TriangleNCT04730349 · STUDY IN CONTEXT
A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer
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
Number of participants with dose-limiting toxicities (DLTs). DLTs were collected and evaluated for Part A within the DLT evaluation period, which started on Cycle 1 Day 1 (first dose) and ended at Day 42 (42 days after first dose of the study therapy).
Number of participants with adverse events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Number of participants with serious adverse events (SAEs). SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Number of participants with drug-related adverse events. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Number of participants with adverse events leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Number of participants who died.
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-ewing-sarcoma
- nct id
- NCT04730349
- trial label
- A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer
- 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
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT04730349
- outcome key
- om-0000
- source section id
- NCT04730349-om-0000
- source outcome index
- 0
- endpoint
- Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A
- endpoint definition
- Number of participants with dose-limiting toxicities (DLTs). DLTs were collected and evaluated for Part A within the DLT evaluation period, which started on Cycle 1 Day 1 (first dose) and ended at Day 42 (42 days after first dose of the study therapy).
- time origin
- From first dose to 42 days after first dose
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All treated participants in Part A
- 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-ewing-sarcoma
- nct id
- NCT04730349
- outcome key
- om-0001
- source section id
- NCT04730349-om-0001
- source outcome index
- 1
- endpoint
- Number of Participants With Adverse Events (AEs) - Part A
- endpoint definition
- Number of participants with adverse events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
- time origin
- From first dose to 30 days after last dose (up to approximately 6 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All treated participants in Part A
- 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-ewing-sarcoma
- nct id
- NCT04730349
- outcome key
- om-0002
- source section id
- NCT04730349-om-0002
- source outcome index
- 2
- endpoint
- Number of Participants With Serious Adverse Events (SAEs) - Part A
- endpoint definition
- Number of participants with serious adverse events (SAEs). SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
- time origin
- From first dose to 30 days after last dose (up to approximately 6 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All treated participants in Part A
- 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-ewing-sarcoma
- nct id
- NCT04730349
- outcome key
- om-0003
- source section id
- NCT04730349-om-0003
- source outcome index
- 3
- endpoint
- Number of Participants With Drug-Related Adverse Events - Part A
- endpoint definition
- Number of participants with drug-related adverse events. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
- time origin
- From first dose to 30 days after last dose (up to approximately 6 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All treated participants in Part A
- 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-ewing-sarcoma
- nct id
- NCT04730349
- outcome key
- om-0004
- source section id
- NCT04730349-om-0004
- source outcome index
- 4
- endpoint
- Number of Participants With Adverse Events Leading to Discontinuation - Part A
- endpoint definition
- Number of participants with adverse events leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
- time origin
- From first dose to 30 days after last dose (up to approximately 6 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All treated participants in Part A
- 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-ewing-sarcoma
- nct id
- NCT04730349
- outcome key
- om-0005
- source section id
- NCT04730349-om-0005
- source outcome index
- 5
- endpoint
- Number of Participants Who Died - Part A
- endpoint definition
- Number of participants who died.
- time origin
- From first dose to 30 days after last dose (up to approximately 6 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All treated participants in Part A
- 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-ewing-sarcoma
- nct id
- NCT04730349
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg)
- regimen
- Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04730349-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT04730349
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
- regimen
- Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04730349-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT04730349
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg)
- regimen
- Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04730349-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT04730349
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
- regimen
- Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04730349-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT04730349
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg)
- regimen
- Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04730349-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT04730349
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
- regimen
- Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04730349-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT04730349
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg)
- regimen
- Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04730349-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT04730349
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
- regimen
- Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04730349-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT04730349
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg)
- regimen
- Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04730349-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT04730349
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
- regimen
- Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04730349-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT04730349
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg)
- regimen
- Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04730349-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT04730349
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
- regimen
- Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04730349-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT04730349
- harm key
- EG000
- source section id
- NCT04730349-ae
- event group key
- EG000
- event group label
- Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg)
- serious affected
- 8
- serious at risk
- 8
- other affected
- 8
- other at risk
- 8
- frequency threshold
- 5
- collection period
- Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
- event definition
- Source null
- 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-ewing-sarcoma
- nct id
- NCT04730349
- harm key
- EG001
- source section id
- NCT04730349-ae
- event group key
- EG001
- event group label
- Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)
- serious affected
- 5
- serious at risk
- 7
- other affected
- 7
- other at risk
- 7
- frequency threshold
- 5
- collection period
- Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
- event definition
- Source null
- 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