Phase 1/2 Study of Bempegaldesleukin in Combination With Nivolumab in Children, Adolescents, and Young Adults With Recurrent or Refractory Malignancies (PIVOT IO 020)

Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A

时间窗: From first dose to 42 days after first dose

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) - Part A

时间窗: From first dose to 30 days after last dose (up to approximately 6 months)

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.

Maximum Observed Plasma Concentration (Cmax) - Part A

时间窗: From first dose to 30 days after last dose (up to approximately 6 months)

Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.

Number of Participants With Serious Adverse Events (SAEs) - Part A

时间窗: From first dose to 30 days after last dose (up to approximately 6 months)

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 - Part A

时间窗: From first dose to 30 days after last dose (up to approximately 6 months)

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 - Part A

时间窗: From first dose to 30 days after last dose (up to approximately 6 months)

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 - Part A

时间窗: From first dose to 30 days after last dose (up to approximately 6 months)

Number of participants who died.

Trough Observed Concentration (Ctrough) - Part A

时间窗: From first dose to 30 days after last dose (up to approximately 6 months)

Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.

Area Under the Plasma Concentration (AUC) - Part A

时间窗: From first dose to 30 days after last dose (up to approximately 6 months)

Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.