Safety and response assessments
neurotoxicity, toxicities, toxicity, Cancer
ADVERSE EVENTS, ADVERSE EVENT, CYTOKINE RELEASE SYNDROME, CANCER
Incidence and nature of adverse events to define dose-limiting toxicities was documented using the National Cancer Institute’s Common Terminology Criteria for Adverse Events v.5.0 except for cytokine release syndrome and neurotoxicity, which were evaluated per the American Society for Transplantation and Cellular Therapy consensus criteria. The dose-limiting toxicity assessment window was from day 0 to day 28. A safety review team was chartered to review safety after each dose level and before opening up enrolment for IL-2 treatment. Response assessment for overall response rate was determined by investigator assessment using RECIST v.1.1 on day 28 and confirmed by repeat assessment ≥4 weeks after initial documentation.