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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)
Who can join
Ages 18 and older · Women
Full eligibility criteria
Key Inclusion criteria * Participants with confirmed diagnosis of high-grade serous EOC, primary peritoneal cancer, or fallopian tube cancer. * Participants must have platinum-resistant disease: * 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 must have received at least one, but no more than 3, prior systemic lines of anti-cancer therapy, and for whom single-agent therapy is appropriate as the next line of treatment * Participants with documented BRCA mutation (germline and/or somatic) must have received prior PARPi if the participant is eligible per approved label and standard-of-care institutional guidelines, except in cases of documented contraindication, precaution or intolerance. * Provision of an FFPE tumour tissue sample Key Exclusion criteria * 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. * Participant has non-infectious ILD/pneumonitis or has a history of non-infectious ILD/pneumonitis that required oral or IV steroids or supplemental oxygen, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. * Prior treatment with any FRα-targeted therapy, including MIRV, or any TOP1i ADC. * Major surgical procedure within 4 weeks of the first dose of study intervention
About the study
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.
What is being tested
- AZD5335 (drug)
- Mirvetuximab Soravtansine (MIRV) (drug)
- Paclitaxel (drug)
- Pegylated liposomal Doxorubicin (PLD) (drug)
- Topotecan (drug)
Sponsor: AstraZeneca · Participants: 1,100 · Started: Dec 29, 2025
Contact the study team
- AstraZeneca Clinical Study Information Center · Phone: 1-877-240-9479
Official record on ClinicalTrials.gov — NCT07218809
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.