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
- Edmonton, Hamilton, Kingston, Montreal, and Québec, CanadaSee the 5 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with high-grade, platinum-resistant ovarian, fallopian tube or primary peritoneal cancer. It compares AZD5335 with standard treatment.
- Age
- 18 years or older
- Sex
- Women only
- Disease stage
- High-grade serous ovarian, fallopian tube or primary peritoneal cancer that is platinum-resistant and has grown on or after the most recent treatment.
- Earlier treatment
- Must have had 1 to 3 earlier lines of anti-cancer drug treatment, including platinum treatment. People with a BRCA mutation must have had a PARP inhibitor unless there was a medical reason not to. No earlier FRα-targeted treatment, including MIRV, and no earlier TOP1i ADC.
- Biomarker or test result
- A tumour tissue sample must be provided. The trial groups people by high or low FRα level in the tumour.
Main reasons for not taking part
- Endometrioid, clear cell, mucinous or sarcomatous cancer, mixed tumours with these types, or low-grade or borderline tumour
- Cancer that never responded to first platinum treatment or grew within 3 months of its last dose
- Active or long-term eye (corneal) disorders, or a past corneal transplant
- Signs of bowel obstruction
- Non-infectious lung inflammation (ILD/pneumonitis) now or in the past that needed steroids or oxygen
Read by machine on 9 November 2026.
Where in Canada
- Edmonton, AlbertaHospital not named in the registryNot yet recruiting
- Hamilton, OntarioHospital not named in the registryNot yet recruiting
- Kingston, OntarioHospital not named in the registryNot yet recruiting
- Montreal, QuebecHospital not named in the registryNot yet recruiting
- Québec, QuebecHospital not named in the registryNot yet recruiting
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.