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

RecruitingPhase 3

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

Sponsor: AstraZeneca · Participants: 1,100 · Started: Dec 29, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07218809

Locations in the U.S.

AlabamaResearch Site, Birmingham
ArkansasResearch Site, Little Rock (Not yet recruiting)
CaliforniaResearch Site, La Jolla (Not yet recruiting)
District of ColumbiaResearch Site, Washington D.C.
FloridaResearch Site, Fort Lauderdale (Not yet recruiting)
Research Site, Gainesville
Research Site, Jupiter
Research Site, Miami
Research Site, Weston (Not yet recruiting)
IllinoisResearch Site, Chicago (Not yet recruiting)
Research Site, Evanston (Not yet recruiting)
Research Site, Peoria
Research Site, Urbana
IndianaResearch Site, Fort Wayne
Research Site, Indianapolis
KentuckyResearch Site, Louisville
MarylandResearch Site, Towson
MassachusettsResearch Site, Burlington
Research Site, Worcester (Not yet recruiting)
MinnesotaResearch Site, Minneapolis
MissouriResearch Site, Springfield
MontanaResearch Site, Billings
NebraskaResearch Site, Omaha
NevadaResearch Site, Las Vegas
New HampshireResearch Site, Lebanon (Not yet recruiting)
New JerseyResearch Site, Camden (Not yet recruiting)
New YorkResearch Site, The Bronx (Not yet recruiting)
North CarolinaResearch Site, Chapel Hill
OhioResearch Site, Blue Ash
Research Site, Dayton
Research Site, Sylvania (Not yet recruiting)
OregonResearch Site, Portland
PennsylvaniaResearch Site, York (Not yet recruiting)
TennesseeResearch Site, Germantown
TexasResearch Site, San Antonio
Research Site, Tyler
VirginiaResearch Site, Fairfax
Research Site, Roanoke
WashingtonResearch Site, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.