Efficacy of PErioperative PEmbrolizumab Treatment in Patients With Resectable Metastases From Kidney Cancer

In this study, approximately 81 participants with ccRCC will be enrolled. The RESORT and E2810 clinical trials reported a rate of patients free of relapse of about 50% at 24 months. This study aims to improve this rate from 50% to 70% corresponding to an Hard Ratio of 0.51. Therefore, the sample size required for demonstrating this relapse-free survival (RFS) advantage includes a total of 74 patients that will be randomized 2:1 in the arm A or B respectively. The study will detect a treatment difference with the 80% probability at a one-sided p and 10.0% significance level, if the true hazard ratio is 0.51. This is based on the assumption that the accrual period will be 30 months, the follow up period will be 24 months, and the median RFS is 24 months. Because 10% of dropout has been estimated, the final number of patients is 81.