Skip to main content
. 2023 Dec 7;30(4):767–778. doi: 10.1158/1078-0432.CCR-23-2084

Table 1.

Summary of trial designs.

CO40151 IPATunity130, Cohort C IPATunity170
Design Phase Ib Open-label single-arm cohort within phase III Two-cohort placebo-controlled randomized phase III
Geographic locations Australia, France, Spain, UK, USA Europe, North and South America, Asia Europe, Asia, Australia, North and South America
Taxane backbone Paclitaxel or nab-paclitaxel Paclitaxel Paclitaxel
Comparator arms None None PD-L1–positive cohort: atezolizumab + paclitaxel
PD-L1–negative/unknown cohort: paclitaxel alone or paclitaxel + ipatasertib
PIK3CA/AKT1/PTEN mutation status Unselected Not altered Unselected
Known BRCA1/2 mutation eligible Yes Yes No (unless ineligible for PARP inhibitor)
Primary endpoint Confirmed ORR and DoR PFS PFS and OS
Secondary efficacy endpoints PFS, confirmed CBR, OS Confirmed ORR (RECIST version 1.1), DoR, CBR, OS, 1-year PFS rate, 1-year OS rate All nonprimary predefined endpoints were exploratory

Abbreviations: CBR, clinical benefit rate (stable disease for ≥24 weeks or confirmed complete/partial response); DoR, duration of response (interval between confirmed complete/partial response and disease progression or death).