Study Endpoints and Assessments
toxicities, tumor
ADVERSE EVENTS, DISEASE PROGRESSION, TUMOR
The primary objective of the study was to evaluate safety and determine the recommended Phase II dose (RP2D) of ipatasertib plus carboplatin and paclitaxel (Arm A), carboplatin (Arm B), or capecitabine and atezolizumab (Arm C). Secondary endpoints were RR, PFS, and OS. Responses were assessed by RECIST 1.1, and safety analysis was carried out based on toxicities assessed by CTCAE 5.0. Immune-related adverse events (irAEs) were also collected for Arm C.Patients underwent tumor assessments with CT scan of chest, abdomen, pelvis, and bone scan of at baseline, every 3 cycles (12 weeks) following treatment initiation regardless of dose delays, until radiographic disease progression per RECIST v1.1 or intolerance. All measurable and evaluable lesions were re-assessed at each subsequent tumor evaluation. An objective response was confirmed by repeat assessments ≥4 weeks after initial response.