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RECRUITING

NCT07218809

PHASE3

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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

2029-12-27

Last Updated

2026-07-21

Healthy Volunteers

Conditions

Epithelial Ovarian Cancer

Interventions

DRUG

AZD5335

antibody drug conjugate

DRUG

Mirvetuximab Soravtansine (MIRV)

antibody drug conjugate

DRUG

Paclitaxel

chemotherapy

DRUG

Pegylated liposomal Doxorubicin (PLD)

chemotherapy

DRUG

Topotecan

chemotherapy

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

Locations (299)

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Birmingham, Alabama, United States

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Little Rock, Arkansas, United States

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La Jolla, California, United States

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Washington D.C., District of Columbia, United States

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Fort Lauderdale, Florida, United States

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Gainesville, Florida, United States

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Jupiter, Florida, United States

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Miami, Florida, United States

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Weston, Florida, United States

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Chicago, Illinois, 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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Fort Wayne, Indiana, United States

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Indianapolis, Indiana, United States

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Louisville, Kentucky, 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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Springfield, Missouri, United States

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Billings, Montana, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Lebanon, New Hampshire, United States

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Camden, New Jersey, United States

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The Bronx, New York, United States

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Chapel Hill, North Carolina, United States

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Blue Ash, Ohio, United States

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Dayton, Ohio, United States

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Sylvania, Ohio, United States

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Portland, Oregon, United States

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York, Pennsylvania, United States

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Germantown, Tennessee, United States

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San Antonio, Texas, United States

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Tyler, Texas, United States

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Salt Lake City, Utah, United States

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Fairfax, Virginia, United States

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Roanoke, Virginia, United States

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Seattle, Washington, United States

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Adelaide, Australia

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Auchenflower, Australia

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Campbelltown, Australia

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Camperdown, Australia

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Clayton, Australia

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Cudgen, Australia

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Garran, Australia

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Gosford, Australia

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Heidelberg, Australia

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Kogarah, Australia

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Melbourne, Australia

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Richmond, Australia

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St Leonards, Australia

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Waratah, Australia

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Charleroi, Belgium

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Edegem, Belgium

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Ghent, Belgium

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Leuven, Belgium

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Libramont-Chevigny, Belgium

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Namur, Belgium

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Barretos, Brazil

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Bela Vista, Brazil

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Curitiba, Brazil

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Goiânia, Brazil

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Natal, Brazil

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Porto Alegre, Brazil

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Porto Alegre, Brazil

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Porto Alegre, Brazil

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Porto Alegre, Brazil

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Porto Velho, Brazil

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Rio de Janeiro, 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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Montreal, Quebec, Canada

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Québec, Canada

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Port Montt, Chile

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Providencia, 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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Santiago, Chile

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Viña del Mar, Chile

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Beijing, China

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Beijing, China

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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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Chengdu, China

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Chongqing, China

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Fuzhou, China

And 199 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (299)