Stopped: Business objectives have changed
The purpose of this study is to first, in Part A, assess the safety, tolerability and drug levels of Bempegaldesleukin (BEMPEG) in combination with nivolumab and then, in Part B, to estimate the preliminary efficacy in children, adolescents and young adults with recurrent or treatment-resistant cancer.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A
Timeframe: From first dose to 42 days after first dose
Number of Participants With Adverse Events (AEs) - Part A
Timeframe: From first dose to 30 days after last dose (up to approximately 6 months)
Number of Participants With Serious Adverse Events (SAEs) - Part A
Timeframe: From first dose to 30 days after last dose (up to approximately 6 months)
Number of Participants With Drug-Related Adverse Events - Part A
Timeframe: From first dose to 30 days after last dose (up to approximately 6 months)
Number of Participants With Adverse Events Leading to Discontinuation - Part A
Timeframe: From first dose to 30 days after last dose (up to approximately 6 months)
Number of Participants Who Died - Part A
Timeframe: From first dose to 30 days after last dose (up to approximately 6 months)
Maximum Observed Plasma Concentration (Cmax) - Part A
Timeframe: From first dose to 30 days after last dose (up to approximately 6 months)
Trough Observed Concentration (Ctrough) - Part A
Timeframe: From first dose to 30 days after last dose (up to approximately 6 months)
Area Under the Plasma Concentration (AUC) - Part A
Timeframe: From first dose to 30 days after last dose (up to approximately 6 months)