A Randomised, Open-label, Phase III Study of AZD5335 Versus Mirvetuximab Soravtansine in FRα-high and AZD5335 Versus Investigator's Choice Chemotherapy in FRα-low Expressing High-grade Platinum-resistant Epithelial Ovarian Cancer Patients (TREVI-OC-01)
Summary
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.
Detailed description
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.
Arms & interventions
- DrugAZD5335
antibody drug conjugate
- DrugMirvetuximab Soravtansine (MIRV)
antibody drug conjugate
- DrugPaclitaxel
chemotherapy
- DrugPegylated liposomal Doxorubicin (PLD)
chemotherapy
- DrugTopotecan
chemotherapy
Outcome measures
Primary
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.
Time frame: Up to approximately 5 years
Secondary
Overall survival (OS)
Time frame: Up to approximately 5 years
Eligibility criteria
Study locations (17)
Research Site
Fort Lauderdale, Florida, 33316
Research Site
Jupiter, Florida, 33458
Research Site
Evanston, Illinois, 60201
Research Site
Peoria, Illinois, 61637
Research Site
Urbana, Illinois, 61801
Research Site
Towson, Maryland, 21204
Research Site
Burlington, Massachusetts, 01805
Research Site
Worcester, Massachusetts, 01655
Research Site
Minneapolis, Minnesota, 55404
Research Site
Omaha, Nebraska, 68114
Research Site
Las Vegas, Nevada, 89106
Research Site
The Bronx, New York, 10461
Research Site
Dayton, Ohio, 45459
Research Site
Sylvania, Ohio, 43560
Research Site
San Antonio, Texas, 78229
Research Site
Tyler, Texas, 75702
Research Site
Fairfax, Virginia, 22031