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AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer
Sponsor: AstraZeneca
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.
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)
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1100
Start Date
2025-12-29
Completion Date
2030-05-27
Last Updated
2026-01-16
Healthy Volunteers
No
Conditions
Interventions
AZD5335
antibody drug conjugate
Mirvetuximab Soravtansine (MIRV)
antibody drug conjugate
Paclitaxel
chemotherapy
Pegylated liposomal Doxorubicin (PLD)
chemotherapy
Topotecan
chemotherapy
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