drug through 30 days after the last dose of study drug (Up to 116 Months)
- event definition
- Participants who received at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected and reported by treatment regimen. Gender specific events only occurring in male or female participants have had the number of participants "At Risk" adjusted accordingly.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- harm key
- EG007
- source section id
- NCT02009449-ae
- event group key
- EG007
- event group label
- Part B: Pegilodecakin 0.4/0.5 mg + Platinum/Taxane
- serious affected
- 1
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 0
- collection period
- From first dose of study drug through 30 days after the last dose of study drug (Up to 116 Months)
- event definition
- Participants who received at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected and reported by treatment regimen. Gender specific events only occurring in male or female participants have had the number of participants "At Risk" adjusted accordingly.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- harm key
- EG008
- source section id
- NCT02009449-ae
- event group key
- EG008
- event group label
- Part B: Pegilodecakin 0.8/1 mg + Platinum/Taxane
- serious affected
- 10
- serious at risk
- 18
- other affected
- 18
- other at risk
- 18
- frequency threshold
- 0
- collection period
- From first dose of study drug through 30 days after the last dose of study drug (Up to 116 Months)
- event definition
- Participants who received at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected and reported by treatment regimen. Gender specific events only occurring in male or female participants have had the number of participants "At Risk" adjusted accordingly.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- harm key
- EG009
- source section id
- NCT02009449-ae
- event group key
- EG009
- event group label
- Part C: Pegilodecakin 0.2/0.25 mg + FOLFOX
- serious affected
- 3
- serious at risk
- 4
- other affected
- 4
- other at risk
- 4
- frequency threshold
- 0
- collection period
- From first dose of study drug through 30 days after the last dose of study drug (Up to 116 Months)
- event definition
- Participants who received at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected and reported by treatment regimen. Gender specific events only occurring in male or female participants have had the number of participants "At Risk" adjusted accordingly.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- harm key
- EG010
- source section id
- NCT02009449-ae
- event group key
- EG010
- event group label
- Part C: Pegilodecakin 0.4/0.5 mg + FOLFOX
- serious affected
- 14
- serious at risk
- 29
- other affected
- 29
- other at risk
- 29
- frequency threshold
- 0
- collection period
- From first dose of study drug through 30 days after the last dose of study drug (Up to 116 Months)
- event definition
- Participants who received at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected and reported by treatment regimen. Gender specific events only occurring in male or female participants have had the number of participants "At Risk" adjusted accordingly.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT02009449
- harm key
- EG011
- source section id
- NCT02009449-ae
- event group key
- EG011
- event group label
- Part C: Pegilodecakin 0.8/1 mg + FOLFOX
- serious affected
- 3
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 0
- collection period
- From first dose of study drug through 30 days after the last dose of study drug (Up to 116 Months)
- event definition
- Participants who received at least one dose of study intervention. Based on the planned safety analysis, adverse events were collected and reported by treatment regimen. Gender specific events only occurring in male or female participants have had the number of participants "At Risk" adjusted accordingly.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice