RecruitingPhase 3NCT07218809
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)
Sponsor
AstraZeneca
Enrollment
1,100 participants
Start Date
Dec 29, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria8
- 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 Criteria7
- 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
Interventions
DRUGAZD5335
antibody drug conjugate
DRUGMirvetuximab Soravtansine (MIRV)
antibody drug conjugate
DRUGPaclitaxel
chemotherapy
DRUGPegylated liposomal Doxorubicin (PLD)
chemotherapy
DRUGTopotecan
chemotherapy
Locations(125)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07218809
Related Trials
Prehabilitation for EOC, Fallopian Tube, Primary Peritoneal Carcinoma and Pancreatic Cancer w/ NACT
NCT064125101 location
Dual-Targeting CAR-NK Cells for Recurrent Ovarian Cancer (MSLN, FRα, MUC16)
NCT074809541 location
Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Patients w/ Advanced EOC, Fallopian Tube or Primary Peritoneal Cancer
NCT069150257 locations
A Study to Assess Anti-Tumor Activity of Intravenously (IV) Infused Carboplatin With Mirvetuximab Soravtansine in Participants With Newly Diagnosed Folate Receptor Alpha (FRα)Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer.
NCT0689033850 locations
[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
NCT074326331 location