Primary objectives: - To assess Pogression Free Survival (PFS) of treatment Primary endpoints: Progression-free survival (PFS) rate at 1 years after randomisation
aMean of 1,000 bootstrap analyses for PK and PD-2 estimates and mean of 100 bootstrap analyses for PD-1 estimates. bThe 2.5th and 97.5th values of the ranked bootstrap parameter estimates. cCL(S) mL/h