NCT07218809

AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,100 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epithelial Ovarian Cancer

Interventions

Type	Name	Description
DRUG	AZD5335	antibody drug conjugate
DRUG	Mirvetuximab Soravtansine (MIRV)	antibody drug conjugate
DRUG	Paclitaxel	chemotherapy
DRUG	Pegylated liposomal Doxorubicin (PLD)	chemotherapy
DRUG	Topotecan	chemotherapy

Timeline

• Start date: 2025-12-29
• Primary completion: 2028-11-17
• Completion: 2030-05-27
• First posted: 2025-10-20
• Last updated: 2026-01-16

Locations

125 sites across 21 countries: United States, Australia, Belgium, Brazil, Canada, Chile, China, Czechia, Denmark, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Spain, Sweden, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study