Statistical Analysis
tumor
TUMOR
Data cutoff was on March 7, 2022. Trial enrollment for this phase 2 cohort was planned for 40 patients (1 − β = 0.90; estimated dropout rate, 5%). The clinically sufficient response rate was specified with π1 = 35%; the clinically insufficient response rate was specified with π0 = 15%. In the primary efficacy analysis, tumor responses of all patients were determined by central review and used as the primary assessment in the overall response analysis. The primary end point of response was estimated using the minimax 3-stage design for phase 2 oncology clinical trials with 2 interim analyses (eTable 3 in 