Endpoints
abdominal pain, Cancer
SECONDARY, CANCER
The primary endpoint was PFS per RECIST version 1.1 as determined by an IRC. Key secondary endpoints were OS and time to confirmed deterioration in scores for European Organization for Research and Treatment of Cancer global health status and quality of life, physical functioning and abdominal pain and discomfort assessments, which were determined as clinically meaningful to patients; time to confirmed deterioration data are pending the clinically meaningful threshold obtained from the ongoing exit survey study per protocol and will be reported in a future publication. Additional secondary endpoints were ORR and DOR per RECIST version 1.1 as determined by an IRC, safety and tolerability of zolbetuximab, additional patient-reported outcomes and pharmacokinetics and immunogenicity of zolbetuximab; patient-reported outcomes will also be reported in a future publication.PFS, OS, ORR and DOR were assessed in the ITT population, which consisted of all randomized patients. Safety was assessed in all patients who received at least one dose of any study drug.