Tests AZD5335 against standard treatments in platinum-resistant ovarian cancer
Tests AZD5335 against standard drugs in adults with ovarian cancer that stopped responding to platinum.
Plain-language title generated from the registry record
Registry title: AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer
Key facts
- Where
- Afula, Beersheba, Hadera, Haifa, Holon, Jerusalem, Kfar Saba, Nahariya, Ramat Gan, Sofia, and Tel Aviv, IsraelSee the 11 sites
- Phase
- Phase 3
Where in Israel
- AfulaAfula, IsraelNot yet recruiting
- BeershebaBeersheba, IsraelTaking people
- HaderaHadera, IsraelTaking people
- HaifaHaifa, IsraelTaking people
- HolonHolon, IsraelTaking people
- JerusalemJerusalem, IsraelTaking people
- Kfar SabaKfar Saba, IsraelTaking people
- NahariyaNahariya, IsraelTaking people
- Ramat GanRamat Gan, IsraelNot yet recruiting
- SofiaSofia, IsraelNo longer taking part
- Tel AvivTel Aviv, IsraelTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT07218809EU 2025-520466-22-00
- Record updated
- 21 July 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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.
Exclusion: 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; 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; Participants with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumours containing any of the above histologies, or low-grade or borderline ovarian tumour.