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

Epithelial Ovarian Cancer

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

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatments for women with platinum-resistant ovarian cancer (cancer that stopped responding to platinum-based chemotherapy). Depending on whether a protein called folate receptor alpha (FRα) is highly expressed in the tumor, participants will be randomized to either AZD5335 (a new experimental drug) versus mirvetuximab soravtansine, or AZD5335 versus standard chemotherapy. **You may be eligible if...** - You have confirmed high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer - Your cancer is platinum-resistant (came back or grew within 6 months of the last platinum chemotherapy) - You have received between 1 and 3 prior lines of anti-cancer treatment - If you have a BRCA mutation, you have already received a PARP inhibitor (unless you could not tolerate it) - A tumor tissue sample is available for testing **You may NOT be eligible if...** - Your cancer has not been confirmed as platinum-resistant - You have received more than 3 prior lines of treatment - You have not yet had platinum-based chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAZD5335

antibody drug conjugate

DRUGMirvetuximab Soravtansine (MIRV)

antibody drug conjugate

DRUGPaclitaxel

chemotherapy

DRUGPegylated liposomal Doxorubicin (PLD)

chemotherapy

DRUGTopotecan

chemotherapy

Locations(125)

Research Site

Fort Lauderdale, Florida, United States

Research Site

Jupiter, Florida, United States

Research Site

Evanston, Illinois, United States

Research Site

Peoria, Illinois, United States

Research Site

Urbana, Illinois, United States

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Towson, Maryland, United States

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Burlington, Massachusetts, United States

Research Site

Worcester, Massachusetts, United States

Research Site

Minneapolis, Minnesota, United States

Research Site

Omaha, Nebraska, United States

Research Site

Las Vegas, Nevada, United States

Research Site

The Bronx, New York, United States

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Dayton, Ohio, United States

Research Site

Sylvania, Ohio, United States

Research Site

San Antonio, Texas, United States

Research Site

Tyler, Texas, United States

Research Site

Fairfax, Virginia, United States

Research Site

Adelaide, Australia

Research Site

Auchenflower, Australia

Research Site

Box Hill, Australia

Research Site

Campbelltown, Australia

Research Site

Clayton, Australia

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Melbourne, Australia

Research Site

St Leonards, Australia

Research Site

Waratah NSW, Australia

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Charleroi, Belgium

Research Site

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

Research Site

São Paulo, Brazil

Research Site

Edmonton, Alberta, Canada

Research Site

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

Research Site

Santiago, Chile

Research Site

Viña del Mar, Chile

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Beijing, China

Research Site

Bengbu, China

Research Site

Changchun, China

Research Site

Changsha, China

Research Site

Changsha, China

Research Site

Chongqing, China

Research Site

Guangzhou, China

Research Site

Guangzhou, China

Research Site

Hangzhou, China

Research Site

Hangzhou, China

Research Site

Hangzhou, China

Research Site

Jinan, China

Research Site

Jinan, China

Research Site

Nanchang, China

Research Site

Nanjing, China

Research Site

Nanjing, China

Research Site

Nanning, China

Research Site

Shenyang, China

Research Site

Shenyang, China

Research Site

Shijiazhuang, China

Research Site

Tianjin, China

Research Site

Wuhan, China

Research Site

Wuhan, China

Research Site

Xi'an, China

Research Site

Zhengzhou, China

Research Site

Nový Jičín, Czechia

Research Site

Olomouc, Czechia

Research Site

Prague, Czechia

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Prague, Czechia

Research Site

Aarhus, Denmark

Research Site

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

Research Site

Saint-Priest-en-Jarez, France

Research Site

Tours, France

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Bonn, Germany

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Dresden, Germany

Research Site

Schwäbisch Hall, Germany

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Tübingen, Germany

Research Site

Wiesbaden, Germany

Research Site

Athens, Greece

Research Site

Athens, Greece

Research Site

Pátrai, Greece

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Bhubaneswar, India

Research Site

Delhi, India

Research Site

Dhanvantari Nagar, India

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Kolkata, India

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Nagpur, India

Research Site

Nashik, India

Research Site

Surat, India

Research Site

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

Research Site

Jerusalem, Israel

Research Site

Kfar Saba, Israel

Research Site

Ramat Gan, Israel

Research Site

Tel Aviv, Israel

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Brescia, Italy

Research Site

Catania, Italy

Research Site

Florence, Italy

Research Site

Lecco, Italy

Research Site

Milan, Italy

Research Site

Milan, Italy

Research Site

Milan, Italy

Research Site

Milan, Italy

Research Site

Parma, Italy

Research Site

Pisa, Italy

Research Site

Roma, Italy

Research Site

Roma, Italy

Research Site

Torino, Italy

Research Site

Sendai, Japan

Research Site

Sunto-gun, Japan

Research Site

Tsu, Japan

Research Site

A Coruña, Spain

Research Site

Uppsala, Sweden

Research Site

Tainan, Taiwan

Research Site

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07218809

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