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AZD5335 versus mirvetuximab or chemotherapy for FRα-high and FRα-low platinum-resistant ovarian, fallopian tube, or peritoneal 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)

Phase 3 Interventional AstraZeneca · NCT07218809

This will test whether AZD5335 works better than mirvetuximab for FRα-high tumors or better than single-agent chemotherapy for FRα-low tumors in women with high-grade, platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1100 (estimated)
Ages18 Years and up
SexFemale
SponsorAstraZeneca Industry-sponsored
Drugs / interventionschemotherapy, mirvetuximab
Locations125 sites (Fort Lauderdale, Florida and 124 other locations)
Trial IDNCT07218809 on ClinicalTrials.gov

What this trial studies

About 1,100 adults with high-grade, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer will be centrally tested for folate receptor alpha (FRα) and placed into two cohorts (approximately 550 FRα-high and 550 FRα-low). Within each cohort participants are randomized 1:1 to receive AZD5335 or the relevant standard of care (mirvetuximab soravtansine in the FRα-high cohort; investigator-choice single-agent chemotherapy in the FRα-low cohort). Participants remain on assigned treatment with tumor assessments per RECIST v1.1 until progression or discontinuation, and all are followed for overall survival. An independent data monitoring committee will periodically review unblinded safety and interim efficacy data to protect participants and study integrity.

Who should consider this trial

Good fit: Adult women with confirmed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer that is platinum-resistant, who have had 1–3 prior systemic lines of therapy and are appropriate for single-agent treatment and willing to undergo central FRα testing are ideal candidates.

Not a fit: Patients who are platinum-sensitive, have had more than three prior systemic therapies, have inadequate organ function or performance status, or are not appropriate for single-agent therapy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, AZD5335 could lengthen the time cancer is controlled and potentially improve overall survival, offering a new treatment option for women with platinum-resistant disease.

How similar studies have performed: Targeting FRα has shown clinical benefit with mirvetuximab in FRα-high platinum-resistant ovarian cancer, but AZD5335 is a novel agent being tested head-to-head and its benefit in FRα-low disease remains less explored.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Fort Lauderdale, Florida and 124 other locations

+75 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Epithelial Ovarian CancerPeritoneal CancerFollopian Tube CancerPlatinum Resistant Ovarian Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.