A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer

Titre officiel

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

Sommaire:

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.

Description de l'essai

Primary Outcome:

• Incidence of dose-limiting toxicities
• Incidence of adverse events (AEs)
• Incidence of serious AEs (SAEs)
• Incidence of drug-related AEs
• Incidence of AEs leading to discontinuation
• Incidence of death
• Pharmacokinetic (PK) parameters: Peak concentration
• Pharmacokinetic (PK) parameters: Trough concentration
• Pharmacokinetic (PK) parameters: Time-averaged concentration
• Pharmacokinetic (PK) parameters: Clearance (CL)
• Pharmacokinetic (PK) parameters: Volume of distribution (Vd)
• Investigator-assessed objective response rate (ORR)

• Incidence of AEs
• Incidence of SAEs
• Incidence of drug-related AEs
• Incidence of AEs leading to discontinuation
• Incidence of death
• Incidence of laboratory abnormalities: Hematology tests
• Incidence of laboratory abnormalities: Clinical chemistry tests
• Progression-free survival (PFS)
• Overall survival (OS)

Voir cet essai sur ClinicalTrials.gov