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.
Participants with confirmed diagnosis of high-grade serous EOC, primary peritoneal cancer, or fallopian tube cancer.
Participants who have only had one prior line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a response (CR or PR) and then progressed between > 3 months and ≤ 6 months after the date of the last dose of platinum.
Participants who have received 2 or 3 lines of platinum therapy must have progressed ≤ 6 months after the date of the last dose of platinum.
Participants must have radiologically progressed on or after their most recent line of therapy.
Participants with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumours containing any of the above histologies, or low-grade or borderline ovarian tumour.
Primary platinum-refractory disease, defined as disease that did not respond to or has progressed ≤ 3 months after the last dose of first line platinum-containing chemotherapy.
Participants with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring
Current signs, symptoms, or clinical investigations consistent with bowel obstruction, including sub-occlusive disease.
Parallel
AZD5335
Drugantibody drug conjugate
Mirvetuximab Soravtansine (MIRV)
Drugantibody drug conjugate
Paclitaxel
Drugchemotherapy
Pegylated liposomal Doxorubicin (PLD)
Drugchemotherapy
Topotecan
Drugchemotherapy
Progression free Survival (PFS)
PFS is defined as the time from randomization to radiographic progression as assessed by the Investigator per RECIST v1.1, or death due to any cause.
Overall survival (OS)
OS is defined as the time from randomisation until the date of death due to any cause.
Second progression free survival (PFS2)
Time from randomization to second progression or death (PFS2) is defined as the time from randomization to the earliest progression event (following the initial progression) subsequent to the first subsequent therapy, or death.
Objective response date (ORR)
ORR is defined as the proportion of participants who have a complete or partial response, as determined by the investigator, per RECIST v1.1.
Duration of response (DoR)
DoR is defined as the time from the date of first documented response until the date of documented progression per RECIST v1.1, as assessed by the investigator, or death due to any cause.
Health-related Quality of Life (HrQoL)
Change from baseline in selected subscales of EORTC QLQ C30; global health status, physical function and EORTC QLQ OV28 hormonal symptoms (EORTC IL).
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AstraZeneca
Lead sponsor
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Collaborator
GOG Foundation
Collaborator
Ventana Medical Systems, Inc
Collaborator
