Endpoints
PD, death
DISEASE
The primary endpoint was the occurrence of DLTs, AEs, and changes from baseline in other safety measures, such as laboratory values. Secondary endpoints included evaluations of best response (eg, ORR, defined as partial [PR] or complete response [CR]) and PFS per irRECIST (defined as the time from beginning of treatment to progressive disease [PD] or death, whichever occurred first), durable response rate (defined as the percentage of patients with CR or PR lasting ≥ 26 weeks), and duration of response (DOR; time from first evidence of PR or CR to confirmation of PD).