Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected

This study enrolled adult women with platinum-resistant or platinum-refractory high-grade serous ovarian cancer (HGSOC) who did not have a detected germline BRCA mutation. In this open-label, active-controlled study, participants were randomized 1:1 to receive either alpelisib plus olaparib or single-agent cytotoxic chemotherapy (paclitaxel or pegylated liposomal doxorubicin \[PLD\]). The study comprised four phases: a 28-day pre-treatment phase, a randomized treatment phase, a post-treatment follow-up phase for safety and efficacy assessments, and a post-treatment survival follow-up phase. Participants continued study treatment until disease progression, unacceptable toxicity, death, or discontinuation for any other reason. Because the study did not achieve its primary objective, Protocol Amendment 03 removed the post-treatment survival follow-up phase. Subsequently, Protocol Amendment 04 modified the study design by removing the efficacy follow-up phase.