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AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer
NCT07218809 · AstraZeneca
In plain English
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Official title
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)
About this study
Approximately 1100 adult participants will be enrolled after central FRα testing into two independent cohorts (about 550 FRα-high and 550 FRα-low) and randomized 1:1 within each cohort to receive AZD5335 or the relevant standard of care (mirvetuximab soravtansine in FRα-high; investigator's choice single-agent chemotherapy in FRα-low). Participants will remain on assigned treatment and undergo regular tumor evaluations per RECIST v1.1 until disease progression or another reason for treatment discontinuation.
All participants will be followed for overall survival. An independent data monitoring committee (IDMC) of external experts will periodically review unblinded safety and interim efficacy to confirm participant safety and study integrity.
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
Study design
Enrollment target: 1100 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2025-12-29
Estimated completion: 2030-05-27
Last updated: 2026-01-16
Interventions
Drug: AZD5335Drug: Mirvetuximab Soravtansine (MIRV)Drug: PaclitaxelDrug: Pegylated liposomal Doxorubicin (PLD)Drug: Topotecan
Primary outcomes
- • Progression free Survival (PFS) (Up to approximately 5 years)
Sponsor
AstraZeneca · industry
With: European Network of Gynecological Oncological Trial Groups (ENGOT), GOG Foundation, Inc. (GOG Foundation), Ventana Medical Systems, Inc
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
All locations (125)
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Fort Lauderdale, Florida, United States
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Jupiter, Florida, United States
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Evanston, Illinois, United States
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Peoria, Illinois, United States
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Urbana, Illinois, United States
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Towson, Maryland, United States
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Burlington, Massachusetts, United States
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Worcester, Massachusetts, United States
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Minneapolis, Minnesota, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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The Bronx, New York, United States
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Dayton, Ohio, United States
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Sylvania, Ohio, United States
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San Antonio, Texas, United States
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Tyler, Texas, United States
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Fairfax, Virginia, United States
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Adelaide, Australia
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Auchenflower, Australia
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Box Hill, Australia
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Campbelltown, Australia
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Clayton, Australia
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Melbourne, Australia
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St Leonards, Australia
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Waratah NSW, Australia
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Charleroi, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Porto Alegre, Brazil
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São José do Rio Preto, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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Edmonton, Alberta, Canada
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Hamilton, Ontario, Canada
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Kingston, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Port Montt, Chile
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Santiago, Chile
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Santiago, Chile
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Santiago, Chile
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Santiago, Chile
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Santiago, Chile
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Viña del Mar, Chile
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Beijing, China
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Bengbu, China
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Changchun, China
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Changsha, China
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Changsha, China
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Chongqing, China
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Guangzhou, China
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Guangzhou, China
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Hangzhou, China
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Hangzhou, China
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Hangzhou, China
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Jinan, China
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Jinan, China
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Nanchang, China
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Nanjing, China
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Nanjing, China
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Nanning, China
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Shenyang, China
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Shenyang, China
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Shijiazhuang, China
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Tianjin, China
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Wuhan, China
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Wuhan, China
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Xi'an, China
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Zhengzhou, China
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Nový Jičín, Czechia
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Olomouc, Czechia
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Prague, Czechia
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Prague, Czechia
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Aarhus, Denmark
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Amiens, France
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Avignon, France
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Paris, France
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Pau, France
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Saint-Herblain, France
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Saint-Priest-en-Jarez, France
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Tours, France
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Bonn, Germany
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Dresden, Germany
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Schwäbisch Hall, Germany
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Tübingen, Germany
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Wiesbaden, Germany
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Athens, Greece
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Athens, Greece
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Pátrai, Greece
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Bhubaneswar, India
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Delhi, India
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Dhanvantari Nagar, India
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Kolkata, India
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Nagpur, India
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Nashik, India
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Surat, India
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Cork, Ireland
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Dublin, Ireland
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Hadera, Israel
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Haifa, Israel
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Jerusalem, Israel
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Jerusalem, Israel
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Kfar Saba, Israel
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Ramat Gan, Israel
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Tel Aviv, Israel
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Brescia, Italy
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Catania, Italy
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Florence, Italy
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Lecco, Italy
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Milan, Italy
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Milan, Italy
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Milan, Italy
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Milan, Italy
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Parma, Italy
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Pisa, Italy
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Roma, Italy
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Roma, Italy
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Torino, Italy
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Sendai, Japan
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Sunto-gun, Japan
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Tsu, Japan
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A Coruña, Spain
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Uppsala, Sweden
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Tainan, Taiwan
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London, United Kingdom