Clinical response statistics
toxicities
SECONDARY
The primary objective of the study was to evaluate ORR of pembrolizumab plus doxorubicin. The secondary objective was to assess clinical benefit rate (CBR) (no progression for > 24 weeks), progression-free survival (PFS), and overall survival (OS). Additional secondary endpoints were to assess the safety and tolerability of anthracycline plus pembrolizumab regimen. Responses were assessed by RECIST 1.1, and safety analysis was carried out based on toxicities assessed by CTCAE 4.0.A safety lead-in employing a 3-at-risk rolling design was used [