The intention of the study is to demonstrate superiority of AZD5335 versus standard of
care by assessment of progression-free survival (PFS) in women with high-grade,
platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer,
expressing high or low FRα levels.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07218809.
Approximately 1100 adult participants will be enrolled after central FRα testing into two
independent cohorts (about 550 FRα-high and 550 FRα-low) and randomized 1:1 within each
cohort to receive AZD5335 or the relevant standard of care (mirvetuximab soravtansine in
FRα-high; investigator's choice single-agent chemotherapy in FRα-low). Participants will
remain on assigned treatment and undergo regular tumor evaluations per RECIST v1.1 until
disease progression or another reason for treatment discontinuation.
All participants will be followed for overall survival. An independent data monitoring
committee (IDMC) of external experts will periodically review unblinded safety and
interim efficacy to confirm participant safety and study integrity.
Lead OrganizationAstraZeneca Pharmaceuticals LP