Endpoints
death
DISEASE PROGRESSION, DISEASE
The primary endpoint was confirmed objective response rate (ORR) defined as a confirmed CR or PR at any point during trial treatment according to RECIST criteria, version 1.1. Secondary endpoints included duration of response (defined as time from the first documentation of CR or PR until date of disease progression or last date of follow-up), clinical benefit rate (defined as CR, PR, or SD for more than 6 months during trial treatment), progression-free survival (PFS; defined as time from cohort entry to first date of either confirmed progression of disease according to RECIST criteria or death from any cause), safety and tolerability of therapies.