Outcome measures
PD
CPS
The primary endpoint for Cohorts 1–3 was the 9-month (9-m) clinical benefit rate (CBR) assessed by local investigators according to RECIST 1.1, defined as the factual percentage of patients achieving CR, partial response (PR), or SD at 9-m after the initiation of durvalumab plus tremelimumab treatment. The primary endpoint for Cohort 4 was the 9-m overall survival (OS) rate, defined as the percentage of patients alive at 9-m after initiation of durvalumab plus tremelimumab therapy. The primary endpoint for each cohort was chosen based on the stipulated benchmarksSecondary activity endpoints included: ORR, duration of response (DoR) defined as the time elapsed from the first response to PD; progression-free survival (PFS) according to irRECIST; and OS. Safety was based on the assessment of AEs, clinical laboratory test results, vital signs, and physical examination. AEs and laboratory values were graded according to the NCI-CTCAE v. 4.03. The trial included an exploratory analysis to correlate the expression of PD-L1 CPS and activity endpoints.