AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer
- Conditions
- Epithelial Ovarian Cancer
- Interventions
- Drug: Mirvetuximab Soravtansine (MIRV)
- Registration Number
- NCT07218809
- Lead Sponsor
- AstraZeneca
- Brief 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 1100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AZD5335 in FRa-high cohort AZD5335 AZD5335 IV (intravenous) in FRa-high cohort Mirvetuximab Soravtansine (MIRV) in FRa-high cohort Mirvetuximab Soravtansine (MIRV) MIRV AIBW IV in FRa-high cohort AZD5335 in FRa-low cohort AZD5335 AZD5335 IV (intravenous) in FRa-low cohort Investigator´s choice chemotherapy in FRa-low cohort Paclitaxel Investigator's choice of chemotherapy Paclitaxel IV Pegylated liposomal Doxorubicin (PLD) IV or Topotecan IV in FRa-low cohor Investigator´s choice chemotherapy in FRa-low cohort Pegylated liposomal Doxorubicin (PLD) Investigator's choice of chemotherapy Paclitaxel IV Pegylated liposomal Doxorubicin (PLD) IV or Topotecan IV in FRa-low cohor Investigator´s choice chemotherapy in FRa-low cohort Topotecan Investigator's choice of chemotherapy Paclitaxel IV Pegylated liposomal Doxorubicin (PLD) IV or Topotecan IV in FRa-low cohor
- Primary Outcome Measures
Name Time Method Progression free Survival (PFS) Up to approximately 5 years 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.
- Secondary Outcome Measures
Name Time Method Overall survival (OS) Up to approximately 5 years OS is defined as the time from randomisation until the date of death due to any cause.